XML 29 R11.htm IDEA: XBRL DOCUMENT v3.22.0.1
Revenue from Contracts with Customers
12 Months Ended
Dec. 31, 2021
Revenue From Contract With Customer [Abstract]  
Revenue from Contracts with Customers

3. REVENUE FROM CONTRACTS WITH CUSTOMERS

 

During the years ended December 31, 2021, 2020 and 2019, the Company recorded product sales, net, as follows:

 

 

 

Year Ended December 31,

 

(In thousands)

 

2021

 

 

2020

 

 

2019

 

VIVITROL

 

$

343,853

 

 

$

310,722

 

 

$

335,365

 

ARISTADA and ARISTADA INITIO

 

 

275,356

 

 

 

241,038

 

 

 

189,134

 

LYBALVI

 

 

8,215

 

 

 

 

 

 

 

Total product sales, net

 

$

627,424

 

 

$

551,760

 

 

$

524,499

 

During the years ended December 31, 2021, 2020 and 2019, the Company recorded manufacturing and royalty revenues from its collaboration arrangements as follows:

 

 

 

Year Ended December 31, 2021

 

(In thousands)

 

Manufacturing Revenue

 

 

Royalty Revenue

 

 

Total

 

Long-acting INVEGA products

 

$

 

 

$

303,106

 

 

$

303,106

 

VUMERITY

 

 

25,808

 

 

 

61,614

 

 

 

87,422

 

RISPERDAL CONSTA

 

 

40,413

 

 

 

10,456

 

 

 

50,869

 

AMPYRA/FAMPYRA

 

 

27,406

 

 

 

20,479

 

 

 

47,885

 

Other

 

 

12,001

 

 

 

40,524

 

 

 

52,525

 

 

 

$

105,628

 

 

$

436,179

 

 

$

541,807

 

 

 

 

Year Ended December 31, 2020

 

(In thousands)

 

Manufacturing Revenue

 

 

Royalty Revenue

 

 

Total

 

Long-acting INVEGA products

 

$

 

 

$

274,200

 

 

$

274,200

 

VUMERITY

 

 

8,848

 

 

 

13,693

 

 

 

22,541

 

RISPERDAL CONSTA

 

 

56,893

 

 

 

14,468

 

 

 

71,361

 

AMPYRA/FAMPYRA

 

 

26,909

 

 

 

20,984

 

 

 

47,893

 

Other

 

 

26,384

 

 

 

41,621

 

 

 

68,005

 

 

 

$

119,034

 

 

$

364,966

 

 

$

484,000

 

 

 

 

Year Ended December 31, 2019

 

(In thousands)

 

Manufacturing Revenue

 

 

Royalty Revenue

 

 

Total

 

Long-acting INVEGA products

 

$

 

 

$

256,947

 

 

$

256,947

 

RISPERDAL CONSTA

 

 

50,433

 

 

 

15,950

 

 

 

66,383

 

AMPYRA/FAMPYRA

 

 

22,071

 

 

 

15,170

 

 

 

37,241

 

Other

 

 

31,750

 

 

 

55,561

 

 

 

87,311

 

 

 

$

104,254

 

 

$

343,628

 

 

$

447,882

 

 

In November 2021, the Company received notice of partial termination in the U.S. of its license agreement with Janssen related to INVEGA SUSTENNA, INVEGA TRINZA, and INVEGA HAFYERA. The basis for this termination is Janssen’s assertion that it does not utilize the Company’s NanoCrystal technology licensed under the license agreement. The Company strongly disagrees with Janssen’s position and is prepared to pursue all options at its disposal to enforce its contractual rights and address any unauthorized use of its intellectual property. When the termination became effective in February 2022, the Company stopped recognizing royalty revenue related to net sales of INVEGA SUSTENNA, INVEGA TRINZA, and INVEGA HAFYERA in the U.S.

 

The research and development revenue and license revenue recorded during the year ended December 31, 2019 primarily related to revenue earned under the Company’s license and collaboration agreement with Biogen for VUMERITY. Except in limited circumstances, the Company was responsible for the development of VUMERITY until it was approved by the FDA. Following FDA approval of VUMERITY in October 2019, and except for the manufacturing responsibilities discussed below, Biogen is now

responsible for development and commercialization activities for VUMERITY and other products covered by patents licensed to Biogen.

Under a license and collaboration agreement with Biogen, which the Company entered into in November 2017 and amended in October 2018, January 2019 and October 2019, the Company granted Biogen a worldwide, exclusive, sublicensable license to develop, manufacture and commercialize VUMERITY and other products covered by patents licensed to Biogen under the agreement.

Under the license and collaboration agreement, the Company received an up-front cash payment and was also eligible to receive additional payments upon achievement of certain milestones with respect to VUMERITY. In November 2019, the Company received a payment of $150.0 million following the FDA approval of the New Drug Application (“NDA”) for VUMERITY and transfer of such NDA to Biogen. The Company is also eligible to receive additional payments upon achievement of other milestones, including development milestones with respect to the first two products other than VUMERITY covered by patents licensed to Biogen under the license and collaboration agreement. In January 2018, Biogen became responsible for all VUMERITY development costs that the Company incurred, subject to annual budget limitations. Following FDA approval of the NDA for VUMERITY in October 2019, the NDA and any further development responsibilities with respect to VUMERITY were transferred to Biogen.

