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Collaboration, Licensing and Other Arrangements (Tables)
9 Months Ended
Sep. 30, 2022
Organization Consolidation And Presentation Of Financial Statements [Abstract]  
Schedule of Revenue from Collaboration and Services

Revenue from collaborations and services for the three and nine months ended September 30, 2022 and 2021 are as follows (in thousands):

 

 

Three Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

UT CSA Agreement(1)

 

$

9,916

 

 

$

 

 

$

15,795

 

 

$

 

UT License Agreement(2)

 

 

393

 

 

 

12,313

 

 

 

1,949

 

 

 

33,475

 

Vertice Pharma Co-Promotion Agreement

 

 

 

 

 

 

 

 

325

 

 

 

1,147

 

Cipla License and Distribution Agreement

 

 

37

 

 

 

37

 

 

 

110

 

 

 

110

 

Other

 

 

 

 

 

77

 

 

 

200

 

 

 

161

 

Receptor CLA

 

 

 

 

 

31

 

 

 

1

 

 

 

206

 

Total revenue from collaborations and services

 

$

10,346

 

 

$

12,458

 

 

$

18,380

 

 

$

35,099

 

_________________________

(1)

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

(2)

Amounts consist of revenue recognized for Next-Gen R&D Services and R&D Services and License for the periods presented.

 

 

 

Three Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

UT Revenue (in thousands)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

UT CSA Agreement

 

$

9,916

 

 

$

 

 

$

15,795

 

 

$

 

UT License Agreement

 

 

393

 

 

 

12,313

 

 

 

1,949

 

 

 

33,475

 

Royalties — Collaborations (1)

 

 

6,220

 

 

 

 

 

 

6,524

 

 

 

 

Total revenue from UT

 

$

16,529

 

 

$

12,313

 

 

$

24,268

 

 

$

33,475

 

_________________________

(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 condensed consolidated balance sheets.

Schedule of Effect of Modification on Transaction Price

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 to the activities and deliverables under the CSA.

 

 

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)

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.

(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)

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.

(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 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 $144.5 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.

 

 

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

 

_________________________

Notes presented in the previous modification table above also apply to this modification table unless noted otherwise.

(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.