Spectrum Pharmaceuticals Reports Third Quarter 2018 Pipeline Update and Financial Results
- Poziotinib interim data from the MD Anderson Phase 2 study presented in Q3 demonstrated strong efficacy in metastatic, heavily pretreated EGFR and HER2 exon 20 mutations in NSCLC patients
Spectrum has submitted a request for Breakthrough Therapy Designation
(BTD) for poziotinib and expects a response from the
FDAby end of the year
- Enrollment of the EGFR, previously treated cohort in the poziotinib ZENITH20 trial is expected to be completed by first quarter of 2019
- ROLONTIS® (eflapegrastim) Biologics License Application (BLA) filing is expected by the end of the year
KHAPZORY™ (levoleucovorin) for injection received
FDAapproval and preparing for a first quarter 2019 launch
Q3 revenues were
$25.3 million, including $24.6 millionin product sales
“In Q3 at the
Clinical Program Overview:
Poziotinib, an irreversible tyrosine kinase inhibitor targeting EGFR and HER2 mutations:
Updated interim data from the MD Anderson Phase 2 trial in heavily
pre-treated, non-small cell lung cancer (NSCLC) patients with exon 20
mutations were presented at the
World Conference on Lung Cancerin September.
- In evaluable patients with EGFR exon 20 mutations, the confirmed overall response rate (ORR) was 43% and disease control rate was 90%. Median progression free survival (PFS) was 5.5 months (ITT).
- In evaluable patients with HER2 exon 20 mutations, the confirmed overall response rate (ORR) was 42% and disease control rate was 83%. Median progression free survival (PFS) was 5.1 months (ITT).
- EGFR-related toxicities (including rash, diarrhea, and paronychia) were manageable and required dose reductions in 60% of patients. Discontinuation due to poor tolerance was rare (approximately 3% of patients).
Spectrum submitted a request for Breakthrough Therapy Designation for
poziotinib in previously treated metastatic NSCLC with EGFR exon 20
mutations and expects a response from the
FDAby the end of 2018.
Spectrum’s Phase 2 ZENITH20 trial studying poziotinib in NSCLC
patients with EGFR or HER2 exon 20 insertion mutations is well
underway and enrolling in four distinct cohorts.
- First-line cohorts in both EGFR and HER2 were initiated in the third quarter of 2018.
- Enrollment in the EGFR, previously treated cohort is expected to be completed by the first quarter of 2019.
ROLONTIS (eflapegrastim), a novel long-acting G-CSF:
Spectrum had a positive pre-BLA meeting with the
FDAin the third quarter of 2018 and expects to file for a BLA in the fourth quarter of 2018.
Data from the RECOVER Phase 3 study will be presented in a poster
session at the San Antonio Breast Cancer Symposium in early
Spectrum is refining its full year 2018 revenue guidance and is now
Three-Month Period Ended
Total product sales were
Spectrum recorded net loss of
Spectrum recorded non-GAAP net loss of
Thursday, November 8, 2018 @ 4:30 p.m. Eastern/1:30 p.m. Pacific
|Domestic:||(877) 837-3910, Conference ID# 3075918|
|International:||(973) 796-5077, Conference ID# 3075918|
This conference call will also be webcast. Listeners may access the
webcast, which will be available on the investor relations page
Spectrum Pharmaceuticals is a leading biopharmaceutical 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.
Certain statements in this press release may constitute
“forward-looking statements” within the meaning of
SPECTRUM PHARMACEUTICALS, INC.
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
|Three Months Ended
|Nine Months Ended
|Product sales, net||$||24,556||$||31,234||$||76,419||$||88,235|
|License fees and service revenue||712||5,161||3,511||11,562|
|Operating costs and expenses:|
|Cost of sales (excluding amortization of intangible assets)||6,472||12,179||19,891||31,618|
|Cost of service revenue||—||—||—||4,221|
|Selling, general and administrative||19,837||18,527||67,393||55,052|
|Research and development||21,060||13,815||60,442||43,760|
|Amortization of intangible assets||6,923||6,928||20,804||20,718|
|Total operating costs and expenses||54,292||51,449||168,530||155,369|
|Loss from operations||(29,024||)||(15,054||)||(88,600||)||(55,572||)|
|Other (expense) income:|
|Interest expense, net||(12||)||(2,014||)||(484||)||(6,196||)|
|Change in fair value of contingent consideration related to acquisitions||1,200||(2,942||)||717||(3,236||)|
|Other (expense) income, net||(40,880||)||251||17,583||901|
|Total other (expense) income||(39,692||)||(4,705||)||17,816||(8,531||)|
|Loss before income taxes||(68,716||)||(19,759||)||(70,784||)||(64,103||)|
|(Provision) benefit for income taxes||(2||)||1,466||(8||)||1,412|
|Net loss per share:|
|Weighted average shares outstanding:|
SPECTRUM PHARMACEUTICALS, INC.
Condensed Consolidated Balance Sheets
(In thousands, expect per share and par value amounts)
|Cash and cash equivalents||$||166,541||$||227,323|
|Accounts receivable, net of allowance for doubtful accounts of $71 and $71, respectively||29,485||32,260|
|Prepaid expenses and other assets||8,300||10,067|
|Total current assets||267,450||277,746|
|Property and equipment, net of accumulated depreciation||437||589|
|Intangible assets, net of accumulated amortization||116,273||137,159|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Accounts payable and other accrued liabilities||$||57,633||$||58,117|
|Accrued payroll and benefits||7,744||9,261|
|FOLOTYN development liability||211||275|
|Convertible senior notes||35,357||38,224|
|Total current liabilities||100,945||109,749|
|FOLOTYN development liability, less current portion||11,905||12,111|
|Deferred revenue, less current portion||—||315|
|Acquisition-related contingent obligations||5,555||6,272|
|Deferred tax liabilities||1,447||1,438|
|Other long-term liabilities||5,997||6,215|
|Commitments and contingencies|
|Preferred stock, $0.001 par value; 5,000,000 shares authorized; no shares issued and outstanding||—||—|
|Common stock, $0.001 par value; 300,000,000 shares authorized; 106,060,681 and 100,742,735 shares issued and outstanding at September 30, 2018 and December 31, 2017, respectively||106||100|
|Additional paid-in capital||840,681||837,347|
|Accumulated other comprehensive (loss) income||(3,342||)||15,999|
|Total stockholders’ equity||286,778||351,339|
|Total liabilities and stockholders’ equity||$||412,627||$||487,439|
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 product sales, net and license fees and service revenue, non-GAAP selling, general and administrative expenses, non-GAAP research and development expenses, non-GAAP net loss and non-GAAP net loss per share. 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 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 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.