The Company evaluated the license and collaboration agreement under Topic 606 and determined that it had four deliverables: (i) the grant of a distinct, right-to-use license of IP to Biogen; (ii) future development services; (iii) clinical supply; and (iv) participation on a joint steering committee with Biogen. The Company’s participation on the joint steering committee was considered to be perfunctory and thus not recognized as a performance obligation. The deliverables, aside from the participation in the joint steering committee which was considered to be perfunctory, were determined to be separate performance obligations as the license is separately identifiable from the development services and clinical supply, and the development services are not expected to significantly modify or customize the IP.

The Company allocated the arrangement consideration to each performance obligation using the standalone selling prices based on its estimate of selling price for the license and other deliverables. The Company used a discounted cash flow model to estimate the standalone selling price of the license in order to allocate the consideration to the performance obligations. To estimate the standalone selling price of the license, the Company assessed the likelihood of the FDA’s approval of VUMERITY and estimated the expected future cash flows assuming FDA approval and maintenance of the IP protecting VUMERITY. The Company then discounted these cash flows using a discount rate of 8.0%, which it believed captures a market participant’s view of the risk associated with the expected cash flows. The estimate of selling price of the development services and clinical supply were determined through third-party evidence. The Company believes that a change in the assumptions used to determine its estimate of selling price for the license most likely would not have a significant effect on the allocation of consideration transferred.

 

The Company allocated the $150.0 million milestone payment received in November 2019 to the relevant performance obligations as follows: $144.8 million to the delivery of the license; and $5.2 million to future development services and clinical supply. The amounts allocated to the license were recognized upon receipt of the payments as delivery of the license occurred upon entry into the agreement in 2017. The amounts allocated to the development services and clinical supply were recognized over the course of the development work and as clinical supply was delivered to Biogen in 2020.

 

In addition, the Company receives a 15% royalty on worldwide net sales of VUMERITY, subject to, under certain circumstances, minimum annual payments for the first five years following FDA approval of VUMERITY. The Company is also entitled to receive royalties on net sales of products other than VUMERITY covered by patents licensed to Biogen under the license and collaboration agreement, at tiered royalty rates calculated as percentages of net sales ranging from high-single digits to sub-teen double digits. All royalties are payable on a product-by-product and country-by-country basis until the later of (i) the last-to-expire patent right covering the applicable product in the applicable country and (ii) a specified period of time from the first commercial sale of the applicable product in the applicable country. Royalties for all products and the minimum annual payments for VUMERITY are subject to customary reductions, as set forth in the license and collaboration agreement.

 

The Company determined that the future development milestones and sales-based royalties that it may be entitled to receive are variable consideration. The Company is using the most likely amount method for estimating the variable consideration to be received related to the milestones under this arrangement. The royalties are subject to the sales-based exception and are recorded when the corresponding sale occurs.

 

Under the license and collaboration agreement, Biogen appointed the Company as the toll manufacturer of clinical and commercial supplies of VUMERITY, subject to Biogen’s right to manufacture or have manufactured commercial supplies as a back-up manufacturer and subject to good faith agreement by the parties on the terms of such manufacturing arrangements. In October 2019, the Company entered into a commercial supply agreement with Biogen for the commercial supply of VUMERITY, an

amendment to such commercial supply agreement and an amendment to the November 2017 license and collaboration agreement with Biogen. Under these agreements, Biogen elected to initiate a technology transfer relating to the manufacture of VUMERITY (the “Tech Transfer”) and, following a transition period, to assume responsibility for the manufacture (itself or through a designee) of clinical supplies of VUMERITY and up to 100% of commercial supplies of VUMERITY in exchange for an increase in the royalty rate to be paid by Biogen to the Company on net sales of that portion of product that is manufactured by Biogen or its designee. The Company evaluated the commercial supply agreement and the related amendments under Topic 606 and determined that these agreements should be combined and accounted for as a separate contract since the commercial supply agreement and amendment to the November 2017 license and collaboration agreement were negotiated together to achieve a common economic objective and the additional performance obligations under the commercial supply agreement are considered distinct obligations priced at their standalone selling prices. The Company determined that it had two separate performance obligations, the commercial supply of VUMERITY and services to be performed by the Company in connection with the Tech Transfer. There are other deliverables under the agreements that were determined to be perfunctory or immaterial.

 

In connection with the entry into the commercial supply agreement and the related amendments, the Company received payments in the aggregate amount of $5.8 million in the fourth quarter of 2019 and the Company will be eligible to receive an additional $5.0 million payment upon the earlier of successful completion of the Tech Transfer or a date in the fourth quarter of 2022. The $5.8 million received in the fourth quarter of 2019 plus amounts that will be received in connection with the Tech Transfer are allocated to each of the performance obligations using the standalone selling prices based on the Company’s estimate of selling price for the commercial supply of VUMERITY and the services related to the Tech Transfer, and this additional arrangement consideration will be recognized as the Company delivers commercial supply of VUMERITY and/or provides services relating to the Tech Transfer. The Company began performing under this commercial supply agreement in 2020.