ROOT, Switzerland / Oct 26, 2023 / Business Wire / Novocure (NASDAQ: NVCR) today reported financial results for the quarter ended September 30, 2023. 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).
“We are focused on extending survival in some of the most aggressive forms of cancer,” said Asaf Danziger, Novocure’s Chief Executive Officer. “This quarter we continued our very successful launch in France and took significant strides in the rollout of our new arrays, which are thinner, lighter, and more flexible than our first-generation product. We are eager to build on this momentum as we prepare to treat significantly larger patient populations in the coming years.”
“In Q3, we made considerable progress towards our goal of treating patients with non-small cell lung cancer,” said William Doyle, Novocure’s Executive Chairman. “Primary data from our phase 3 LUNAR clinical trial were published in The Lancet Oncology; and multiple, post-hoc analyses were presented at major medical congresses, further illuminating the strength of the LUNAR clinical trial results. We look forward to completing the regulatory steps required to launch in our key markets.”
Financial updates for the third quarter ended September 30, 2023:
Operational updates for the third quarter ended September 30, 2023:
Quarterly updates and achievements:
Anticipated clinical milestones:
Conference call details
Novocure will host a conference call and webcast to discuss third quarter 2023 financial results at 8 a.m. EDT today, Thursday, October 26, 2023. 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 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 February 23, 2023, 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.
Consolidated Statements of Operations
USD in thousands (except share and per share data)
| Three months ended September |
| Nine months ended September |
| Year ended | ||||||||||||||
|
| 2023 |
|
|
| 2022 |
|
|
| 2023 |
|
|
| 2022 |
|
|
| 2022 |
|
| Unaudited |
| Unaudited |
| Audited | ||||||||||||||
Net revenues | $ | 127,321 |
|
| $ | 130,998 |
|
| $ | 375,554 |
|
| $ | 409,411 |
|
| $ | 537,840 |
|
Cost of revenues |
| 32,092 |
|
|
| 29,749 |
|
|
| 95,724 |
|
|
| 85,979 |
|
|
| 114,867 |
|
Gross profit |
| 95,229 |
|
|
| 101,249 |
|
|
| 279,830 |
|
|
| 323,432 |
|
|
| 422,973 |
|
|
|
|
|
|
|
|
|
|
| ||||||||||
Operating costs and expenses: |
|
|
|
|
|
|
|
|
| ||||||||||
Research, development and clinical studies |
| 53,623 |
|
|
| 51,956 |
|
|
| 168,754 |
|
|
| 151,265 |
|
|
| 206,085 |
|
Sales and marketing |
| 57,964 |
|
|
| 41,395 |
|
|
| 167,621 |
|
|
| 124,029 |
|
|
| 173,658 |
|
General and administrative |
| 41,887 |
|
|
| 32,509 |
|
|
| 124,609 |
|
|
| 94,683 |
|
|
| 132,753 |
|
Total operating costs and expenses |
| 153,474 |
|
|
| 125,860 |
|
|
| 460,984 |
|
|
| 369,977 |
|
|
| 512,496 |
|
|
|
|
|
|
|
|
|
|
| ||||||||||
Operating income (loss) |
| (58,245 | ) |
|
| (24,611 | ) |
|
| (181,154 | ) |
|
| (46,545 | ) |
|
| (89,523 | ) |
Financial income (expenses), net |
| 10,023 |
|
|
| 1,194 |
|
|
| 27,948 |
|
|
| (2,743 | ) |
|
| 7,677 |
|
|
|
|
|
|
|
|
|
|
| ||||||||||
Income (loss) before income taxes |
| (48,222 | ) |
|
| (23,417 | ) |
|
| (153,206 | ) |
|
| (49,288 | ) |
|
| (81,846 | ) |
Income taxes |
| 1,263 |
|
|
| 3,159 |
|
|
| 6,758 |
|
|
| 5,943 |
|
|
| 10,688 |
|
Net income (loss) | $ | (49,485 | ) |
| $ | (26,576 | ) |
| $ | (159,964 | ) |
| $ | (55,231 | ) |
| $ | (92,534 | ) |
|
|
|
|
|
|
|
|
|
| ||||||||||
Basic and diluted net income (loss) per ordinary share | $ | (0.46 | ) |
| $ | (0.25 | ) |
| $ | (1.51 | ) |
| $ | (0.53 | ) |
