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Contract Manufacturing Agreements
12 Months Ended
Dec. 31, 2018
Commitments And Contingencies Disclosure [Abstract]  
Contract Manufacturing Agreements

7. Contract Manufacturing Agreements

 

Andexxa Manufacturing Agreements

AGC Biologics Commercial Supply Agreement (“CSA”)

In July 2014, we entered into a CSA with AGC Biologics, formerly CMC ICOS Biologics, Inc. (“AGC”), pursuant to which AGC manufactures clinical and commercial supply of andexanet alfa. The terms of the CSA required us to purchase an aggregate fixed number of batches from AGC through 2021. In December 2016, we entered into an Amended and Restated Commercial Supply Agreement (“aCSA”) with AGC that amended and restated the terms of the original CSA. Under the aCSA, AGC continues to manufacture bulk drug substance for Andexxa under our Gen 1 manufacturing process and supports other regulatory and manufacturing activities.

Under the consolidation guidance, we determined that AGC is a Variable Interest Entity (“VIE”) and we are not the primary beneficiary and therefore consolidation of AGC is not required. We came to this conclusion as we do not control those activities most significant to AGC, and therefore we are not considered to be the primary beneficiary of AGC. As of December 31, 2018, we have not provided financial or other support to AGC that was not previously contractually required. We have recorded $0.1 million of accounts payable, $2.3 million of accrued manufacturing and no accrued research and development in our consolidated balance sheet as of December 31, 2018. Neither the original CSA nor the aCSA require us to fund operations at AGC and therefore, historically we have quantified our maximum exposure to loss as the aggregate value of prepaid manufacturing services as of each reporting date. There is no prepaid manufacturing services outstanding in our consolidated balance sheet as of December 31, 2018. We believe that our total exposure to losses associated with the fixed pricing terms of this agreement is de minimis given the cost per batch, number of batches and time frame over which the batches will be manufactured, pursuant to the amended agreement.

Lonza Manufacturing Services Agreement

In August 2017, we executed a Manufacturing Services Agreement with Lonza AG (“Lonza”) to develop a second manufacturing site and to continue to develop our Gen 2 manufacturing process for Andexxa bulk drug substance and to manufacture commercial supply. The manufacturing commitments included therein are contingent upon marketing approval by either the FDA or the EMA of Andexxa manufactured at the current Porrino facility under the Gen 2 process and will remain in effect for a period of ten years. Additionally, the agreement provides Lonza with two separate rights to purchase shares of our common stock at a purchase price of $1.00 per share, contingent upon certain events. The first purchase right will be earned by Lonza upon the approval of the Gen 2 process and the commencement of process transfer activities to an additional, new facility. The second purchase right will be earned by Lonza upon the approval of the drug substance manufactured at the new facility and the number of shares will be determined based on the achievement of specified performance metrics at the new facility. The number of shares subject to each of the first and the second purchase rights will be capped at the lesser of either: (1) the number of shares with an aggregate market value of $15.0 million based on a 20-day trailing market value average from the date such purchase right is earned by Lonza, or (2) 500,000 shares. This agreement provides net cash settlement provision in the event a change of control or an assignment of this agreement occurs prior to Lonza earning entitlement to the first and/or second tranche purchase rights.

We measure the fair value of the equity instrument contingently issuable to Lonza by using the stock price and other measurement assumptions as of the earlier of the date at which either: (1) a commitment for performance by the counterparty has been reached; or (2) the counterparty’s performance is complete. We determined that Lonza does not have a performance commitment in this arrangement because there is no substantive disincentive for nonperformance. As such, our measurement date for the contingently issuable equity awards will be when the specified performance criteria have been achieved. Until such achievement, the contingently issuable equity awards will be measured at their then-current lowest aggregate fair value at each financial reporting date.

Upon the Gen2 approval on December 31, 2018, the only remaining performance condition for the first tranche award was the commencement of the technology transfer. As this is considered to be within Lonza’s control, recognition of the then-current fair value of the equity awards prior to the measurement date was assessed based on the probability that Lonza will perform. We expect that it is probable that Lonza will perform, and as such, we recorded the award at the fair value of $9.2 million using the valuation assumptions described in Note 4, “Fair Value Measurements” as of December 31, 2018.The $9.2 million non-cash charge was classified as research and development expense.

 

Bevyxxa Manufacturing Agreement

 

In 2016 we entered into a Manufacturing Agreement, as amended, with Hovione, Limited, (“Hovione”), pursuant to which Hovione agreed to manufacture active pharmaceutical ingredient (“API”) for Bevyxxa at commercial scale and perform process validation during the term of the agreement. As of December 31, 2018, we have recorded $10.9 million in prepaid and other long-term assets and we expect to make up to $2.9 million of additional payments over the remaining term of the Hovione Agreement, ending in 2019.