- An oral presentation of updated Phase 2
poziotinib data including EGFR and HER2 patients with exon 20
mutations will occur on September 24 at the World Conference on
Lung Cancer in Toronto
- Spectrum’s current poziotinib Phase 2
study is viewed as the pivotal registrational trial following
recent conversations with the FDA
- Both Phase 3
ROLONTIS® (eflapegrastim) studies, RECOVER and ADVANCE,
have met the primary efficacy endpoint; Spectrum is preparing for a
pre-BLA meeting with the FDA in the third quarter
- Q2 revenues were $24.2 million,
including $23.8 million in product sales
Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology
company with fully integrated commercial and drug development
operations with a primary focus in hematology and oncology,
announced today financial results for the three-month period ended
June 30, 2018.
“The second quarter marked significant progress and data
milestones for our two lead programs poziotinib and ROLONTIS,
moving us closer to our ultimate goal of delivering targeted
and novel therapies to cancer patients,” said Joe Turgeon,
President and Chief Executive Officer of Spectrum Pharmaceuticals.
“We have strong momentum going into the second half of the
year as we aggressively broaden our poziotinib clinical
program and continue to gain additional regulatory clarity.”
Clinical Program Overview:
Poziotinib, an irreversible tyrosine kinase inhibitor
targeting EGFR and HER2 mutations:
- Updated data from the MD Anderson Phase
2 trial in non-small cell lung cancer with exon 20 mutations will
be presented at the World Conference on Lung Cancer in Toronto on
September 24. Updated data will include EGFR and HER2 patients with
exon 20 mutations. The abstract will be released online on
September 5.
- Spectrum recently had a meeting with
the FDA regarding poziotinib to gain clarity on the regulatory
pathway. Based on that conversation, Spectrum views the current
poziotinib phase 2 study as the pivotal registrational trial needed
for the Agency’s review.
- Data published in Nature Medicine from
the first 11 NSCLC patients with EGFR exon 20 mutations
receiving poziotinib in MD Anderson’s Phase 2 clinical trial
demonstrated a confirmed objective response rate of 64 percent. The
median progression-free survival had not been reached, with a
median follow up of 6.6 months. The safety profile was consistent
with what has been previously described for poziotinib and other
TKIs with the two most common adverse events being known EGFR
inhibitor-related toxicities: skin rash and diarrhea.
- Data presented at AACR demonstrated
that HER2 exon 20 mutations were prevalent across multiple solid
tumors.
ROLONTIS (eflapegrastim), a novel long-acting GCSF:
- Spectrum plans to conduct a pre-BLA
meeting in the third quarter to ensure alignment with the FDA in
preparation for a planned BLA filing in the fourth quarter of
2018.
- Top line data from RECOVER, the second
Phase 3 ROLONTIS study, demonstrated that the study met the primary
efficacy endpoint of non-inferiority in the duration of severe
neutropenia (DSN) between ROLONTIS and pegfilgrastim. Both Phase 3
ROLONTIS clinical trials, ADVANCE and RECOVER which studied more
than 600 patients combined, have met the primary efficacy endpoint.
Additional RECOVER data will be released at a future medical
meeting.
- ADVANCE data released as part of ASCO
2018 demonstrated that ROLONTIS was non-inferior to pegfilgrastim
in the reduction of duration of severe neutropenia (DSN) in all
four cycles of the study. Mean DSN±SD was 0.19±0.478 days for
ROLONTIS and 0.34±0.668 days for pegfilgrastim, demonstrating
non-inferiority with 95 percent confidence interval (CI) of DSN:
[-0.260, -0.035]; p<0.0001) in Cycle 1. There were no
statistically significant differences in all secondary endpoints in
Cycle 1. The adverse event profiles were similar across groups. The
most common treatment emergent adverse events in both treatment
arms were fatigue, nausea, neutropenia, and lymphopenia.
- In an oral presentation at MASCC 2018,
data from the ADVANCE Phase 3 study demonstrated an absolute risk
reduction of severe neutropenia of 8.5 percent (95% CI: 0.2%,
16.2%) versus pegfilgrastim in Cycle 1. Absolute risk reduction was
defined as the difference in percentage of patients experiencing no
severe neutropenia (ROLONTIS 84.2 percent; pegfilgrastim 75.7
percent).
Financial Guidance
Spectrum’s 2018 revenue guidance remains between $95 to $115
million. Additionally, Spectrum anticipates current cash and
marketable securities will be sufficient to fund operations into
2020.
