On February 27, 2020 Immunomedics, Inc. (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates, reported financial results for the fourth quarter and full year 2019 (Press release, Immunomedics, FEB 27, 2020, View Source [SID1234554902]). Please refer to the Company’s Annual Report on Form 10-K for more details on the Company’s financial results.
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"We are pleased to have submitted our Biologics License Application (BLA) in late November – our top priority for 2019," said Dr. Behzad Aghazadeh, executive chairman of Immunomedics. "While we are working closely with the FDA to facilitate their review of our BLA, we continued to execute against key initiatives across our commercial, clinical, and manufacturing operations. Our commercial team has been actively preparing for launch readiness, and, as we wait for an FDA decision, we are well positioned to commercialize sacituzumab govitecan in metastatic triple-negative breast cancer (mTNBC) on or before the June 2, 2020 PDUFA goal date. In addition, our main goals for 2020 include maximizing the global commercial potential of sacituzumab govitecan, while accelerating its development as a single agent and in combination with checkpoint inhibitors across a number of clinical settings to meet our commitment to help transform the lives of people with hard-to-treat cancers worldwide."
2019 Highlights
Resubmitted BLA seeking accelerated approval for sacituzumab govitecan in mTNBC, which was accepted for filing by the FDA with a PDUFA target action date of June 2, 2020.
Completed enrollment of the Phase 3 confirmatory ASCENT study of sacituzumab govitecan in mTNBC.
Initiated the Phase 3 registrational TROPiCS-02 study of sacituzumab govitecan in hormone receptor-positive/human epidermal growth factor receptor 2-negative (HER2‒) metastatic breast cancer.
Continued to expand clinical collaborations to move sacituzumab govitecan into earlier lines of therapy in breast cancer, including the combination with Roche’s Tecentriq in frontline mTNBC and the German Breast Group’s Phase 3 study in the curative setting of HER2‒ breast cancer as a single-agent.
Corroborated the positive Phase 2 results of sacituzumab govitecan in metastatic urothelial cancer with an interim 29% overall response rate presented at ESMO (Free ESMO Whitepaper) 2019 Congress on 35 patients, while completing enrollment of the full cohort of 100 patients previously treated with platinum-based chemotherapies and immune checkpoint inhibitor.
Initiated the multi-cohort, Trop-2-enriched Phase 2 TROPiCS-03 study of sacituzumab govitecan for patients with metastatic non-small cell lung cancer (mNSCLC).
Closed the largest single-asset biologics license deal for Greater China to date, with $65 million upfront, $60 million to be received upon FDA approval, up to $710 million in additional development and sales milestone payments, and escalating royalties that begin in the mid-teens.
These accomplishments have positioned Immunomedics to have a transformative 2020. We entered the year with a robust balance sheet that will enable us to meet our goals.
The Company continued to bolster the leadership team, both at the board and the executive management level, with the nomination of Robert Azelby to the board, and the permanent appointment of Dr. Loretta Itri to the chief medical officer position.
The company has recently also broadened the development program for sacituzumab govitecan by expanding the TROPHY U-01 study to include a third cohort of checkpoint inhibitor-naïve patients to assess the combination with pembrolizumab. Furthermore, a new Phase 2 study in persistent or recurrent endometrial cancer was launched by Dr. Alessandro Santin, Professor of Obstetrics, Gynecology, and Reproductive Sciences at Yale University. Finally, to help alleviate the unmet need of mTNBC patients between now and potential approval of sacituzumab govitecan, the Company instituted its first Expanded Access Program in January 2020. Details of this program can be obtained from View Source
Anticipated Key 2020 Milestones
Besides the FDA action date in the second quarter and a potential commercial launch, we anticipate the following key milestones in 2020:
Topline data from Phase 3 confirmatory ASCENT study around mid-year
Topline data from full cohort of 100 patients with prior platinum-based and immune checkpoint inhibitor therapies from Phase 2 pivotal TROPHY U-01 study
Enrollment completion for the Phase 3 registrational TROPiCS-02 study
Enrollment completion for the 40-patient cohort of cisplatin-ineligible patients in TROPHY U-01
Evaluate preliminary results from signal-seeking Phase 2 TROPiCS-03 study in mNSCLC
Continue to expand combination development opportunities between sacituzumab govitecan and checkpoint inhibitors across indications, internally and through partnerships
Fourth Quarter and Full Year 2019 Financial Results
Total revenues were $0.3 million for both the quarter and the year ended December 31, 2019 due to service fee revenues earned related to the Janssen Promotion Agreement. The Company had no revenues in 2018 for the comparable quarter ended, and $0.9 million for the year ended December 31, 2018.
Total costs and expenses were $91.5 million for the quarter and $325.1 million for the year ended December 31, 2019, compared to $87.4 million for the comparable quarter and $235.4 million for the year ended December 31, 2018. The increases were primarily due to an increase in research and development expenses, mostly attributable to activities related to preparations for the approval and commercial launch of sacituzumab govitecan for patients with at least two prior lines of treatment for mTNBC in the United States, and CRL remediation costs, including outside manufacturers’ organizations services costs, and external consulting services to improve our manufacturing and regulatory functions.
The increases in research and development costs were partially offset by a decrease in general and administrative expenses, which was primarily due to decreased legal and advisory expenses resulted from reduced reliance on outside legal counsel, as well as a decrease in other and consulting services, partially offset by an increase in labor costs.
The Company had no non-cash warrant-related income or expense for the quarter and the year ended December 31, 2019, compared to a $0.2 million of non-cash gain for the comparable quarter and a $47.6 million warrant-related expense for the year ended December 31, 2018, due to changes in the fair value of then outstanding warrants. There were no warrants outstanding at December 31, 2019 and 2018.
Interest expense was $10.0 million for the quarter and $40.3 million for the year ended December 31, 2019, compared to $9.9 million for the comparable quarter and $40.4 million for the year ended December 31, 2018. The differences were due primarily to changes in the fair value of our debt balances as a result of the agreement with RPI Finance Trust.
Net loss attributable to stockholders was $99.6 million, or $0.50 per share, for the quarter ended December 31, 2019, compared to $93.5 million, or $0.50 per share, for the comparable quarter ended December 31, 2018. Net loss attributable to stockholders was $357.2 million, or $1.84 per share, for the year ended December 31, 2019, compared to $310.2 million, or $1.74 per share, for the year ended December 31, 2018.
As of December 31, 2019, the Company had $613.2 million in cash, cash equivalents, and marketable securities. The Company believes this amount is adequate to accelerate commercial launch readiness, pending FDA approval, of sacituzumab govitecan in the United States in mTNBC; continue to expand the clinical development programs for sacituzumab govitecan; invest in the broader clinical development of the ADC platform (including IMMU-130 and IMMU-140); continued scale up of manufacturing and manufacturing process improvements; and general working capital requirements.
Conference Call
The Company will host a conference call and live audio webcast today at 5:00 p.m. Eastern Time to discuss fourth quarter and full year 2019 financial results and provide a corporate update. To access the conference call, please dial (877) 303-2523 or (253) 237-1755 using the Conference ID 4365097. The conference call will be webcast via the Investors page on the Company’s website at View Source Approximately two hours following the live event, a webcast replay of the conference call will be available on the Company’s website for approximately 30 days.