Novocure Reports Third Quarter 2022 Financial Results
Novocure (NASDAQ: NVCR) reported third-quarter 2022 net revenues of $131 million, down 2% from 2021. The company invested $52 million in R&D, aiming to enhance its Tumor Treating Fields (TTFields) therapy and expand into new markets. Notably, gross margin was 77%, while the company recorded a net loss of $26.6 million or $0.25 per share. Novocure anticipates pivotal trial data releases starting in January 2023, potentially allowing treatment for tens of thousands more patients. Cash reserves stood strong at $970.3 million.
- Anticipated multiple pivotal trial data releases beginning January 2023.
- Strong cash reserves of $970.3 million.
- Gross margin maintained at 77%.
- Third-quarter revenues decreased by 2% year-over-year.
- Net loss of $26.6 million with a loss per share of $0.25.
- Increased expenses in R&D (8%) and sales & marketing (27%).
- Delay in completion of METIS study enrollment to Q1 2023.
Quarterly net revenues of
Entering a transformational period with multiple pivotal trial readouts anticipated in coming quarters
ROOT,
“In the third quarter, we showed consistent execution in service of our mission to extend survival in some of the most aggressive forms of cancer,” said
“Novocure is approaching a period that should be transformational for our company and patients,” said
Financial updates for the third quarter ended
-
Total net revenues for the quarter were
, a decrease of$131.0 million 2% compared to the same period in 2021.-
The United States , EMEA andJapan contributed ,$102.7 million , and$14.3 million in quarterly net revenues, respectively.$7.9 million -
Net revenues were impacted by the volume of cash collections from aged claims in the
U.S. , the ongoing impact of German coverage updates and foreign exchange pressure. -
Revenue in
Greater China from Novocure’s partnership with Zai Lab totaled .$6.2 million
-
-
Gross margin for the quarter was
77% . -
Research, development and clinical studies expenses for the quarter were
, an increase of$52.0 million 8% from the same period in 2021. -
Sales and marketing expenses for the quarter were
, an increase of$41.4 million 27% 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
, an increase of$32.5 million 4% compared to the same period in 2021. -
Net loss for the quarter was
with loss per share of$26.6 million .$0.25 -
Adjusted EBITDA* for the quarter was
.$4.4 million -
Cash, cash equivalents and short-term investments were
as of$970.3 million September 30, 2022 .
Operational updates for the third quarter ended
-
As of
September 30, 2022 , there were 3,420 active patients on therapy. Active patients fromNorth America , EMEA andJapan contributed 2,181, 885 and 354 active patients, respectively. -
1,389 prescriptions were received in the quarter. Prescriptions from
North America , EMEA andJapan contributed 978, 332 and 79 prescriptions, respectively.
Quarterly updates and achievements:
- Today, we are announcing preliminary data from the phase 2 EF-33 pilot study evaluating the safety and efficacy of high density arrays in 25 patients with recurrent glioblastoma (GBM). Among those who used Optune® as directed for at least one month, median progression-free survival was 4.5 months compared to 2.2 months in the historical control, Novocure’s pivotal EF-11 study. Further, notwithstanding the increased TTFields intensity, EF-33 patients reported no TTFields-related toxicity.
- Our phase 3 pivotal METIS study for the treatment of brain metastases from non-small cell lung cancer (NSCLC) continues to enroll well, and we have visibility to final patient enrollment; however, we now expect to complete enrollment in the first quarter of 2023 versus the fourth quarter of 2022. This will begin the final patient’s 12-month follow-up period, and we anticipate top-line data in the first quarter of 2024.
-
In
September 2022 , we announced the creation of ourU.S. CNS (central nervous system) Cancers Franchise, intended to strengthen focus on growth in ourU.S. GBM business by streamlining decision-making and improving coordination.
Anticipated clinical milestones:
- Top-line readout from phase 3 pivotal LUNAR study in NSCLC cancer (Q1 2023)
- Data from phase 3 pivotal INNOVATE-3 study in recurrent ovarian cancer (2023)
- Data from phase 3 pivotal METIS study in brain metastases (2024)
- 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 third quarter 2022 financial results at
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.
About Novocure
Novocure is a global oncology company working to extend survival in some of the most aggressive forms of cancer through the development and commercialization of its innovative therapy, Tumor Treating Fields. Novocure’s commercialized products are approved in certain countries for the treatment of adult patients with glioblastoma and malignant pleural mesothelioma. Novocure has ongoing or completed clinical studies investigating Tumor Treating Fields in brain metastases, gastric cancer, glioblastoma, liver cancer, non-small cell lung cancer, pancreatic cancer and ovarian cancer.
