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Purchase Commitments
9 Months Ended
Sep. 30, 2016
Commitments And Contingencies Disclosure [Abstract]  
Purchase Commitments

6. Purchase Commitments

Commercial Supply Agreement

In July 2014, we entered into an agreement with CMC ICOS Biologics, Inc. (“CMC Biologics”), a subsidiary of CMC Biologics S.à.r.l., a privately-held contract manufacturing organization, pursuant to which CMC Biologics will manufacture clinical and commercial supply of andexanet alfa.

Under the agreement, we are required to purchase an aggregate fixed number of batches of andexanet alfa from CMC Biologics beginning in 2015 through 2021. The fixed commitment to purchase batches is divided between two manufacturing lines at CMC Biologics: (i) the 2,500 liter manufacturing line which has been used since inception of the program to supply clinical drug product, referred to as “Line A/B”; and (ii) the 6x2,000 liter manufacturing line referred to as “Line C” which was intended to satisfy the drug product requirements of our initial commercial launch. Total batch commitments under the agreement can be increased or decreased based on the achievement of milestones relating to the regulatory approval process for andexanet alfa, expansion of existing manufacturing capacity and operational qualification of CMC Biologics’ manufacturing facilities. We made an upfront payment to CMC Biologics in the amount of $10.0 million in July 2014 and a reservation payment to CMC Biologics of $4.6 million in November 2014. Both payments were intended to be credited against our future purchases of batches under the agreement.

Total fixed commitments under the agreement for the purchases of clinical and commercial batches, not taking into account possible price and batch adjustments per the terms of the agreement, are approximately $276.1 million.  

The term of the agreement is seven years and may be early terminated by either party for the other party’s uncured material breach or insolvency. We may also terminate the agreement if CMC Biologics is unable to add additional manufacturing capacity on a timely basis, if certain manufacturing-related regulatory events do not occur before certain deadlines, or if the batch yield is below a certain threshold, in which case we are not obligated to pay CMC Biologics a termination payment and CMC Biologics will be obligated to refund the uncredited amounts of the upfront payment and reservation payment.

In addition, we may terminate the agreement unilaterally if we discontinue the development and commercialization of andexanet alfa for regulatory, safety, efficacy or other commercial reasons, or if the projected market demand or gross margin of andexanet alfa is below a minimum threshold. The termination provisions will obligate us to pay CMC Biologics a termination fee between $5.0 million and $30.0 million, depending on the date of termination. The termination fee is highest from 2015 through 2017, and then decreases through 2021. Any remaining upfront payments or reservation payments we have made, not yet credited against the purchase of batches, at the time of termination will be applied against the termination fee.

 

In February 2016, we filed a Biologics License Application (“BLA”) based on the Line A/B manufacturing process.  On August 17 2016, we received a Complete Response Letter, or CRL from the FDA that focused primarily on Line A/B manufacturing.  Since the amount of drug substance yielded by Line A/B will support only a limited launch, our intent was to seek approval for Line C subsequent to the approval of Line A/B in an effort to bridge the supply gap until the commercial scale generation 2 process manufactured at Lonza was approved. Given the time and effort required to address the deficiencies raised in the CRL and re-submit the BLA, we made the corporate decision to suspend manufacturing activities on Line C in order to focus on getting AndexXa approved using Line A/B and then transition commercial manufacturing to generation 2 as quickly as possible.

Given the uncertainty about whether we will consume the services originally contracted regarding Line C, we can no longer assert recoverability of the carrying amounts of the (i) unamortized upfront and reservation payments of $12.3 million recorded as $8.9 million in prepaid and other long-term assets and $3.4 million in prepaid research and development; (ii) unamortized payments made for the purchase of batches of $13.3 million recorded in prepaid research and development; nor (iii) other miscellaneous receivables of $1.7 million recorded in prepaid and other current assets. Accordingly, we have recorded a charge of $27.3 million in research and development expense in our condensed consolidated statement of operations for the period ended September 30, 2016.

Under the consolidation guidance, we determined that CMC Biologics is and continues to be a VIE, but that we are not CMC Biologics’ primary beneficiary and therefore consolidation of CMC Biologics by us is not required.

As of September 30, 2016, we have not provided financial or other support to CMC Biologics that was not previously contractually required. We have recorded $1.3 million of prepaid and other current assets, $352,000 of prepaid research and development, $367,000 of accounts payable and $1.8 million of accrued research and development in the condensed consolidated balance sheet as of September 30, 2016. These assets represent our maximum exposure to loss under this agreement at September 30, 2016.We are currently not able to quantify our total exposure to losses associated with the fixed pricing terms of this agreement and the potential losses associated with our inability to resolve manufacturing issues with CMC.

 

Betrixaban Manufacturing Agreement

In April 2016, we entered into a Manufacturing Agreement (“the Hovione Agreement”) with Hovione, Limited, (“Hovione”), pursuant to which Hovione will manufacture active pharmaceutical ingredient (“API”) for betrixaban at commercial scale and perform process validation during the term of the agreement.

 

Pursuant to the Hovione Agreement, as amended in September 2016, we have made advance payments of $18.7 million recorded as $12.7 million in prepaid research and development and $6.0 million in prepaid and other long-term assets, and will make up to $24.1 million of additional cancellable payments throughout the term of the Hovione Agreement ending June 2018. The additional payments can be cancelled with notice being provided by dates indicated in the Hovione Agreement. Further, if the regulatory approval timeline for betrixaban is delayed for regulatory reasons, there is no cancellation right, however the timing of manufacturing and payments under the Hovione Agreement will be adjusted up to one year to align with such new regulatory approval timeline. The Hovione Agreement may be early terminated by either party for the other party’s uncured material breach or insolvency. Also, we may terminate the Hovione Agreement if the FDA does not approve betrixaban or the regulatory application for betrixaban with the FDA is withdrawn by us or the FDA.