Novocure Reports Third Quarter 2024 Financial Results
Quarterly net revenues of
FDA approves Optune Lua® for the treatment of metastatic non-small cell lung cancer
After 22 years as CEO,
ROOT,
“This was a period of strong execution and achievement at Novocure,” said
Financial updates for the third quarter ended
-
Total net revenues for the quarter were
$155.1 million , an increase of 22% compared to the same period in 2023. This increase is primarily driven by our successful launch inFrance and improvedU.S. approval rates.-
The
U.S. ,Germany ,France andJapan contributed$98.3 million ,$17.0 million ,$15.2 million and$8.6 million , respectively, with other active markets contributing$11.3 million . -
Improved approval rates in the
U.S. resulted in$4.7 million of increased net revenue from prior period claims during the quarter. We do not expect this benefit to recur. -
Revenue in
Greater China from Novocure’s partnership with Zai Lab totaled$4.6 million .
-
The
- Gross margin for the quarter was 77%.
-
Research, development and clinical studies expenses for the quarter were
$51.9 million , a decrease of 3% from the same period in 2023. -
Sales and marketing expenses for the quarter were
$59.8 million , an increase of 3% compared to the same period in 2023. -
General and administrative expenses for the quarter were
$40.1 million , a decrease of 4% compared to the same period in 2023. -
Net loss for the quarter was
$30.6 million with loss per share of$0.28 . -
Adjusted EBITDA* for the quarter was
$1.7 million . -
Cash, cash equivalents and short-term investments were
$959.9 million as ofSeptember 30, 2024 .
Operational updates for the third quarter ended
-
1,586 prescriptions were received in the quarter, an increase of 8% compared to the same period in 2023. Prescriptions from the
U.S. ,Germany ,France andJapan contributed 934; 217; 171 and 99 prescriptions, respectively, with the remaining 165 prescriptions received in other active markets. -
As of
September 30, 2024 , there were a record 4,113 active patients on therapy. Active patients from theU.S. ,Germany ,France andJapan contributed 2,200; 570; 393 and 437 active patients, respectively, with the remaining 513 active patients contributed by other active markets.
Quarterly updates and achievements:
-
In October, based on the results from the Phase 3 LUNAR trial, the
U.S. Food and Drug Administration (FDA) approved our Premarket Approval (PMA) application for Optune Lua for concurrent use with PD-1/PD-L1 inhibitors or docetaxel for the treatment of adult patients with metastatic NSCLC who have progressed on or after a platinum-based regimen. Our commercial launch in theU.S. is underway with physician certification ongoing and first prescription received shortly after approval. -
In October, the
U.S. FDA granted Breakthrough Device designation for the use of TTFields therapy for brain metastases from non-small cell lung cancer. Breakthrough Device designation gives us more frequent, faster and interactive access to the FDA review team and senior management during the review process, priority review of our marketing application upon filing, and expedited review of pre-PMA manufacturing and quality systems compliance inspections. -
In September, we announced the retirement of Chief Executive Officer (CEO)
Asaf Danziger , effectiveJanuary 1, 2025 .Mr. Danziger will be succeeded by Chief Financial Officer (CFO)Ashley Cordova . In October, we appointedChristoph Brackmann to succeedMs. Cordova as CFO, effectiveJanuary 1, 2025 . In addition, we announced the promotion ofMukund Paravasthu to the role of Chief Operating Officer, effectiveOctober 1, 2024 .
Anticipated clinical milestones:
- Top-line data from Phase 3 PANOVA-3 clinical trial in locally advanced pancreatic cancer (Q4 2024)
- Data from Phase 2 PANOVA-4 clinical trial in metastatic pancreatic cancer (2026)
- Data from Phase 3 TRIDENT clinical trial in newly diagnosed glioblastoma (2026)
Conference call details
Novocure will host a conference call and webcast to discuss third quarter 2024 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, non-small cell lung cancer, malignant pleural mesothelioma and pleural mesothelioma. Novocure has several additional ongoing or completed clinical trials exploring the use of Tumor Treating Fields therapy in the treatment of glioblastoma, non-small cell lung cancer and pancreatic cancer.
