Growth in U.S. sales and/or potential milestone payments and royalties associated with regulatory approval of FOLOTYN in the European Union have the potential to further extend the Company’s cash resources assuming operating costs remain consistent with the Company’s projections.
Non-GAAP financial information is utilized by the Company’s management to provide a useful measure of the Company’s operating performance. Non-GAAP financial information herein includes the financial guidance related to projected operating expenditures for 2012 through 2015. The Company reports the expected reimbursements from Mundipharma as license and other revenue in accordance with generally accepted accounting principles but has netted such reimbursements against its operating expenditures for purposes of presentation herein.
2011 and Recent Key Highlights
- Achieved sequential growth in year-over-year and quarterly net product sales during 2011; reported 43% sequential increase in full year 2011 over 2010 and 17% sequential increase in fourth quarter 2011 over third quarter 2011.
- Received a permanent Level II Health Care Common Procedure Coding System (HCPCS) J-Code for FOLOTYN from the Centers for Medicare and Medicaid Services (CMS) effective for dates of service on or after January 1, 2011.
- Submitted a request to the European Medicines Agency (EMA) for a re-examination of the negative opinion issued in January 2012 by the EMA’s Committee for Medicinal Products for Human Use (CHMP) for conditional approval of FOLOTYN for the treatment of patients with peripheral T-cell lymphoma (PTCL) whose disease has progressed after at least one prior systemic therapy. The Company expects a final opinion on the re-examination to be issued by the CHMP in the second quarter of 2012. Mundipharma has also submitted applications seeking regulatory approval of FOLOTYN for the treatment of patients with relapsed or refractory PTCL in Australia, South Korea and Switzerland and is pursuing regulatory discussions in Japan with plans for initiation of a bridging study in the second half of 2012.
- Reached agreement with U.S. Food and Drug Administration under its Special Protocol Assessment (SPA) process on the design of the Company’s Phase 3 randomized clinical trial of sequential FOLOTYN in newly diagnosed patients with PTCL who have achieved an objective response following initial treatment with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) or a CHOP-like regimen (first-line PTCL). The first patient was enrolled in this trial in August 2011.
- Announced the publication of the Company’s pivotal Phase 2 PROPEL study demonstrating clinical activity of FOLOTYN in patients with relapsed or refractory PTCL in the Journal of Clinical Oncology.
- Reported interim results from the Company’s ongoing Phase 1 combination study of FOLOTYN and bexarotene in patients with relapsed or refractory cutaneous T-cell lymphoma at the Fourth Annual T-cell Lymphoma Forum. The combination treatments demonstrated encouraging activity in heavily pre-treated patients (median of 3 prior systemic regimens). The cohort determined to be the recommended dose/schedule is being expanded to evaluate FOLOTYN and bexarotene in a total of 30 patients at the maximum tolerated dose.
- Entered into a strategic collaboration agreement with Mundipharma to co-develop FOLOTYN. Under the agreement, Allos retains full commercialization rights for FOLOTYN in the United States and Canada, with Mundipharma having exclusive rights to commercialize FOLOTYN in the rest of the world. Allos received an upfront payment of $50 million upon execution of the agreement and may receive potential regulatory and commercial progress- and sales-dependent milestone payments of up to $310.5 million. Allos is also entitled to receive tiered double-digit royalties based on net sales of FOLOTYN within Mundipharma’s licensed territories. Allos and Mundipharma will jointly fund development costs, initially on a 60:40 basis, which will change to a 50:50 basis if certain pre-defined milestones are achieved .
- Continue to grow U.S. sales of FOLOTYN for relapsed or refractory PTCL and manage expenses to drive to future profitability
- Pursue regulatory approval to market FOLOTYN for relapsed or refractory PTCL in Europe and other countries in collaboration with Mundipharma
- Advance FOLOTYN development program in hematologic malignancies, including first-line PTCL and relapsed or refractory cutaneous T-cell lymphoma in collaboration with Mundipharma
- Explore opportunities to grow revenues through product acquisition and/or in-licensing that leverages the Company’s existing infrastructure