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Notes Payable
3 Months Ended
Mar. 31, 2018
Debt Disclosure [Abstract]  
Notes Payable

9. Notes Payable

BMS and Pfizer Promissory Notes

In December 2016, we entered into a supplemental funding support agreement with BMS and Pfizer whereby we received $50.0 million in exchange for two promissory notes totaling $65.0 million that become due in December 2024 (“Notes”). The use of funds is restricted to development activities needed for regulatory approval of Andexxa by the FDA and European Medicines Agency (“EMA”) as provided for in the agreement.

Pursuant to the terms of the agreement, we are required to pay down the Notes each quarter in an amount equal to 5% of net sales of Andexxa in the United States and European Union (“EU”). Should the initial regulatory approval of Andexxa in the United States and EU not be achieved by January 1, 2019, one hundred percent of payments due to us under the Japan License agreement and fifty percent of all other Andexxa license fees and milestone payments received from third-party collaborators will be applied to the Notes. In addition, if the approval of Andexxa in the United States and EU is not achieved by January 1, 2019, we are able to reduce the repayment amount to $60.0 million if such amount is paid by December 31, 2021 and regardless of the timing of regulatory approval, we may reduce the repayment amount to $62.5 million if such amount is paid by December 31, 2023.  Any unpaid amounts shall become immediately due upon: 1) a change of control of our company; 2) an event of default; and 3) termination for breach. We have the right to prepay the repayment amount at any time without any penalty.

The accounting for such funding agreement requires us to make certain estimates and assumptions, including timing of Andexxa approval, timing of royalty payments due to BMS and Pfizer, the expected rate of return to BMS and Pfizer, the split between current and long-term portions of the obligation and accretion of related interest expense.

The upfront cash receipt of $50.0 million is recorded as Notes payable, long term at issuance. We are accruing for interest over the term of the related note. The carrying values of the Notes payable at March 31, 2018 and December 31, 2017, including accrued interest of $5.1 million and $4.2 million, are $51.4 million and $50.6 million, respectively. The total carrying value of the Notes, including accrued interest, will be classified as long-term on the condensed consolidated balance sheet until we receive regulatory approval of Andexxa or until amounts are contractually payable to BMS and Pfizer.

We evaluated the features of the Notes and determined that certain features require acceleration of payments such as pursuant to a change of control or an event of default, as well as the terms that adjust the total amount of interest required to be paid based upon the timing of initial regulatory approval in the United States and EU. We determined that these features (embedded derivatives) require bifurcation and fair value recognition. We determined the fair value of each derivative using a Monte Carlo simulation model taking into account the probability of these events occurring and potential repayment amounts and timing of such payments that would result under various scenarios (see Note 3 “Revenue Recognition” to these condensed consolidated financial statements). We will remeasure the embedded derivatives to fair value each reporting period until the repayment, termination or maturity of the long-term note payable.  For the three months ended March 31, 2018, we recognized $0.6 million loss upon remeasurement of the embedded derivatives.

The estimated fair value of the Notes payable at March 31, 2018 and December 31, 2017 was $54.0 million and $55.5 million, respectively, and the fair value was measured using Level 3 inputs. The estimated fair market value was calculated using a Monte Carlo simulation model with inputs consistent with those used in determining the embedded derivative values as described in Note 3 “Revenue Recognition” to these condensed consolidated financial statements.    

          

Royalty-based Financing

In February 2017, we entered into a purchase and sale agreement (the “Royalty Sales Agreement”) with HealthCare Royalty Partners and its affiliates. (“HCR”) whereby HCR acquired a royalty interest in future worldwide net sales of Andexxa. We received $50.0 million upon closing and are due to receive an additional $100.0 million following the U.S. regulatory approval of Andexxa in May 2018.

We are required to pay HCR a royalty of 2.0% based on tiered net worldwide sales of Andexxa. Upon the second closing and receipt of $100.0 million from HCR, the tiered royalty rate will increase to a range of 7.85% to 3.58%, as the applicable rate decreases starting at worldwide net sales levels above $150.0 million. Total royalty payments are capped at 195% of the funded amount, however, the royalty rates are subject to increase based on the timing of manufacturing approvals from the FDA and/or EMA. We have evaluated the terms of the Royalty Sales Agreement and concluded that the features of the funded amount are similar to those of a debt instrument.  Accordingly, we have accounted for the transaction as long-term debt.

As the repayment of the funded amount is contingent upon the sales volumes of Andexxa, the repayment term may be shortened or extended depending on the actual sales of Andexxa. The repayment period is commencing from the first commercial sale of Andexxa in any country and expiring on the date when HCR has received cash payments totaling an aggregate of 195% of the funded amounts.

We evaluated the terms of the debt and determined that certain features, such as the increase in the repayment amount up to $125.0 million upon a change of control and the variability in the royalty payments based upon the timing of initial regulatory approval in the United States and EU, are embedded derivatives that require bifurcation from the debt instrument and fair value recognition. We determined the fair value of each derivative using a Monte Carlo simulation model taking into account the probability of these events occurring and potential repayment amounts and timing of such payments that would result under various scenarios, as further described in Note 3 “Revenue Recognition” to these condensed consolidated financial statements. We will remeasure the embedded derivatives to fair value each reporting period until the time the features lapse and/or termination of the Royalty Sales Agreement. For the three months ended March 31, 2018, we recognized a gain of $2.2 million upon remeasurement of the embedded derivatives.    

The effective interest rate as of March 31, 2018 was 14.0%. For the three months ended March 31, 2018 and 2017, accrued interest in the amount of $1.8 million and $0.9 million, respectively, were added to the principal balance of the debt.

In connection with the Royalty Sales Agreement, we paid HCR a fee of $2.0 million and incurred additional debt issuance costs totaling $0.6 million, which includes expenses that we paid on behalf of HCR and expenses incurred directly by us. Debt issuance costs have been netted against the debt as of March 31, 2018 and are being amortized over the estimated term of the debt using the effective interest method. For the three months ended March 31, 2018 and 2017, we recognized interest expense, including amortization of the debt discount, related to the debt of $1.8 million and $0.9 million, respectively. The assumptions used in determining the expected repayment term of the debt and amortization period of the issuance costs requires that we make estimates that could impact the short and long-term classification of these costs, as well as the period over which these costs will be amortized. The carrying value of the long-term debt as of March 31, 2018 and December 31, 2017 was $56.0 million and $54.3 million, respectively, inclusive of accrued interest expense of $9.2 million and $7.4 million, respectively, and net of unamortized debt discount of $2.3 million and $2.3 million, respectively. The total carrying value of the debt, including accrued interest, will be classified as long-term on the consolidated balance sheet until we achieve regulatory approval of Andexxa.

The estimated fair value of long-term debt at March 31, 2018 and December 31, 2017 was $57.8 million and $58.8 million, respectively, and the fair value was measured using Level 3 inputs. The estimated fair market value was calculated using a Monte Carlo simulation model with inputs consistent with those used in determining the embedded derivative values as described in Note 3 “Revenue Recognition” to these condensed consolidated financial statements.