Strategic Agreements | 9 Months Ended |
Sep. 30, 2013 |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | ' |
Strategic Agreements | ' |
Note 2. Strategic Agreements |
The collaborative research and development and other revenues associated with the Company’s major third-party collaborators are as follows (in thousands): |
|
| | | | | | | | | | | | | | | | |
| | Three months ended | | | Nine months ended | |
September 30, | September 30, |
| | 2013 | | | 2012 | | | 2013 | | | 2012 | |
Collaborator | | | | | | | | | | | | | | | | |
Zogenix, Inc. (Zogenix) (1) | | $ | 103 | | | $ | 179 | | | $ | 602 | | | $ | 1,816 | |
Pfizer Inc. (Pfizer) (2) | | | 7 | | | | 652 | | | | 20 | | | | 11,779 | |
Pain Therapeutics, Inc. (Pain Therapeutics) | | | 2 | | | | 13 | | | | 3 | | | | 14 | |
Hospira, Inc. (Hospira) (3) | | | — | | | | — | | | | — | | | | 23,726 | |
Nycomed Danmark, APS (Nycomed) (4) | | | — | | | | — | | | | — | | | | 3,705 | |
Others | | | 246 | | | | 282 | | | | 1,551 | | | | 641 | |
| | | | | | | | | | | | | | | | |
Total collaborative research and development and other revenue | | $ | 358 | | | $ | 1,126 | | | $ | 2,176 | | | $ | 41,681 | |
| | | | | | | | | | | | | | | | |
|
-1 | Amounts related to the ratable recognition of upfront fees were $64,000 and $177,000 for the three and nine months ended September 30, 2013, respectively, compared to $78,000 and $234,000 for the corresponding periods in 2012. | | | | | | | | | | | | | | | |
-2 | Amounts related to the recognition of upfront fees were zero for the three and nine months ended September 30, 2013, respectively, compared to zero and $9.9 million for the corresponding periods in 2012. In February 2011, Pfizer acquired King Pharmaceuticals (King) and thereby assumed the rights and obligations of King under the agreements the Company formerly had in place with King; accordingly amounts attributed to King are now shown as Pfizer figures. In February 2012, the Company was notified that Pfizer was terminating the worldwide Development and License Agreement between Alpharma (acquired by King which subsequently was acquired by Pfizer) and the Company dated September 19, 2008 relating to the development and commercialization of ELADUR. As a result, the Company recognized as revenue all of the remaining upfront fees during the three months ended March 31, 2012 that had previously been deferred. | | | | | | | | | | | | | | | |
-3 | Amounts related to the recognition of upfront fees were zero for the three and nine months ended September 30, 2013, respectively, compared to zero and $21.8 million for the corresponding periods in 2012. In March 2012, the Company was notified that Hospira was terminating the Development and License Agreement between Hospira and the Company dated June 1, 2010 relating to the development and commercialization of POSIDUR in the United States and Canada. As a result, the Company recognized as revenue all of the remaining upfront fees during the three months ended March 31, 2012 that had previously been deferred. | | | | | | | | | | | | | | | |
-4 | Amounts related to the ratable recognition of upfront fees were zero for the three and nine months ended September 30, 2013, respectively, compared to zero and $3.7 million for the corresponding periods in 2012. In January 2012, the Company was notified that Nycomed was terminating the Development and License Agreement between Nycomed and the Company dated November 26, 2006, as amended relating to the development and commercialization of POSIDUR (SABER-Bupivacaine) in Europe and their other licensed territories. As a result, the Company recognized as revenue all of the remaining upfront fees during the three months ended March 31, 2012 that had previously been deferred. | | | | | | | | | | | | | | | |
Agreement with Pain Therapeutics, Inc. |
In December 2002, the Company entered into an exclusive agreement with Pain Therapeutics, Inc. (Pain Therapeutics) to develop and commercialize on a worldwide basis REMOXY and other oral sustained release, abuse deterrent opioid products incorporating four specified opioid drugs, using the ORADUR technology. Total collaborative research and development revenue recognized under the agreements with Pain Therapeutics was $2,000 and $3,000 for the three and nine months ended September 30, 2013, respectively, compared with $13,000 and $14,000 for the corresponding periods in 2012. The cumulative aggregate payments received by the Company from Pain Therapeutics as of September 30, 2013 were $34.2 million under this agreement. |
Under the terms of this agreement, Pain Therapeutics paid the Company an upfront license fee of $1.0 million, with the potential for an additional $9.3 million in performance milestone payments based on the successful development and approval of the four ORADUR-based opioids. Of these potential milestones, $9.3 million are development-based milestones (of which $1.7 million had been achieved as of September 30, 2013). There are no sales-based milestones under the agreement. |
In March 2009, King assumed the responsibility for further development of REMOXY from Pain Therapeutics. As a result of this change, the Company continues to perform REMOXY-related activities in accordance with the terms and conditions set forth in the license agreement between the Company and Pain Therapeutics. Accordingly, King was substituted in lieu of Pain Therapeutics with respect to interactions with the Company in its performance of those activities including the obligation to pay the Company with respect to all REMOXY-related costs incurred by the Company. In February 2011, Pfizer acquired King and thereby assumed the rights and obligations of King with respect to REMOXY; accordingly amounts attributed to King are now shown as Pfizer figures. Total collaborative research and development revenue recognized for REMOXY-related work performed by the Company for Pfizer was $7,000 and $20,000 for the three and nine months ended September 30, 2013, respectively, compared with $611,000 and $1.8 million for the corresponding periods in 2012. Prior to March 2009, the Company recognized collaborative research and development revenue for REMOXY-related work under the agreements with Pain Therapeutics. The cumulative aggregate payments received by the Company from Pfizer and King as of September 30, 2013 were $7.1 million under this agreement. |
