Full year 2023 net revenues of $509 million and fourth quarter
net revenues of $134 million
PMA application for TTFields in NSCLC accepted for review by
U.S. Food and Drug Administration
Enrollment completed in phase 3 TRIDENT trial studying the use
of TTFields therapy and concomitant radiation for the treatment of
newly diagnosed GBM
Novocure (NASDAQ: NVCR) today reported financial results for the
quarter and full year ended December 31, 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).
“In 2023, we reached many milestones in our commercial, clinical
and product development programs,” said Asaf Danziger, Novocure’s
Chief Executive Officer. “Our launch in France is off to a strong
start and globally we finished the year with 9% year-over-year
growth in active patients.
“Our LUNAR phase 3 clinical trial in non-small cell lung cancer
met its primary endpoint and we submitted marketing applications to
the regulatory bodies in our key markets,” continued Mr. Danziger.
“We also completed enrollment of three additional phase 3 trials –
METIS, PANOVA-3, and most recently, TRIDENT. Finally, we
successfully introduced our next generation arrays in several
European markets and we have filed for regulatory approval to
launch in the U.S. I am incredibly proud of our colleagues’
achievements in 2023 and look forward to an exciting 2024.”
“2024 will be a pivotal year for Novocure,” said William Doyle,
Novocure’s Executive Chairman. “We are laser-focused on achieving
three core objectives – growing our GBM business, launching
TTFields therapy in non-small cell lung cancer, and delivering the
promise of our clinical trial and product development pipelines.
Achieving our goals should position Novocure for sustained success
for years to come.”
Financial updates for the full year and fourth quarter ended
December 31, 2023:
- Total net revenues for the year were $509.3 million, a decrease
of 5% year-over-year. This decrease resulted primarily from $48
million in reduced collections from denied or appealed claims in
the U.S., which were largely exhausted in 2022. We expect future
net revenue to more closely reflect core drivers of net revenue:
number of active patients on therapy, duration of therapy, and net
realized price per month.
- Total net revenues for the quarter were $133.8 million, an
increase of 4% year-over-year.
- The United States, Germany and Japan contributed $91.3 million,
$14.7 million and $7.6 million in quarterly net revenues,
respectively, with our other active markets contributing $15.9
million.
- Revenue in Greater China from Novocure’s partnership with Zai
Lab totaled $4.4 million.
- Gross margin for the quarter was 76%. Gross margin was impacted
by increased investments in patient support capacity and the
rollout of our next generation arrays. In time, we expect these
impacts to be offset by increased active patient counts as well as
improved efficiencies and scale within our supply chain as we
optimize manufacturing for our new arrays.
- Research, development and clinical studies expenses for the
quarter were $54.3 million, a decrease of 1% from the same period
in 2022. Clinical trial expenses can fluctuate quarter-to-quarter
dependent upon the number of clinical trials actively underway,
amount of clinical research organization services delivered and
clinical materials procured.
- Sales and marketing expenses for the quarter were $59.2
million, an increase of 19% from the same period in 2022. This
primarily reflects increased costs associated with geographic
expansion and pre-launch activities intended to increase awareness
of TTFields therapy in anticipation of our launch in non-small cell
lung cancer (NSCLC).
- General and administrative expenses for the quarter were $39.4
million, an increase of 4% from the same period in 2022.
- Net loss for the quarter was $47.1 million with loss per share
of $0.45.
- Adjusted EBITDA* for the quarter was $(31.6) million.
- Cash, cash equivalents and short-term investments were $910.6
million as of December 31, 2023.
Operational updates for the fourth quarter ended December 31,
2023:
- 1,564 prescriptions were received in the quarter, an increase
of 14% year-over-year. Prescriptions from the United States,
Germany and Japan contributed 960, 217 and 105 prescriptions,
respectively, with the remaining 282 prescriptions received in our
other active markets.
- As of December 31, 2023, there were 3,755 active patients on
therapy, an increase of 9% year-over-year. Active patients from the
United States, Germany and Japan contributed 2,162, 525 and 375
active patients, respectively, with the remaining 693 active
patients contributed by our other active markets.
Quarterly updates and achievements:
- In December, Novocure submitted a Premarket Approval (PMA)
application to the U.S. Food and Drug Administration (FDA) seeking
approval for the use of TTFields therapy together with standard
therapies for the treatment of NSCLC, following progression on or
after platinum-based therapy. In January, the FDA accepted the
application for filing and it is now under substantive review as of
December 15, 2023. Novocure also has active regulatory submissions
under review in the European Union and Japan.
- In December 2023, Novocure submitted a PMA supplement to the
FDA for Optune Gio® next generation arrays for newly diagnosed
glioblastoma.
- In January, Novocure completed enrollment in the phase 3
TRIDENT clinical trial evaluating the efficacy of initiating Optune
Gio use concurrent with radiation therapy and temozolomide for the
treatment of adult patients with newly diagnosed GBM. Patients will
be followed for a minimum of 24 months with data anticipated in
2026.
