Collaborative Arrangements and Licensing Agreements

6 Months Ended

Jun. 30, 2023

Collaborative Arrangements and Licensing Agreements [Abstract]

Collaborative Arrangements and Licensing Agreements

5.  Collaborative Arrangements and Licensing Agreements

Below, we have included our AstraZeneca, Biogen and GSK collaborations, which are our only collaborations with substantive changes during 2023 from those included in Part IV, Item 15, Note 7, Collaborative Arrangements and Licensing Agreements, of our audited financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2022.

AstraZeneca

We have two collaborations with AstraZeneca, one focused on the joint development and commercialization of eplontersen for the treatment of transthyretin amyloidosis, or ATTR, and one focused on the treatment of cardiovascular, renal and metabolic diseases. From inception through June 30, 2023, we have received nearly $610 million from these collaborations.

We are jointly developing and preparing to commercialize eplontersen with AstraZeneca in the U.S. In addition, we granted AstraZeneca exclusive rights to commercialize eplontersen outside the U.S. In the second quarter of 2023, we earned a $20 million license fee payment when we licensed rights to Latin America for eplontersen to AstraZeneca. We recognized the upfront payment in full in the second quarter of 2023 because AstraZeneca had full use of the license without any continuing involvement from us. We will achieve the next payment of up to $50 million upon the first regulatory approval under this collaboration.

Under our collaboration for cardiovascular, renal and metabolic diseases, AstraZeneca has licensed multiple medicines from us. AstraZeneca is responsible for global development, regulatory and commercialization activities and costs for each of the medicines it has licensed from us. In the second quarter of 2023, we achieved a $20 million milestone payment when AstraZeneca initiated a Phase 2b study for ION839, an investigational ligand-conjugated antisense, or LICA, medicine designed to inhibit the production of patatin-like phospholipase domain-containing 3, or PNPLA3, protein. We recognized these milestone payments as R&D revenue in full in the second quarter of 2023 because we did not have any remaining performance obligations related to the milestone payments. We will achieve the next payment of up to $30 million if AstraZeneca licenses a medicine under this collaboration.

During the three and six months ended June 30, 2023 and 2022, we earned the following revenue from our relationship with AstraZeneca (in thousands, except percentages):

	Three Months Ended June 30,						Six Months Ended June 30,
	2023			2022			2023			2022
Revenue from our relationship with AstraZeneca	$	59,501		$	17,768		$	83,926		$	37,611
Percentage of total revenue		32	%		13	%		26	%		14	%

We did not have any deferred revenue from our relationship with AstraZeneca at June 30, 2023 or December 31, 2022.

Biogen

We have several strategic collaborations with Biogen focused on using antisense technology to advance the treatment of neurological disorders. We developed and licensed to Biogen SPINRAZA, our approved medicine to treat people with spinal muscular atrophy, or SMA. Under our 2013 strategic neurology collaboration, Biogen developed QALSODY (tofersen), our recently approved medicine to treat people with superoxide dismutase 1 amyotrophic lateral sclerosis, or SOD1-ALS. Under our collaborations, we and Biogen are currently developing numerous investigational medicines to treat neurodegenerative diseases in addition to SMA and SOD1-ALS, including medicines in development to treat people with amyotrophic lateral sclerosis, or ALS, Angelman Syndrome, Alzheimer’s disease and Parkinson’s disease. In addition to these medicines, our collaborations with Biogen include a substantial research pipeline that addresses a broad range of neurological diseases. From inception through June 30, 2023, we have received more than $3.6 billion in payments from our Biogen collaborations.

In the second quarter of 2023, we earned a $16 million milestone payment from Biogen when the FDA approved Biogen’s New Drug Application, or NDA, for QALSODY. We recognized this milestone payment as R&D revenue in full in the second quarter of 2023 because we did not have any remaining performance obligations related to the milestone payment. Under our collaboration agreement with Biogen, we are eligible to receive tiered royalties ranging from 11 percent to 15 percent on sales of QALSODY. Following the NDA approval in April 2023, we began earning royalties from QALSODY sales, which we recognize as other commercial revenue in our condensed consolidated statements of operations. We will achieve the next milestone payment for QALSODY of $20 million if the European Medicines Agency approves Biogen’s Marketing Authorization Application filing of QALSODY.

During the three and six months ended June 30, 2023 and 2022, we earned the following revenue from our relationship with Biogen (in thousands, except percentages):

	Three Months Ended June 30,						Six Months Ended June 30,
	2023			2022			2023			2022
Revenue from our relationship with Biogen	$	97,402		$	76,887		$	167,903		$	170,754
Percentage of total revenue		52	%		58	%		53	%		62	%

Our condensed consolidated balance sheets at June 30, 2023 and December 31, 2022 included deferred revenue of $323.1 million and $351.2 million, respectively, from our relationship with Biogen.

GSK

In March 2010, we entered into a collaboration with GSK using our antisense drug discovery platform to discover and develop new medicines against targets for serious and rare diseases, including infectious diseases and some conditions causing blindness. Our collaboration with GSK currently includes bepirovirsen, our medicine in development targeting hepatitis B virus, or HBV. We designed this medicine to reduce the production of viral proteins associated with HBV infection. In the third quarter of 2019, following positive Phase 2 results, GSK licensed our HBV program. GSK is responsible for all global development, regulatory and commercialization activities and costs for the HBV program. From inception through June 30, 2023, we have received more than $105 million in an upfront payment and payments related to the HBV program.

In the first quarter of 2023, we earned a $15 million milestone payment when GSK initiated a Phase 3 program of bepirovirsen. We recognized this milestone payment as R&D revenue in full in the first quarter of 2023 because we did not have any remaining performance obligations related to the milestone payment. We will achieve the next payment of $15 million if the FDA accepts an NDA filing of bepirovirsen for review.

During the three and six months ended June 30, 2023 and 2022, we earned the following revenue from our relationship with GSK (in thousands, except percentages):

	Three Months Ended June 30,						Six Months Ended June 30,
	2023			2022			2023			2022
Revenue from our relationship with GSK	$	—		$	—		$	15,000		$	—
Percentage of total revenue		0	%		0	%		5	%		0	%

We did not have any deferred revenue from our relationship with GSK at June 30, 2023 or December 31, 2022.