Eflapegrastim BLA resubmitted to FDA
Poziotinib NDA accepted for FDA review in
previously treated patients with NSCLC harboring HER2 exon 20
insertion mutations, PDUFA date November 24, 2022
Positive poziotinib results in treatment naïve
patients with NSCLC harboring HER2 exon 20 insertion mutations
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 and full year ended December 31, 2021.
“We have made significant progress against our core business
objectives including the acceptance of the poziotinib NDA and
resubmission of the eflapegrastim BLA to the FDA. We have also
recently released positive data in front-line NSCLC patients
harboring HER2 exon 20 insertion mutations,” said Tom Riga,
President and Chief Executive Officer of Spectrum Pharmaceuticals.
“Additionally, we have strengthened our strategic corporate
partnerships, restructured our operations, and are focused on
advancing our mission.”
Pipeline Updates
Eflapegrastim, a novel long-acting G-CSF
- The company has resubmitted the Biologics License Application
(BLA) with an expected six-month review for eflapegrastim following
remediation of manufacturing deficiencies. The FDA has indicated
that a reinspection of the drug substance manufacturing facility in
South Korea will be required.
Poziotinib, a Pan ErbB inhibitor targeting HER2 exon20
mutations
- The New Drug Application (NDA) was accepted for review by the
FDA under a Fast Track designation. The NDA is based on the
positive results of Cohort 2 in patients with previously treated
locally advanced or metastatic non-small cell lung cancer (NSCLC)
harboring HER2 exon 20 insertion mutations. The agency has set a
Prescription Drug User Fee Act (PDUFA) date of November 24, 2022.
There is no FDA approved therapy for patients with NSCLC harboring
HER2 exon 20 insertion mutations.
- Data from Cohort 4 of the ZENITH20 study in patients with
treatment-naïve NSCLC harboring HER2 exon 20 insertion mutations
were recently delivered in an oral presentation at the European
Society for Medical Oncology Targeted Anticancer Therapies (ESMO
TAT) Congress 2022. The results showed a confirmed objective
response rate (ORR) of 41% (95% CI:30%-54%), as evaluated centrally
by an independent image review committee using RECIST 1.1 criteria.
The evaluable patient population showed an ORR of 50%. The study
met its primary endpoint as the observed lower bound of 30%
exceeded the pre-specified lower bound of 20%. The safety profile
was consistent with the tyrosine kinase inhibitor (TKI) class.
Notably, on-target AEs were reduced with BID dosing.
- Preclinical data showing synergy of poziotinib combined with
KRAS inhibitors in KRASG12C mutant specific cell lines, was
presented in a poster titled “Pan-ErbB inhibition enhances activity
of KRASG12C inhibitors in preclinical models of KRASG12C mutant
cancers” at the International Conference on Molecular Targets and
Cancer Therapeutics (AACR-NCI-EORTC). The data showed that
inhibition of EGFR, HER2, HER3, and HER4 (Pan ErbB) signaling was
synergistic when combined with KRASG12C inhibitors.
Corporate Updates
- As of December 31, 2021, Tom Riga, who had been serving as
Chief Commercial and Chief Operating Officer became President and
Chief Executive Officer of Spectrum Pharmaceuticals and joined the
Board of Directors. On February 23, 2022, Kurt Gustafson, Chief
Financial Officer, provided notice of his resignation to pursue
other professional opportunities. His last day at the company is
March 18, 2022. The company has initiated a selection process to
name a new chief financial officer.
- Hanmi Pharmaceutical completed a $20 million strategic equity
investment in Spectrum in January 2022, which included revisions to
the licensing agreement for eflapegrastim and poziotinib.
- Juhyun Lim was appointed to the company’s Board of Directors.
Ms. Lim currently serves as President, Global Strategy and Planning
at Hanmi Science and Hanmi Pharmaceutical, where she leads the
execution of corporate strategy and investment. She also serves as
Director, Healthcare Investment at Hanmi Ventures.
- Strategic restructuring with a ~30% staff reduction and ~20-25%
reduction in operating cash burn was announced in January 2022 to
focus the company's development activities on late-stage assets,
poziotinib and eflapegrastim. Further development activity for its
early-stage pipeline have been deprioritized.
Three-Month Period Ended December 31,
2021 (All numbers are from Continuing Operations)
GAAP Results
Spectrum recorded net loss of $39.8 million, or $0.26 per basic
and diluted share, in the three-month period ended December 31,
2021, compared to net loss of $49.9 million, or $0.36 per basic and
diluted share, in the comparable period in 2020. Total research and
development expenses were $18.0 million in the quarter, as compared
to $47.2 million in the same period in 2020. Selling, general and
administrative expenses were $18.9 million in the quarter, compared
to $15.7 million in the same period in 2020.
