Quarterly net revenues of $127 million with 3,639 active
patients on therapy as of September 30, 2023
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:
- Total net revenues for the quarter were $127.3 million, a
decrease of 3% compared to the same period in 2022. The decrease
resulted primarily from $14.5 million in reduced collections from
denied or appealed claims in the U.S.
- The United States, Germany and Japan contributed $86.2 million,
$14.7 million and $7.6 million, respectively, with our other active
markets contributing $12.1 million.
- Revenue in Greater China from Novocure’s partnership with Zai
Lab totaled $6.8 million.
- Gross margin for the quarter was 75%.
- Research, development and clinical studies expenses for the
quarter were $53.6 million, an increase of 3% from the same period
in 2022. This primarily reflects the increase in quality assurance,
regulatory affairs, product development and safety costs in
anticipation of clinical trial launches and regulatory filings.
Total clinical trial expenses can fluctuate quarter-to-quarter
dependent upon the amount of clinical research organization
services delivered, clinical materials procured and number of
trials actively underway. As our current phase 3 clinical trials
near completion, we expect to backfill our clinical trial pipeline
with new phase 2 and 3 trials.
- Sales and marketing expenses for the quarter were $58.0
million, an increase of 40% compared to 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 future approvals in new
indications.
- General and administrative expenses for the quarter were $41.9
million, an increase of 29% compared to the same period in 2022.
This primarily reflects increased personnel and project costs to
support larger patient populations, new geographic launches, supply
chain expansion and information technology enhancements.
- Net loss for the quarter was $49.5 million with loss per share
of $0.46.
- Adjusted EBITDA* for the quarter was $(29.1) million.
- Cash, cash equivalents and short-term investments were $921.2
million as of September 30, 2023.
Operational updates for the third quarter ended September 30,
2023:
- 1,467 prescriptions were received in the quarter, an increase
of 6% compared to the same period in 2022. Prescriptions from the
United States, Germany and Japan contributed 920, 163 and 85
prescriptions, respectively, with the remaining 299 prescriptions
received in our other active markets.
- As of September 30, 2023, there were 3,639 active patients on
therapy. Active patients from the United States, Germany and Japan
contributed 2,179, 492 and 353 active patients, respectively, with
the remaining 615 active patients contributed by our other active
markets.
Quarterly updates and achievements:
- In August, the primary data from the phase 3 LUNAR clinical
trial were published in The Lancet Oncology. These data were the
basis for a CE Mark submission in June and will be submitted as
part of a Premarket Approval submission to the U.S. Food and Drug
Administration later this year.
- In September, the first patient was enrolled in the phase 2
PANOVA-4 clinical trial evaluating the safety and efficacy of
TTFields therapy together with atezolizumab, gemcitabine and
nab-paclitaxel in the treatment of metastatic pancreatic cancer.
The PANOVA-4 trial is the result of a clinical study collaboration
with Roche.
- In October, we entered an agreement with Stanford University to
establish the Stanford School of Medicine Tumor Treating Fields
Research Program, intended to support both preclinical and clinical
trials exploring the use of TTFields.
- In August, we announced the phase 3 INNOVATE-3 clinical trial
for the treatment of platinum-resistant ovarian cancer did not meet
the primary endpoint of overall survival at final analysis. An
exploratory subgroup analysis suggested a potential survival
benefit in patients who received only one prior line of therapy.
Consistent with previously reported studies, TTFields therapy was
well-tolerated with no added systemic toxicities. Full evaluation
of the trial data, including subgroup analyses, is ongoing and we
will work with trial investigators to share the full results with
the scientific community in the future.
Anticipated clinical milestones:
- Top-line data from phase 3 METIS clinical trial in brain
metastases (Q1 2024)
- Top-line data from phase 3 PANOVA-3 clinical trial in locally
advanced pancreatic cancer (H2 2024)
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
30,
Nine months ended September
30,
Year ended December
31,
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,
2023
December 31, 2022
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,
2023
December 31, 2022
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
)%
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231026667219/en/
Investors: Ingrid Goldberg investorinfo@novocure.com
610-723-7427
Media: Leigh Labrie media@novocure.com 610-723-7428
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