Novocure Reports First Quarter 2024 Financial Results

Rhea-AI Summary

Novocure (NASDAQ: NVCR) reported strong financial results for the first quarter of 2024 with total net revenues of $138.5 million, up 13% year-over-year. The company had 3,845 active patients on therapy as of March 31, 2024. The METIS Phase 3 clinical trial met its primary endpoint and will be presented at ASCO 2024. Novocure also completed a successful Day-100 meeting with the FDA for the LUNAR PMA application.

Positive

• Strong quarterly net revenues of $138.5 million, up 13% year-over-year.

• Successful meeting with the FDA for the LUNAR PMA application.

• Completion of the METIS Phase 3 clinical trial with positive results to be presented at ASCO 2024.

• Continued growth in active patients on therapy, reaching 3,845 as of March 31, 2024.

Negative

• Net loss for the quarter was $38.8 million with a loss per share of $0.36.

• Adjusted EBITDA for the quarter was $(4.6) million.

• Increased sales and marketing expenses compared to the same period in 2023.

• Anticipated PMA decision for Optune Lua in NSCLC in the second half of 2024.

Insights

Financial Analyst

The reported 13% year-over-year revenue growth to $139 million and the increase in active patients to 3,845 exhibit a solid market acceptance and expansion of Novocure's therapies. The entry into the French market and improved U.S. approval rates are positive signals for scalability. However, investors should note the net loss of $38.8 million and a loss per share of $0.36, which, while not uncommon for a growth-phase biotech, indicate the company is still in an investment-heavy phase. The $870 million in cash and equivalents, bolstered by the new $400 million credit facility, provides liquidity and financial flexibility, which is critical for future research and commercialization efforts. The financials suggest a strategic focus on growth and market penetration, which could pay off with the successful launch of treatments in new indications such as non-small cell lung cancer.

Medical Research Analyst

The positive outcome of the Phase 3 METIS trial in brain metastases from non-small cell lung cancer is a significant clinical milestone. Meeting the primary endpoint may enhance the company's valuation by increasing the potential for label expansion and market penetration. Investors should recognize the value of a favorable Day-100 FDA meeting for the LUNAR PMA application, which indicates a smooth regulatory process thus far. The approval of the IND application for the KEYNOTE D58 trial and the exploratory analysis presented at the European Society of Gynaecological Oncology also add to the company's scientific credibility and could signal future revenue streams if the subsequent results are positive. These clinical developments could have a substantial impact on the company's long-term growth trajectory, making it an area to watch closely.

Market Research Analyst

Novocure's expansion into France and the growth in prescription rates reflect a strong market demand and the effectiveness of sales and marketing strategies. The 8% increase in sales and marketing expenses demonstrates a commitment to capturing market share, especially in anticipation of potential new launches. The global distribution of revenue, with significant contributions from the U.S., Germany and Japan, indicates a diversified and resilient market presence. The company seems well-positioned to leverage its international footprint to drive future growth, especially if the upcoming PMA decision for non-small cell lung cancer therapy is favorable. Investors might see this as an opportunity for Novocure to establish a robust competitive position in the oncology segment.

Quarterly net revenues of $139 million, up 13% year-over-year, with 3,845 active patients on therapy as of March 31, 2024

Phase 3 METIS trial in brain metastases from non-small cell lung cancer met primary endpoint and will be presented as late-breaking abstract at ASCO 2024

LUNAR PMA application for TTFields in NSCLC Day 100 FDA meeting complete

ROOT, Switzerland--(BUSINESS WIRE)-- Novocure (NASDAQ: NVCR) today reported financial results for the quarter ended March 31, 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 first quarter was a period of strong execution,” said William Doyle, Novocure’s Executive Chairman. “In Q1, GBM active patients grew 11%, we announced the METIS Phase 3 clinical trial met its primary endpoint, and we met with the U.S. Food and Drug Administration (FDA) in a Day-100 meeting for the LUNAR PMA application. We have multiple milestones ahead of us in 2024, and I remain grateful for our teams’ dedication and hard work.”

