- Poziotinib:
- Objective Response Rate of 73% was
observed in preliminary analysis from an ongoing Phase 2 study
conducted by MD Anderson Cancer Center in Non-Small-Cell Lung
Cancer (NSCLC) patients with EGFR exon 20 insertion
mutations.
- The Company has initiated a
multicenter clinical trial to expedite the development of
poziotinib in lung cancer patients with exon 20 insertion
mutations.
- ROLONTISTM
(eflapegrastim):
- Topline results expected in Q1 2018
from the fully enrolled ADVANCE Study under a Special Protocol
Assessment (SPA) from the FDA.
- RECOVER, a second smaller Phase 3
study, is enrolling patients internationally.
- BLA filing expected in Q4
2018.
- QAPZOLA®:
- Phase 3 study under an SPA is
currently enrolling patients.
- Financials:
- Q3 revenues were $36.4 million,
including $31.2 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
September 30, 2017.
"We have been focused on developing our late-stage pipeline and
I am proud of our progress,” said Rajesh C. Shrotriya, MD,
Chairman and Chief Executive Officer of Spectrum
Pharmaceuticals. “Encouraging data from the Phase 2 lung cancer
study from poziotinib was presented at the World Conference on Lung
Cancer in Japan two weeks ago. We remain very excited about
poziotinib’s prospects in lung cancer as well as other solid
tumors. We also look forward to receiving top-line results from
ROLONTIS’s ADVANCE registrational Phase 3 study in the first
quarter of 2018. We are enthusiastic about developing our pipeline
strategically and expeditiously.”
Pipeline Update:
- Poziotinib, an irreversible tyrosine
kinase inhibitor: Three Phase 2 studies evaluating poziotinib
in lung cancer and breast cancer are currently enrolling patients
in the U.S.
- An investigator sponsored trial is
currently enrolling at the University of Texas MD Anderson Cancer
Center in non-small cell lung cancer patients with exon 20
insertion mutations in EGFR or HER2. The study yielded preliminary
results demonstrating evidence of significant antitumor activity in
NSCLC patients with EGFR exon 20 insertion mutations, with
preliminary data showing an Objective Response Rate of 73%.
Toxicities have included rash, diarrhea, paronychia, and mucositis
consistent with those previously described for poziotinib and other
TKIs, which led to dose reduction in 55% of the patients.
- In consultation with the FDA, the
Company has initiated a multicenter study. This trial will enroll
up to 87 patients with EGFR exon 20 insertion mutations and up to
87 patients with HER2 exon 20 insertion mutations at several
leading cancer institutions. The study will evaluate objective
response rate (ORR) as the primary endpoint, and disease control
rate (DCR), duration of response (DOR), and safety as secondary
endpoints.
- Spectrum is also conducting a Phase 2
breast cancer study in the third-line setting in the U.S.
- ROLONTIS (eflapegrastim), a
novel long-acting GCSF: A registrational Phase 3 study ADVANCE
was initiated under an SPA with the FDA last year to evaluate
ROLONTIS in the management of chemotherapy-induced neutropenia. The
Company has completed enrollment in the ADVANCE study with 406
patients randomized and expects to report topline data in Q1 2018.
To strengthen the regulatory package in Europe and the U.S., the
Company is currently enrolling the 218-patient international
RECOVER study, which has a similar design. The Company expects to
file the BLA in Q4 2018.
- QAPZOLA, a potent tumor-activated
drug for bladder cancer is being investigated for low and
intermediate risk non-muscle invasive bladder cancer: The
Company has an SPA from the FDA and is currently enrolling patients
in a Phase 3 study. The Phase 3 study has incorporated learnings
from the previous studies, as well as recommendations from
the FDA. The Phase 3 study will enroll approximately 425
evaluable patients, using a single dose of 8 mg, and will evaluate
time-to-recurrence as the primary endpoint.
Three-Month Period Ended
September 30, 2017 (All numbers are
approximate)
GAAP Results
Total product sales were $31.2 million in the third quarter of
2017. Product sales in the third quarter included: FUSILEV®
(levoleucovorin) net sales of $1.8 million, FOLOTYN® (pralatrexate
injection) net sales of $11.6 million, ZEVALIN® (ibritumomab
tiuxetan) net sales of $2.7 million, MARQIBO® (vinCRIStine sulfate
LIPOSOME injection) net sales of $1.2 million, BELEODAQ®
(belinostat) for injection net sales of $3.4 million, and EVOMELA®
(melphalan) for injection net sales of $10.5 million.
Spectrum recorded a net loss of $18.7 million, or $0.22 per
basic and diluted share in the three-month period ended
September 30, 2017, compared to a net loss of $17.5 million,
or $0.22 per basic and diluted share in the comparable period in
2016. Total research and development expenses were $13.9 million in
the quarter, as compared to $13.3 million in the same period in
2016. Selling, general and administrative expenses were $18.9
million in the quarter, compared to $19.5 million in the same
period in 2016.
