FDA deferred action on the BLA for ROLONTIS®
(eflapegrastim) due to inability to conduct inspection of the
manufacturing facility citing COVID-19 related travel
restrictions
Pre-NDA meeting with FDA is scheduled for
poziotinib in NSCLC HER2 exon-20 insertion mutations in previously
treated patients
Management to host webcast and conference call
today at 4:30 p.m. ET / 1:30 p.m. PT
Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a
biopharmaceutical company focused on novel and targeted oncology
therapies, announced today financial results for the three-month
period ended September 30, 2020.
“The third quarter was marked by significant progress in our
drug development programs and a strengthened financial position,”
said Joe Turgeon, President and CEO, Spectrum Pharmaceuticals. “Our
team is preparing for the upcoming pre-NDA meeting with the FDA for
poziotinib and actively working to obtain an approval for ROLONTIS
as soon as possible.”
Pipeline Updates
Poziotinib, an irreversible tyrosine kinase inhibitor
targeting EGFR and HER2 mutations
- Spectrum has a pre-NDA meeting with the FDA to review the
positive results from Cohort 2 and the path forward for poziotinib
registration for the treatment of patients with previously treated
locally advanced or metastatic NSCLC with HER2 exon 20 insertion
mutations.
- Spectrum presented the results from Cohort 2 at the European
Society for Medical Oncology (ESMO) Virtual Congress 2020 in
September. This marked the first presentation to the medical and
scientific community of the positive results from this
registrational cohort from the ZENITH20 clinical trial.
- Spectrum expects to provide poziotinib update, including dosing
strategy and topline results from Cohort 3 of the ZENITH20 trial in
first-line EGFR NSCLC patients, by year-end 2020.
ROLONTIS (eflapegrastim), a novel long-acting G-CSF
- The FDA deferred its action on the BLA for ROLONTIS, due to an
inability to inspect the Hanmi Bioplant in South Korea citing
travel restrictions related to the COVID-19 pandemic.
- Spectrum has confirmed with the FDA that the deferral is not a
Complete Response Letter (CRL). The company is actively working to
find a way to expedite the plant inspection.
Three-Month Period Ended September 30,
2020 (All numbers are from Continuing Operations and are
approximate)
GAAP Results
Spectrum recorded a net loss of $48.5 million, or $0.37 loss per
basic and diluted share, in the three-month period ended September
30, 2020, compared to a net loss of $26.6 million, or $0.24 loss
per basic and diluted share, in the comparable period in 2019.
Total research and development expenses were $24.5 million in the
quarter, as compared to $17.2 million in the same period in 2019.
Selling, general and administrative expenses were $15.1 million in
the quarter, compared to $13.1 million in the same period in
2019.
The company ended the quarter with cash, cash equivalents, and
marketable securities of $198.3 million.
Non-GAAP Results
Spectrum recorded a non-GAAP net loss of $35.2 million, or $0.27
loss per basic and diluted share, in the three-month period ended
September 30, 2020, compared to a non-GAAP net loss of $24.5
million, or $0.22 per basic and diluted share, in the comparable
period in 2019. Non-GAAP research and development expenses were
$23.3 million, as compared to $16.1 million in the same period of
2019. Non-GAAP selling, general and administrative expenses were
$12.3 million, as compared to $9.9 million in the same period in
2019.
Conference Call and Webcast
Spectrum’s management will host a webcast and conference call
today, November 4, 2020, at 4:30 p.m. ET / 1:30 p.m. PT to discuss
the financial results and provide a corporate update. The live call
may be accessed by dialing (877) 837-3910 for domestic callers and
(973) 796-5077 for international callers and entering the
conference ID#: 1281757. A live webcast of the call will be
available from the Investor Relations section of the company’s
website at http://investor.sppirx.com/events-and-presentations
and will be archived there shortly after the live event.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a biopharmaceutical company focused
on acquiring, developing, and commercializing novel and targeted
oncology therapies. Spectrum has a strong track record of
successfully executing across the biopharmaceutical business model,
from in-licensing and acquiring differentiated drugs, clinically
developing novel assets, successfully gaining regulatory approvals
and commercializing in a competitive healthcare marketplace.
Spectrum has a late-stage pipeline with novel assets that serve
areas of unmet need. This pipeline has the potential to transform
the company in the near future. For additional information on
Spectrum Pharmaceuticals, please visit www.sppirx.com.
About ZENITH20
The ZENITH20 study consists of seven cohorts of NSCLC patients.
