ROOT, Switzerland--(BUSINESS WIRE)--Novocure (NASDAQ: NVCR) today reported financial results for the quarter ended June 30, 2024. 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).
“The second quarter was a period of consistent execution at Novocure,” said Asaf Danziger, Novocure’s Chief Executive Officer. “We began the year with three key objectives – grow our commercial business in glioblastoma, launch our next indication in non-small cell lung cancer, and deliver on the promise of our clinical and product development pipelines. I am pleased to share we have made significant progress on all fronts this quarter.”
Financial updates for the second quarter ended June 30, 2024:
-
Total net revenues for the quarter were $150.4 million, an increase of 19% compared to the same period in 2023. This increase is primarily driven by our successful launch in France and improved U.S. approval rates.
- The United States, Germany, France and Japan contributed $95.7 million, $15.1 million, $14.3 million and $7.7 million, respectively, with other active markets contributing $11.8 million.
- Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $5.8 million.
- Improved approval rates in the U.S. resulted in $5.0 million of increased net revenue from prior period claims during the quarter. In addition, we received $2.6 million in net revenues from a private payer in the United Kingdom where payments are not routine. We do not expect these two benefits, totaling $7.6 million, to recur.
- Gross margin for the quarter was 77%.
- Research, development and clinical studies expenses for the quarter were $55.0 million, a decrease of 1% from the same period in 2023.
- Sales and marketing expenses for the quarter were $56.6 million, a decrease of 3% compared to the same period in 2023. This primarily reflects lower personnel expenses associated with support functions.
- General and administrative expenses for the quarter were $37.7 million, a decrease of 8% compared to the same period in 2023. This primarily reflects lower personnel expenses.
- Net loss for the quarter was $33.4 million with loss per share of $0.31.
- Adjusted EBITDA* for the quarter was $1.1 million.
- Cash, cash equivalents and short-term investments were $951.2 million as of June 30, 2024.
Operational updates for the second quarter ended June 30, 2024:
- 1,634 prescriptions were received in the quarter, an increase of 5% compared to the same period in 2023. Prescriptions from the United States, Germany, France and Japan contributed 957, 206, 176 and 108 prescriptions, respectively, with the remaining 187 prescriptions received in other active markets.
- As of June 30, 2024, there were 3,963 active patients on therapy, an increase of 11% compared to the same period in 2023. Active patients from the United States, Germany, France and Japan contributed 2,175, 538, 369 and 403 active patients, respectively, with the remaining 478 active patients contributed by other active markets.
Quarterly updates and achievements:
- In June, we presented positive results from the phase 3 METIS trial, evaluating the use of TTFields therapy and supportive care for the treatment of patients with brain metastases from non-small cell lung cancer (NSCLC) following stereotactic radiosurgery at the 2024 American Society of Clinical Oncology (ASCO) annual meeting. The METIS trial met its primary endpoint, demonstrating a statistically significant improvement in time to intracranial progression for adult patients treated with TTFields therapy and supportive care compared to patients treated with supportive care alone.
- In June, we presented top-line results from the prospective, non-interventional TIGER study at the 2024 ASCO annual meeting. TIGER investigated the use of TTFields therapy in routine clinical use in the treatment of newly diagnosed GBM in Germany. The outcomes observed in the TIGER study are consistent with the survival and safety results from our phase 3 EF-14 clinical trial. TTFields therapy use was not associated with an increase in systemic toxicity and was well tolerated.
Anticipated clinical milestones:
- Top-line data from phase 3 PANOVA-3 clinical trial in locally advanced pancreatic cancer (Q4 2024)
Conference call details
Novocure will host a conference call and webcast to discuss second quarter 2024 financial results at 8:00 a.m. EDT today, Thursday, July 25, 2024. To access the conference call by phone, use the following conference call registration link and dial-in details will be provided. To access the webcast, use the following webcast registration link.
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, malignant pleural mesothelioma and pleural mesothelioma. Novocure has ongoing or completed clinical trials 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, Switzerland and with a growing global footprint, Novocure has regional operating centers in Portsmouth, New Hampshire and Tokyo, as well as a research center in Haifa, Israel. For additional information about the company, please visit Novocure.com and follow @Novocure on LinkedIn and Twitter.
*Non-GAAP Financial Measurements
We measure our performance based upon a non-U.S. GAAP measurement of earnings before interest, taxes, depreciation, amortization and shared-based compensation ("Adjusted EBITDA"). We believe Adjusted EBITDA is useful to investors in evaluating our operating performance because it helps investors compare the results of our operations from period to period by removing the impact of earnings attributable to our capital structure, tax rate and material non-cash items, specifically share-based compensation.
