Annual report pursuant to Section 13 and 15(d)

Collaboration and License Agreements

v3.19.1
Collaboration and License Agreements
12 Months Ended
Dec. 31, 2018
Collaboration And License Agreements [Abstract]  
Collaboration and License Agreements

5. Collaboration and License Agreements

The Company has recognized revenue from its collaboration and license agreements as follows:

 

 

 

Year Ended December 31,

 

 

 

2018

 

 

2017

 

 

2016

 

 

 

(in thousands)

 

Collaboration revenue:

 

 

 

 

 

 

 

 

 

 

 

 

Celgene Corporation (“Celgene”) (1)

 

 

 

 

 

 

 

 

 

 

 

 

Recognition of up-front payment

 

$

6,567

 

 

$

16,694

 

 

$

27,730

 

Research and development services

 

 

119

 

 

 

660

 

 

 

-

 

Milestones and contingent payments

 

 

10,000

 

 

 

27,252

 

 

 

26,271

 

Total

 

 

16,686

 

 

 

44,606

 

 

 

54,001

 

Merck Sharp & Dohme Corporation (“Merck”)—

   related party:

 

 

 

 

 

 

 

 

 

 

 

 

Recognition of up-front payment

 

 

6,985

 

 

 

-

 

 

 

 

 

Research and development services

 

 

1,541

 

 

 

-

 

 

 

 

 

Total

 

 

8,526

 

 

 

-

 

 

 

-

 

Merck KGaA, Darmstadt, Germany (operating in

   the United States and Canada under the name

   “EMD Serono”):

 

 

 

 

 

 

 

 

 

 

 

 

Recognition of up-front payment

 

 

4,142

 

 

 

4,120

 

 

 

4,120

 

Research and development services

 

 

3,033

 

 

 

3,015

 

 

 

1,610

 

Total

 

 

7,175

 

 

 

7,135

 

 

 

5,730

 

Total collaboration revenue

 

$

32,387

 

 

$

51,741

 

 

$

59,731

 

Other revenue

 

 

 

 

 

 

 

 

 

 

 

 

Celgene Corporation (1):

 

 

 

 

 

 

 

 

 

 

 

 

Development and manufacturing services and

   clinical product supply

 

$

4,501

 

 

$

-

 

 

 

 

 

SutroVax—related party:

 

 

 

 

 

 

 

 

 

 

 

 

Supply and other

 

 

1,531

 

 

 

-

 

 

 

 

 

Total other revenue

 

$

6,032

 

 

$

-

 

 

$

-

 

Total revenue

 

$

38,419

 

 

$

51,741

 

 

$

59,731

 

 

(1)

Includes $5.0 million of collaboration revenue and $3.9 million of other revenue from Celgene as related party revenue. Celgene was a related party through September 30, 2018 as it held more than 10% of our common stock for the periods presented until the closing of our IPO.

 

2014 Celgene Agreement

In September 2014, the Company signed a Collaboration and License Agreement with Celgene (the “2014 Celgene Agreement”) to discover and develop bispecific antibodies and/or antibody-drug conjugates (“ADCs”), focused primarily on the field of immuno-oncology, using the Company’s proprietary integrated cell-free protein synthesis platform, XpressCF™.

Upon signing the 2014 Celgene Agreement, the Company received an up-front, nonrefundable payment totaling $83.1 million. The Company was recognizing revenues from the up-front payment ratably over an approximate three-year period starting in September 2014 prior to entering into the Amended and Restated Collaboration and License Agreement with Celgene (the “2017 Celgene Agreement”).

In March 2015, the Company received a $15.0 million contingent payment (“March 2015 payment”) from Celgene under the 2014 Celgene Agreement that provided Celgene a right to access certain of the Company’s technology for use in conjunction with certain Celgene intellectual property. In June 2016, the Company received a $25.0 million milestone (“June 2016 payment”) upon completion of certain preclinical activities. The March 2015 and June 2016 payments were being recognized as revenue over the remaining portion of the estimated period of the research term prior to entering into the 2017 Celgene Agreement.  Additionally, in June 2016, the Company earned a $10.0 million substantive milestone for certain manufacturing accomplishments. The entire $10.0 million amount was recognized as revenue when earned, as the Company had completed its performance obligations related to the achievement of the substantive milestone.

2017 Celgene Agreement

In August 2017, the Company entered into the 2017 Celgene Agreement to refocus its 2014 Celgene Agreement on four programs that are advancing through preclinical development, including an ADC program targeting B cell maturation antigen.