Cohorts 1 (EGFR) and 2 (HER2) have completed enrollment of
previously treated NSCLC patients with exon 20 mutations. Cohort 3
(EGFR) has completed enrollment and Cohort 4 (HER2) is currently
enrolling first-line NSCLC patients with exon 20 mutations. Cohorts
1- 4 are each independently powered for a pre-specified statistical
hypothesis and the primary endpoint is objective response rate
(ORR). Cohort 5 includes previously treated or treatment-naïve
NSCLC patients with EGFR or HER2 exon 20 insertion mutations.
Cohort 6 includes NSCLC patients with classical EGFR mutations who
progressed while on treatment with first-line osimertinib and
developed an additional EGFR mutation. Cohort 7 includes NSCLC
patients with a variety of less common mutations in EGFR or HER2
exons 18-21 or the extracellular or transmembrane domains.
Notice Regarding Forward-Looking Statements
Certain statements in this press release may constitute
“forward-looking statements” within the meaning of the United
States Private Securities Litigation Reform Act of 1995, as amended
to date. These forward-looking statements relate to a variety of
matters, including, without limitation, statements that relate to
Spectrum’s business and its future, including the significance of
Cohort 2’s reported results; the outcome of the upcoming pre-NDA
meeting with the FDA regarding poziotinib and the FDA’s
determination of a path forward for poziotinib; poziotinib’s
potential to significantly advance the treatment of NSCLC patients
with HER2 exon 20 insertion mutations; the timing and results of
future FDA decisions, including the timing of the FDA’s inspection
of the Hanmi Bioplant in South Korea and its action on the ROLONTIS
BLA; the timing of the poziotinib update, including dosing strategy
and topline results from Cohort 3; the overall progression of the
poziotinib and ROLONTIS development programs; the company’s ability
to advance and fund the development and commercialization of its
late-stage pipeline assets and such assets’ ability to serve areas
of unmet need; the future potential of the company’s existing drug
pipeline and its ability to transform the company in the near
future; and other statements that are not purely statements of
historical fact. These forward-looking statements are made on the
basis of the current beliefs, expectations, and assumptions of the
management of Spectrum and are subject to significant risks and
uncertainties that could cause actual results to differ materially
from what may be expressed or implied in these forward-looking
statements. Risks that could cause actual results to differ
include, but are not limited to, the possibility that the different
methodologies, assumptions and applications the company utilizes to
assess particular safety or efficacy parameters may yield different
statistical results, and even if the company believes the data
collected from the clinical trials of its product candidates,
including poziotinib, are positive, these data may not be
sufficient to support approval by the FDA; the ongoing effects of
the COVID-19 pandemic, including the duration of travel
restrictions related thereto; the possibility that success in early
clinical trials, especially if based on a small patient sample,
might not result in success in later clinical trials, and other
unforeseen events during clinical trials which could cause delays
or other adverse consequences; other uncertainties inherent in new
product development; the possibility that Spectrum’s new and
existing drug candidates, including ROLONTIS and poziotinib, may
not ultimately prove to be safe or effective; the possibility that
Spectrum’s new and existing drug candidates, if approved, may not
be more effective, safer, or more cost efficient than competing
drugs; and other risks that are described in further detail in the
company's reports filed with the Securities and Exchange
Commission. The company does not plan to update any such
forward-looking statements and expressly disclaims any duty to
update the information contained in this press release except as
required by law. For a further discussion of risks and
uncertainties that could cause actual results to differ from those
expressed in these forward-looking statements, as well as risks
relating to the business of Spectrum in general, see the risk
disclosures in the Annual Report on Form 10-K of Spectrum for the
year ended December 31, 2019, and in subsequent reports on Forms
10-Q and 8-K and other filings made with the SEC by Spectrum.
SPECTRUM PHARMACEUTICALS, INC.® and ROLONTIS® are registered
trademarks of Spectrum Pharmaceuticals, Inc. and its affiliates.
REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals’ logos are
trademarks owned by Spectrum Pharmaceuticals, Inc. Any other
trademarks are the property of their respective owners.
© 2020 Spectrum Pharmaceuticals, Inc. All Rights Reserved
SPECTRUM PHARMACEUTICALS,
INC.
