Strategic Agreements | 3 Months Ended |
Mar. 31, 2015 |
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): |
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| | Three months ended | |
March 31, |
| | 2015 | | | 2014 | |
Collaborator | | | | | | | | |
Zogenix, Inc. (Zogenix) (1) | | $ | 1,158 | | | $ | 782 | |
Santen Pharmaceutical Co. Ltd. (Santen) (2) | | | 307 | | | | — | |
Impax Laboratories, Inc. (Impax) (3) | | | — | | | | 2,090 | |
Pain Therapeutics, Inc. (Pain Therapeutics) | | | — | | | | 451 | |
Pfizer Inc. (Pfizer) | | | — | | | | 14 | |
Others | | | 273 | | | | 175 | |
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Total collaborative research and development and other revenue | | $ | 1,738 | | | $ | 3,512 | |
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-1 | Amounts related to ratable recognition of upfront fees were $64,000 for the three months ended March 31, 2015 and 2014. | | | | | | | |
-2 | Amounts related to ratable recognition of upfront fees were $71,000 and zero for three months ended March 31, 2015 and 2014, respectively; the Company and Santen signed a license agreement effective December 11, 2014. | | | | | | | |
-3 | Amounts related to recognition of upfront fees were zero and $2.0 million for three months ended March 31, 2015 and 2014, respectively; the Company and Impax signed a license agreement effective January 3, 2014. | | | | | | | |
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 zero and $451,000 for the three months ended March 31, 2015 and 2014, respectively. In the first quarter of 2015, Pain Therapeutics notified the Company that they intend to return to the Company all of Pain Therapeutics’ rights and obligations under the Company’s license agreement to develop and commercialize ORADUR-based formulations of oxymorphone and hydrocodone but without impacting the rights and obligations of the two parties with respect to REMOXY and hydromorphone. Under the agreement with Pain Therapeutics, subject to and upon the achievement of predetermined development and regulatory milestones for the two drug candidates, the Company is entitled to receive milestone payments of up to $5.1 million in the aggregate. The cumulative aggregate payments received by the Company from Pain Therapeutics as of March 31, 2015 were $37.7 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 $5.1 million in performance milestone payments based on the successful development and approval of the two ORADUR-based opioids. Of these potential milestones, all $5.1 million are development-based milestones. As of March 31, 2015, the Company had received $1.7 million in cumulative milestone payments. There are no sales-based milestones under the agreement. |
In March 2009, King Pharmaceuticals (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. 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. In October 2014, Pfizer notified Pain Therapeutics that Pfizer had decided to discontinue development of REMOXY, and that Pfizer would return all rights, including responsibility for regulatory activities, to Pain Therapeutics and that Pfizer will continue ongoing activities under the agreement until the scheduled termination date in April 2015. |
Total collaborative research and development revenue recognized for REMOXY-related work performed by the Company for Pfizer was zero and $14,000 for the three months ended March 31, 2015 and 2014, respectively. 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 as of March 31, 2015 were $7.1 million under this agreement. |
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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. In February 2011, Pfizer acquired King and thereby assumed the rights and obligations of King with respect to this long term supply agreement. 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. |
The term of the agreement commenced on August 5, 2009 and will continue in effect until the earlier of the expiration of all licenses granted under the development and license agreement between the Company and Pain Therapeutics or the termination or expiration of the 2005 development and license agreement between Pain Therapeutics and King, unless the agreement is terminated earlier in accordance with its terms. The agreement provides each party with specified termination rights, which include, but are not limited to, the right of King to terminate the agreement in the event that governmental action requires the withdrawal of REMOXY from all countries in the territory or results in the withdrawal of required manufacturing approvals, or upon a change of control of the Company, in which case termination will be effective one year after notice by King. The Company may terminate the agreement if the Company is unable to procure suitable and sufficient quantities of certain raw materials required to produce the excipient ingredients. Each party may terminate the agreement upon material breach of the agreement by, or the bankruptcy or insolvency of, the other party, in each case subject to a cure period. The agreement further specifies the rights and obligations of the Company and King with respect to plant allocation, adding additional production capacity and sourcing of raw materials, as well as other terms and conditions customary for this type of agreement, including those regarding forecasting, purchasing, invoicing, representations, warranties and indemnities. |
Total revenues recognized related to these excipients were $96,000 and zero in the three months ended March 31, 2015 and 2014, respectively. The associated cost of goods sold was $51,000 and zero in the three months ended March 31, 2015 and 2014, respectively. |
Agreement with Zogenix, Inc. |
On July 11, 2011, the Company and Zogenix, Inc., (Zogenix), entered into a Development and License Agreement (the Zogenix 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 Zogenix 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 will be 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 developments, regulatory and sales milestones. Of these potential milestones, $28 million are development-based milestones (none of which has been achieved as of March 31, 2015), and $75 million are sales-based milestones (none of which has been achieved as of March 31, 2015). 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 III clinical trial and commercial product requirements on the terms set forth in the Zogenix Agreement. Zogenix may terminate the Zogenix Agreement without cause at any time upon prior written notice, and either party may terminate the Zogenix Agreement upon certain circumstances including written notice of a material uncured breach. |