Upon signing of the 2017 Celgene Agreement, the Company received an option fee payment of $12.5 million in August 2017 and is entitled to receive a second option fee payment of $12.5 million following the first investigational new drug (“IND”) clearance, if any, for one of the four programs, if Celgene desires to maintain its option to acquire the U.S. rights to develop and commercialize a second collaboration program to reach IND status. If Celgene exercises its option to acquire from the Company U.S. rights to a second collaboration program, it will make an option exercise fee payment to the Company, the amount of which depends on which program reaches IND status. The Company determined that the initial $12.5 million payment should be deferred and recognized over the entire potential period during which Celgene has an option to acquire worldwide rights to a second collaboration program. Consequently, the Company is recognizing revenue from such payment ratably over an approximate three-year period starting in August 2017 and ending in September 2020.  In September 2017, the Company earned a $10.0 million milestone for certain manufacturing accomplishments, which payment was received from Celgene in October 2017.  The entire $10.0 million amount was recognized as revenue when earned, as the Company had completed its performance obligations related to the achievement of the substantive milestone.  In December 2018, the Company earned a $10.0 million milestone for certain manufacturing accomplishments, which payment was received from Celgene in the same month. The entire $10.0 million amount was recognized as revenue when earned, as the Company had completed its performance obligations related to the achievement of the substantive milestone.

The Company evaluated the terms of the 2017 Celgene Agreement, relative to the 2014 Celgene Agreement, and determined the 2017 Celgene Agreement to be a material modification to the 2014 Celgene Agreement for financial reporting purposes. As a result, the Company determined that the remaining deferred revenue balance of $8.2 million as of the date of entering into the 2017 Celgene Agreement, related to certain Celgene payments to the Company under the 2014 Celgene Agreement, will also be recognized ratably over an approximate three-year period starting in August 2017 and ending in September 2020 (the “Celgene Agreements”). The Company has received and will be eligible to receive financial support for research and development services assigned to the Company by Celgene, based on an agreed-upon level of full-time equivalent personnel effort and related reimbursement rate, which will be recognized as revenue as the related reimbursable activities approved by Celgene and the Company are performed by the Company.

Under the terms of the 2017 Celgene Agreement, the Company is entitled to earn development and regulatory contingent payments for each of the four programs under the collaboration, and royalties on sales of any commercial products that may result from the 2017 Celgene Agreement.  For licensed products for which Celgene holds worldwide rights, the Company is eligible to receive aggregate milestone and option fee payments of up to $295.0 million for certain licensed products and up to $393.7 million for certain other licensed products under the collaboration, if approved in multiple indications, and, depending on the licensed product, tiered royalties ranging from mid-single digits to low teen percentages on worldwide sales of any commercial products that may result from the 2017 Celgene Agreement. Additionally, for licensed products for which Celgene holds ex-U.S. rights, the Company will also be eligible to receive pre-commercial contingent payments and tiered royalties ranging from mid to high single digit percentages. The contingent payments under the 2017 Celgene Agreement are not considered to be substantive milestones because the receipt of such payments is based solely on the performance of Celgene.

Celgene may terminate the 2017 Celgene Agreement at any time with 120 days’ prior written notice. Either the Company or Celgene has the right to terminate the 2017 Celgene Agreement based on the other party’s uncured material breach, challenge of the validity and enforceability of intellectual property, or bankruptcy.

As of December 31, 2018 and 2017, there was $11.4 million and $18.0 million, respectively, of deferred revenue related to payments received by the Company under the Celgene Agreements.

As of December 31, 2018 and 2017, the Company had $0.6 million and $0.8 million, respectively, of receivables from Celgene related to the Celgene Agreements, which are included in accounts receivable on the balance sheet.

2018 Celgene Master Services Agreement

In March 2018, the Company entered into a Master Development and Clinical Manufacturing Services Agreement (the “2018 Celgene Master Services Agreement”) with Celgene, wherein Celgene requested the Company to provide development, manufacturing and supply chain management services, including clinical product supply. The consideration for the services is based on an agreed-upon level of full-time equivalent personnel effort and related reimbursement rate in addition to agreed-upon pricing for the clinical product supply.   

For the year ended December 31, 2018, the Company earned $4.5 million in other revenue under the Master Services Agreement.