Three-Month Period Ended June 30,
2018 (All numbers are approximate)
GAAP Results
Total product sales were $23.8 million in the second quarter of
2018. Product sales in the second quarter included: FOLOTYN®
(pralatrexate injection) net sales of $11.7 million, EVOMELA®
(melphalan) for injection net sales of $5.8 million, BELEODAQ®
(belinostat) for injection net sales of $2.7 million, ZEVALIN®
(ibritumomab tiuxetan) net sales of $1.6 million, MARQIBO®
(vinCRIStine sulfate LIPOSOME injection) net sales of $1.1 million,
and FUSILEV® (levoleucovorin) net sales of $0.8 million.
Spectrum recorded net income of $13.7 million, or $0.13 income
per basic share and $0.13 per diluted share in the three-month
period ended June 30, 2018, compared to net loss of $(20.9)
million, or $(0.27) loss per basic and diluted share in the
comparable period in 2017. Total research and development expenses
were $21.5 million in the quarter, as compared to $15.2 million in
the same period in 2017. Selling, general and administrative
expenses were $23.5 million in the quarter, compared to $17.4
million in the same period in 2017.
Non-GAAP Results
Spectrum recorded non-GAAP net loss of $(21.6) million, or
$(0.21) loss per basic and diluted share in the three-month period
ended June 30, 2018, compared to non-GAAP net loss of $(8.6)
million, or $(0.11) loss per basic and diluted share in the
comparable period in 2017. Non-GAAP research and development
expenses were $20.1 million, as compared to $14.6 million in the
same period of 2017. Non-GAAP selling, general and administrative
expenses were $19.6 million, as compared to $14.5 million in the
same period in 2017.
Conference Call
Thursday, August 9, 2018 @ 4:30
p.m. Eastern/1:30 p.m. Pacific
Domestic:
(877) 837-3910
Conference ID# 9084737
International:
(973) 796-5077
Conference ID# 9084737
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: www.sppirx.com on August 9,
2018 at 4:30 p.m. Eastern/1:30
p.m. Pacific.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a leading biotechnology company
focused on acquiring, developing, and commercializing drug
products, with a primary focus in hematology and oncology. Spectrum
currently markets six hematology/oncology drugs, and has an
advanced stage pipeline that has the potential to transform
the company. Spectrum's strong track record for in-licensing and
acquiring differentiated drugs, and expertise in clinical
development have generated a robust, diversified, and growing
pipeline of product candidates in advanced-stage Phase 2 and Phase
3 studies. More information on Spectrum is available at
www.sppirx.com.
Forward-looking statement - This press release may contain
forward-looking statements regarding future events and the future
performance of Spectrum Pharmaceuticals that involve risks and
uncertainties that could cause actual results to differ materially.
These statements are based on management's current beliefs and
expectations. These statements include, but are not limited to,
statements that relate to Spectrum’s business and its future,
including certain company milestones, Spectrum's ability to
identify, acquire, develop and commercialize a broad and diverse
pipeline of late-stage clinical and commercial products, the timing
and results of FDA decisions, and any statements that relate to the
intent, belief, plans or expectations of Spectrum or its
management, or that are not a statement of historical fact. Risks
that could cause actual results to differ include the possibility
that Spectrum’s existing and new drug candidates may not prove safe
or effective, the possibility that our existing and new
applications to the FDA and other regulatory agencies may not
receive approval in a timely manner or at all, the possibility that
our existing and new drug candidates, if approved, may not be more
effective, safer or more cost efficient than competing drugs, the
possibility that our efforts to acquire or in-license and develop
additional drug candidates may fail, our dependence on third
parties for clinical trials, manufacturing, distribution and
quality control 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.
SPECTRUM PHARMACEUTICALS, INC.®, FUSILEV®, FOLOTYN®, ZEVALIN®,
MARQIBO®, BELEODAQ®, EVOMELA®, 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.
