BLA for ROLONTIS® (eflapegrastim)
accepted for FDA review - PDUFA date on October 24, 2020
Data from poziotinib Cohort 1 of ZENITH20
accepted for podium presentation on March 18 at 11th Annual
Congress on Pulmonary and Respiratory Medicine in Amsterdam
Spectrum plans to hold a conference call
following the data presentation to review the data and strategy of
the program
Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a
biopharmaceutical company focused on novel and targeted oncology
therapies, announced today financial results for the three-month
period and year ended December 31, 2019.
“ROLONTIS is in active review by the FDA and we are preparing to
launch shortly following approval,” said Joe Turgeon, President and
CEO, Spectrum Pharmaceuticals. “We believe this market represents a
significant commercial opportunity and our prelaunch activities are
well underway. We have a podium presentation on poziotinib in a few
short weeks, we have taken steps to adjust our strategy and we have
multiple data catalysts in 2020. I look forward to updating you on
our progress throughout the year.”
Pipeline Updates
ROLONTIS (eflapegrastim), a novel long-acting G-CSF
- FDA is actively reviewing the BLA for ROLONTIS for the
treatment of chemotherapy-induced neutropenia. The PDUFA target
action date for the ROLONTIS BLA has been set for October 24,
2020.
- In October 2019, Spectrum presented a poster at the ASCO
Supportive Care in Oncology Symposium in San Francisco. The poster
highlighted integrated efficacy data from the Phase 3 ROLONTIS
clinical trials, ADVANCE and RECOVER, which studied more than 600
patients combined and met all primary and secondary endpoints.
- An abstract reporting preclinical data on eflapegrastim or
pegfilgrastim using “same day dosing” as chemotherapy has been
accepted for presentation at the AACR meeting April 24-29 in San
Diego.
Poziotinib, an irreversible tyrosine kinase inhibitor
targeting EGFR and HER2 mutations
- The pre-specified primary endpoint in a Phase 2 clinical trial
(ZENITH20) evaluating poziotinib in previously treated non-small
cell lung cancer (NSCLC) patients with EGFR exon 20 insertion
mutations was not achieved in Cohort 1.
- Data from Cohort 1 will be presented in a podium presentation
at the 11th Annual Congress on Pulmonary and Respiratory Medicine
in Amsterdam on March 18th.
- Cohort 2 of the ZENITH20 trial enrolling previously treated
HER2 non-small cell lung cancer patients is fully accrued and is
expected to have topline results by mid-year 2020. Cohort 3 of the
ZENITH20 trial enrolling first-line EGFR NSCLC patients is expected
to have topline results by year-end 2020. Either cohort has the
potential to support a future NDA submission.
Three-Month Period Ended December 31,
2019 (All numbers are from Continuing Operations)
GAAP Results
Spectrum recorded net loss of $40.2 million, or $0.36 per basic
and diluted share, in the three-month period ended December 31,
2019, compared to net loss of $53.1 million, or $0.50 per basic and
diluted share, in the comparable period in 2018. Total research and
development expenses were $23.3 million in the quarter, as compared
to $29.9 million in the same period in 2018. Selling, general and
administrative expenses were $15.1 million in the quarter, compared
to $16.6 million in the same period in 2018.
Non-GAAP Results
Spectrum recorded non-GAAP net loss of $33.4 million, or $0.30
per basic and diluted share, in the three-month period ended
December 31, 2019, compared to non-GAAP net loss of $43.4 million,
or $0.41 per basic and diluted share, in the comparable period in
2018. Non-GAAP research and development expenses were $22.4
million, as compared to $29.2 million in the same period of 2018.
Non-GAAP selling, general and administrative expenses were $11.6
million, as compared to $14.0 million in the same period in
2018.
Twelve-Month Period Ended December 31,
2019 (All numbers are from Continuing Operations)
GAAP Results
Spectrum recorded net loss of $135.4 million, or $1.22 per basic
and diluted share, in the twelve-month period ended December 31,
2019, compared to net loss of $126.7 million, or $1.23 per basic
and diluted share, in the comparable period in 2018. Total research
and development expenses were $79.3 million for the year, as
compared to $75.2 million in the same period in 2018. Selling,
general and administrative expenses were $61.4 million for the
year, compared to $62.7 million in the same period in 2018.