Novocure’s global headquarters is located in Root Switzerland, with
*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 trial 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 and other more specific risks and uncertainties facing Novocure such as those set forth in its Annual Report on Form 10-K filed on
NOVOCURE LIMITED AND SUBSIDIARIES
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Three months ended |
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Nine months ended |
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Year ended |
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2024 |
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2023 |
|
2024 |
|
2023 |
|
2023 |
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Unaudited |
|
Unaudited |
|
Audited |
||||||||||||||
Net revenues |
$ |
155,095 |
|
|
$ |
127,321 |
|
|
$ |
443,954 |
|
|
$ |
375,554 |
|
|
$ |
509,338 |
|
Cost of revenues |
|
35,372 |
|
|
|
32,092 |
|
|
|
103,715 |
|
|
|
95,724 |
|
|
|
128,280 |
|
Gross profit |
|
119,723 |
|
|
|
95,229 |
|
|
|
340,239 |
|
|
|
279,830 |
|
|
|
381,058 |
|
|
|
|
|
|
|
|
|
|
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Operating costs and expenses: |
|
|
|
|
|
|
|
|
|
||||||||||
Research, development and clinical studies |
|
51,882 |
|
|
|
53,623 |
|
|
|
158,435 |
|
|
|
168,754 |
|
|
|
223,062 |
|
Sales and marketing |
|
59,830 |
|
|
|
57,964 |
|
|
|
171,652 |
|
|
|
167,621 |
|
|
|
226,809 |
|
General and administrative |
|
40,103 |
|
|
|
41,887 |
|
|
|
117,344 |
|
|
|
124,609 |
|
|
|
164,057 |
|
Total operating costs and expenses |
|
151,815 |
|
|
|
153,474 |
|
|
|
447,431 |
|
|
|
460,984 |
|
|
|
613,928 |
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Operating income (loss) |
|
(32,092 |
) |
|
|
(58,245 |
) |
|
|
(107,192 |
) |
|
|
(181,154 |
) |
|
|
(232,870 |
) |
Financial income (expenses), net |
|
10,507 |
|
|
|
10,023 |
|
|
|
31,236 |
|
|
|
27,948 |
|
|
|
41,130 |
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Income (loss) before income tax |
|
(21,585 |
) |
|
|
(48,222 |
) |
|
|
(75,956 |
) |
|
|
(153,206 |
) |
|
|
(191,740 |
) |
Income tax |
|
8,985 |
|
|
|
1,263 |
|
|
|
26,749 |
|
|
|
6,758 |
|
|
|
15,303 |
|
Net income (loss) |
$ |
(30,570 |
) |
|
$ |
(49,485 |
) |
|
$ |
(102,705 |
) |
|
$ |
(159,964 |
) |
|
$ |
(207,043 |
) |
|
|
|
|
|
|
|
|
|
|
||||||||||
Basic and diluted net income (loss) per ordinary share |
$ |
(0.28 |
) |
|
$ |
(0.46 |
) |
|
$ |
(0.95 |
) |
|
$ |
(1.51 |
) |
|
$ |
(1.95 |
) |
Weighted average number of ordinary shares used in computing basic and diluted net income (loss) per share |
|
108,247,716 |
|
|
|
106,772,814 |
|
|
|
107,679,501 |
|
|
|
106,219,194 |
|
|
|
106,391,178 |
|
Consolidated Balance Sheets
|
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NOVOCURE LIMITED AND SUBSIDIARIES
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||
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Unaudited |
|
Audited |
||
ASSETS |
|
|
|
||
CURRENT ASSETS: |
|
|
|
||
Cash and cash equivalents |
$ |
185,422 |
|
$ |
240,821 |
Short-term investments |
|
774,476 |
|
|
669,795 |
Restricted cash |
|
3,777 |
|
|
1,743 |
Trade receivables, net |
|
67,060 |
|
|
61,221 |
Receivables and prepaid expenses |
|
25,437 |
|
|
22,677 |
Inventories |
|
39,096 |
|
|
38,152 |
Total current assets |
|