2018 Merck Agreement – Related Party

In July 2018, the Company entered into an Exclusive Patent License and Research Collaboration Agreement (the “2018 Merck Agreement”) with Merck, a related party of the Company, to jointly develop up to three research programs focusing on cytokine derivatives for cancer and autoimmune disorders.

Under the 2018 Merck Agreement, the Company received from Merck a non-refundable, non-creditable, upfront payment of $60.0 million in August 2018 for access to the Company’s technology and the identification of the preclinical research and development of two target programs, with an option for Merck to engage the Company to continue these activities for a third program upon the payment of an additional amount. The Company identified multiple deliverables under the 2018 Merck Agreement, which include access to certain intellectual property rights, performance of research and development services, and joint project team participation, and the value of the arrangement was allocated amongst the units of accounting using the Company’s best estimate of selling price (BESP) of the associated deliverables. The BESP of the deliverables was developed using an estimate of the costs to provide access to the technology and personnel as described in the agreement and developed with reference to the workplans created by the parties and the associated profit margin developed by management.  The Company allocated $4.4 million of the upfront payment received to the contingent third program, with such allocation representing the estimated significant incremental discount associated with the contingent deliverable.  Recognition of the $4.4 million as revenue will begin upon commencement of the third program. The remaining $55.6 million of the upfront payment received was allocated to each of the units of accounting proportionately, based on BESP. The allocated revenue pertaining to the research and development services is being recognized on a proportion of performance basis, using the number of full-time equivalent (FTE) personnel effort as the basis of measurement, with such performance expected to occur over each program estimated duration of approximately three years.  The allocated amount pertaining to the intellectual property rights and joint project team participation is being recognized over the total estimated term of the 2018 Merck Agreement. For the year ended December 31, 2018, the Company recognized $7.0 million of revenue associated with the upfront payment received. Additionally, the Company recognized revenue of approximately $1.5 million for FTE funding provided by Merck.

The Company is also eligible to receive aggregate milestone payments of up to $1.6 billion, assuming the development and sale of all therapeutic candidates and all possible indications identified under the collaboration. If one or more products from each of the target programs are developed for non-oncology or a single indication, the Company will be eligible for reduced aggregate milestone payments. In addition, the Company is eligible to receive tiered royalties ranging from mid-single digit to low teen percentages on the worldwide sales of any commercial products that may result from the collaboration.

Merck may terminate the 2018 Merck Agreement at any time with 60 days’ prior written notice. Either the Company or Merck has the right to terminate the 2018 Merck Agreement based on the other party’s uncured material breach or bankruptcy.

As of December 31, 2018, there was $53.0 million of deferred revenue related to the upfront payment received by the Company under the 2018 Merck Agreement.  As of December 31, 2018, the Company had a $0.9 million receivable from Merck related to the 2018 Merck Agreement, which is included in accounts receivable on the balance sheet.

During 2018, Merck purchased 74,794,315 shares of the Company’s Series E redeemable convertible preferred stock at a price per share of $0.2674, resulting in gross proceeds of $20.0 million in July 2018.  In a private placement concurrent with the Company’s IPO, which was completed on October 1, 2018, Merck purchased 666,666 shares of common stock at a price per share of $15.00, resulting in proceeds of approximately $10.0 million.  As a result of the investments in the Company’s equity, Merck is a related party.

EMD Serono Agreement

The Company signed a Collaboration Agreement and a License Agreement with EMD Serono in May 2014 and September 2014, respectively, which were entered into in contemplation of each other and therefore treated as a single agreement for accounting purposes. The Collaboration Agreement was terminated upon execution of the License Agreement (the “MDA Agreement”), which agreement is to develop ADCs for multiple cancer targets.

Upon signing the Collaboration Agreement, the Company received an up-front, nonrefundable, non-creditable payment totaling $10.0 million. Upon signing the MDA Agreement, the Company received an additional up-front, nonrefundable payment totaling $10.0 million and will receive financial support for research and development services to be provided by the Company, based on an agreed-upon level of full-time equivalent personnel effort and related reimbursement rate.