Financial updates for the first quarter ended March 31, 2024:

• Total net revenues for the quarter were $138.5 million, an increase of 13% compared to the same period in 2023. This increase was primarily driven by our successful launch in France and improved U.S. approval rates.
  • The United States, Germany and Japan contributed $90.5 million, $15.7 million and $7.8 million, respectively, with other active markets contributing $19.5 million.
  • Revenue in Greater China from Novocure’s partnership with Zai Lab totaled $4.9 million.
• Gross margin for the quarter was 76%.
• Research, development, and clinical studies expenses for the quarter were $51.6 million, a decrease of 14% from the same period in 2023. This primarily reflects decreased personnel expenses and reduced direct clinical trial expenses driven by the timing of activities within the clinical trial portfolio.
• Sales and marketing expenses for the quarter were $55.2 million, an increase of 8% compared to the same period in 2023. This primarily reflects sales force expansion and increased marketing activities in anticipation of our potential launch in non-small cell lung cancer.
• General and administrative expenses for the quarter were $39.5 million, a decrease of 6% compared to the same period in 2023. This primarily reflects lower personnel expenses.
• Net loss for the quarter was $38.8 million with loss per share of $0.36.
• Adjusted EBITDA* for the quarter was $(4.6) million.
• Cash, cash equivalents and short-term investments were $870 million as of March 31, 2024.
• In May, we entered into a new five-year senior secured credit facility agreement with affiliates of Pharmakon Advisors for up to $400 million, drawn across up to four tranches of $100 million. This non-dilutive, multi-tranche, delayed-draw, debt facility strengthens our cash position and further solidifies our balance sheet while providing valuable flexibility as we invest in our future.

Operational updates for the first quarter ended March 31, 2024:

• 1,643 prescriptions were received in the quarter, an increase of 10% compared to the same period in 2023. Prescriptions from the United States, Germany and Japan contributed 990, 206 and 91 prescriptions, respectively, with the remaining 356 prescriptions received in other active markets.
• As of March 31, 2024, there were 3,845 active patients on therapy. Active patients from the United States, Germany and Japan contributed 2,137, 540 and 379 active patients, respectively, with the remaining 789 active patients contributed by other active markets.

Quarterly updates and achievements:

• In April, we met with the FDA in a Day-100 meeting for the PMA application for Optune Lua in non-small cell lung cancer (NSCLC). The meeting was productive with no indication that the PMA will be referred to an advisory panel. We continue to anticipate the PMA decision in the second half of 2024.
• In March 2024, we announced the METIS Phase 3 clinical trial met its primary endpoint, demonstrating a statistically significant extension in time to intracranial progression for patients with brain metastases from NSCLC. The METIS trial data will be presented as a late-breaking abstract at the upcoming American Society of Clinical Oncology (ASCO) scientific congress in June.
• In March, the FDA approved the Investigational New Drug (IND) application for the randomized, Phase 3 KEYNOTE D58 trial. KEYNOTE D58 will explore the use of TTFields therapy together with temozolomide and the immunotherapy pembrolizumab for the treatment of newly diagnosed glioblastoma.
• In March, an exploratory subgroup analysis of the randomized, Phase 3 INNOVATE-3 trial was selected as a Best Oral Presentation at the European Society of Gynaecological Oncology 2024 Congress. The exploratory analysis found that pegylated liposomal doxorubicin (PLD) -naïve patients randomized to receive TTFields therapy and paclitaxel exhibited median overall survival of 16.0 months compared to 11.7 months in PLD-naïve patients treated with paclitaxel alone.

Anticipated 2024 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 first quarter 2024 financial results at 8:00 a.m. EDT today, Thursday, May 2, 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.