Headquartered in Root,
*Non-GAAP Financial Measurements
We measure our performance based upon a non-
Forward-Looking Statements
In addition to historical facts or statements of current condition, this press release may contain forward-looking statements. Forward-looking statements provide Novocure’s current expectations or forecasts of future events. These may include statements regarding anticipated scientific progress on its research programs, clinical study progress, development of potential products, interpretation of clinical results, prospects for regulatory approval, manufacturing development and capabilities, market prospects for its products, coverage, collections from third-party payers and other statements regarding matters that are not historical facts. You may identify some of these forward-looking statements by the use of words in the statements such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or other words and terms of similar meaning. Novocure’s performance and financial results could differ materially from those reflected in these forward-looking statements due to general financial, economic, environmental, regulatory and political conditions as well as issues arising from the COVID-19 pandemic and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on
Consolidated Statements of Operations USD in thousands (except share and per share data) |
||||||||||||||||||||
|
Three months ended
|
|
Nine months ended
|
|
Year ended
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|||||||||||||||
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
2021 |
|
|
|
Unaudited |
|
Unaudited |
|
Audited |
|||||||||||||||
Net revenues |
$ |
130,998 |
|
|
$ |
133,606 |
|
|
$ |
409,411 |
|
|
$ |
401,818 |
|
|
$ |
535,031 |
|
|
Cost of revenues |
|
29,749 |
|
|
|
30,206 |
|
|
|
85,979 |
|
|
|
85,190 |
|
|
|
114,877 |
|
|
Gross profit |
|
101,249 |
|
|
|
103,400 |
|
|
|
323,432 |
|
|
|
316,628 |
|
|
|
420,154 |
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
Operating costs and expenses: |
|
|
|
|
|
|
|
|
|
|||||||||||
Research, development and clinical studies |
|
51,956 |
|
|
|
48,141 |
|
|
|
151,265 |
|
|
|
144,372 |
|
|
|
201,303 |
|
|
Sales and marketing |
|
41,395 |
|
|
|
32,580 |
|
|
|
124,029 |
|
|
|
98,075 |
|
|
|
137,057 |
|
|
General and administrative |
|
32,509 |
|
|
|
31,231 |
|
|
|
94,683 |
|
|
|
95,116 |
|
|
|
126,127 |
|
|
Total operating costs and expenses |
|
125,860 |
|
|
|
111,952 |
|
|
|
369,977 |
|
|
|
337,563 |
|
|
|
464,487 |
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
Operating income (loss) |
|
(24,611 |
) |
|
|
(8,552 |
) |
|
|
(46,545 |
) |
|
|
(20,935 |
) |
|
|
(44,333 |
) |
|
Financial expenses (income), net |
|
(1,194 |
) |
|
|
1,981 |
|
|
|
2,743 |
|
|
|
5,567 |
|
|
|
7,742 |
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
Income (loss) before income taxes |
|
(23,417 |
) |
|
|
(10,533 |
) |
|
|
(49,288 |
) |
|
|
(26,502 |
) |
|
|
(52,075 |
) |
|
Income taxes |
|
3,159 |
|
|
|
2,591 |
|
|
|
5,943 |
|
|
|
5,391 |
|
|
|
6,276 |
|
|
Net income (loss) |
$ |
(26,576 |
) |
|
$ |
(13,124 |
) |
|
$ |
(55,231 |
) |
|
$ |
(31,893 |
) |
|
$ |
(58,351 |
) |
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
Basic net income (loss) per ordinary share |
$ |
(0.25 |
) |
|
$ |
(0.13 |
) |
|
$ |
(0.53 |
) |
|
$ |
(0.31 |
) |
|
$ |
(0.56 |
) |
|
Weighted average number of ordinary shares used in computing basic net income (loss) per share |
|
104,884,583 |
|
|
|
103,731,147 |
|
|
|
104,552,803 |
|
|
|
103,281,380 |
|
|
|
103,433,274 |
|
|
Diluted net income (loss) per ordinary share |
$ |
(0.25 |
) |
|
$ |
(0.13 |
) |
|
$ |
(0.53 |
) |
|
$ |
(0.31 |
) |
|
$ |
(0.56 |
) |
|
Weighted average number of ordinary shares used in computing diluted net income (loss) per share |