Non-GAAP Results
Spectrum recorded non-GAAP net loss of $111.9 million, or $1.01
per basic and diluted share, in the twelve-month period ended
December 31, 2019, compared to non-GAAP net loss of $124.3 million,
or $1.20 per basic and diluted share, in the comparable period in
2018. Non-GAAP research and development expenses were $72.0
million, as compared to $72.1 million in the same period of 2018.
Non-GAAP selling, general and administrative expenses were $45.5
million, as compared to $53.2 million in the same period in
2018.
Cash Position and
Guidance
Spectrum reported cash, cash equivalents, restricted cash, and
marketable securities of approximately $224 million as of December
31, 2019, compared to $204 million at December 31, 2018. Based on
current operating plans, Spectrum expects that SG&A expense
will increase in the second half of this year as we scale up our
commercial operations in preparation to launch ROLONTIS.
Conference
Call
Thursday,
February 27, 2020 @ 4:30 p.m. Eastern/1:30 p.m.
Pacific
Domestic:
(877) 837-3910, Conference ID# 4475135
International:
(973) 796-5077, Conference ID# 4475135
This conference call will also be webcast. Listeners may access
the webcast, which will be available on the investor relations page
of Spectrum Pharmaceuticals' website:
http://investor.sppirx.com/events-and-presentations on February 27,
2020 at 4:30 p.m. Eastern/1:30 p.m. Pacific.
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) and 4 (HER2) are 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 likelihood and
timing of FDA approval of ROLONTIS, the size of the potential
market for ROLONTIS and the timing of its commercial launch, the
company’s ability to advance development of its late-stage pipeline
assets, the ability of such assets to meet currently unaddressed
medical needs, the timing of the results of cohort 2 and cohort 3
in Spectrum’s ZENITH20 study and their potential to support future
NDA submissions, the future potential of Spectrum’s existing drug
pipeline, the progression of the poziotinib development program 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 uncertainties inherent in new product development,
including clinical trial results and additional analysis of
existing preclinical and clinical data, the possibility that
Spectrum's new and existing drug candidates, including 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 per share
amounts)
(Unaudited)
Three Months Ended December
31,
Twelve Months Ended December
31,
2019
2018
2019
2018
Revenues
$
—
$
—
$
—
$
—
Operating costs and expenses:
Selling, general and administrative
15,065
16,575
61,373
62,690
Research and development
23,290
29,883
79,325
75,157
Total operating costs and expenses
38,355
46,458
140,698
137,847
Loss from continuing operations before
other (expense) income and income taxes
(38,355
)
(46,458
)
(140,698
)
(137,847
)
Other (expense) income :
Interest income (expense), net
920
143
4,996
(340
)
Other (expense) income, net
(3,345
)
(8,003
)
(8,892
)
9,580
Total other (expense) income
(2,425
)
(7,860
)
(3,896
)
9,240
Loss from continuing operations before
income taxes
(40,780
)
(54,318
)
(144,594
)
(128,607
)
Benefit for income taxes from continuing
operations
579
1,201
9,208
1,901
Loss from continuing operations
$
(40,201
)
$
(53,117
)
$
(135,386
)
$
(126,706
)
Income from discontinued operations, net
of income taxes
1,150
4,974
22,697
5,965
Net loss
$
(39,051
)
$
(48,143
)
$
(112,689
)
$
(120,741
)
Basic and diluted loss per share:
Loss per common share from continuing
operations
$
(0.36
)
$
(0.50
)
$
(1.22
)
$
(1.23
)
Income per common share from discontinued
operations
$
0.01
$
0.05
$
0.21
$
0.06
Net loss per common share
$
(0.35
)
$
(0.46
)
$
(1.02
)
$
(1.17
)
Weighted average shares outstanding:
Basic
111,355,254
105,633,296
110,585,768
103,305,911
Diluted
111,355,254
105,633,296
110,585,768
103,305,911
SPECTRUM PHARMACEUTICALS,
INC.
