August 3, 2017
Spectrum Pharmaceuticals Reports Second Quarter 2017 Financial Results and Pipeline Update ROLONTIS™ (eflapegrastim):» BLA filing expected next year.
» Enrollment completed in registrational ADVANCE Study under a Special Protocol Assessment (SPA) with the FDA. Topline results expected in Q1 2018.
» A second smaller study RECOVER is enrolling patients in EU and U.S. Enrollment completion expected in Q1 2018.
Poziotinib:» Interim results are expected before year end from an ongoing Phase 2 study in non-small cell lung cancer patients with exon 20 insertion mutations in EGFR or HER2. This study is being conducted at The University of Texas MD Anderson Cancer Center.
» Following discussions with the FDA, the Company is initiating an additional multicenter clinical trial to expedite the development of poziotinib in this patient population.
Financials:» Q2 revenues were $34.3 million, including $31.2 million in product sales.
» FOLOTYN® (pralatrexate injection) was recently approved in Japan and the Company expects multiple related milestone payments totaling approximately $5 million from Mundipharma in the second half of the year.
HENDERSON, Nev.--(BUSINESS WIRE)-- 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, 2017.
"During the second quarter we made significant progress in our highest priority clinical programs and achieved solid performance across our commercial business," said Rajesh C. Shrotriya, MD, Chairman and Chief Executive Officer
of Spectrum Pharmaceuticals. "We completed enrollment in ROLONTIS's ADVANCE registrational Phase 3 study ahead of schedule and enrollment in a second international study RECOVER is well under way in Europe and U.S. We are also very excited about the prospects of poziotinib in cancer patients with exon 20 insertion mutations and expect interim results from the Phase 2 lung cancer study before the end of the year. We are driven to bring our novel drugs to patients with unmet medical needs and look forward to multiple near-term development catalysts that could shape the Company's future."
Pipeline Update:
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 405 patients randomized and expects to report topline data in Q1 2018. To strengthen the regulatory package in the Europe and U.S., the Company is currently enrolling the 218-patient international RECOVER study. The Company continues to expect to file the BLA next year. Poziotinib, a potential best-in-class, novel, pan-HER inhibitor: 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 is expected to yield interim results before year end. Following discussions with the FDA, the Company is initiating an additional multicenter study in a similar patient population.Spectrum is also conducting a Phase 2 breast cancer study in the third-line setting in the U.S., based on promising Phase 1 study efficacy data in breast cancer patients who had failed multiple HER2-directed therapies. The Company is in discussions with the FDA about a combination trial of poziotinib and standard of care therapy in HER2+ breast cancer patients in the second-line setting.
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 for a new Phase 3 study incorporating learnings from the previous studies, as well as recommendations from the FDA. Compared to the previous program, this new Phase 3 study will include fewer evaluable patients (n=425 versus 1,557 patients), use a higher dosage of QAPZOLA (8 mg versus 4 mg), and will evaluate time-to-recurrence as the primary endpoint. Approximately 50 sites have been selected thus far for enrolling patients in the Phase 3 study and patients are currently being screened.Three-Month Period Ended June 30, 2017 (All numbers are approximate)
GAAP Results
Total product sales were $31.2 million in the second quarter of 2017. Product sales in the second quarter included: FUSILEV® (levoleucovorin) net sales of $2.1 million, FOLOTYN® (pralatrexate injection) net sales of $11.2 million, ZEVALIN® (ibritumomab tiuxetan) net sales of $2.3 million, MARQIBO® (vinCRIStine sulfate LIPOSOME injection) net sales of $2.2 million, BELEODAQ® (belinostat) for injection net sales of $3.4 million, and EVOMELA® (melphalan) for injection net sales of $10.1 million.
Spectrum recorded a net loss of $20.5 million, or $0.26 per basic and diluted share in the three-month period ended June 30, 2017, compared to a net loss of $24.3 million, or $0.35 per basic and diluted share in the comparable period in 2016. Total research and development expenses were $15.1 million in the quarter, as compared to $14.3 million in the same period in 2016. Selling, general and administrative expenses were $17.1 million in the quarter, compared to $27.6 million in the same period in 2016.
Our June 30, 2017 cash and equivalents balance is $138.6 million. In July 2017, we sold and issued 3.2 million shares of our common stock for net proceeds of $23.7 million under our ATM. These shares and proceeds are not included in our June 30, 2017 financial statements. We have now fully utilized the ATM facility.
