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Collaboration, Licensing and Other Arrangements

12 Months Ended

Dec. 31, 2022

Organization Consolidation And Presentation Of Financial Statements [Abstract]

Collaboration, Licensing and Other Arrangements

11. Collaboration, Licensing and Other Arrangements

Revenue from collaborations and services for the years ended December 31, 2022, 2021 and 2020 are as follows (in thousands):

	Year Ended December 31,
	2022		2021		2020
UT CSA Agreement⁽¹⁾	$	24,826	$	267	$	—
UT License Agreement⁽²⁾		2,426		34,145		32,213
Vertice Pharma Co-Promotion Agreement		325		1,147		—
Other		200		323		—
Cipla License and Distribution Agreement		147		147		147
Receptor CLA		—		245		250
UT Research Agreement		—		—		210
Total revenue from collaborations and services	$	27,924	$	36,274	$	32,820

_________________________

(1)	Amount consists of revenue recognized for Manufacturing Services and sales of product to UT for the periods presented.

(2)	Amount consists of revenue recognized for Next-Gen R&D Services and R&D Services and License for the periods presented.

The activity related to deferred revenue and the related revenue recognized for collaborations and services is as follows (in thousands):

	December 31,
	2022			2021
Deferred revenue:
Beginning balance	$	20,370		$	34,937
Additions		46,971			21,707
Revenue — collaborations and services		(27,924	)		(36,274	)
Ending balance	$	39,417		$	20,370

United Therapeutics License Agreement — In September 2018, the Company and UT entered into an exclusive global license and collaboration agreement (the “UT License Agreement”), pursuant to which UT is responsible for global development, regulatory and commercial activities with respect to Tyvaso DPI. The Company is responsible for manufacturing clinical supplies and commercial supplies of Tyvaso DPI.

Revenue from UT for the years ended December 31, 2022, 2021 and 2020 are as follows (in thousands):

	Year Ended December 31,
	2022		2021		2020
UT Revenue
UT CSA Agreement	$	24,826	$	267	$	—
UT License Agreement		2,426		34,145		32,213
Royalties — Collaborations ⁽¹⁾		15,599		—		—
Total revenue from UT	$	42,851	$	34,412	$	32,213

_________________________

(1)	Amount consists of royalties associated with the UT License Agreement.

The current portion of contract assets related to the royalties is included in prepaid expense and other current assets in the consolidated balance sheets.

Under the terms of the UT License Agreement, the Company received an upfront payment of $45.0 million in October 2018 and four $12.5 million milestone payments between April 2019 and November 2020. The Company will also be entitled to receive low double-digit royalties on net sales of Tyvaso DPI as well as a manufacturing margin on commercial supplies of the product. UT, at its option, may expand the scope of the products covered by the UT License Agreement to include products with certain other active ingredients for the treatment of pulmonary arterial hypertension. Each such optioned product would be subject to UT’s payment to the Company of up to $40.0 million in additional option exercise and development milestone payments, as well as a low double-digit royalty on net sales of any such product.

At the inception of the agreement, the Company identified one distinct, performance obligation. The Company determined that the key deliverables include the license, supply of product to be used in clinical development, and certain research services upon achievement of specified development targets (“R&D Services”). Due to the specialized and unique nature of these services and their direct relationship with the license, the Company has determined that these deliverables represent one distinct bundle and thus, one performance obligation. The Company also determined that UT’s option to expand the scope of the products to include products with other active ingredients is not a material right, and thus, not a performance obligation at the onset of the agreement. The consideration for the option will be accounted for upon exercise of the option.

The Company expected to complete the activities specified in the initial development plan and to achieve the milestone events by December 31, 2021 for total consideration of approximately $105.8 million, which included an upfront payment, four milestone payments, various pass-through costs and payments for clinical supplies. Revenue was allocated as follows:

Distinct Performance Obligation

Transaction Price

Allocation of Price

Recognition Method

Progress Measure

Recognition Period

(in millions)

R&D Services and License

105.8

100%

Over time

Ratably

Sep 2018 - Dec 2021

⁽¹⁾

_________________________

(1)	Recognition period represents the estimated period to satisfy the performance obligation.