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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 March 31, 2015 were $15.7 million under these agreements. |
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| | Three months ended | |
March 31, |
| | 2015 | | | 2014 | |
Ratable recognition of upfront payment | | $ | 64 | | | $ | 64 | |
Research and development expenses reimbursable by Zogenix | | | 1,094 | | | | 718 | |
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Total collaborative research and development revenue | | $ | 1,158 | | | $ | 782 | |
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Agreement with Impax Laboratories, Inc. |
On January 3, 2014, the Company and Impax Laboratories, Inc. (Impax) entered into a definitive agreement (the Impax Agreement). Pursuant to the Agreement, the Company has granted Impax an exclusive worldwide license to the Company’s proprietary TRANSDUR transdermal delivery technology and other intellectual property to develop and commercialize ELADUR, the Company’s investigational transdermal bupivacaine patch for the treatment of pain associated with post-herpetic neuralgia (PHN), in addition to selling certain assets and rights in and related to the product. Impax will control and fund the development and commercialization programs, and the parties will establish a joint management committee to oversee, review and coordinate the development and commercialization activities of the parties under the Impax Agreement. Impax will reimburse the Company for certain future research and development it may be requested to conduct on the product. |
In connection with the Agreement, Impax paid a non-refundable upfront fee to the Company of $2.0 million in January 2014. The Company’s technology transfer activities were considered integral to utilizing the licensed intellectual property and, accordingly, the deliverables were accounted for as a single unit of accounting. The $2.0 million upfront fee was recognized as collaborative research and development revenue in the first quarter of 2014 when the license to the intellectual property right was delivered and the technology transfer with respect to this product candidate was completed. Impax agreed to make contingent cash payments to the Company of up to $61.0 million payable based upon the achievement of predefined milestones, of which $31.0 million are development-based milestones and $30.0 million are sales-based milestones (none of which has been achieved as of March 31, 2015). Since the milestones are expected to be achieved at a point in time when there are no performance obligations or remaining deliverables of the Company, the milestones are expected to be recognized in full upon achievement. Upon the first commercialization of ELADUR by Impax, the Company would also receive a tiered mid single-digit to low double-digit royalty on annual net product sales determined on a country-by-country basis. Impax is also required to pay to the Company a percentage of fees received in connection with any sublicense of the licensed rights. Impax may terminate the Impax Agreement without cause at any time upon prior written notice, and either party may terminate the Impax Agreement upon certain circumstances including written notice of a material uncured breach. |
The following table provides a summary of collaborative research and development revenue recognized under the Impax Agreement (in thousands). The cumulative aggregate payments received by the Company as of March 31, 2015 were $2.1 million under the agreement. |
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| | Three months ended | |
March 31, |
| | 2015 | | | 2014 | |
Recognition of upfront payment | | $ | — | | | $ | 2,000 | |
Research and development expenses reimbursable by Impax | | | — | | | | 90 | |
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Total collaborative research and development revenue | | $ | — | | | $ | 2,090 | |
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Agreement with Santen Pharmaceutical Co., Ltd. |
On December 11, 2014, the Company and Santen Pharmaceutical Co., Ltd. (Santen) entered into a definitive agreement (the Santen Agreement). Pursuant to the Santen Agreement, the Company granted Santen an exclusive worldwide license to the Company’s proprietary SABER formulation platform and other intellectual property to develop and commercialize a sustained release product utilizing the Company’s SABER technology to deliver an ophthalmology drug. Santen will control and fund the development and commercialization program, and the parties will establish a joint management committee to oversee, review and coordinate the development activities of the parties under the Santen Agreement. |
In connection with the Santen agreement, Santen agreed to pay the Company an upfront fee of $2.0 million in cash and to make contingent cash payments to the Company of up to $76.0 million upon the achievement of certain milestones, of which $13.0 million are development-based milestones and $63.0 million are commercialization-based milestones including milestones requiring the achievement of certain product sales targets (none of which has been achieved as of March 31, 2015). Santen will also pay for certain Company costs incurred in the development of the licensed product. If the product is commercialized, the Company would also receive a tiered royalty on annual net product sales ranging from single-digit to the low double digits, determined on a country-by-country basis. Santen may terminate the Santen Agreement without cause at any time upon prior written notice, and either party may terminate the Santen Agreement upon certain circumstances including written notice of a material uncured breach. As of March 31, 2015, the cumulative aggregate payments received by the Company under this agreement were $2.4 million. |
The following table provides a summary of collaborative research and development revenue recognized under the Santen Agreement (in thousands). |
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| | Three months ended | |
March 31, |
| | 2015 | | | 2014 | |
Ratable recognition of upfront payment | | $ | 71 | | | $ | — | |
Research and development expenses reimbursable by Santen | | | 236 | | | | — | |
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Total collaborative research and development revenue | | $ | 307 | | | $ | — | |
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