Condensed Consolidated
Statements of Operations
(In thousands, except share and
per share amounts)
(Unaudited)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2020
2019
2020
2019
Revenues
$
—
$
—
$
—
$
—
Operating costs and expenses:
Selling, general and administrative
15,116
13,126
44,654
46,308
Research and development
24,453
17,167
62,192
56,035
Total operating costs and expenses
39,569
30,293
106,846
102,343
Loss from continuing operations before
other income (expense) and income taxes
(39,569
)
(30,293
)
(106,846
)
(102,343
)
Other income (expense):
Interest income, net
188
1,521
1,217
4,076
Other income (expense), net
(9,131
)
2,015
(15,720
)
(5,547
)
Total other income (expense)
(8,943
)
3,536
(14,503
)
(1,471
)
Loss from continuing operations before
income taxes
(48,512
)
(26,757
)
(121,349
)
(103,814
)
(Provision) benefit for income taxes from
continuing operations
(6
)
200
(15
)
8,628
Loss from continuing operations
$
(48,518
)
$
(26,557
)
$
(121,364
)
$
(95,186
)
Income from discontinued operations, net
of income taxes
66
572
255
21,547
Net loss
$
(48,452
)
$
(25,985
)
$
(121,109
)
$
(73,639
)
Basic and diluted loss per share:
Loss from continuing operations
$
(0.37
)
$
(0.24
)
$
(1.02
)
$
(0.86
)
Income from discontinued operations
$
0.00
$
0.01
$
0.00
$
0.20
Net loss per share, basic and diluted
$
(0.37
)
$
(0.23
)
$
(1.02
)
$
(0.67
)
Weighted average shares outstanding, basic
and diluted
131,455,727
111,178,880
118,664,914
110,291,090
SPECTRUM PHARMACEUTICALS,
INC.
Condensed Consolidated Balance
Sheets
(In thousands, expect per share
and par value amounts)
(Unaudited)
September 30,
2020
December 31,
2019
ASSETS
Current assets:
Cash and cash equivalents
$
77,132
$
64,418
Marketable securities
121,179
159,455
Accounts receivable, net of allowance for
credit losses of $43 and $43, respectively
453
441
Other receivables
3,186
9,558
Prepaid expenses and other current
assets
10,876
10,148
Total current assets
212,826
244,020
Property and equipment, net
18,456
11,607
Facility and equipment under lease
2,662
3,806
Other assets
3,994
4,000
Total assets
$
237,938
$
263,433
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable and other accrued
liabilities
$
52,985
$
54,284
Accrued payroll and benefits
8,113
7,686
Total current liabilities
61,098
61,970
Other long-term liabilities
8,480
11,070
Total liabilities
69,578
73,040
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $0.001 par value;
5,000,000 shares authorized; no shares issued and outstanding
—
—
Common stock, $0.001 par value;
300,000,000 shares authorized; 145,931,172 and 113,299,612 issued
and outstanding at September 30, 2020 and December 31, 2019,
respectively
146
113
Additional paid-in capital
1,016,474
918,205
Accumulated other comprehensive loss
(2,724
)
(3,498
)
Accumulated deficit
(845,536
)
(724,427
)
Total stockholders’ equity
168,360
190,393
Total liabilities and stockholders’
equity
$
237,938
$
263,433
Non-GAAP Financial Measures (from Continuing
Operations)
In this press release, Spectrum reports certain historical
results that have not been prepared in accordance with generally
accepted accounting principles (GAAP), including non-GAAP selling,
general and administrative expenses, non-GAAP research and
development expenses, non-GAAP net loss and non-GAAP net loss per
share. Non-GAAP financial measures are reconciled to the most
directly comparable GAAP financial measures in the tables of this
press release and the accompanying footnotes. The non-GAAP
financial measures contained herein are a supplement to the
corresponding financial measures prepared in accordance with GAAP.
The non-GAAP financial measures presented exclude the items
summarized in the below table.
Management believes that adjustments for these items assist
investors in making comparisons of period-to-period operating
results and that these items are not indicative of the company's
on-going core operating performance. Management uses non-GAAP net
income (loss) in its evaluation of the company's core after-tax
results of operations and trends between fiscal periods and
believes that these measures are important components of its
internal performance measurement process. Management believes that
these non-GAAP financial measures are useful to investors in
providing greater transparency to the information used by
management in its operational decision-making. Management believes
that the use of these non-GAAP financial measures also facilitates
a comparison of the company’s underlying operating performance with
that of other companies in its industry, which use similar non-GAAP
measures to supplement their GAAP results.