© 2018 Spectrum Pharmaceuticals, Inc. All Rights Reserved
SPECTRUM PHARMACEUTICALS, INC. Condensed Consolidated
Statements of Operations (In thousands, except per share
amounts) (Unaudited)
Three Months Ended
Six Months Ended June 30, June 30,
2018 2017
2018 2017 Revenues:
Product sales, net $ 23,753 $ 31,156 $ 51,863 $ 57,001 License fees
and service revenue 415 3,145
2,799 6,401 Total revenues $ 24,168 $
34,301 $ 54,662 $ 63,402 Operating costs and
expenses: Cost of sales (excludes amortization of intangible
assets) 6,606 11,303 13,420 19,439 Cost of service revenue — 2,118
— 4,221 Selling, general and administrative 23,451 17,421 47,556
36,525 Research and development 21,488 15,167 39,382 29,945
Amortization of intangible assets 6,934 6,901
13,880 13,790 Total operating
costs and expenses 58,479 52,910
114,238 103,920 Loss from operations
(34,311 ) (18,609 ) (59,576 ) (40,518 ) Other
income (expense): Interest expense, net (242 ) (2,131 ) (472 )
(4,182 ) Change in fair value of contingent consideration related
to acquisitions (192 ) (97 ) (483 ) (294 ) Other income, net
48,492 240 58,463 650
Total other income (expense) 48,058
(1,988 ) 57,508 (3,826 ) Income (loss) before
income taxes 13,747 (20,597 ) (2,068 ) (44,344 ) Provision for
income taxes (3 ) (255 ) (6 ) (54 ) Net
income (loss) $ 13,744 $ (20,852 ) $ (2,074 ) $ (44,398 )
Net income (loss) per share: Basic $ 0.13 $ (0.27 ) $ (0.02
) $ (0.57 ) Diluted $ 0.13 $ (0.27 ) $ (0.02 ) $ (0.57 )
Weighted average shares outstanding: Basic 102,597,059
78,576,260 101,747,416
78,366,610 Diluted 112,617,150
78,576,260 101,747,416 78,366,610
SPECTRUM PHARMACEUTICALS, INC. Condensed
Consolidated Balance Sheets (In thousands, expect per share and
par value amounts) (Unaudited)
June 30,
December 31, 2018 2017
ASSETS Current assets: Cash and cash equivalents $
174,371 $ 227,323 Marketable securities 95,287 248 Accounts
receivable, net of allowance for doubtful accounts of $70 and $71,
respectively 27,658 32,260 Other receivables 2,915 2,133
Inventories 4,520 5,715 Prepaid expenses and other assets
4,769 10,067 Total current assets 309,520
277,746 Property and equipment, net of accumulated depreciation 523
589 Intangible assets, net of accumulated amortization 123,214
137,159 Goodwill 18,106 18,162 Other assets 13,159
53,783 Total assets $ 464,522 $ 487,439
LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities:
Accounts payable and other accrued liabilities $ 49,886 $ 58,117
Accrued payroll and benefits 4,946 9,261 Deferred revenue — 3,872
FOLOTYN development liability 211 275 Convertible senior notes
39,427 38,224 Total current liabilities
94,470 109,749 FOLOTYN development liability, less current portion
11,980 12,111 Deferred revenue, less current portion — 315
Acquisition-related contingent obligations 6,755 6,272 Deferred tax
liabilities 1,447 1,438 Other long-term liabilities 5,751
6,215 Total liabilities 120,403 136,100
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; 105,130,603 and 100,742,735 shares
issued and outstanding at June 30, 2018 and December 31, 2017,
respectively 103 100 Additional paid-in capital 829,052 837,347
Accumulated other comprehensive (loss) income (3,088 ) 15,999
Accumulated deficit (481,948 ) (502,107 ) Total
stockholders’ equity 344,119 351,339
Total liabilities and stockholders’ equity $ 464,522 $
487,439
Non-GAAP Financial Measures
In this press release, Spectrum reports certain historical and
expected non-GAAP results. Non-GAAP financial measures are
reconciled to the most directly comparable GAAP financial measure
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
generally accepted accounting principles (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 providing these non-GAAP
financial measures allows investors to view the company's financial
results in the way that management views the financial 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. The non-GAAP financial measures presented by
the company may be different from the non-GAAP financial measures
used by other companies.