The Company identified multiple deliverables under the MDA Agreement, which include access to certain intellectual property rights, performance of research and development services, and joint project team participation. The Company considered the provisions of the multiple-element arrangement guidance in determining whether access to the intellectual property rights under the arrangement has stand-alone value. Based on the Company’s expertise in applying its proprietary technology, it concluded that there is no stand-alone value of the intellectual property rights accessed by EMD Serono. Consequently, the Company determined that the identified deliverables comprise a single unit of accounting, and the up-front cash payments will be deferred and recognized over the relevant estimated period during which the Company has significant obligations to perform research and development services and participate in joint project team activities for EMD Serono. Consequently, the Company is recognizing revenues from the up-front payments ratably over an estimated five-year period starting in June 2014. Revenue for research and development services under the MDA Agreement will be recognized as revenue as the related reimbursable activities approved by EMD Serono and the Company are performed by the Company.

The Company is eligible to receive up to $52.5 million for each product developed under the MDA Agreement, primarily from pre-commercial contingent payments. In addition, the Company is eligible to receive tiered royalties ranging from low-to-mid single digit percentages, along with certain additional one-time royalties, on worldwide sales of any commercial products that may result from the MDA Agreement. The MDA Agreement term expires on a product-by-product and country-by-country basis upon the later of the expiration of the patents covering products licensed under the MDA Agreement or ten years after the first commercial sale of a product covered under the MDA Agreement. Upon expiration, EMD Serono will have a fully paid-up, royalty-free, perpetual, and irrevocable non-exclusive license, with the right to grant sublicenses, under certain Company intellectual property rights.

EMD Serono may terminate the MDA Agreement at any time with 90 days’ prior written notice or upon the inability of the Company to provide EMD Serono access to a specified number of cancer drug targets. Either the Company or EMD Serono has the right to terminate the MDA Agreement based on the other party’s uncured material breach or bankruptcy.

As of December 31, 2018 and 2017, there was $1.7 million and $5.9 million, respectively, of deferred revenue related to the upfront payments received by the Company under the MDA Agreement. As of December 31, 2018 and 2017, the Company had $0.9 million and $0.8 million, respectively, of receivables from EMD Serono related to the MDA Agreement, which are included in accounts receivable on the balance sheet.

SutroVax, Inc. Supply Agreement – Related Party

In May 2018, the Company entered into a Supply Agreement (the “Supply Agreement”) with SutroVax, Inc., (“SutroVax”), wherein SutroVax engaged the Company to supply extracts and custom reagents, as requested by SutroVax. The pricing is based on an agreed upon cost plus arrangement. For the year ended December 31, 2018, the Company recognized $1.5 million in other revenue-related parties under the Supply Agreement. As of December 31, 2018, the Company had a $49,000 receivable from SutroVax related to the Supply Agreement, which is included in accounts receivable on the balance sheet.

The Leukemia & Lymphoma Society, Inc.

In August 2018, the Company entered into a Research, Development and Commercialization Agreement (the “LLS Agreement”) with The Leukemia & Lymphoma Society (“LLS”), under which LLS has agreed to contribute up to $6.0 million in clinical development funding for STRO-001, the Company’s CD74-targeting ADC to treat relapsed and/or refractory multiple myeloma and non-Hodgkin lymphoma. The funding will be provided in installments based upon the achievement of funding milestones, with any excess funding above actual expenditures refundable to LLS. The initial payment of $0.5 million was received by the Company upon execution of the LLS Agreement. As of December 31, 2018, the Company had received total payments from LLS of $1.0 million, of which $0.9 million was reflected as an offset against other income (expense) and the remaining $0.1 million was recorded in other current liabilities. In consideration for the funding to the Company under the LLS Agreement, the Company may be required in the future to make payments to LLS, contingent upon reaching certain pre-specified late-stage clinical development, regulatory and commercialization milestones and should the Company enter into certain transactions relating to STRO-001 with a third party, which payments in aggregate could total up to a maximum $19.5 million, assuming receipt by the Company from LLS of the entire $6.0 million in clinical development funding for STRO-001. As of December 31, 2018, no events have occurred that would require such payments to LLS. The LLS Agreement terminates upon the earlier of (a) fulfillment of all payment obligations by both parties or (b) 12 years after the effective date.  LLS may terminate the LLS Agreement at any time with 60 days’ prior written notice. Either the Company or LLS has the right to terminate the LLS Agreement based on the other party’s uncured material breach.

The Company concluded that the contingent payments were an embedded derivative and recorded a related liability of approximately $0.1 million as part of other noncurrent liabilities as of December 31, 2018, with the corresponding amount recorded in the statement of operations as other income (expense), net. The value of the embedded derivative was estimated based on the probability-adjusted and discounted value of future payments.