Spectrum Pharmaceuticals Reports Robust Clinical Data and Strong 2014 Financial Results
Development Highlights: 2 Near-term NDA's and 2 Potential Blockbusters
SPI-2012, a novel long-acting GCSF, demonstrated
non-inferiority to pegfilgrastim at the 135 µg/kg dose (p= 0.002), and
superiority at the 270 µg/kg dose (p= 0.023) in a randomized Phase 2
Study. Phase 3 protocols are being finalized following productive
meetings with regulatory agencies in the U.S. and
- Poziotinib, a novel pan-HER inhibitor, showed promising Phase 1 data (ORR= 60%) in heavily pretreated breast cancer patients who had failed multiple other HER2-directed therapies.
Captisol-Enabled™ Melphalan, a propylene-glycol free
formulation with improved stability, accepted for NDA review by
FDAwith a PDUFA action date of October 23, 2015.
- Apaziquone, a potent tumor-activated pro-drug for non-muscle invasive bladder cancer, showed statistically significant results in a post-hoc subgroup analysis of two Phase 3 studies (p=0.001); Company plans NDA submission this year.
Financial Highlights: Strong Growth in Sales and Non-GAAP Earnings
Total product sales for the year ended
December 31, 2014were $186.5 million, a 30% increase year over year.
Total product sales for the three months ended
December 31, 2014were $51.7 million.
Non-GAAP diluted EPS was
$0.09, and GAAP EPS was ( $0.05) during the three months ended December 31, 2014.
"2014 was a strong year of revenue and non-GAAP earnings growth, and we
now have one of the strongest pipelines in Spectrum's history," said
Three-Month Period Ended
Total revenues were
Product sales in the fourth quarter included: FUSILEV®
(levoleucovorin) net sales of
Spectrum recorded net loss of
Spectrum recorded non-GAAP net income of
Twelve-Month Period Ended
Consolidated revenue of
Product sales in 2014 were comprised of: FUSILEV® sales of
The Company recorded net loss of
The Company recorded non-GAAP net income of
SPI-2012: a novel, biologic GCSF that could expand treatment options
- A Phase 2 randomized study demonstrated SPI-2012 to be non-inferior to pegfilgrastim at the 135 µg/kg dose (0.44 versus 0.31 days, respectively; p= 0.002), and superior at the 270 µg/kg dose (0.03 versus 0.31 days, respectively, p= 0.023) based on the primary endpoint, Mean Duration of Severe Neutropenia (DSN).
- All SPI-2012 doses showed acceptable safety profile with no significant dose-related or unexpected toxicities, and AE incidences were comparable to pegfilgrastim; there was a low incidence of immunogenicity.
Company plans two randomized, active controlled Phase 3 studies of
SPI-2012 versus pegfilgrastim in patients with breast cancer, one in
North Americaand one international, with a primary endpoint of DSN; study start-up is ongoing.
Poziotinib: an oral, irreversible, pan-HER inhibitor under development with best in class potential
- Poziotinib shows targeted activity to HER1 (EGFR), HER2, HER4, and receptor mutations including EGFR T790M in vitro.
- In vitro data demonstrates the superior activity of poziotinib to neratinib and afatinib in several HER2 positive cell lines (SK-Br-3- IC50s: 1.0 versus 2.0 and 16.0 nM, respectively; MDA-MB-175- IC50s: 0.1 versus 2.5 and 2.4 nM, respectively; MDA-MB-453 (PIK3CA mutant)- IC50s: 5.4 versus 17.8 and 92.4 nM, respectively).
- Poziotinib has promising Phase 1 data in heavily pretreated breast cancer patients who had failed other HER2-directed therapies with an Overall Response Rate (ORR) of 60% (n=10), and activity in other solid tumors.
- Poziotinib showed an acceptable safety profile in Phase 1 with a treatment duration > 3 months in 42.9% of patients, > 6 months in 22.2%, and > 12 months in 7.9% patients (n=63).
- Additional Phase 2 studies are ongoing in multiple tumor types.
Captisol-enabled Melphalan: a new melphalan formulation with improved stability
Captisol-enabled Melphalan (Propylene Glycol-Free) 505(b)(2) NDA
accepted for review with a PDUFA action date of
October 23, 2015.
- Proposed labeling includes current IV melphalan indication for palliative treatment of patients with multiple myeloma (MM), for whom oral therapy is not appropriate, and also an additional indication as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with MM.
- Phase 2 data met the primary endpoint of bioequivalence for this new formulation to Alkeran® (melphalan hydrochloride) for Injection. High-dose therapy with CE-Melphalan (200 mg/m2) was associated with promising efficacy (ORR = 95%, Complete Response Rate = 31%; Very Good Partial Response Rate or better in 74% of patients), successful myeloablation, and engraftment following HSCT.