Non-GAAP Results
Spectrum recorded non-GAAP net loss of $26.4 million, or $0.17
per basic and diluted share, in the three-month period ended
December 31, 2021, compared to non-GAAP net loss of $28.9 million,
or $0.20 per basic and diluted share, in the comparable period in
2020. Non-GAAP research and development expenses were $16.7
million, as compared to $17.1 million in the same period of 2020.
Non-GAAP selling, general and administrative expenses were $10.2
million, as compared to $12.3 million in the same period in
2020.
Twelve-Month Period Ended December 31,
2021 (All numbers are from Continuing Operations)
GAAP Results
Spectrum recorded net loss of $158.4 million, or $1.02 per basic
and diluted share, in the twelve-month period ended December 31,
2021, compared to net loss of $171.3 million, or $1.38 per basic
and diluted share, in the comparable period in 2020. Total research
and development expenses were $87.3 million for the year, as
compared to $109.4 million in the same period in 2020. Selling,
general and administrative expenses were $60.4 million for the
year, compared to $60.4 million in the same period in 2020.
Non-GAAP Results
Spectrum recorded non-GAAP net loss of $120.7 million, or $0.78
per basic and diluted share, in the twelve-month period ended
December 31, 2021, compared to non-GAAP net loss of $120.9 million,
or $0.97 per basic and diluted share, in the comparable period in
2020. Non-GAAP research and development expenses were $79.2
million, as compared to $75.6 million in the same period of 2020.
Non-GAAP selling, general and administrative expenses were $42.8
million, as compared to $47.2 million in the same period in
2020.
Cash Position and
Guidance
Spectrum reported cash, cash equivalents, and marketable
securities of approximately $100.6 million as of December 31, 2021,
compared to $180 million at December 31, 2020. In January, the
company received a $20 million strategic equity investment from
Hanmi. The additional cash, combined with the restructuring, is
expected to extend the company’s cash runway into 2023.
Conference Call
Thursday, March 17, 2022 @ 4:30 p.m.
Eastern/1:30 p.m. Pacific
Domestic: (877) 837-3910, Conference ID#
4573715 International: (973) 796-5077, Conference ID# 4573715
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 March 17,
2022 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 the ZENITH20 Clinical Trial
The ZENITH20 study consists of seven cohorts of NSCLC patients.
Cohorts 1 (EGFR) and 2 (HER2) in previously treated NSCLC patients
with exon 20 mutations and Cohort 3 (EGFR) in first-line patients
have completed enrollment. Cohort 4 (HER2) in first-line NSCLC
patients with exon 20 mutations is still enrolling patients.
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 the FDA approval of poziotinib, including the results of
the FDA’s review of the NDA submission for poziotinib, the
significance of the results from Cohort 4 of the ZENITH20 clinical
trial and the pre-clinical data showing the synergistic impact of
poziotinib when combined with KRAS inhibitors, the outcome of the
company’s resubmission of its BLA for eflapegrastim, as well as the
results of the reinspection of Hanmi’s manufacturing facility, the
outcome of the company’s restructuring efforts, the future
potential of Spectrum’s existing drug pipeline, the progression of
the poziotinib and eflapegrastim development programs 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 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, if approved, may
not be more effective, safer, or more cost-efficient than competing
drugs; the company’s ability to remediate the deficiencies cited in
the CRL for eflapegrastim; 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, 2021, and in subsequent reports on Forms
10-Q and 8-K and other filings made with the SEC by Spectrum.
SPECTRUM PHARMACEUTICALS, INC.® is registered trademark 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.
© 2022 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,
2021
2020
2021
2020
Operating costs and expenses:
Selling, general and administrative
18,891
15,703
60,406
60,357
Research and development
17,962
47,185
87,297
109,377
Total operating costs and expenses
36,853
62,888
147,703
169,734
Loss from continuing operations before
other income (expense) and income taxes
(36,853
)
(62,888
)
(147,703
)
(169,734
)
Other income (expense):
Interest income (expense), net
41
125
163
1,342
Other (expense) income, net
(2,943
)
12,780
(10,892
)
(2,940
)
Total other (expense) income
(2,902
)
12,905
(10,729
)
(1,598
)
Loss from continuing operations before
income taxes
(39,755
)
(49,983
)
(158,432
)
(171,332
)
(Provision) benefit for income taxes from
continuing operations
5
75
(4
)
60
Loss from continuing operations
$
(39,750
)
$
(49,908
)
$
(158,436
)
$
(171,272
)
Income from discontinued operations, net
of income taxes
36
10,149
(192
)
10,404
Net loss
$
(39,714
)
$
(39,759
)
$
(158,628
)
$
(160,868
)
Basic and diluted loss per share:
Loss per common share from continuing
operations
$
(0.26
)
$
(0.36
)
$
(1.02
)
$
(1.38
)
Income per common share from discontinued
operations
$
0.00
$
0.07
$
—
$
0.08
Net loss per common share, basic and
diluted
$
(0.26
)
$
(0.29
)
$
(1.02
)
$
(1.29
)
Weighted average shares outstanding, basic
and diluted
154,680,363
141,432,302
154,861,704
124,386,545
SPECTRUM PHARMACEUTICALS,
INC.