In May 2021, UT and the Company updated the development plan under the UT License Agreement to provide for additional process-development and stability-testing activities as well as the expansion of the Company’s commercial manufacturing capacity. The activities and deliverables under the current development plan resulted in four distinct performance obligations which include: (1) the continued development and approval process for an NDA (“R&D Services”); (2) certain pre-commercial services in preparation for commercial launch of Tyvaso DPI (“Pre-Commercial Services”); (3) development activities for the next generation of Tyvaso DPI (“Next-Gen R&D Services”); and (4) certain design and construction activities in anticipation of expansion of the Company’s commercial manufacturing facility (“Facility Expansion Services”).

The total consideration for the updated development plan of $50.9 million was allocated to the four distinct performance obligations based on management’s assessment of the stand-alone selling price of each performance obligation. Revenue was allocated as follows:

Description

Transaction Price

Allocation of Price⁽¹⁾

Recognition Method

Progress Measure

Revenue

Recognition

(in millions)

Total transaction price

50.9

Distinct Performance Obligation

R&D Services and License

18.4

Over time

Ratably

May 2021 - Oct 2021

⁽²⁾

Pre-Commercial Services

4.6

Over time

Input

% of completion of costs

⁽³⁾

Next-Gen R&D Services

7.2

Over time

Input

% of completion of costs

⁽³⁾

Facility Expansion Services⁽⁴⁾

20.7

Point in time

Transfer of control

⁽⁵⁾

_________________________

(1)	Allocation is based on management’s assessment of the stand-alone selling price of each performance obligation.

(2)	Represents the estimated period when the R&D Services performance obligation will be substantially complete.

(3)

Pre-Commercial Services and Next-Gen R&D Services performance obligations will be satisfied over time using the input method based on the costs incurred to date as a percentage of the total estimated costs to fulfill the contract. Incurred cost represents work performed, which corresponds with, and thereby best depicts, the transfer of control to the customer.

(4)

The Company also acts as agent for the procurement of equipment for the manufacturing expansion for the UT Equipment. The Company received $5.0 million from UT for the UT Equipment, which was recognized as deposits from customer on the consolidated balance sheet and will be released as the title is transferred to UT.

(5)	The Facility Expansion Services performance obligation would be recognized as control of manufactured products is transferred to the customer.

In August 2021, the Company and UT entered into a commercial supply agreement (as amended, the “CSA”), pursuant to which the Company is responsible for manufacturing and supplying to UT, and UT is responsible for purchasing from the Company on a cost-plus basis, Tyvaso DPI and BluHale inhalation profiling devices, as required for commercial distribution and sale by UT. In addition, UT is responsible for supplying treprostinil at its expense in quantities necessary to enable the Company to manufacture Tyvaso DPI as required by the CSA. Also pursuant to the CSA, UT will remit a reimbursement of certain pre-production costs incurred by the Company to support the manufacturing and supply of Tyvaso DPI.

The activities and deliverables under the CSA and the current development plan resulted in three distinct performance obligations which include: (1) the license, supply of product to be used in clinical development, and continued development and approval support for Tyvaso DPI (“R&D Services and License”); (2) development activities for the next generation of Tyvaso DPI (“Next-Gen R&D Services”); and (3) a material right associated with current and future commercial manufacturing and supply of product (“Manufacturing Services”).

The total revised anticipated cash flows of $221.5 million from the transaction was allocated to the three distinct performance obligations as follows.

Anticipated

Description

Cash Flow

Revenue Allocation⁽¹⁾

Recognition Method

Progress Measure

Revenue

Recognition

(in millions)

Total anticipated cash flow

221.5

Distinct Performance Obligation

R&D Services and License⁽²⁾

6.0

Over time

Ratably

Aug 2021 - Oct 2021

⁽³⁾

Next-Gen R&D Services

8.8

Over time

Input

% of completion of costs

⁽⁴⁾

Manufacturing Services

206.7

Point in time

Transfer of control

⁽⁵⁾

_________________________

(1)	Allocation is based on management’s assessment of the stand-alone selling price of each performance obligation.

(2)

The license for the Company’s IP was considered to be interdependent with the development activities to support approval of Tyvaso DPI. A sales-based royalty is promised in exchange for the IP license; therefore, the royalties associated with the license are excluded from the determination of the transaction price and the Company will recognize revenue as the sale of Tyvaso DPI to a patient occurs.