- Safety profile comparable to IV melphalan with no unexpected toxicities, and a low incidence of Grade 3 mucositis (13%); and no Grade 4 mucositis.
Apaziquone: a tumor-activated pro-drug; potentially 1st new drug for NMIBC in > 40 years
- Adjuvant use of apaziquone for immediate intravesical instillation following transuretheral resection (TUR) of non-muscle invasive bladder cancer (NMIBC) demonstrate a high response rate of marker lesions (69%) with nearly 50% of patients remaining tumor-free after 18 months in Phase 1/Phase 2 studies.
- Reanalysis of data from two completed randomized, placebo-controlled Phase 3 studies demonstrates a lower 2 year recurrence rate with apaziquone compared to placebo in the intent-to-treat (ITT) Population (Study 1 (n=802): 36.9% versus 42.2%, respectively, p= 0.130; Study 2 (n=812): 40.0% versus 46.1%, respectively, p= 0.082).
- Statistically significant differences in 2 year recurrence rates shown in the subgroup of ITT patients receiving apaziquone 30 to 90 minutes post-TUR (Study 1 (n=141): 24.4% versus 40.7%, respectively, p= 0.040; Study 2 (n=152): 32.9% versus 51.3%, respectively, p= 0.022) likely due to less post-TUR bleeding.
- Integrated analyses of the two Phase 3 studies also demonstrate statistically significant differences in 2 year recurrence rates for apaziquone versus placebo in both the overall TaG1G2 Population (n=1,146; 38.8% versus 45.5%, respectively, p= 0.022) and in the combined subgroup analysis (n=217; 28.2% versus 50.0%, respectively, p= 0.001).
- The drug is well tolerated with no systemic toxicities.
- An NDA submission for apaziquone based on the completed studies is planned for this year.
- A new Phase 3 study in NMIBC is planned that will specifically focus on the administration of apaziquone to all patients in the 31 to 90 minute window post-TUR, and will also include a second intravesical administration 8 days later.
Domestic: (877) 837-3910, Conference ID# 82077760
International: (973) 796-5077, Conference ID# 82077760
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 March 13, 2015 at 10:00 a.m. Eastern/7:00 a.m. Pacific.
About Captisol-Enabled Melphalan
Captisol-Enabled, Propylene Glycol -free Melphalan is a novel
intravenous formulation of melphalan being investigated for the multiple
myeloma transplant setting, for which it has been granted an Orphan Drug
Designation by the
Captisol is a patent-protected, chemically modified cyclodextrin with a
structure designed to optimize the solubility and stability of drugs.
Captisol was invented and initially developed by scientists in the
laboratories of Dr.
Forward-looking statement — This press release may contain
forward-looking statements regarding future events and the future
Three Months Ended
Twelve Months Ended
|Product sales, net||$||51,670||$||40,479||$||186,537||$||143,475|
|License fees and service revenue||191||1,039||293||12,379|
Cost of product sales (excludes amortization of intangible assets)
|Selling, general and administrative||24,485||25,714||97,412||99,315|
|Research and development||14,410||10,760||69,662||46,670|
|Amortization and impairment of intangible assets||6,525||5,245||24,288||20,074|
|Total operating expenses||53,493||48,028||218,399||194,639|
|(Loss) from operations||(1,632)||(6,510)||(31,569)||(38,785)|
|Change in fair value of contingent consideration related to acquisition||2,897||2,871||987||2,871|
|Other (expense) income, net||(2,129)||666||(4,367)||1,470|
|Loss before income taxes||(3,044)||(3,623)||(43,533)||(36,636)|
|(Provision) benefit for income taxes||68||(35,749)||(2,186)||(25,498)|
|Net loss per share:|
|Weighted average shares outstanding:|
|Cash and equivalents||$||129,942||$||156,306|
Accounts receivable, net of allowance for doubtful accounts of
|Prepaid expenses and other current assets||3,774||3,213|
|Deferred income taxes||—||1,659|
|Total current assets||222,469||235,190|
|Property and equipment, net||1,405||1,535|
|Intangible assets, net||230,100||231,352|
|Deferred tax assets||—||—|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accounts payable and other accrued obligations||$||84,994||$||79,837|
|Accrued payroll and related expenses||8,444||6,872|
|Drug development liability||1,141||3,119|
|Acquisition related contingent obligations||4,901||—|
|Total current liabilities||109,439||89,984|
|Drug development liability, less current portion||14,644||14,623|
|Acquisition related contingent obligations||2,441||8,329|
|Deferred tax liability||6,569||7,168|
|Other long-term obligations||6,088||5,965|
|Convertible senior notes||96,298||91,480|
|Commitments and contingencies|
Series B junior participating preferred stock,
Series E convertible voting preferred stock,
|Additional paid-in capital||538,553||518,144|
|Accumulated other comprehensive income||(850)||894|
|Total stockholders' equity||254,554||281,606|
|TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY||$||490,033||$||499,155|
Non-GAAP Financial Measures
In this press release, Spectrum reports certain historical and expected non-GAAP results. Non-GAAP financial measures are reconciled to the most directly comparable GAAP financial measure in the tables of this press release and the accompanying footnotes. The non-GAAP financial measures contained herein are a supplement to the corresponding financial measures prepared in accordance with generally accepted accounting principles (GAAP). The non-GAAP financial measures presented exclude the items summarized in the below table. Management believes that adjustments for these items assist investors in making comparisons of period-to-period operating results and that these items are not indicative of the Company's on-going core operating performance.