| $ | (0.88 | ) |
Weighted average number of ordinary shares used in computing basic and diluted net income (loss) per share |
| 106,772,814 |
|
|
| 104,884,583 |
|
|
| 106,219,194 |
|
|
| 104,552,803 |
|
|
| 104,660,476 |
|
Consolidated Balance Sheets
USD in thousands (except share data)
| September 30, |
| December 31, | ||
| Unaudited |
| Audited | ||
ASSETS |
|
|
| ||
CURRENT ASSETS: |
|
|
| ||
Cash and cash equivalents | $ | 154,860 |
| $ | 115,326 |
Short-term investments |
| 766,388 |
|
| 854,099 |
Restricted cash |
| 1,652 |
|
| 508 |
Trade receivables, net |
| 65,133 |
|
| 86,261 |
Receivables and prepaid expenses |
| 23,163 |
|
| 25,959 |
Inventories |
| 36,806 |
|
| 29,376 |
Total current assets |
| 1,048,002 |
|
| 1,111,529 |
LONG-TERM ASSETS: |
|
|
| ||
Property and equipment, net |
| 45,564 |
|
| 32,678 |
Field equipment, net |
| 11,357 |
|
| 12,684 |
Right-of-use assets |
| 29,014 |
|
| 23,596 |
Other long-term assets |
| 12,416 |
|
| 11,161 |
Total long-term assets |
| 98,351 |
|
| 80,119 |
TOTAL ASSETS | $ | 1,146,353 |
| $ | 1,191,648 |
|
|
|
|
Consolidated Balance Sheets
USD in thousands (except share data)
| September 30, |
| December 31, |
| Unaudited |
| Audited |
LIABILITIES AND SHAREHOLDERS' EQUITY |
|
|
|
CURRENT LIABILITIES: |
|
|
|
Trade payables | $ 79,668 |
| $ 85,197 |
Other payables, lease liabilities and accrued expenses | 77,493 |
| 73,580 |
Total current liabilities | 157,161 |
| 158,777 |
LONG-TERM LIABILITIES: |
|
|
|
Long-term debt, net | 567,986 |
| 565,509 |
Deferred revenues | — |
| 2,878 |
Long-term leases | 22,054 |
| 18,762 |
Employee benefit liabilities | 5,373 |
| 4,404 |
Other long-term liabilities | 75 |
| 148 |
Total long-term liabilities | 595,488 |
| 591,701 |
TOTAL LIABILITIES | 752,649 |
| 750,478 |
|
|
|
|
COMMITMENTS AND CONTINGENCIES |
|
|
|
|
|
|
|
SHAREHOLDERS' EQUITY: |
|
|
|
Share capital - |
|
|
|
Ordinary shares no par value, unlimited shares authorized; issued and outstanding: 106,748,270 shares and 105,049,411 shares at September 30, 2023 (unaudited) and December 31, 2022, respectively | — |
| — |
Additional paid-in capital | 1,334,120 |
| 1,222,063 |
Accumulated other comprehensive income (loss) | (1,992) |
| (2,433) |
Retained earnings (accumulated deficit) | (938,424) |
| (778,460) |
TOTAL SHAREHOLDERS' EQUITY | 393,704 |
| 441,170 |
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ 1,146,353 |
| $ 1,191,648 |
Non-U.S. GAAP financial measures reconciliation
USD in thousands
Three months ended September 30, |
| Nine months ended September 30, | |||||||||||||||||||
|
| 2023 |
|
|
| 2022 |
|
| % Change |
|
| 2023 |
|
|
| 2022 |
|
| % Change | ||
Net income (loss) | $ | (49,485 | ) |
| $ | (26,576 | ) |
| 86 | % |
| $ | (159,964 | ) |
| $ | (55,231 | ) |
| 190 | % |
Add: Income tax |
| 1,263 |
|
|
| 3,159 |
|
| (60 | )% |
|
| 6,758 |
|
|
| 5,943 |
|
| 14 | % |
Add: Financial expenses (income), net |
| (10,023 | ) |
|
| (1,194 | ) |
| 739 | % |
|
| (27,948 | ) |
|
| 2,743 |
|
| (1,119 | )% |
Add: Depreciation and amortization |
| 2,803 |
|
|
| 2,659 |
|
| 5 | % |
|
| 8,246 |
|
|
| 7,924 |
|
| 4 | % |
EBITDA | $ | (55,442 | ) |
| $ | (21,952 | ) |
| 153 | % |
| $ | (172,908 | ) |
| $ | (38,621 | ) |
| 348 | % |
Add: Share-based compensation |
| 26,346 |
|
|
| 26,305 |
|
| — | % |
|
| 98,170 |
|
|
| 77,173 |
|
| 27 | % |
Adjusted EBITDA | $ | (29,096 | ) |
| $ | 4,353 |
|
| (768 | )% |
| $ | (74,738 | ) |
| $ | 38,552 |
|
| (294 | )% |
Last Trade: | US$16.88 |
Daily Change: | -1.17 -6.48 |
Daily Volume: | 1,165,194 |
Market Cap: | US$1.830B |
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