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 February 22, 2024, and subsequent filings with the U.S. Securities and Exchange Commission. Given these risks and uncertainties, any or all of these forward-looking statements may prove to be incorrect. Therefore, you should not rely on any such factors or forward-looking statements. Furthermore, Novocure does not intend to update publicly any forward-looking statement, except as required by law. Any forward-looking statements herein speak only as of the date hereof. The Private Securities Litigation Reform Act of 1995 permits this discussion.
NOVOCURE LIMITED AND SUBSIDIARIES CONSOLIDATED STATEMENTS OF OPERATIONS |
|||||||||||||||||||
U.S. dollars in thousands (except share and per share data) |
|||||||||||||||||||
|
Three months ended June 30, |
|
Six months ended June 30, |
|
Year ended
|
||||||||||||||
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
2023 |
||||||||||
|
Unaudited |
|
Unaudited |
|
Audited |
||||||||||||||
Net revenues |
$ |
150,356 |
|
|
$ |
126,051 |
|
|
$ |
288,859 |
|
|
$ |
248,233 |
|
|
$ |
509,338 |
|
Cost of revenues |
|
34,654 |
|
|
|
34,018 |
|
|
|
68,343 |
|
|
|
63,632 |
|
|
|
128,280 |
|
Gross profit |
|
115,702 |
|
|
|
92,033 |
|
|
|
220,516 |
|
|
|
184,601 |
|
|
|
381,058 |
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Operating costs and expenses: |
|
|
|
|
|
|
|
|
|
||||||||||
Research, development and clinical studies |
|
54,955 |
|
|
|
55,427 |
|
|
|
106,553 |
|
|
|
115,131 |
|
|
|
223,062 |
|
Sales and marketing |
|
56,616 |
|
|
|
58,488 |
|
|
|
111,822 |
|
|
|
109,657 |
|
|
|
226,809 |
|
General and administrative |
|
37,711 |
|
|
|
40,778 |
|
|
|
77,241 |
|
|
|
82,722 |
|
|
|
164,057 |
|
Total operating costs and expenses |
|
149,282 |
|
|
|
154,693 |
|
|
|
295,616 |
|
|
|
307,510 |
|
|
|
613,928 |
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Operating income (loss) |
|
(33,580 |
) |
|
|
(62,660 |
) |
|
|
(75,100 |
) |
|
|
(122,909 |
) |
|
|
(232,870 |
) |
Financial income (expenses), net |
|
10,851 |
|
|
|
8,756 |
|
|
|
20,729 |
|
|
|
17,925 |
|
|
|
41,130 |
|
|
|
|
|
|
|
|
|
|
|
||||||||||
Income (loss) before income tax |
|
(22,729 |
) |
|
|
(53,904 |
) |
|
|
(54,371 |
) |
|
|
(104,984 |
) |
|
|
(191,740 |
) |
Income tax |
|
10,646 |
|
|
|
3,514 |
|
|
|
17,764 |
|
|
|
5,495 |
|
|
|
15,303 |
|
Net income (loss) |
$ |
(33,375 |
) |
|
$ |
(57,418 |
) |
|
$ |
(72,135 |
) |
|
$ |
(110,479 |
) |
|
$ |
(207,043 |
) |
|
|
|
|
|
|
|
|
|
|
||||||||||
Basic and diluted net income (loss) per ordinary share |
$ |
(0.31 |
) |
|
$ |
(0.54 |
) |
|
$ |
(0.67 |
) |
|
$ |
(1.04 |
) |
|
$ |
(1.95 |
) |
Weighted average number of ordinary shares used in computing basic and diluted net income (loss) per share |
|
107,700,284 |
|
|
|
106,289,073 |
|
|
|
107,483,241 |
|
|
|
105,979,791 |
|
|
|
106,391,178 |
|
Consolidated Balance Sheets |
|||||
USD in thousands (except share data) |
|||||
NOVOCURE LIMITED AND SUBSIDIARIES CONSOLIDATED BALANCE SHEETS |
|||||
U.S. dollars in thousands (except share data) |
|||||
|
June 30,
|
|
December 31,
|
||
|
Unaudited |
|
Audited |
||
ASSETS |
|
|
|
||
CURRENT ASSETS: |
|
|
|
||
Cash and cash equivalents |
$ |
164,796 |
|
$ |
240,821 |
Short-term investments |
|
786,390 |
|
|
669,795 |
Restricted cash |