1,095,268 |
|
|
1,034,409 |
LONG-TERM ASSETS: |
|
|
|
||
Property and equipment, net |
|
73,251 |
|
|
51,479 |
Field equipment, net |
|
12,913 |
|
|
11,384 |
Right-of-use assets |
|
28,330 |
|
|
34,835 |
Other long-term assets |
|
12,224 |
|
|
14,022 |
Total long-term assets |
|
126,718 |
|
|
111,720 |
TOTAL ASSETS |
$ |
1,221,986 |
|
$ |
1,146,129 |
Consolidated Balance Sheets
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|
Unaudited |
|
Audited |
||||
The accompanying notes are an integral part of these unaudited consolidated financial statements. |
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LIABILITIES AND SHAREHOLDERS' EQUITY |
|
|
|
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CURRENT LIABILITIES: |
|
|
|
||||
Convertible note |
$ |
557,333 |
|
|
|
— |
|
Trade payables |
|
91,319 |
|
|
$ |
94,391 |
|
Other payables, lease liabilities and accrued expenses |
|
86,350 |
|
|
|
84,724 |
|
Total current liabilities |
|
735,002 |
|
|
|
179,115 |
|
LONG-TERM LIABILITIES: |
|
|
|
||||
Convertible note |
|
— |
|
|
|
568,822 |
|
Senior secured credit facility, net |
|
97,149 |
|
|
|
— |
|
Long-term leases |
|
21,144 |
|
|
|
27,420 |
|
Employee benefit liabilities |
|
7,892 |
|
|
|
8,258 |
|
Other long-term liabilities |
|
18 |
|
|
|
18 |
|
Total long-term liabilities |
|
126,203 |
|
|
|
604,518 |
|
TOTAL LIABILITIES |
|
861,205 |
|
|
|
783,633 |
|
COMMITMENTS AND CONTINGENCIES |
|
|
|
||||
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SHAREHOLDERS' EQUITY: |
|
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|
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Share capital - |
|
|
|
||||
Ordinary shares no par value, unlimited shares authorized; issued and outstanding: 108,100,392 shares and 107,075,754 shares at |
|
— |
|
|
|
— |
|
Additional paid-in capital |
|
1,454,367 |
|
|
|
1,353,468 |
|
Accumulated other comprehensive income (loss) |
|
(5,378 |
) |
|
|
(5,469 |
) |
Retained earnings (accumulated deficit) |
|
(1,088,208 |
) |
|
|
(985,503 |
) |
TOTAL SHAREHOLDERS' EQUITY |
|
360,781 |
|
|
|
362,496 |
|
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY |
$ |
1,221,986 |
|
|
$ |
1,146,129 |
|
Non- |
|||||||||||||||||||||
|
Three months ended |
|
Nine months ended |
||||||||||||||||||
|
2024 |
|
2023 |
|
% Change |
|
2024 |
|
2023 |
|
% Change |
||||||||||
Net income (loss) |
$ |
(30,570 |
) |
|
$ |
(49,485 |
) |
|
(38 |
)% |
|
$ |
(102,705 |
) |
|
$ |
(159,964 |
) |
|
(36 |
)% |
Add: Income tax |
|
8,985 |
|
|
|
1,263 |
|
|
611 |
% |
|
|
26,749 |
|
|
|
6,758 |
|
|
296 |
% |
Add: Financial expenses (income), net |
|
(10,507 |
) |
|
|
(10,023 |
) |
|
5 |
% |
|
|
(31,236 |
) |
|
|
(27,948 |
) |
|
12 |
% |
Add: Depreciation and amortization |
|
2,458 |
|
|
|
2,803 |
|
|
(12 |
)% |
|
|
8,131 |
|
|
|
8,246 |
|
|
(1 |
)% |
EBITDA |
$ |
(29,634 |
) |
|
$ |
(55,442 |
) |
|
(47 |
)% |
|
$ |
(99,061 |
) |
|
$ |
(172,908 |
) |
|
(43 |
)% |
Add: Share-based compensation |
|
31,364 |
|
|
|
26,346 |
|
|
19 |
% |
|
|
97,278 |
|
|
|
98,170 |
|
|
(1 |
)% |
Adjusted EBITDA |
$ |
1,730 |
|
|
$ |
(29,096 |
) |
|
(106 |
)% |
|
$ |
(1,783 |
) |
|
$ |
(74,738 |
) |
|
(98 |
)% |
View source version on businesswire.com: https://www.businesswire.com/news/home/20241030502767/en/
Investors:
investorinfo@novocure.com
Media:
media@novocure.com
Source: Novocure