Condensed Consolidated Balance
Sheets
(In thousands, expect per share
and par value amounts)
December 31,
2021
2020
ASSETS
Current assets:
Cash and cash equivalents
$
88,539
$
46,009
Marketable securities
12,108
134,016
Accounts receivable, net
—
67
Other receivables
1,028
2,394
Prepaid expenses and other current
assets
2,277
4,161
Total current assets
103,952
186,647
Property and equipment, net
455
3,577
Facility and equipment under lease
2,505
2,247
Other assets
4,636
4,327
Total assets
$
111,548
$
196,798
LIABILITIES AND STOCKHOLDERS’
EQUITY
Current liabilities:
Accounts payable and other accrued
liabilities
$
41,258
$
43,771
Accrued payroll and benefits
11,971
9,375
Total current liabilities
53,229
53,146
Other long-term liabilities
10,766
9,409
Total liabilities
63,995
62,555
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; 164,502,013 and 146,083,110 issued
and outstanding at December 31, 2021 and 2020, respectively
165
146
Additional paid-in capital
1,094,353
1,021,221
Accumulated other comprehensive loss
(3,042
)
(1,829
)
Accumulated deficit
(1,043,923
)
(885,295
)
Total stockholders’ equity
47,553
134,243
Total liabilities and stockholders’
equity
$
111,548
$
196,798
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,
2021
2020
2021
2020
(1)
GAAP selling, general and
administrative
$
18,891
$
15,703
$
60,406
$
60,357
Non-GAAP adjustments to SG&A:
Stock-based compensation expense
(3,676
)
(3,354
)
(12,405
)
(13,127
)
Depreciation expense
(72
)
(55
)
(278
)
(130
)
Lease expense
(65
)
23
(49
)
69
Severance expense
(4,861
)
—
(4,861
)
—
Non-GAAP selling, general and
administrative
$
10,217
$
12,317
$
42,813
$
47,169
(2)
GAAP research and development
$
17,962
$
47,185
$
87,297
$
109,377
Non-GAAP adjustments to R&D:
Stock-based compensation expense
(1,241
)
(1,094
)
(5,197
)
(4,692
)
Depreciation expense
(2
)
(33
)
(8
)
(131
)
Impairment of second source
manufacturer
—
(28,197
)
(2,912
)
(28,197
)
Other R&D milestone payments
—
(750
)
—
(750
)
Non-GAAP research and
development
$
16,719
$
17,111
$
79,180
$
75,607
(3)
GAAP net loss from continuing
operations
$
(39,750
)
$
(49,908
)
$
(158,436
)
$
(171,272
)
Non-GAAP adjustments to net loss from
continuing operations:
Adjustments to SG&A and R&D as
noted above
9,917
33,460
25,710
46,958
Adjustments to other (income) expense
3,389
(12,379
)
12,052
3,521
Adjustments to benefit for income
taxes
(5
)
(75
)
4
(60
)
Non-GAAP net loss from continuing
operations
$
(26,449
)
$
(28,902
)
$
(120,670
)
$
(120,853
)
(4)
GAAP net loss from continuing
operations - per basic and diluted share
$
(0.26
)
$
(0.35
)
$
(1.02
)
$
(1.38
)
Non-GAAP net loss from continuing
operations - per basic and diluted share
$
(0.17
)
$
(0.20
)
$
(0.78
)
$
(0.97
)
Weighted average shares outstanding, basic
and diluted
154,680,363
141,432,302
154,861,704
124,386,545
(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, lease and severance expense). 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 other R&D milestone achievement
payments, and impairment of second source manufacturer 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; and (iv)
reversal of realized gain recorded on the sales of our equity
holdings.
(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/20220317005872/en/
Robert Uhl Managing Director, Westwicke ICR 858.356.5932
robert.uhl@westwicke.com
Tom Riga Chief Executive Officer 949.788.6700
InvestorRelations@sppirx.com
Spectrum Pharmaceuticals (NASDAQ:SPPI)
Historical Stock Chart
From Mar 2024 to Apr 2024
Spectrum Pharmaceuticals (NASDAQ:SPPI)
Historical Stock Chart
From Apr 2023 to Apr 2024
