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Collaboration and License Agreements
12 Months Ended
Dec. 31, 2020
Collaboration and License Agreements  
Collaboration and License Agreements

Note 10. Collaboration and License Agreements

Option and License Agreement with Licensee

 

In April 2019, the Company entered into an amended and restated option and license agreement with a privately-held biopharmaceutical company (“Licensee”), pursuant to which the Company granted Licensee (i) exclusive worldwide rights to develop and market IMO-8400 for the treatment, palliation and diagnosis of all diseases, conditions or indications in humans (the “IMO-8400 License”), (ii) an exclusive right and license to develop IMO-9200 in accordance with certain IMO-9200 pre-option exercise protocols (the “IMO-9200 Option Period License”), and (iii) an exclusive one-year option, exercisable at Licensee’s discretion, to obtain the exclusive worldwide rights to develop and market IMO-9200 for the treatment, palliation and diagnosis of all diseases, conditions or indications in humans (the “IMO-9200 Option”) (collectively, the “Licensee Agreement”).  In connection with the Licensee Agreement, the Company transferred certain drug material to Licensee for Licensee’s use in development activities.  Licensee is solely responsible for the development and commercialization of IMO-8400 and, if Licensee exercises the IMO-9200 Option, Licensee would be solely responsible for the development and commercialization of IMO-9200.

Under the terms of the Licensee Agreement, the Company received upfront, non-refundable fees totaling approximately $1.4 million and ownership of 10% of Licensee’s outstanding common stock, subject to future adjustment, for granting Licensee the IMO-8400 License, the IMO-9200 Option Period License and transfer of related drug materials. In addition, following expiry of the IMO-9200 Option in 2020, the Company is now only eligible to receive certain development and sales-based milestone payments and royalties on global net sales related to the IMO-8400 Compound and potential future IMO-8400 Products, each as defined in the Licensee Agreement. The Company does not anticipate the receipt of any of the future milestones or royalties in the short term, if ever.

The Company accounts for the Licensee Agreement in accordance with ASC 606. As of December 31, 2020, the total transaction price of the contract was $1.4 million, which excluded the Option Fee and all development and sales milestones as all such payments were fully constrained. Additionally, as of December 31, 2020, there were no remaining performance obligations under the Licensee Agreement. The Company re-evaluates its performance obligations and transaction price in each reporting period and as uncertain events are resolved or other changes in circumstances occur.

 

Note 10. Collaboration and License Agreements (Continued)

As disclosed above, in connection with the Licensee Agreement, the Company owns 10% of Licensee’s outstanding common stock, subject to future adjustment. The Company evaluated the guidance in ASC Topic 321, Investments-Equity Securities, and elected to account for the investment using the measurement alternative as the equity securities are without a readily determinable fair value, and the arrangement does not result in Idera having control or significant influence over Licensee. Accordingly, the securities are measured at cost, less any impairment, plus or minus changes resulting from observable price changes and are recorded in Other assets at a value of less than $0.1 million in the accompanying balance sheets. As of December 31, 2020, the Company considered the cost of the investment to not exceed the fair value of the investment and did not identify any observable price changes.

 

Collaboration with GSK

In November 2015, the Company entered into a collaboration and license agreement with GSK to license, research, develop and commercialize pharmaceutical compounds from the Company’s nucleic acid chemistry technology for the treatment of selected targets in renal disease (the “GSK Agreement”). In connection with the GSK Agreement, GSK identified an initial target for the Company to attempt to identify a potential population of development candidates to address such target under a mutually agreed upon research plan. Prior to the wind-down of its discovery operations as more fully described in Note 10, the Company created multiple development candidates to address the initial target designated by GSK. Until November 2019, the expiration of the collaboration term, GSK had the right to designate one development candidate in its sole discretion, from the population of identified candidates, to move forward into clinical development. However, GSK did not designate any candidate for development during the collaboration term. If such designation had occurred, GSK would have been solely responsible for the development and commercialization activities of that designated development candidate.

The GSK Agreement also provided GSK with the option to select up to two additional targets at any time during the first two years of the GSK agreement, for further research under mutually agreed upon research plans. Upon selecting additional targets, GSK then had the option to designate one development candidate for each additional target, at which time GSK would have sole responsibility to develop and commercialize each such designated development candidate. GSK did not select any additional targets for research through expiry of the option period.

Under the terms of the GSK Agreement, the Company received a $2.5 million upfront, non-refundable, non-creditable cash payment upon the execution of the GSK Agreement. Additionally, the Company was initially eligible to receive a total of up to approximately $100 million in license, research, clinical development and commercialization milestone payments, of which $9 million of these milestone payments would have been payable by GSK upon the identification of the additional targets, the completion of current and future research plans and the designation of development candidates and $89 million would have been payable by GSK upon the achievement of clinical milestones and commercial milestones. As a result of GSK not designating a development candidate during the collaboration term, the Company is no longer eligible to receive any additional license, research, clinical development and commercialization milestone payments, or any royalty payments.

For the year ended December 31, 2018, the Company recognized Alliance revenues of $0.5 million pursuant to the GSK Agreement primarily related to the amortization of the $2.5 million upfront, non-refundable, non-creditable cash payment received upon the execution of the GSK Agreement, which was recognized as revenue on a straight-line basis over the estimated 36-month research plan period, which approximated the timing in which performance obligations were satisfied. No such revenues were recognized during 2020 or 2019.