|
104,884,583 |
|
|
|
103,731,147 |
|
|
|
104,552,803 |
|
|
|
103,281,380 |
|
|
|
103,433,274 |
|
Consolidated Balance Sheets USD in thousands (except share data) |
||||||
|
2022 |
|
2021 |
|||
|
Unaudited |
|
Audited |
|||
ASSETS |
|
|
|
|||
CURRENT ASSETS: |
|
|
|
|||
Cash and cash equivalents |
$ |
243,805 |
|
$ |
208,802 |
|
Short-term investments |
|
726,515 |
|
|
728,898 |
|
Restricted cash |
|
231 |
|
|
807 |
|
Trade receivables, net |
|
87,552 |
|
|
93,567 |
|
Receivables and prepaid expenses |
|
17,478 |
|
|
17,025 |
|
Inventories |
|
26,792 |
|
|
24,427 |
|
Total current assets |
|
1,102,373 |
|
|
1,073,526 |
|
LONG-TERM ASSETS: |
|
|
|
|||
Property and equipment, net |
|
29,745 |
|
|
22,693 |
|
Field equipment, net |
|
11,985 |
|
|
12,923 |
|
Right-of-use assets |
|
19,405 |
|
|
18,267 |
|
Other long-term assets |
|
10,707 |
|
|
12,086 |
|
Total long-term assets |
|
71,842 |
|
|
65,969 |
|
TOTAL ASSETS |
$ |
1,174,215 |
|
$ |
1,139,495 |
|
|
|
|
|
Consolidated Balance Sheets USD in thousands (except share data) |
||||||||
|
2022 |
|
2021 |
|||||
|
Unaudited |
|
Audited |
|||||
LIABILITIES AND SHAREHOLDERS' EQUITY |
|
|
|
|||||
CURRENT LIABILITIES: |
|
|
|
|||||
Trade payables |
$ |
77,026 |
|
|
$ |
72,600 |
|
|
Other payables, lease liabilities and accrued expenses |
|
64,050 |
|
|
|
70,002 |
|
|
Total current liabilities |
|
141,076 |
|
|
|
142,602 |
|
|
LONG-TERM LIABILITIES: |
|
|
|
|||||
Long-term debt, net |
|
564,677 |
|
|
|
562,216 |
|
|
Deferred revenue |
|
3,924 |
|
|
|
6,477 |
|
|
Long-term leases |
|
14,827 |
|
|
|
12,997 |
|
|
Employee benefit liabilities |
|
4,088 |
|
|
|
4,543 |
|
|
Other long-term liabilities |
|
222 |
|
|
|
166 |
|
|
Total long-term liabilities |
|
587,738 |
|
|
|
586,399 |
|
|
TOTAL LIABILITIES |
|
728,814 |
|
|
|
729,001 |
|
|
|
|
|
|
|||||
COMMITMENTS AND CONTINGENCIES |
|
|
|
|||||
|
|
|
|
|||||
SHAREHOLDERS' EQUITY: |
|
|
|
|||||
Share capital - |
|
|
|
|||||
Ordinary shares no par value, unlimited shares authorized; issued and outstanding:
104,942,941 shares and 103,971,263 shares at |
|
— |
|
|
|
— |
|
|
Additional paid-in capital |
|
1,188,864 |
|
|
|
1,099,589 |
|
|
Accumulated other comprehensive income (loss) |
|
(2,306 |
) |
|
|
(3,169 |
) |
|
Retained earnings (accumulated deficit) |
|
(741,157 |
) |
|
|
(685,926 |
) |
|
TOTAL SHAREHOLDERS' EQUITY |
|
445,401 |
|
|
|
410,494 |
|
|
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY |
$ |
1,174,215 |
|
|
$ |
1,139,495 |
|
Non- USD in thousands |
||||||||||||||||||||||
|
Three months ended |
|
Nine months ended |
|||||||||||||||||||
|
|
2022 |
|
|
|
2021 |
|
|
% Change |
|
|
2022 |
|
|
|
2021 |
|
|
% Change |
|||
Net income (loss) |
$ |
(26,576 |
) |
|
$ |
(13,124 |
) |
|
102 |
% |
|
$ |
(55,231 |
) |
|
$ |
(31,893 |
) |
|
73 |
% |
|
Add: Income tax |
|
3,159 |
|
|
|
2,591 |
|
|
22 |
% |
|
|
5,943 |
|
|
|
5,391 |
|
|
10 |
% |
|
Add: Financial expenses (income), net |
|
(1,194 |
) |
|
|
1,981 |
|
|
(160 |
) % |
|
|
2,743 |
|
|
|
5,567 |
|
|
(51 |
) % |
|
Add: Depreciation and amortization |
|
2,659 |
|
|
|
2,734 |
|
|
(3 |
) % |
|
|
7,924 |
|
|
|
7,584 |
|
|
4 |
% |
|
EBITDA |
$ |
(21,952 |
) |
|
$ |
(5,818 |
) |
|
277 |
% |
|
$ |
(38,621 |
) |
|
$ |
(13,351 |
) |
|
189 |
% |
|
Add: Share-based compensation |
|
26,305 |
|
|
|
25,758 |
|
|
2 |
% |
|
|
77,173 |
|
|
|
72,502 |
|
|
6 |
% |
|
Adjusted EBITDA |
$ |
4,353 |
|
|
$ |
19,940 |
|
|
(78 |
) % |
|
$ |
38,552 |
|
|
$ |
59,151 |
|
|
(35 |
) % |
View source version on businesswire.com: https://www.businesswire.com/news/home/20221027005570/en/
Investors:
investorinfo@novocure.com
610-723-7427
Media:
media@novocure.com
610-723-7428
Source: Novocure
FAQ
What are Novocure's Q3 2022 earnings results?
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