- In January, Novocure announced the appointment of Dr. Nicolas
Leupin to the role of Chief Medical Officer. Dr. Leupin joins
Novocure with an established track record of leadership and
innovation in the biopharmaceutical sector, built upon extensive
experience as a practicing medical oncologist and educator.
Anticipated clinical milestones:
- Top-line data from the phase 3 METIS clinical trial in brain
metastases (late Q1 2024)
- Top-line data from the phase 3 PANOVA-3 clinical trial in
locally advanced pancreatic cancer (Q4 2024)
- Data from the phase 3 TRIDENT clinical trial in newly diagnosed
glioblastoma (2026)
Conference call details Novocure will host a conference
call and webcast to discuss fourth quarter and full year 2023
financial results at 8:00 a.m. EST today, Thursday, February 22,
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 and 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 studies 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 study
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
flings 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
December 31,
Twelve months ended December
31,
2023
2022
2023
2022
Net revenues
$
133,784
$
128,429
$
509,338
$
537,840
Cost of revenues
32,556
28,888
128,280
114,867
Gross profit
101,228
99,541
381,058
422,973
Operating costs and expenses:
Research, development and clinical
studies
54,308
54,820
223,062
206,085
Sales and marketing
59,188
49,629
226,809
173,658
General and administrative
39,448
38,070
164,057
132,753
Total operating costs and expenses
152,944
142,519
613,928
512,496
Operating income (loss)
(51,716
)
(42,978
)
(232,870
)
(89,523
)
Financial (expenses) income, net
13,182
10,420
41,130
7,677
Income (loss) before income tax
(38,534
)
(32,558
)
(191,740
)
(81,846
)
Income tax
8,545
4,745
15,303
10,688
Net income (loss)
$
(47,079
)
$
(37,303
)
$
(207,043
)
$
(92,534
)
Basic and diluted net income (loss) per
ordinary share
$
(0.45
)
$
(0.36
)
$
(1.95
)
$
(0.88
)
Weighted average number of ordinary shares
used in computing basic and diluted net income (loss) per share
106,983,693
105,026,945
106,391,178
104,660,476
Consolidated Balance Sheets
USD in thousands (except share data)
December 31,
2023
2022
Assets
Current assets:
Cash and cash equivalents
$
240,821
$
115,326
Short-term investments
669,795
854,099
Restricted cash
1,743
508
Trade receivables, net
61,221
86,261
Receivables and prepaid expenses
22,677
25,959
Inventories
38,152
29,376
Total current assets
1,034,409
1,111,529
Long-term assets:
Property and equipment, net
51,479
32,678
Field equipment, net
11,384
12,684
Right-of-use assets
34,835
23,596
Other long-term assets
14,022
11,161
Total long-term assets
111,720
80,119
Total assets
$
1,146,129
$
1,191,648
Consolidated Balance Sheets
USD in thousands (except share data)
December 31,
2023
2022
Liabilities and shareholders’
equity
Current liabilities:
Trade payables
$
94,391
$
85,197
Other payables, lease liabilities and
accrued expenses
84,724
73,580
Total current liabilities
179,115
158,777
Long-term liabilities:
Long-term debt, net
568,822
565,509
Deferred revenues
—
2,878
Employee benefit liabilities
8,258
4,404
Long term leases
27,420
18,762
Other long-term liabilities
18
148
Total long-term liabilities
604,518
591,701
Total liabilities
783,633
750,478
Commitments and contingencies
Shareholders’ equity:
Share capital -
Ordinary shares - No par value, Unlimited
shares authorized; Issued and outstanding: 107,075,754 shares and
105,049,411 shares at December 31, 2023 and December 31, 2022
respectively;
—
—
Additional paid-in capital
1,353,468
1,222,063
Accumulated other comprehensive loss
(5,469
)
(2,433
)
Accumulated deficit
(985,503
)
(778,460
)
Total shareholders’ equity
362,496
441,170
Total liabilities and shareholders’
equity
$
1,146,129
$
1,191,648
Non-U.S. GAAP financial measures
reconciliation
USD in thousands
Three months ended December
31,
Twelve months ended December
31,
2023
2022
% Change
2023
2022
% Change
Net income (loss)
$
(47,079
)
$
(37,303
)
26
%
$
(207,043
)
$
(92,534
)
124
%
Add: Income tax
8,545
4,745
80
%
$
15,303
$
10,688
43
%
Add: Financial expenses (income), net
(13,182
)
(10,420
)
27
%
$
(41,130
)
$
(7,677
)
436
%
Add: Depreciation and amortization
2,723
2,700
1
%
$
10,969
$
10,624
3
%
EBITDA
$
(48,993
)
$
(40,278
)
22
%
$
(221,901
)
$
(78,899
)
181
%
Add: Share-based compensation
17,438
29,782
(41)
%
$
115,608
$
106,955
8
%
Adjusted EBITDA
$
(31,555
)
$
(10,496
)
201
%
$
(106,293
)
$
28,056
(479)
%
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240222751967/en/
Investors & Media: Ingrid Goldberg 610-723-7427
investorinfo@novocure.com media@novocure.com
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