Non-GAAP Results
Spectrum recorded non-GAAP net loss of $8.6 million, or $0.11 per basic and diluted share in the three-month period ended June 30, 2017, compared to non-GAAP net loss of $3.7 million, or $0.05 per basic share and diluted share in the comparable period in 2016. Non-GAAP research and development expenses were $14.6 million, as compared to $12.9 million in the same period of 2016. Non-GAAP selling, general and administrative expenses were $14.5 million, as compared to $16.1 million in the same period in 2016.
Conference Call
Thursday, August 3, 2017 @ 4:30 p.m. Eastern/1:30 p.m. Pacific
Domestic: (877) 837-3910, Conference ID# 44585743
International: (973) 796-5077, Conference ID# 44585743
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 3, 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®, and
EVOMELA® are registered trademarks of Spectrum Pharmaceuticals, Inc. and its affiliates. REDEFINING CANCER CARE™, ROLONTIS™, QAPZOLA™ 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 Ended June 30, Six Months Ended June 30,Revenues:
2017 2016 2017 2016Product sales, net $ 31,156 $ 30,887 $ 57,001 $ 66,129
License fees and service revenue 3,145 3,062 6,401 11,686
Total revenues 34,301 33,949 63,402 77,815
Operating costs and expenses: Cost of product sales (excludes amortization and impairment | ||||
charges of intangible assets) | 11,303 | 5,609 | 19,439 | 11,212 |
Cost of service revenue | 2,118 | 2,214 | 4,221 | 3,495 |
Selling, general and administrative | 17,107 | 27,620 | 35,715 | 49,583 |
Research and development | 15,097 | 14,281 | 29,792 | 29,744 |
Amortization and impairment charges of intangible assets | 6,901 | 6,306 | 13,790 | 12,145 |
Total operating costs and expenses | 52,526 | 56,030 | 102,957 | 106,179 |
Loss from operations | (18,225) | (22,081) | (39,555) | (28,364) |
Other (expense) income: | ||||
Interest expense, net | (2,131) | (2,375) | (4,182) | (4,714) |
Change in fair value of contingent consideration related to acquisitions | (97) | (285) | (294) | (1,327) |
Other income, net | 240 | 340 | 650 | 618 |
Total other expenses | (1,988) | (2,320) | (3,826) | (5,423) |
Loss before income taxes | (20,213) | (24,401) | (43,381) | (33,787) |
(Provision) benefit for income taxes | (255) | 106 | (54) | 171 |
Net loss | $ (20,468) | $ (24,295) | $ (43,435) | $ (33,616) |
Net loss per share: Basic and diluted | $ (0.26) | $ (0.35) | $ (0.55) | $ (0.50) |
Weighted average shares outstanding: | ||||
Basic and diluted | 78,576,260 | 68,575,021 | 78,366,610 | 67,146,188 |
(In thousands, expect per share and par value amounts) (Unaudited)
ASSETSCurrent assets:
June 30, 2017 December 31, 2016Cash and cash equivalents $138,313 $ 158,222
Marketable securities 248 247
Accounts receivable, net of allowance for doubtful accounts of $88, respectively 41,977 39,782 Other receivables 3,950 5,754
Inventories 10,157 8,715
Prepaid expenses and other assets 4,369 3,930
Total current assets 199,014 216,650
Property and equipment, net of accumulated depreciation 517 449
Intangible assets, net of accumulated amortization and impairment charges 150,815 164,234
Goodwill 18,057 17,886
Other assets 26,684 29,549
Total assets $395,087 $ 428,768
LIABILITIES AND STOCKHOLDERS' EQUITYCurrent liabilities:
Accounts payable and other accrued liabilities $ 55,617 $ 52,483 Accrued payroll and benefits 6,244 8,981
Deferred revenue 2,551 3,188
Drug development liability 153 861
Acquisition-related contingent obligations - -
Total current liabilities 64,565 65,513
Drug development liability, less current portion 12,410 12,269 Deferred revenue, less current portion 326 323
Acquisition-related contingent obligations 1,609 1,315
Deferred tax liabilities 6,802 6,675
Other long-term liabilities 10,451 9,604
Convertible senior notes 100,157 97,043
Total liabilities 196,320 192,742
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; 81,257,192 and 80,466,735
shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively 80 80
Additional paid-in capital 646,542 640,166
Accumulated other comprehensive loss (1,779) (1,579)
Accumulated deficit (446,076) (402,641)
Total stockholders' equity 198,767 236,026
Total liabilities and stockholders' equity $395,087 $ 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
Spectrum Pharmaceuticals Inc. published this content on 03 August 2017 and is solely responsible for the information contained herein.
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