Consolidated Statements of Operations
USD in thousands (except share and per share data)
		Three months ended March 31,								Year ended December 31,
		2024				2023				2023
		Unaudited								Audited
Net revenues		$	138,503			$	122,182			$	509,338
Cost of revenues			33,689				29,614				128,280
Gross profit			104,814				92,568				381,058
Operating costs and expenses:
Research, development and clinical studies			51,598				59,704				223,062
Sales and marketing			55,206				51,169				226,809
General and administrative			39,530				41,944				164,057
Total operating costs and expenses			146,334				152,817				613,928
Operating income (loss)			(41,520	)			(60,249	)			(232,870	)
Financial income (expenses), net			9,878				9,169				41,130
Income (loss) before income taxes			(31,642	)			(51,080	)			(191,740	)
Income taxes			7,118				1,981				15,303
Net income (loss)		$	(38,760	)		$	(53,061	)		$	(207,043	)
Basic and diluted net income (loss) per ordinary share		$	(0.36	)		$	(0.50	)		$	(1.95	)
Weighted average number of ordinary shares used in computing basic and diluted net income (loss) per share			107,266,198				105,667,072				106,391,178

Consolidated Balance Sheets
USD in thousands (except share data)
		March 31, 2024			December 31, 2023
		Unaudited			Audited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents		$	453,763		$	240,821
Short-term investments			416,384			669,795
Restricted cash			3,600			1,743
Trade receivables, net			65,091			61,221
Receivables and prepaid expenses			21,479			22,677
Inventories			42,391			38,152
Total current assets			1,002,708			1,034,409
LONG-TERM ASSETS:
Property and equipment, net			58,917			51,479
Field equipment, net			11,911			11,384
Right-of-use assets			32,994			34,835
Other long-term assets			14,899			14,022
Total long-term assets			118,721			111,720
TOTAL ASSETS		$	1,121,429		$	1,146,129

Consolidated Balance Sheets
USD in thousands (except share data)
		March 31, 2024				December 31, 2023
		Unaudited				Audited
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES:
Trade payables		$	84,316			$	94,391
Other payables, lease liabilities and accrued expenses			75,914				84,724
Total current liabilities			160,230				179,115
LONG-TERM LIABILITIES:
Long-term debt, net			569,652				568,822
Long-term leases			25,608				27,420
Employee benefit liabilities			6,566				8,258
Other long-term liabilities			18				18
Total long-term liabilities			601,844				604,518
TOTAL LIABILITIES			762,074				783,633
COMMITMENTS AND CONTINGENCIES
SHAREHOLDERS' EQUITY:
Share capital -
Ordinary shares no par value, unlimited shares authorized; issued and outstanding: 107,603,774 shares and 107,075,754 shares at March 31, 2024 (unaudited) and December 31, 2023, respectively			—				—
Additional paid-in capital			1,387,765				1,353,468
Accumulated other comprehensive income (loss)			(4,147	)			(5,469	)
Retained earnings (accumulated deficit)			(1,024,263	)			(985,503	)
TOTAL SHAREHOLDERS' EQUITY			359,355				362,496
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY		$	1,121,429			$	1,146,129

Non-U.S. GAAP financial measures reconciliation
USD in thousands
		Three months ended March 31,
		2024				2023				% Change
Net income (loss)		$	(38,760	)		$	(53,061	)		(27	)%
Add: Income tax			7,118				1,981			259	%
Add: Financial expenses (income), net			(9,878	)			(9,169	)		8	%
Add: Depreciation and amortization			2,815				2,722			3	%
EBITDA		$	(38,705	)		$	(57,527	)		(33	)%
Add: Share-based compensation			34,084				39,084			(13	)%
Adjusted EBITDA		$	(4,621	)		$	(18,443	)		(75	)%

 

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Investors & Media:

Ingrid Goldberg

investorinfo@novocure.com

media@novocure.com

610-723-7427

Source: Novocure

FAQ

What were Novocure's total net revenues for the first quarter of 2024?

Novocure reported total net revenues of $138.5 million for the first quarter of 2024, representing a 13% increase year-over-year.

How many active patients were on therapy as of March 31, 2024?

As of March 31, 2024, Novocure had 3,845 active patients on therapy.

What milestone did Novocure achieve with the METIS Phase 3 clinical trial?

The METIS Phase 3 clinical trial met its primary endpoint, demonstrating positive results, and will be presented at ASCO 2024.

What financial milestone did Novocure reach in the first quarter of 2024?

Novocure reported a gross margin of 76% for the quarter, reflecting a strong financial performance.

What was Novocure's net loss for the first quarter of 2024?

Novocure reported a net loss of $38.8 million with a loss per share of $0.36 for the first quarter of 2024.