Quarterly report pursuant to Section 13 or 15(d)

Collaboration and License Agreements

v3.19.2
Collaboration and License Agreements
6 Months Ended
Jun. 30, 2019
Organization Consolidation And Presentation Of Financial Statements [Abstract]  
Collaboration and License Agreements

 

8.

Collaboration and License Agreements

In December 2016, the Company entered into the Collaboration Agreement, pursuant to which the Company granted Novartis an exclusive option to collaborate with the Company to develop products containing emricasan. Pursuant to the Collaboration Agreement, the Company received a non-refundable upfront payment of $50.0 million from Novartis.

In May 2017, Novartis exercised its option under the Collaboration Agreement. In July 2017, the Company received a $7.0 million option exercise payment, at which time the license under the Collaboration Agreement became effective (the License Effective Date). Under the Collaboration Agreement, the Company is eligible to receive up to an aggregate of $650.0 million in milestone payments over the term of the Collaboration Agreement, contingent on the achievement of certain development, regulatory and commercial milestones, as well as royalties or profit and loss sharing on future product sales in the United States, if any.

Novartis will generally pay 50% of the Company’s Phase 2b and observational study costs pursuant to an agreed upon budget. Upon completion of the ongoing Phase 2b trials, Novartis will assume 100% of the observational study costs. Novartis will assume full responsibility for emricasan’s Phase 3 development and all combination product development. The Company and Novartis have no further development plans for emricasan. Therefore, the Company does not expect to receive any future milestone, royalty or profit and loss sharing payments under the Collaboration Agreement.

Unless terminated earlier, the Collaboration Agreement will remain in effect on a product-by-product and country-by-country basis until Novartis’ royalty obligations expire. Novartis has certain termination rights in the event of a mandated clinical trial hold for any product containing emricasan as its sole active ingredient. Additionally, Novartis has the right to terminate the Collaboration Agreement without cause upon 180 days prior written notice to the Company. In such event, the license granted to Novartis will be terminated and revert to the Company. In the event Novartis terminates the Collaboration Agreement due to the Company’s uncured material breach or insolvency, the license granted to Novartis pursuant to the Collaboration Agreement will become irrevocable, and Novartis will be required to continue to make all milestone and royalty payments otherwise due to the Company under the Collaboration Agreement, provided that if the Company materially breaches the Collaboration Agreement such that the rights licensed to Novartis or the commercial prospects of the emricasan products are seriously impaired, the milestone and royalty payments will be reduced by 50%.

Concurrent with entry into the Collaboration Agreement, the Company entered into the Investment Agreement, whereby the Company was able to borrow up to $15.0 million at a rate of 6% per annum, under one or two notes, with a maturity date of December 31, 2019. On February 15, 2017, the Company issued the Novartis Note in the principal amount of $15.0 million pursuant to the Investment Agreement. The terms of the Novartis Note allowed the Company to convert the principal and accrued interest into the Company’s common stock at a conversion price equal to 120% of the 20-day trailing average closing price per share of the common stock immediately prior to the conversion date. On December 5, 2018, the Company, at its option, converted the entire outstanding principal of $15.0 million and accrued and unpaid interest of the Novartis Note into 2,882,519 shares of the Company’s common stock at a conversion price of $5.77 per share.

Under the Collaboration Agreement, there are two significant performance obligations: the license and the research and development services, but the license is not distinct from the research and development services as Novartis cannot obtain value from the license without the research and development services, which the Company is uniquely able to perform. The Company concluded that progress towards completion of the performance obligations related to the Collaboration Agreement is best measured in an amount proportional to the collaboration expenses incurred and the total estimated collaboration expenses. The transaction price to be recognized as revenue under the Collaboration Agreement consists of the upfront payment, option exercise fee, deemed revenue from the premium paid by Novartis under the Investment Agreement and estimated reimbursable research and development costs. Certain expenses directly related to execution of the Collaboration Agreement were capitalized as assets on the balance sheet and are being expensed in a manner consistent with the methodology used for recognizing revenue.

In connection with emricasan failing to meet the primary endpoints in the ENCORE clinical trials, the Company is discontinuing its ongoing emricasan clinical trials, resulting in a shortened timeline and reduced estimated costs related to completion of emricasan activities. During the three months ended June 30, 2019, the Company significantly reduced the total estimated collaboration expenses related to the Collaboration Agreement, which is used as the measure of progress for recognition of revenue related to the Collaboration Agreement, from the prior estimate as of March 31, 2019. Consequently, during the three months ended June 30, 2019, the Company significantly reduced the transaction price related to the Collaboration Agreement from the prior estimate as of March 31, 2019, to reflect lower estimated reimbursable research and development costs. The net effect of these changes was a cumulative catch-up in revenue of $4.6 million, which was recorded as revenue as a change in estimate during the three months ended June 30, 2019. Execution costs related to the Collaboration Agreement were similarly affected, resulting in a cumulative catch-up in operating expenses of $0.1 million.

A reconciliation of the opening and closing balances of deferred revenue related to the Collaboration Agreement, which represents the unrecognized balance of the transaction price, is as follows (in thousands):

 

 

 

Deferred

Revenue

 

Balance at December 31, 2018

 

$

12,890

 

Additions to deferred revenue

 

 

7,055

 

Revenue recognized

 

 

(17,815

)

Balance at June 30, 2019

 

$

2,130

 

 

The Company expects to recognize deferred revenue related to the Collaboration Agreement within one year.

 

A reconciliation of the opening and closing balances of deferred costs related to execution of the Collaboration Agreement is as follows (in thousands):

 

 

 

Deferred

Costs

 

Balance at December 31, 2018

 

$

310

 

Costs recognized

 

 

(259

)

Balance at June 30, 2019

 

$

51

 

 

The Company expects to recognize deferred costs related to execution of the Collaboration Agreement within one year.