Allos Therapeutics Inc. Reports Operating Results (10-Q)

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Aug 03, 2012
Allos Therapeutics Inc. (ALTH, Financial) filed Quarterly Report for the period ended 2012-06-30.

Allos Therapeutics, Inc. has a market cap of $189.6 million; its shares were traded at around $1.78 with and P/S ratio of 2.3.

Highlight of Business Operations:

License and other revenue for the three months ended June 30, 2012 and 2011 includes $560,000 and $156,000, respectively, related to the 40% joint development cost reimbursement under the Mundipharma Agreements. License and other revenue for the six months ended June 30, 2012 and 2011 includes $1,102,000 and $156,000, respectively, related to the 40% joint development cost reimbursement under the Mundipharma Agreements.

Cost of license and other revenue in the Statement of Operations for the three and six months ended June 30, 2012 was $477,000 and $1,343,000, respectively, and consisted of costs incurred in connection with the regulatory services provided related to the European MAA. Cost of license and other revenue in the Statement of Operations for the three and six months ended June 30, 2011 totaled $10,571,000 and consisted of 20%, or $10.0 million, of the $50.0 million upfront payment to the licensors of FOLOTYN under the terms of the FOLOTYN License Agreement and $571,000 of costs incurred in connection with the regulatory services provided related to the European MAA.

Under the terms of the FOLOTYN License Agreement, we are required to fund all development programs and will have sole responsibility for all commercialization activities. In addition, we pay the licensors royalties based on worldwide graduated annual levels of net sales of FOLOTYN, net of actual rebates, chargebacks and returns, or distributor sales, which may be different than our net product revenue recognized in accordance with U.S. generally accepted accounting principles, or GAAP, or sublicense revenues arising from sublicensing the product, if and when such sales or sublicenses occur. For purposes of the FOLOTYN License Agreement, annual worldwide sales consists of our distributor sales and annual net sales of FOLOTYN in the Mundipharma Territories, as reported to us under the Mundipharma Collaboration Agreement, if and when such sales occur in the Mundipharma Territories. Royalties are 8% of annual worldwide sales up to $150.0 million; 9% of annual worldwide sales of $150.0 million through $300.0 million; and 11% of annual worldwide sales in excess of $300.0 million. For the three and six months ended June 30, 2012 and 2011, our royalties were 8% of our net distributor sales. As of June 30, 2012, accrued royalties were $911,000 and are included in accrued liabilities on the Balance Sheet.

million milestone payment from Mundipharma related to obtaining conditional approval by December 31, 2012 of FOLOTYN for the treatment of patients with relapsed or refractory PTCL in Europe. We may receive potential regulatory milestone payments of up to $11.5 million and commercial progress- and sales-dependent milestone payments of up to $289.0 million. We are also entitled to receive tiered double-digit royalties based on net sales of FOLOTYN within the Mundipharma territories. Of the $50.0 million upfront payment, 20%, or $10.0 million, was paid by Allos to the licensors of FOLOTYN under the terms of our license agreement, as amended, with Sloan-Kettering Institute for Cancer Research, SRI International and Southern Research Institute, or the FOLOTYN License Agreement. Allos and Mundipharma will jointly fund worldwide development costs, initially on a 60:40 basis, respectively; which will change to a 50:50 basis if certain pre-defined milestones are achieved. The parties joint development funding supports mutually agreed-upon clinical development activities, including, but not limited to, the ongoing and planned Phase 3 registration studies of FOLOTYN in patients with previously undiagnosed PTCL and in patients with relapsed or refractory cutaneous T-cell lymphoma, or CTCL. Pursuant to a separate supply agreement with Mundipharma Medical Company, an affiliate of Mundipharma, we will supply FOLOTYN for Mundipharmas clinical and commercial uses. We refer to this as the Mundipharma Supply Agreement, and we refer to the Mundipharma Supply Agreement and the Mundipharma Collaboration Agreement together as the Mundipharma Agreements. During the six months ended June 30, 2012, we recognized $4.1 million of license and other revenue under the Mundipharma Agreements.

Gross product sales to distributors for the three months ended June 30, 2012 were $12.1 million, a $0.4 million decrease as compared to the same period in 2011. This decrease relates to a 5% decrease in the number of units sold to our distributors, partially offset by a 5% increase in price, which became effective on January 1, 2012. Gross product sales to distributors for the six months ended June 30, 2012 were $23.3 million, a $1.3 million decrease as compared to the same period in 2011. This decrease relates to a 10% decrease in the number of units sold to our distributors, partially offset by a 5% increase in price, which became effective on January 1, 2012.

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