Quarterly net revenues of $150 million, up 19% year-over-year,
with 3,963 active patients on therapy as of June 30, 2024
Positive results from Phase 3 METIS trial in brain metastases
from non-small cell lung cancer presented at ASCO 2024
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 December
31,
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, 2024
December 31, 2023
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, 2024
December 31, 2023
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
)%
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240725581079/en/
Investors & Media: Ingrid Goldberg
investorinfo@novocure.com media@novocure.com
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