(3)	Represents the estimated period when the R&D Services performance obligation will be substantially complete.

(4)

The Next-Gen R&D Services performance obligation will be satisfied over time using the input method based on the costs incurred to date as a percentage of the total estimated costs to fulfill the contract. Incurred cost represents work performed, which corresponds with, and thereby best depicts, the transfer of control to the customer.

(5)

The Manufacturing Services performance obligation will be recognized as control of manufactured products is transferred to the customer; therefore, no revenue associated with this obligation was recognized during the year ended December 31, 2021. The allocation of transaction price includes a material right related to manufacturing services. The total anticipated cash flow is based on the Company’s estimated production and the ultimate cash flows may vary as manufacturing purchase orders are received.

As amended , the term of the CSA continues until December 31, 2031 (unless earlier terminated) and is thereafter renewed automatically for additional, successive two-year terms unless (i) United Therapeutics provides notice to the Company at least 24 months in advance of such renewal that United Therapeutics does not wish to renew the CSA or (ii) the Company provides notice to United Therapeutics at least 48 months in advance of such renewal that the Company does not wish to renew the CSA. The Company and United Therapeutics each have normal and customary termination rights, including termination for material breach that is not cured within a specific timeframe or in the event of liquidation, bankruptcy or insolvency of the other party.

The Company accounted for the contract modification as if it were part of the existing contract since the amendment modified the scope and price of the CSA by extending the term and increasing the occupancy rate. The effect of the modification on the transaction price and on the measure of progress is recognized as an adjustment to revenue as of the date of the modification. The modification did not result in a change the activities and deliverables under the CSA. The total revised anticipated cash flows of $463.5 million from the transaction was allocated to the three distinct performance obligations as follows.

Anticipated

Description

Cash Flow

Revenue Allocation⁽¹⁾

Recognition Method

Progress Measure

Revenue

Recognition

(in millions)

Total anticipated cash flow⁽²⁾

463.5

Distinct Performance Obligation

R&D Services and License⁽³⁾

—

Over time

Ratably

Aug 2021 - Oct 2021

⁽⁴⁾

Next-Gen R&D Services⁽⁵⁾

4.8

Over time

Input

% of completion of costs

⁽⁶⁾

Manufacturing Services⁽⁷⁾

458.7

Point in time

Transfer of control

⁽⁸⁾

_________________________

(1)	Allocation is based on management’s assessment of the stand-alone selling price of each performance obligation.

(2)	The total anticipated cash flow includes a transaction price of $64.3 million for the contractual obligations under the CSA for the Manufacturing Services and the Next-Gen R&D Services performance obligations and $399.2 million for future supply of Tyvaso DPI over the remaining term of the CSA.

(3)

(4)	Represents the period when the revenue for the R&D Services performance obligation was recognized.

(5)

The standalone selling price (“SSP”) for the Next-Gen R&D Services performance obligation was based on industry ratios as well as the Company’s historical R&D projects. The transaction price for the Next-Gen R&D Services was based on fixed consideration which was allocated between performance obligations as discussed in note (2) above.

(6)

(7)

Pre-production activities under the CSA, such as facility expansion services and certain other administrative services, were considered bundled services that are part of the Company’s Manufacturing Services performance obligation, given the nature of the Company’s contractual responsibilities and ASC 606 requirements.

(8)

The Manufacturing Services performance obligation will be recognized as control of manufactured products is transferred to the customer. The modification did not result in a cumulative catch-up adjustment as a result of the revenue being deferred for the performance obligations that were affected by the modification. The allocation of the transaction price for the Manufacturing Services includes a material right related to the Company’s estimated production of product in the amount of $144.5 million. The Company will sell product to UT under individual purchase orders, which represent distinct performance obligations. The total anticipated cash flow is based on the Company’s estimated production and the ultimate cash flows may vary as manufacturing purchase orders are received.

In April 2022, the Company and UT agreed to fund $2.3 million in capital improvements to support commercialization and continuous improvement activities and $0.7 million in the development of alternative manufacturing processes. The Company determined that the capital improvements and continuous improvements should be combined with the manufacturing services performance obligation and the alternative manufacturing processes should be combined with the Next-Gen R&D Services and as such no additional performance obligations were noted. The total revised anticipated cash flows of $483.2 million from the transaction was allocated to the three distinct performance obligations as follows.