Management uses non-GAAP net income (loss) in its evaluation of the Company's core after-tax results of operations and trends between fiscal periods and believes that these measures are important components of its internal performance measurement process. Management believes that providing these non-GAAP financial measures allows investors to view the Company's financial results in the way that management views the financial results.
The non-GAAP financial measures presented herein have certain limitations in that they do not reflect all of the costs associated with the operations of the Company's business as determined in accordance with GAAP. Therefore, investors should consider non-GAAP financial measures in addition to, and not as a substitute for, or as superior to, measures of financial performance prepared in accordance with GAAP. The non-GAAP financial measures presented by the Company may be different from the non-GAAP financial measures used by other companies.
Three months ended
|GAAP product sales & license and contract revenue||$||51,861||$||41,516||$||186,830||$||155,854|
|Non GAAP adjustments to product sales & license and contract revenue:||--||--||
|Total adjustments to product sales & license and contract revenues||--||--||
|Non-GAAP product sales & license and contract revenue||51,861||41,516||186,830||148,246|
|GAAP cost of product sales||8,073||6,309||27,037||28,580|
|Non-GAAP adjustments to cost of product sales||--||--||--||--|
|Non-GAAP cost of product sales||8,073||6,309||27,037||28,580|
|GAAP selling, general and administrative expenses||24,485||25,714||97,412||99,315|
|Non GAAP adjustments to SG&A:|
|Talon acquisition legal & professional fees||--||(67)||--||(3,444)|
|Reduction of Staff||--||(12)||--||(1,984)|
|Loan modification expense||--||--||--||(183)|
|Total adjustments to SG&A||(3,090)||(4,256)||(12,549)||(19,259)|
|Non-GAAP selling, general and administrative||21,395||21,458||84,863||80,056|
|GAAP research and development||14,410||10,760||69,662||46,670|
|Non-GAAP adjustments to R&D:|
|TopoTarget milestone payment & stock issuance||--||--||(17,790)||--|
|Reduction in staff||--||(4)||--||(1,375)|
|Non-recurring payment related to co-development agreement||--||--||
|Total adjustments to R&D||(402)||(465)||(19,618)||(2,141)|
|Non-GAAP research and development||14,008||10,295||50,044||44,529|
GAAP amortization of intangibles
|Non-GAAP adjustments to amortization of intangibles:|
|Total adjustments to amortization of intangibles||(6,525)||(5,245)||
|Non-GAAP amortization of intangibles||--||--||--||--|
|GAAP loss from operations||(1,632)||(6,512)||(31,569)||(38,784)|
|Non-GAAP adjustments to income from operations||10,017||9,966||56,455||33,866|
|Non-GAAP income (loss) from operations||8,385||3,454||24,886||(4,919)|
|GAAP other expense, net||(1,412)||2,887||(11,964)||2,149|
|Non-GAAP adjustments to other expense|
|Realized gain on TopoTarget shares||--||--||(2,219)||--|
|Loss on foreign currency exchange||2,186||--||6,824||--|
|Market-to-market of contingent consideration||(2,897)||(2,871)||(987)||(2,871)|
|Accretion of discount on 2018 Convertible Notes||1,261||--||4,818||--|
|Total adjustments to other expense, net||550||(2,871)||8,436||(2,871)|
|Non-GAAP other expense, net||(862)||16||(3,528)||(722)|
|GAAP (provision)/benefit for income taxes||68||(35,749)||(2,186)||(25,498)|
|Adjustment to (provision)/benefit for income taxes||(68)||35,749||2,186||25,498|
|Non-GAAP provision for income taxes||--||--||--||--|
|GAAP net loss||(2,976)||(39,374)||(45,719)||(62,134)|
|Non-GAAP net income||7,523||3,470||21,358||(5,641)|
Non-GAAP income per share:
|Weighted average shares outstanding:|
Vice President, Strategic Planning & Investor Relations
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