The non-GAAP financial measures presented herein have certain
limitations in that they do not reflect all of the costs associated
with the operations of the company's business as determined in
accordance with GAAP. Therefore, investors should consider non-GAAP
financial measures in addition to, and not as a substitute for, or
as superior to, measures of financial performance prepared in
accordance with GAAP. In addition, other companies, including other
companies in our industry, may calculate non-GAAP financial
measures differently than we do, limiting their usefulness as a
comparative tool. Investors and potential investors are encouraged
to review the reconciliation of our non-GAAP financial measures
contained within this news release with our GAAP financial
results.
SPECTRUM PHARMACEUTICALS,
INC.
Reconciliation of Non-GAAP
Adjustments for Condensed Consolidated Statements of
Operations
(In thousands, expect per share
amounts)
CONTINUING OPERATIONS
ONLY
Three Months Ended
September 30,
CONTINUING OPERATIONS
ONLY
Nine Months Ended
September 30,
2020
2019
2020
2019
(1)
GAAP selling, general and
administrative
$
15,116
$
13,126
$
44,654
$
46,308
Non-GAAP adjustments to SG&A:
Stock-based compensation expense
(3,018
)
(3,155
)
(9,773
)
(10,254
)
Depreciation expense
144
(58
)
(74
)
(180
)
Lease expense
23
—
47
(129
)
Severance expense
—
—
—
(1,515
)
Non-GAAP selling, general and
administrative
$
12,265
$
9,913
$
34,854
$
34,230
(2)
GAAP research and development
$
24,453
$
17,167
$
62,192
$
56,035
Non-GAAP adjustments to R&D:
Stock-based compensation expense
(1,090
)
(1,030
)
(3,598
)
(3,190
)
Depreciation expense
(33
)
(30
)
(98
)
(45
)
Severance expense
—
—
—
(260
)
R&D milestones and in-license upfront
fees
—
—
—
(2,751
)
Non-GAAP research and
development
$
23,330
$
16,107
$
58,496
$
49,789
(3)
GAAP net loss from continuing
operations
$
(48,518
)
$
(26,557
)
$
(121,364
)
$
(95,186
)
Non-GAAP adjustments to net loss from
continuing operations:
Adjustments to SG&A and R&D, as
noted above
3,974
4,273
13,496
18,324
Adjustments to other (income) expense
9,317
(1,979
)
15,899
6,449
Adjustments to provision (benefit) for
income taxes
6
(200
)
15
(8,628
)
Non-GAAP net loss from continuing
operations
$
(35,221
)
$
(24,463
)
$
(91,954
)
$
(79,041
)
(4)
GAAP net loss from continuing
operations - per basic and diluted share
$
(0.37
)
$
(0.24
)
$
(1.02
)
$
(0.86
)
Non-GAAP net loss from continuing
operations - per basic and diluted share
$
(0.27
)
$
(0.22
)
$
(0.77
)
$
(0.72
)
Weighted average shares outstanding, basic
and diluted
131,455,727
111,178,880
118,664,914
110,291,090
(1) Non-GAAP selling, general and
administrative expenses (from continuing operations):
These amounts reflect adjustments to reverse allocated operating
expenses for certain non-cash items (including stock-based
compensation, depreciation and lease expense), as well as the
reversal of non-recurring severance expenses. We believe the
resulting non-GAAP SG&A value is reflective of the
period-over-period success of our administrative expense control
and more indicative of our normalized SG&A expense trends.
(2) Non-GAAP research and development
expenses (from continuing operations): These amounts
reflect adjustments to reverse allocated operating expenses for
certain non-cash items (including stock-based compensation and
depreciation), as well as the reversal of non-recurring severance
expenses and R&D milestone achievements and in-license upfront
fees that we record to this expense caption. We believe this
resulting non-GAAP R&D value is more indicative of our
normalized R&D expense trends.
(3) Non-GAAP net loss (from continuing
operations): These amounts reflect all non-GAAP
adjustments described in (1) through (2) above, plus other non-cash
and/or non-recurring items, including: (i) adjustments to reverse
the impact of income taxes; (ii) reversal of foreign exchange gains
and losses (non-cash); (iii) reversal of the mark-to-market
adjustment (non-cash) on our equity securities holdings; and (iv)
reversal of realized gain recorded on the sales of our equity
holdings.
(4) Non-GAAP net loss per share (from
continuing operations): These amounts reflect all
non-GAAP adjustments in (1) through (3) above to present our
overall non-GAAP financial results for each period on a per-share
basis.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201104005642/en/
Robert Uhl Managing Director, Westwicke ICR 858.356.5932
robert.uhl@westwicke.com
Kurt Gustafson Chief Financial Officer 949.788.6700
InvestorRelations@sppirx.com
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