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
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
)%
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240502292080/en/
Investors & Media: Ingrid Goldberg
investorinfo@novocure.com media@novocure.com 610-723-7427
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