|
3,647 |
|
|
1,743 |
Trade receivables, net |
|
64,703 |
|
|
61,221 |
Receivables and prepaid expenses |
|
32,858 |
|
|
22,677 |
Inventories |
|
40,442 |
|
|
38,152 |
Total current assets |
|
1,092,836 |
|
|
1,034,409 |
LONG-TERM ASSETS: |
|
|
|
||
Property and equipment, net |
|
66,477 |
|
|
51,479 |
Field equipment, net |
|
11,719 |
|
|
11,384 |
Right-of-use assets |
|
29,076 |
|
|
34,835 |
Other long-term assets |
|
12,062 |
|
|
14,022 |
Total long-term assets |
|
119,334 |
|
|
111,720 |
TOTAL ASSETS |
$ |
1,212,170 |
|
$ |
1,146,129 |
Consolidated Balance Sheets |
|||||||
USD in thousands (except share data) |
|||||||
|
June 30,
|
|
December 31,
|
||||
|
Unaudited |
|
Audited |
||||
The accompanying notes are an integral part of these unaudited consolidated financial statements. |
|||||||
LIABILITIES AND SHAREHOLDERS' EQUITY |
|
|
|
||||
CURRENT LIABILITIES: |
|
|
|
||||
Trade payables |
$ |
90,171 |
|
|
$ |
94,391 |
|
Other payables, lease liabilities and accrued expenses |
|
79,007 |
|
|
|
84,724 |
|
Total current liabilities |
|
169,178 |
|
|
|
179,115 |
|
LONG-TERM LIABILITIES: |
|
|
|
||||
Convertible note |
|
556,508 |
|
|
|
568,822 |
|
Senior secured credit facility, net |
|
96,962 |
|
|
|
— |
|
Long-term leases |
|
21,731 |
|
|
|
27,420 |
|
Employee benefit liabilities |
|
6,023 |
|
|
|
8,258 |
|
Other long-term liabilities |
|
18 |
|
|
|
18 |
|
Total long-term liabilities |
|
681,242 |
|
|
|
604,518 |
|
TOTAL LIABILITIES |
|
850,420 |
|
|
|
783,633 |
|
COMMITMENTS AND CONTINGENCIES |
|
|
|
||||
|
|
|
|
||||
SHAREHOLDERS' EQUITY: |
|
|
|
||||
Share capital - |
|
|
|
||||
Ordinary shares no par value, unlimited shares authorized; issued and outstanding: 108,013,830 shares and 107,075,754 shares at June 30, 2024 (unaudited) and December 31, 2023, respectively |
|
— |
|
|
|
— |
|
Additional paid-in capital |
|
1,422,903 |
|
|
|
1,353,468 |
|
Accumulated other comprehensive income (loss) |
|
(3,515 |
) |
|
|
(5,469 |
) |
Retained earnings (accumulated deficit) |
|
(1,057,638 |
) |
|
|
(985,503 |
) |
TOTAL SHAREHOLDERS' EQUITY |
|
361,750 |
|
|
|
362,496 |
|
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY |
$ |
1,212,170 |
|
|
$ |
1,146,129 |
|
Non-U.S. GAAP financial measures reconciliation |
|||||||||||||||||||||
USD in thousands |
|||||||||||||||||||||
|
Three months ended June 30, |
|
Six months ended June 30, |
||||||||||||||||||
|
2024 |
|
2023 |
|
% Change |
|
2024 |
|
2023 |
|
% Change |
||||||||||
Net income (loss) |
$ |
(33,375 |
) |
|
$ |
(57,418 |
) |
|
(42 |
)% |
|
$ |
(72,135 |
) |
|
$ |
(110,479 |
) |
|
(35 |
)% |
Add: Income tax |
|
10,646 |
|
|
|
3,514 |
|
|
203 |
% |
|
|
17,764 |
|
|
|
5,495 |
|
|
223 |
% |
Add: Financial expenses (income), net |
|
(10,851 |
) |
|
|
(8,756 |
) |
|
24 |
% |
|
|
(20,729 |
) |
|
|
(17,925 |
) |
|
16 |
% |
Add: Depreciation and amortization |
|
2,858 |
|
|
|
2,721 |
|
|
5 |
% |
|
|
5,673 |
|
|
|
5,443 |
|
|
4 |
% |
EBITDA |
$ |
(30,722 |
) |
|
$ |
(59,939 |
) |
|
(49 |
)% |
|
$ |
(69,427 |
) |
|
$ |
(117,466 |
) |
|
(41 |
)% |
Add: Share-based compensation |
|
31,830 |
|
|
|
32,740 |
|
|
(3 |
)% |
|
|
65,914 |
|
|
|
71,824 |
|
|
(8 |
)% |
Adjusted EBITDA |
$ |
1,108 |
|
|
$ |
(27,199 |
) |
|
(104 |
)% |
|
$ |
(3,513 |
) |
|
$ |
(45,642 |
) |
|
(92 |
)% |