Our September 30, 2017 cash and equivalents balance is $248
million.
Non-GAAP Results
Spectrum recorded non-GAAP net loss of $9.2 million, or $0.11
per basic and diluted share in the three-month period ended
September 30, 2017, compared to non-GAAP net loss of $5.3
million, or $0.07 per basic share and diluted share in the
comparable period in 2016. Non-GAAP research and development
expenses were $13.2 million, as compared to $12.8 million in the
same period of 2016. Non-GAAP selling, general and administrative
expenses were $16.1 million, as compared to $15.6 million in the
same period in 2016.
Conference Call
Thursday, November 2, 2017 @ 4:30
p.m. Eastern/1:30 p.m. Pacific
Domestic: (877) 837-3910, Conference ID#
7488227 International: (973) 796-5077, Conference ID# 7488227
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 November 2,
2017 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 QAPZOLA® are registered trademarks
of Spectrum Pharmaceuticals, Inc. and its affiliates. REDEFINING
CANCER CARE™, ROLONTIS™, and the Spectrum Pharmaceuticals' logos
are trademarks owned by Spectrum Pharmaceuticals, Inc. Any other
trademarks are the property of their respective owners.
© 2017 Spectrum Pharmaceuticals, Inc. All Rights Reserved
SPECTRUM PHARMACEUTICALS, INC. Condensed
Consolidated Statements of Operations
(In thousands, except per share
amounts)
(Unaudited)
Three Months EndedSeptember 30, Nine
Months EndedSeptember 30, 2017 2016
2017 2016 Revenues: Product sales, net $
31,234 $ 30,272 $ 88,235 $ 96,401 License fees and service revenue
5,161 3,121 11,562 14,807 Total
revenues 36,395 33,393 99,797 111,208
Operating costs and expenses: Cost of sales (excludes amortization
and impairment charges of intangible assets) 12,179 7,503 31,618
18,715 Cost of service revenue — 2,221 4,221 5,716 Selling, general
and administrative 18,880 19,465 54,595 69,047 Research and
development 13,878 13,293 43,670 43,037 Amortization and impairment
charges of intangible assets 6,928 6,907 20,718
19,052 Total operating costs and expenses 51,865
49,389 154,822 155,567 Loss from
operations (15,470 ) (15,996 ) (55,025 ) (44,359 ) Other (expense)
income: Interest expense, net (2,014 ) (2,373 ) (6,196 ) (7,087 )
Change in fair value of contingent consideration related to
acquisitions (2,942 ) 78 (3,236 ) (1,249 ) Other income, net 251
372 901 990 Total other expenses (4,705
) (1,923 ) (8,531 ) (7,346 ) Loss before income taxes (20,175 )
(17,919 ) (63,556 ) (51,705 ) Benefit for income taxes 1,466
464 1,412 635 Net loss $ (18,709 ) $ (17,455 )
$ (62,144 ) $ (51,070 ) Net loss per share: Basic and diluted $
(0.22 ) $ (0.22 ) $ (0.78 ) $ (0.73 ) Weighted average shares
outstanding: Basic and diluted 83,463,153 79,303,380
80,177,370 70,437,885
SPECTRUM
PHARMACEUTICALS, INC. Condensed Consolidated Balance
Sheets
(In thousands, expect per share and par
value amounts)
(Unaudited)
September 30, 2017 December 31,
2016 ASSETS Current assets: Cash and cash equivalents
$ 247,468 $ 158,222 Marketable securities 248 247 Accounts
receivable, net of allowance for doubtful accounts of $88 and $88,
respectively 37,767 39,782 Other receivables 5,876 5,754
Inventories 8,983 8,715 Prepaid expenses and other assets 2,957
3,930 Total current assets 303,299 216,650 Property
and equipment, net of accumulated depreciation 615 449 Intangible
assets, net of accumulated amortization and impairment charges
144,036 164,234 Goodwill 18,131 17,886 Other assets 35,736
29,549 Total assets $ 501,817 $ 428,768
LIABILITIES AND STOCKHOLDERS’ EQUITY Current liabilities:
Accounts payable and other accrued liabilities $ 49,635 $ 52,483
Accrued payroll and benefits 7,636 8,981 Deferred revenue 2,783
3,188 FOLOTYN development liability 153 861 Total
current liabilities 60,207 65,513 FOLOTYN development
liability, less current portion 12,273 12,269 Deferred revenue,
less current portion 324 323 Acquisition-related contingent
obligations 4,551 1,315 Deferred tax liabilities 6,829 6,675 Other
long-term liabilities 11,127 9,604 Convertible senior notes 101,770
97,043 Total liabilities 197,081 192,742 Commitments
and contingencies Stockholders’ equity: Preferred stock, $0.001 par
value; 5,000,000 shares authorized; no shares issued and
outstanding — — Series B junior participating preferred stock,
$0.001 par value; 1,500,000 shares authorized; no shares issued and