Condensed Consolidated Balance
Sheets
(In thousands, expect per share
and par value amounts)
December 31,
2019
2018
ASSETS
Current assets:
Cash and cash equivalents
$
64,418
$
157,480
Marketable securities
159,455
46,508
Accounts receivable, net of allowance for
doubtful accounts of $43 and $67, respectively
441
29,873
Other receivables
9,558
3,698
Prepaid expenses and other assets
10,148
7,574
Discontinued operations, current
assets
—
5,555
Total current assets
244,020
250,688
Property and equipment, net of accumulated
depreciation
11,607
385
Other assets
4,000
7,188
Facility and equipment under lease
3,806
—
Discontinued operations, non-current
assets
—
132,625
Total assets
$
263,433
$
390,886
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable and other accrued
liabilities
$
54,284
$
81,312
Accrued payroll and benefits
7,686
9,853
Contract liabilities
—
4,850
Discontinued operations, current
liabilities
—
2,311
Total current liabilities
61,970
98,326
Deferred tax liabilities, net
—
1,469
Other long-term liabilities
11,070
5,650
Discontinued operations, non-current
liabilities
—
14,031
Total liabilities
73,040
119,476
Commitments and contingencies (Note
10)
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; 113,299,612 and 110,525,141 issued
and outstanding at December 31, 2019 and 2018, respectively
113
110
Additional paid-in capital
918,205
886,740
Accumulated other comprehensive loss
(3,498
)
(3,702
)
Accumulated deficit
(724,427
)
(611,738
)
Total stockholders’ equity
190,393
271,410
Total liabilities and stockholders’
equity
$
263,433
$
390,886
Non-GAAP Financial Measures
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 from continuing operations
and non-GAAP net loss per share from continuing operations.
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
loss from continuing operations in its evaluation of the company's
core 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
CONTINUING OPERATIONS
ONLY
Three Months Ended December
31,
Twelve Months Ended December
31,
2019
2018
2019
2018
(1)
GAAP selling, general and
administrative
$
15,065
$
16,575
$
61,373
$
62,690
Non-GAAP adjustments to SG&A:
Stock-based compensation expense
(3,393
)
(2,582
)
(13,822
)
(9,268
)
Depreciation expense
(96
)
(22
)
(276
)
(213
)
Lease expense
(25
)
—
(282
)
—
Severance expense
—
—
(1,515
)
—
Non-GAAP selling, general and
administrative
$
11,551
$
13,971
$
45,478
$
53,209
(2)
GAAP research and development
$
23,290
$
29,883
$
79,325
$
75,157
Non-GAAP adjustments to R&D:
Stock-based compensation expense
(882
)
(681
)
(4,254
)
(2,566
)
Depreciation expense
(36
)
(2
)
(81
)
(9
)
Severance expense
—
—
(260
)
—
Other R&D milestone payments
—
—
(2,751
)
(500
)
Non-GAAP research and
development
$
22,372
$
29,200
$
71,979
$
72,082
(3)
GAAP net loss from continuing
operations
$
(40,201
)
$
(53,117
)
$
(135,386
)
$
(126,706
)
Non-GAAP adjustments to net loss from
continuing operations:
Adjustments to SG&A and R&D as
noted above
4,432
3,287
23,241
12,556
Adjustments to other expense (income)
2,969
7,664
9,418
(8,241
)
Adjustments to benefit for income
taxes
(579
)
(1,201
)
(9,208
)
(1,901
)
Non-GAAP net loss from continuing
operations
$
(33,379
)
$
(43,367
)
$
(111,935
)
$
(124,292
)
(4)
GAAP net loss from continuing
operations - per basic and diluted share
$
(0.36
)
$
(0.50
)
$
(1.22
)
$
(1.23
)
Non-GAAP net loss from continuing
operations - per basic and diluted share
$
(0.30
)
$
(0.41
)
$
(1.01
)
$
(1.20
)
Weighted average shares
outstanding:
Basic
111,355,254
105,633,296
110,585,768
103,305,911
Diluted
111,355,254
105,633,296
110,585,768
103,305,911
(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 non-recurring severance expenses and
R&D milestone achievements and upfront in-license 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) and (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; (iv)
reversal of the realized gain on the sale of our equity securities
holdings; and (v) reversal of debt discount accretion expense
(non-cash) for our convertible notes during the prior year
period.
(4) Non-GAAP net loss from continuing
operations - per basic and diluted share: 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/20200227005894/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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