On July 28, 2022 Novocure (NASDAQ: NVCR) reported financial results for the quarter ended June 30, 2022 (Press release, NovoCure, JUL 28, 2022, View Source [SID1234617105]). Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer by developing and commercializing its innovative therapy, Tumor Treating Fields (TTFields) .
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"The second quarter was a period of solid progress, further solidifying the fundamentals of our business," said William Doyle, Novocure’s Executive Chairman. "We generated $141 million in net revenues in the quarter, released promising data from our gastric cancer pilot study, announced a new pivotal trial collaboration with Merck, and advanced our late-stage clinical studies. The future is bright for Novocure, and we are hopeful our progress will enable us to treat many more cancer patients in the near future."
"Novocure is entering a transformational period," said Asaf Danziger, Novocure’s Chief Executive Officer. "In the next 18 months, we expect to reach a number of clinical and product development milestones, including data releases from multiple pivotal trials and the limited release of our new flex arrays. We are eager to continue exploring the potential of our platform therapy, and I would like to thank my Novocure colleagues for their passion and determination in advancing the science and adoption of Tumor Treating Fields."
Financial updates for the second quarter ended June 30, 2022:
Total net revenues for the quarter were $140.9 million, an increase of 6% compared to the same period in 2021.
The United States, EMEA and Japan contributed $108.2 million, $18.5 million, and $8.3 million in quarterly net revenues, respectively.
German revenue was impacted by a reduction in German active patient numbers and approval rates as a result of updated coverage criteria.
Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $5.9 million.
Gross margin for the quarter was 80%.
Research, development and clinical studies expenses for the quarter were $57.1 million, an increase of 13% from the same period in 2021.
Sales and marketing expenses for the quarter were $44.7 million, an increase of 31% compared to the same period in 2021. This reflects increased investments in early commercial and market access capabilities.
General and administrative expenses for the quarter were $31.7 million, a decrease of 3% compared to the same period in 2021.
Net loss for the quarter was $24.0 million with loss per share of $0.23.
Adjusted EBITDA* for the quarter was $7.3 million.
Cash, cash equivalents and short-term investments were $948.5 million as of June 30, 2022.
Operational updates for the second quarter ended June 30, 2022:
As of June 30, 2022, there were 3,454 active patients on therapy. Active patients from North America, EMEA and Japan contributed 2,229, 879 and 346 active patients, respectively.
1,383 prescriptions were received in the quarter. Prescriptions from North America, EMEA and Japan contributed 954, 334 and 95 prescriptions, respectively.
Quarterly updates and achievements:
Today, we are announcing that top-line data from the LUNAR pivotal study will be distributed in early Q1 2023 versus the final week of 2022 to ensure optimal visibility and timing for all audiences. Our clinical operations and data collection efforts remain on track.
In May 2022, we entered into a clinical trial collaboration agreement with MSD, a tradename of Merck & Co., Inc., ("MSD") to conduct a double-blind, placebo-controlled study of TTFields concomitant with pembrolizumab and maintenance temozolomide for the treatment of newly diagnosed GBM. We intend to engage the FDA in pre-submission discussions in the near-term regarding the parameters of the KEYNOTE D58 trial protocol design.
In June 2022, we announced results of the phase 2 pilot EF-31 study evaluating the use of TTFields together with standard-of-care (chemotherapy alone or in combination with trastuzumab for HER2-positive patients) as first-line treatment for gastric cancer. Initial analysis was conducted with a median follow-up period of 8.6 months. The primary endpoint, confirmed objective response rate, was 50%. Median progression-free survival was 7.8 months. Duration of response was 10.3 months. Median overall survival had not yet been reached with a one-year survival rate of 72%. We look forward to further exploration of these potential benefits as we look ahead to a randomized phase 3 clinical study.
In June 2022, we announced the first patient has been enrolled in the phase 2 pilot KEYNOTE B36 study, conducted in collaboration with MSD. KEYNOTE B36 is designed to evaluate the safety and effectiveness of TTFields together with pembrolizumab for the treatment of locally advanced or metastatic intrathoracic NSCLC that expresses PD-L1.
Anticipated clinical milestones:
Data from phase 2 pilot EF-33 study with high-intensity arrays in recurrent GBM (2022)
Last patient enrollment in phase 3 pivotal METIS study in brain metastases (2022)
Data from phase 3 pivotal LUNAR study in NSCLC (early Q1 2023)
Last patient enrollment in phase 3 pivotal PANOVA-3 study in locally advanced pancreatic cancer (2023)
Data from phase 3 pivotal INNOVATE-3 study in recurrent ovarian cancer (2023)
Data from phase 3 pivotal METIS study in brain metastases (2023)
Data from phase 3 pivotal PANOVA-3 study in locally advanced pancreatic cancer (2024)
Conference call details
Novocure will host a conference call and webcast to discuss second quarter 2022 financial results at 8 a.m. EDT today, Thursday, July 28, 2022. Analysts and investors can participate in the conference call by using the following registration link, and dial-in details will be provided.
The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website, as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.