Anticipated

Description

Cash Flow

Revenue Allocation

Recognition Method

Progress Measure

Revenue

Recognition

(in millions)

Total anticipated cash flow⁽¹⁾

483.2

Distinct Performance Obligation

R&D Services and License

—

Over time

Ratably

Aug 2021 - Oct 2021

Next-Gen R&D Services

5.9

Over time

Input

% of completion of costs

Manufacturing Services and

Product Sales⁽²⁾

477.2

Point in time

Transfer of control

_________________________

(1)	The total anticipated cash flow includes a transaction price of $71.5 million for the contractual obligations under the CSA for the Manufacturing Services and the Next-Gen R&D Services performance obligations and $411.7 million for future supply of Tyvaso DPI over the remaining term of the CSA.

(2)

The Manufacturing Services performance obligation will be recognized as control of manufactured products is transferred to UT. The modification did not result in a cumulative catch-up adjustment as a result of the revenue being deferred for the performance obligations that were affected by the modification. The allocation of the transaction price for the Manufacturing Services includes a material right related to the Company’s estimated production of product in the amount of $150.2 million. The Company will sell product to UT under individual purchase orders, which represent distinct performance obligations. The ultimate cash flows may vary as manufacturing purchase orders are received.

In December 2022, the Company and UT agreed to fund an additional $39.5 million to support capital and continuous improvement activities and $2.3 million in the development of alternative manufacturing processes. The Company determined that the capital and continuous improvements should be combined with the manufacturing services performance obligation and the alternative manufacturing processes should be combined with the Next-Gen R&D Services. The total revised anticipated cash flows of $722.3 million from the transaction was allocated to the three distinct performance obligations as follows.

Anticipated

Description

Cash Flow

Revenue Allocation

Recognition Method

Progress Measure

Revenue

Recognition

(in millions)

Total anticipated cash flow⁽¹⁾

722.3

Distinct Performance Obligation

R&D Services and License

—

Over time

Ratably

Aug 2021 - Oct 2021

Next-Gen R&D Services

10.0

Over time

Input

% of completion of costs

Manufacturing Services and

Product Sales⁽²⁾

712.3

Point in time

Transfer of control

__________________________

(1)	The total anticipated cash flow includes a transaction price of $120.0 million for the contractual obligations under the CSA for the Manufacturing Services and the Next-Gen R&D Services performance obligations and $602.3 million for future supply of Tyvaso DPI over the remaining term of the CSA.

(2)

The Manufacturing Services performance obligation will be recognized as control of manufactured products is transferred to UT. The modification did not result in a cumulative catch-up adjustment as a result of the revenue being deferred for the performance obligations that were affected by the modification. The allocation of the transaction price for the Manufacturing Services includes a material right related to the Company’s estimated production of product in the amount of $220.8 million. The Company will sell product to UT under individual purchase orders, which represent distinct performance obligations. The ultimate cash flows may vary as manufacturing purchase orders are received.

As of December 31, 2022, deferred revenue consisted of $37.9 million, of which $1.6 million was classified as current and $36.3 million was classified as long-term on the consolidated balance sheet. As of December 31, 2021, deferred revenue consisted of $18.6 million, of which $0.6 million was classified as current and $18.0 million was classified as long-term on the consolidated balance sheet.

Vertice Pharma Co-Promotion Agreement — In December 2020, the Company entered into a co-promotion agreement with Vertice Pharma pursuant to which the Company’s sales force promoted Thyquidity to healthcare providers who treat hypothyroidism. Vertice Pharma was obligated to pay fixed quarterly payments to the Company, as well as variable consideration based on gross profits resulting from all sales of Thyquidity. Vertice Pharma launched Thyquidity in collaboration with the Company in February 2021.