SPECTRUM PHARMACEUTICALS, INC. Reconciliation of Non-GAAP
Adjustments for Condensed Consolidated Statements of Operations
(In thousands, expect per share
amounts)
Three Months Ended Six Months
Ended June 30, June 30, 2018
2017 2018
2017 (1) GAAP product sales, net
& license fees and service revenue $ 24,168
$ 34,301 $ 54,662 $
63,402 Non-GAAP adjustments to product sales, net &
license fees and service revenue: — —
(2,001 ) —
Non-GAAP product sales, net
& license fees and service revenue $ 24,168
$ 34,301 $ 52,661
$ 63,402 (2) GAAP selling, general
and administrative expenses $ 23,451 $
17,421 $ 47,556 $ 36,525
Non-GAAP adjustments to SG&A: Stock-based compensation (3,832 )
(2,888 ) (7,522 ) (6,126 ) Depreciation expense (61 )
(76 ) (108 ) (166 )
Non-GAAP selling, general and
administrative $ 19,558 $
14,457 $ 39,926 $
30,233 (3) GAAP research and
development $ 21,488 $ 15,167
$ 39,382 $ 29,945 Non-GAAP adjustments
to R&D: Stock-based compensation (902 ) (599 ) (1,689 ) (1,081
) Depreciation expense (2 ) (2 ) (5 ) (5 ) Other R&D milestone
payments (500 ) — (500 ) —
Non-GAAP research and development $
20,084 $ 14,566 $
37,188 $ 28,859 (4)
GAAP net income (loss) $ 13,744 $
(20,852 ) $ (2,074 ) $
(44,398 ) Non-GAAP adjustments to net income (loss):
Adjustments to product sales, net & license fees and service
revenue, SG&A, and R&D as noted above 5,297 3,565 7,823
7,378 Amortization of intangible assets 6,934 6,901 13,880 13,790
Adjustments to other (expense) income (47,596 ) 1,525 (56,847 )
3,098 Adjustments to provision for income taxes 3
255 6 54
Non-GAAP net
loss $ (21,618 ) $ (8,606
) $ (37,212 ) $ (20,078
) (5) GAAP income (loss) per share (Basic) $
0.13 $ (0.27 ) $ (0.02 ) $ (0.57 )
GAAP income (loss) per
share (Diluted) $ 0.13 $ (0.27 ) $ (0.02 ) $ (0.57 )
Non-GAAP loss per share (Basic and Diluted) $ (0.21 ) $
(0.11 ) $ (0.37 ) $ (0.26 )
Weighted average shares
outstanding: Basic 102,597,059 78,576,260
101,747,416 78,366,610 Diluted
112,617,150 78,576,260
101,747,416 78,366,610
(1) Non-GAAP product sales, net &
license fees and service revenue: These amounts reflect
adjustments to reverse revenue recognition for upfront revenue from
out-licenses and revenue from milestone achievement(s) that do not
consistently recur. The resulting non-GAAP revenue solely consists
of our (i) product sales, (ii) percentage-based royalties from our
licensees’ sales, and (iii) on-going service revenue. We believe
this measure of non-GAAP revenue is more indicative of the
period-over-period success of our core ongoing product sales and
service revenue.
(2) Non-GAAP selling, general and
administrative: These amounts reflect adjustments to
reverse allocated operating expenses for certain non-cash items
(including stock-based compensation and depreciation). We believe
the resulting non-GAAP SG&A value is more indicative of the
period-over-period success of our administrative expense control,
and more reflective of our normalized SG&A expense trends.
(3) Non-GAAP research and
development: 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 R&D milestone achievements that we record to
expense for our in-licenses. We believe the resulting non-GAAP
R&D value is more reflective of our true R&D expense
trends.
(4) Non-GAAP net loss: These
amounts reflect all non-GAAP adjustments described in (1) through
(3) above, plus other non-cash and/or non-recurring items,
including: (i) adjustments to reverse sales milestone achievements;
(ii) adjustments to reverse operating expenses for non-cash
amortization and impairment of intangible assets (the reversal of
these non-cash expenses allows for a clearer representation of the
period-over-period success of our overall financial results and
future working capital requirements); (iii) adjustments to reverse
the impact of income taxes; (iv) adjustments to reverse the impact
of mark-to-market contingent consideration (although our contingent
consideration results from prior acquisitions and is a part of our
business strategy, these adjustments through earnings typically
result from variables other than our current commercial activity or
other operating performance measures that are a focus of our
management), (v) reversal of foreign exchange gains and losses
(non-cash), (vi) reversal of debt discount accretion expense
(non-cash) for our convertible notes, and (vii) reversal of the
mark-to-market adjustment on our equity securities.
(5) Non-GAAP loss per share:
These amounts reflect all non-GAAP adjustments in (1) through (4)
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/20180809005713/en/
Spectrum Pharmaceuticals, Inc.Shiv KapoorVice President,
Strategic Planning & Investor Relations702-835-6300InvestorRelations@sppirx.com
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