outstanding — — Series E convertible voting preferred stock, $0.001
par value and $10,000 stated value; 2,000 shares authorized; no
shares issued and outstanding. — — Common stock, $0.001 par value;
175,000,000 shares authorized; 94,061,740 and 80,466,735 shares
issued and outstanding at September 30, 2017 and December 31, 2016,
respectively 94 80 Additional paid-in capital 765,754 640,166
Accumulated other comprehensive income (loss) 3,673 (1,579 )
Accumulated deficit (464,785 ) (402,641 ) Total stockholders’
equity 304,736 236,026 Total liabilities and
stockholders’ equity $ 501,817 $ 428,768
Non-GAAP Financial Measures
In this press release, Spectrum reports certain historical
“non-GAAP financial measures,” as defined in Regulation G of the
Securities Exchange Act of 1934. Non-GAAP financial measures differ
from financial statements reported in conformity to U.S. generally
accepted accounting principles (“GAAP”). In accordance with
Regulation G, we reconciled each non-GAAP financial measure to its
most directly comparable GAAP measure. Management uses non-GAAP
financial measures to assess our company’s performance and allocate
company resources, and 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. We
believe non-GAAP disclosures also provide investors with
information used generally in our industry for evaluating operating
results. Investors should not place undue reliance on non-GAAP
financial measures, nor should investors consider non-GAAP
financial measures as more meaningful than, or as substitutes or
replacements for, 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.
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 reported under
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 EndedSeptember
30, Nine Months EndedSeptember 30, 2017
2016 2017 2016 (1)
GAAP product sales, net & license fees and service
revenue $ 36,395 $ 33,393 $
99,797 $ 111,208 Non GAAP adjustments to
product sales, net & license fees and service revenue: (5,000 )
— (5,000 ) (6,000 )
Non-GAAP product sales, net &
license fees and service revenue $ 31,395
$ 33,393 $ 94,797
$ 105,208 (2) GAAP selling, general
and administrative expenses $ 18,880 $
19,465 $ 54,595 $ 69,047 Non
GAAP adjustments to SG&A: Stock-based compensation (2,750 )
(2,650 ) (8,066 ) (8,209 ) Litigation expenses — (1,133 ) — (11,946
) Depreciation expense (75 ) (103 ) (241 ) (432 )
Non-GAAP
selling, general and administrative $ 16,055
$ 15,579 $ 46,288
$ 48,460 (3) GAAP research and
development $ 13,878 $ 13,293
$ 43,670 $ 43,037 Non-GAAP adjustments
to R&D: Stock-based compensation (660 ) (500 ) (1,588 ) (1,545
) Depreciation expense (2 ) (3 ) (6 ) (9 ) Other R&D milestone
payments — — — (2,826 )
Non-GAAP research
and development $ 13,216 $
12,790 $ 42,076 $
38,657 (4) GAAP net loss $
(18,709 ) $ (17,455 ) $
(62,144 ) $ (51,070 ) Non-GAAP
adjustments to net loss: Adjustments to product sales, net &
license fees and service revenue, SG&A, and R&D as noted
above (1,513 ) 4,389 4,901 18,967 Adjustment to cost of sales 1,000
— 1,000 — Amortization and impairment charges of intangible assets
6,928 6,907 20,718 19,052 Adjustments to other expense, net 4,557
1,358 7,655 5,052 Adjustments to provision (benefit) for income
taxes (1,466 ) (464 ) (1,412 ) (635 )
Non-GAAP net loss
$ (9,203 ) $ (5,265 )
$ (29,282 ) $ (8,634 )
(5) GAAP loss per share (Basic and Diluted) $ (0.22 )
$ (0.22 ) $ (0.78 ) $ (0.73 )
Non-GAAP loss per share (Basic and
Diluted) Basic and diluted $ (0.11 ) $ (0.07 ) $ (0.37 ) $
(0.12 )
Weighted average shares outstanding: Basic and
diluted 83,463,153 79,303,380 80,177,370 70,437,885
(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), as well as
the reversal of irregular operating expense items such as
non-recurring legal fees and settlements. 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 royalty expense on receipts
from regulatory and 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; and (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 (noncash), and (vi) debt discount accretion expense
(non-cash) for our convertible notes.
(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: http://www.businesswire.com/news/home/20171102006465/en/
Spectrum Pharmaceuticals, Inc.Shiv KapoorVice President,
Strategic Planning & Investor Relations702-835-6300InvestorRelations@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