At inception of the agreement, the Company identified a single performance obligation that the Company will satisfy over time. The Company estimated the total transaction price was approximately $6.3 million, consisting of fixed consideration and the unconstrained amount of estimated variable consideration, which was based on gross profit applied to defined revenue benchmarks. The amount of variable consideration was constrained to the amount for which it was probable that a significant reversal of cumulative revenue recognized will not occur and the payments will be received. At the end of each subsequent reporting period, the Company re-evaluated the estimated variable consideration included in the transaction price and any related constraint, and if necessary, adjusted its estimate of the overall transaction price. Any such adjustments were recorded on a cumulative catch-up basis in the period of adjustment. The total transaction price was recognized over a two-year period during which the Company was required to satisfy its performance obligation, using the input method based on the costs incurred to date as a percentage of the total estimated costs to fulfill the contract. Incurred cost represents work performed, which corresponded with, and thereby best depicts, the transfer of control to the customer. In July 2021, the Company and Vertice Pharma entered into an amendment to the Vertice Pharma Co-Promotion Agreement that modified the terms of payment where 50% of the previously fixed consideration was subject to certain promotional conditions, resulting in variable consideration.

In September 2021, the Company and Vertice Pharma mutually agreed that the Company would cease promotional activities under the co-promotion agreement effective September 30, 2021, other than certain transitional activities that continued until October 15, 2021.

As of December 31, 2021, the Company fully reserved $0.8 million of revenue from the co-promotion of Thyquidity, which was recognized as allowance for credit losses – collaborations and services, which is included in accounts receivable, net in the consolidated balance sheet. In addition, the Company recognized an impairment on contract assets of $0.1 million related to variable consideration from gross profits which was recognized during the year ended December 31, 2021.

In June 2022, the Company and Vertice Pharma reached a final settlement of all obligations related to the termination of the co-promotion agreement of $0.3 million, which was recognized as revenue from collaboration and services in the Company’s consolidated statement of operations and the balance was written off against the reserve.

Thirona Collaboration Agreement — In June 2021, the Company and Thirona entered into a collaboration agreement to evaluate the therapeutic potential of Thirona’s compound for the treatment of pulmonary fibrosis. If initial studies are promising, the Company can exercise certain rights to seek a full license to the compound for clinical development and commercialization. The parties will perform their respective obligations and provide reasonable support for research, clinical development and regulatory strategy. The collaboration agreement will be accounted for under ASC 808, Collaborative Agreements; however, no consideration will be exchanged between the parties. The Company will expense the costs incurred as research and development in the consolidated statements of operations. In December 2022, the Company and Thirona extended the collaboration agreement through February 28, 2023.

Biomm Supply and Distribution Agreement — In May 2017, the Company and Biomm S.A. (“Biomm”) entered into a supply and distribution agreement for the commercialization of Afrezza in Brazil. Under this agreement, Biomm was responsible for pursuing regulatory approvals of Afrezza in Brazil, including from the ANVISA and, with respect to pricing matters, from the Camara de Regulação de Mercado de Medicamentos (“CMED”), both of which have been received. Biomm commenced product sales in January 2020. During the year ended December 31, 2020, the Company sold $0.2 million of product to Biomm. No shipments of product were made to Biomm during the years ended December 31, 2022 and 2021.

Cipla License and Distribution Agreement — In May 2018, the Company and Cipla Ltd. (“Cipla”) entered into an exclusive agreement for the marketing and distribution of Afrezza in India and the Company received a $2.2 million nonrefundable license fee. Under the terms of the agreement, Cipla is responsible for obtaining regulatory approvals to distribute Afrezza in India and for all marketing and sales activities of Afrezza in India. The Company is responsible for supplying Afrezza to Cipla. The Company has the potential to receive an additional regulatory milestone payment, minimum purchase commitment revenue and royalties on Afrezza sales in India once cumulative gross sales have reached a specified threshold.

The nonrefundable licensing fee was recorded in deferred revenue and is being recognized in net revenue – collaborations over 15 years, representing the estimated period to satisfy the performance obligation. The additional milestone payments represent variable consideration for which the Company has not recognized any revenue because of the uncertainty of obtaining marketing approval.

As of December 31, 2022, the deferred revenue balance was $1.5 million, of which $0.1 million is classified as current and $1.4 million is classified as long term in the consolidated balance sheets. As of December 31, 2021, the deferred revenue balance was $1.7 million, of which $0.1 million is classified as current and $1.6 million is classified as long term in the consolidated balance sheets.