|
Long Term Supply Agreement with King (now Pfizer) |
In August 2009, the Company signed an exclusive long term excipient supply agreement with respect to REMOXY with King (now Pfizer). This agreement stipulates the terms and conditions under which the Company will supply to King, based on the Company’s manufacturing cost plus a specified percentage mark-up, two key excipients used in the manufacture of REMOXY. In February 2011, Pfizer acquired King and thereby assumed the rights and obligations of King under the agreements we formerly had in place with King; accordingly amounts attributed to King are now shown as Pfizer figures. |
Total revenues recognized related to these excipients were zero and $273,000 in the three and nine months ended September 30, 2013, compared to zero and $51,000 for the corresponding periods in 2012. The associated cost of goods sold was zero and $219,000 in the three and nine months ended September 30, 2013, compared to zero and $33,000 for the corresponding periods in 2012. |
Agreement with Zogenix, Inc. |
On July 11, 2011, the Company and Zogenix, Inc. (Zogenix) entered into a Development and License Agreement (the License Agreement). The Company and Zogenix had previously been working together under a feasibility agreement pursuant to which the Company’s research and development costs were reimbursed by Zogenix. Under the License Agreement, Zogenix will be responsible for the clinical development and commercialization of a proprietary, long-acting injectable formulation of risperidone using the Company’s SABER controlled-release formulation technology in combination with Zogenix’s DosePro® needle-free, subcutaneous drug delivery system. DURECT will be responsible for non-clinical, formulation and CMC development activities. The Company will be reimbursed by Zogenix for its research and development efforts on the product. |
Zogenix paid a non-refundable upfront fee to the Company of $2.25 million in July 2011. The Company’s research and development services are considered integral to utilizing the licensed intellectual property and, accordingly, the deliverables are accounted for as a single unit of accounting. The $2.25 million upfront fee is being recognized as collaborative research and development revenue ratably over the term of the Company’s continuing research and development involvement with Zogenix with respect to this product candidate. Zogenix is obligated to pay the Company up to $103 million in total future milestone payments with respect to the product subject to and upon the achievement of various development, regulatory and sales milestones. Of these potential milestones, $28 million are development-based milestones (none of which had been achieved as of September 30, 2013), and $75 million are sales-based milestones (none of which had been achieved as of September 30, 2013). Zogenix is also required to pay a mid single-digit to low double-digit percentage patent royalty on annual net sales of the product determined on a jurisdiction-by-jurisdiction basis. The patent royalty term is equal to the later of the expiration of all DURECT technology patents or joint patent rights in a particular jurisdiction, the expiration of marketing exclusivity rights in such jurisdiction, or 15 years from first commercial sale in such jurisdiction. After the patent royalty term, Zogenix will continue to pay royalties on annual net sales of the product at a reduced rate for so long as Zogenix continues to sell the product in the jurisdiction. Zogenix is also required to pay to the Company a tiered percentage of fees received in connection with any sublicense of the licensed rights. |
The Company granted to Zogenix an exclusive worldwide license, with sub-license rights, to the Company’s intellectual property rights related to the Company’s proprietary polymeric and non-polymeric controlled-release formulation technology to make and have made, use, offer for sale, sell and import risperidone products, where risperidone is the sole active agent, for administration by injection in the treatment of schizophrenia, bipolar disorder or other psychiatric related disorders in humans. The Company retains the right to supply Zogenix’s Phase 3 clinical trial and commercial product requirements on the terms set forth in the License Agreement. |
The Company retains the right to terminate the License Agreement with respect to specific countries if Zogenix fails to advance the development of the product in such country, either directly or through a sublicensee. In addition, either party may terminate the License Agreement upon insolvency or bankruptcy of the other party, upon written notice of a material uncured breach or if the other party takes any act impairing such other party’s relevant intellectual property rights. Zogenix may terminate the License Agreement upon written notice if during the development or commercialization of the product, the product becomes subject to one or more serious adverse drug experiences or if either party receives notice from a regulatory authority, independent review committee, data safety monitory board or other similar body alleging significant concern regarding a patient safety issue. Zogenix may also terminate the License Agreement with or without cause, at any time upon prior written notice. |
|
The following table provides a summary of collaborative research and development revenue recognized under the agreements with Zogenix (in thousands). The cumulative aggregate payments received by the Company as of September 30, 2013 were $10.6 million under these agreements. |
|
| | | | | | | | | | | | | | | | |
| | Three months ended | | | Nine months ended | |
September 30, | September 30, |
| | 2013 | | | 2012 | | | 2013 | | | 2012 | |
Ratable recognition of upfront payment | | $ | 64 | | | $ | 78 | | | $ | 177 | | | $ | 234 | |
Research and development expenses reimbursable by Zogenix | | | 39 | | | | 101 | | | | 425 | | | | 1,582 | |
| | | | | | | | | | | | | | | | |
Total collaborative research and development revenue | | $ | 103 | | | $ | 179 | | | $ | 602 | | | $ | 1,816 | |
| | | | | | | | | | | | | | | | |