On January 10, 2022 Novocure (NASDAQ: NVCR) reported preliminary unaudited financial results and operational updates for the quarter and full year ended December 31, 2021 (Press release, NovoCure, JAN 10, 2022, View Source [SID1234598529]).* 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). TTFields are electric fields that disrupt cancer cell division.

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!

"Since our founding over 20 years ago, we have generated tremendous scientific data, technological knowledge and commercial experience supporting the clinical impact of Tumor Treating Fields," said William Doyle, Novocure’s Executive Chairman. "With over a half a billion dollars in global annual revenues and numerous late-stage trials nearing completion, Novocure is approaching a critical inflection point for our company and cancer patients."

Financial and operational updates:

Total preliminary net revenues for the year ended December 31, 2021, were $535.0 million, up 8% over the prior year.
Total preliminary net revenues for the fourth quarter 2021 were $133.2 million. In the fourth quarter, the company did not recognize material revenue from its Medicare backlog. This compares to $11 million received from successful appeal of previously denied Medicare claims in the fourth quarter of 2020.
Preliminary fourth quarter 2021 net revenues from the United States, EMEA and Japan contributed $92.0 million, $26.5 million and $8.8 million, respectively. Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $5.8 million.
The number of active patients on therapy and the amount of net revenue recognized per active patient are our principal revenue drivers.
In the fourth quarter 2021, Novocure initiated contract negotiations with several large German payers that drove an update to the net revenue recognized per active patient, which negatively impacted fourth quarter revenue by approximately $4.0 million. Novocure believes this negotiated pricing is sustainable, will reduce the burden of case-by-case appeals and can be leveraged as the company expands into additional European markets.
As of December 31, 2021, there were 3,587 active patients on therapy. Active patients from North America, EMEA and Japan contributed 2,272, 1,008 and 307, respectively.
In the quarter ended December 31, 2021, 1,430 prescriptions were received. Prescriptions from North America, EMEA and Japan contributed 966, 349 and 115, respectively.
In 2022, the company expects to achieve active patient growth rates of 2% to 5%, in-line with the growth rate experienced in the fourth quarter 2021. Longer term, the company continues to expect further adoption in its core glioblastoma business.
Cash, cash equivalents and short-term investments were $937.7 million as of December 31, 2021.
Clinical and Product Development:

Given the limited total number of events seen to date in the fast-recruiting INNOVATE-3 pivotal trial in platinum-resistant ovarian cancer, Novocure anticipates the independent Data Monitoring Committee (DMC) will conduct its interim analysis in early Q2 2022. Timing of final data is unchanged and expected in 2023.
Today, Novocure is announcing its next generation array designed to increase Tumor Treating Fields dose delivery while limiting heat generation, thereby potentially increasing clinical efficacy. The next generation array design is complete, a healthy volunteer study is underway, and the company is working towards a limited market release in the EU later this year.
Novocure reiterates 2022 guidance for final data from its phase 3, pivotal LUNAR trial in non-small cell lung cancer and its phase 2 pilot EF-31 trial in gastric cancer.
Fourth quarter and full year 2021 financial results conference call

Novocure will host a conference call and webcast to discuss fourth quarter and full year 2021 financial results at 8 a.m. EST on Thursday, February 24, 2022. Analysts and investors can participate in the conference call by dialing 855-442-6895 for domestic callers and 509-960-9037 for international callers, using the conference ID 8879093.

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.

* The unaudited results in this press release are preliminary and subject to the completion of the Company’s annual independent audit and, therefore, are subject to adjustment.