From the Spectrum Pharmaceuticals, Inc. 2008 Annual Report
May 1, 2009
At Spectrum, we share a common passion in our commitment to pioneering novel cancer therapies that can enhance and prolong patient lives. Our corporate culture embraces the principle that our people are our most important asset, and that by working together we can achieve extraordinary things.
I am very pleased to report that 2008 has truly been a most exciting year for Spectrum. We have emerged as a well capitalized, commercial stage company with a can-do culture. Today, we are in a stronger position than ever before to bring novel drugs to cancer patients, value to our shareholders, and inspiration to our employees.
In 2008, we achieved a critical inflection point for our young company: the transition from a research and development company to a commercial organization generating sales from two marketed proprietary cancer therapies. In achieving this milestone, we have differentiated ourselves from the vast majority of other small biotech companies.
First, we obtained FDA approval for FUSILEV™, the only commercially available formulation comprised of the pharmacologically active isomer of leucovorin. Second, we acquired the rights to ZEVALIN®, an FDA-approved, radiolabled, monoclonal antibody that is a highly effective treatment for relapsed or refractory, low-grade or follicular B-cell NHL, including patients with rituximab-refractory follicular NHL. Third, we built our own specialized, highly-experienced oncology sales and marketing team to support the commercial success of these drugs.
In a year of unprecedented economic turmoil, which adversely affected many companies in our sector, we generated more cash than ever before, while maintaining tight fiscal discipline. We brought in more than $62 million through non-dilutive strategic alliances and activities. This included entering into a highly profitable alliance with Allergan, Inc., a multi-billion dollar pharmaceutical company, for apaziquone (EOquin®), our lead pipeline candidate in registrational trials for bladder cancer. In taking these measures, we avoided any dilution to our shareholders.
We have successfully met our near-term growth objectives, while laying a solid foundation for long term success and profitability.
As an emerging leader in the area of novel oncology therapies, we have solidified our management team by adding highly experienced individuals with proven track records in the areas of sales, marketing, business development, regulatory and medical affairs, clinical development and pharmaceutical operations.
Spectrum is now well-positioned to meet the challenges facing our sector, and to continue delivering outstanding results to our shareholders. Here are some of the key milestones anticipated in 2009:
ZEVALINPDUFA (Decision) date by July 2009 for 1st Line Consolidation Therapy sBLA Under Review by FDA
Establish reimbursement standards in concert with Centers for Medicare and Medicaid Services (CMS)
FUSILEV
PDUFA (Decision) Date by October 2009 for Advanced Metastatic Colorectal Cancer sNDA Under Review By FDA
Expanded Uptake of FUSILEV in Community Practices and Institutions
Apaziquone
Complete Enrollment in Ongoing Phase 3 Registrational Trials
Initiate Trials in BCG-Failure Bladder Cancer.
Behind these three near term value drivers, we have a portfolio of diversified drugs across all phases of development which represent opportunities for monetization. Strategically, we are stronger than ever, with: sufficient cash to fund our operations without near term dilutive financings; two marketed proprietary oncology drugs, both with significant growth potential; a pipeline of novel, late stage drugs; a balanced business strategy that mitigates development and financial risks and; sufficient infrastructure and resources to support the continued growth of our company. At Spectrum, we remain committed to building on our success as a commercial organization dedicated to the development and marketing of novel cancer therapies. We look forward to 2009 as our best year ever! We thank you for your support.
Sincerely,
Rajesh C. Shrotriya, M.D.
Chairman, CEO and President
Spectrum Pharmaceuticals, Inc.
