Annual report pursuant to Section 13 and 15(d)

INTANGIBLES

v3.23.1
INTANGIBLES
12 Months Ended
Dec. 31, 2022
INTANGIBLES  
INTANGIBLES

NOTE 5. INTANGIBLES

The Company executed the Vyne Product Acquisition Agreement on January 12, 2022. The Company recognized intangible assets of $15.2 million for Amzeeq and $3.8 million for Zilxi, the two FDA approved products acquired in the agreement.

On March 31, 2021, the Company executed an Asset Purchase Agreement (the “Qbrexza APA”) with Dermira, Inc., a subsidiary of Eli Lilly and Company (“Dermira”). Pursuant to the terms of the agreement, the Company acquired the rights to Qbrexza® (glycoprronium), a prescription cloth towelette to treat primary axillary hyperhidrosis in patients nine years of age or older. The Company paid the upfront fee of $12.5 million to Dermira. In addition, the Company is obligated to pay Dermira up to $144 million in the aggregate upon the achievement of certain sales milestones. The royalty structure for the agreement is tiered with royalties for the first two years ranging from approximately 40% to 30%. Thereafter for a period of eight years royalties are approximately 12.0% to 19.0%. Royalty amounts are subject to 50% diminution in the event of loss of exclusivity due to the introduction of an authorized generic.

Upon closing of the Qbrexza® purchase, the Company became substituted for Dermira as the plaintiff in U.S. patent litigation commenced by Dermira on October 21, 2020 in the U.S. District Court of Delaware (the “Patent Litigation”) against Perrigo Pharma

International DAC (“Perrigo”) alleging infringement of certain patents covering Qbrexza® (the “Qbrexza® Patents”), which are included among the proprietary rights to Qbrexza®. The Patent Litigation was initiated following the submission by Perrigo, in accordance with the procedures set out in the Drug Price Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Act”), of an Abbreviated New Drug Application (“ANDA”). The ANDA seeks approval to market a generic version of Qbrexza® prior to the expiration of the Qbrexza® Patents and alleges that the Qbrexza® Patents are invalid. Perrigo is subject to a 30-month stay preventing it from selling a generic version, but that stay is set to expire on March 9, 2023. As of December 31, 2022, the Patent Litigation was settled by and between the parties and case subsequently has been dismissed.

The purchase price of $12.5 million included the asset, Qbrexza, as well as finished goods and raw material inventory. The Company also has the obligation to accept any product returns related to sales made by Dermira. The Company allocated the upfront payment to inventory since the fair value of the inventory and Qbrexza rights exceeded the purchase price. The future contingent milestone payments, if achieved, will be recorded to intangible asset and amortized over the seven-year life of the asset commencing on the closing date.

The table below provides a summary of the Company’s intangible assets at December 31, 2022 and 2021, respectively:

    

December 31, 2022

Estimated

 Useful

Gross

Lives

Carrying

Accumulated

Intangible

($’s in thousands)

    

 (Years)

    

Value

Amortization

    

Assets, Net

Amortizable intangible assets:

Ceracade®

3

$

300

$

(300)

$

Luxamend®

3

 

50

(50)

 

Targadox®

3

 

1,250

(1,250)

 

Ximino®

7

 

7,134

(3,482)

 

3,652

Exelderm®

3

 

1,600

(1,600)

 

Accutane®

5

 

4,727

(1,733)

 

2,994

Amzeeq®

9

15,162

(1,597)

13,565

Zilxi®

6

3,760

(716)

3,044

33,983

(10,728)

23,255

Non-amortizable intangible assets:

 

 

Anti-itch product (1)

3

 

3,942

 

3,942

Total intangible assets

$

37,925

$

(10,728)

$

27,197

(1) As of December 31, 2022, this asset has not yet been placed in service, therefore no amortization expense was recognized on this asset for the year ended December 31, 2022. Commercial launch of this product is expected in 2023.

    

December 31, 2021

Estimated

    

    

    

Useful

Gross

Lives

Carrying

Accumulated

Intangible

($’s in thousands)

(Years)

Value

Amortization

Assets, Net

Amortizable intangible assets:

 

  

 

  

 

  

 

  

Ceracade®

 

3

$

300

$

(300)

$

Luxamend®

 

3

 

50

 

(50)

 

Targadox®

 

3

 

1,250

 

(1,250)

 

Ximino®

 

7

 

7,134

 

(2,463)

 

4,671

Exelderm®

 

3

 

1,600

 

(1,600)

 

Accutane®

 

5

 

4,727

 

(788)

 

3,939

 

15,061

 

(6,451)

 

8,610

Non-amortizable intangible assets:

 

  

 

  

 

  

 

  

Anti-itch product (1)

 

3

 

3,942

 

 

3,942

Total intangible assets

$

19,003

$

(6,451)

$

12,552

(1) As of December 31, 2021, this asset has not yet been placed in service, therefore no amortization expense was recognized on this asset for the year ended December 31, 2021. The commercial launch of this product is expected in 2023.

The table below provides a summary for the year ended December 31, 2022 and 2021, of the Company’s recognized intangible amortization expense related to its product licenses, which was recorded in costs of goods sold on the consolidated statement of operations:

    

Intangible

($’s in thousands)

    

Assets, Net

Balance at December 31, 2020

$

15,029

License acquisition adjustment

 

(3)

Amortization expense

(2,474)

Balance at December 31, 2021

$

12,552

VYNE License agreement

18,922

Amortization expense

(4,277)

Balance at December 31, 2022

$

27,197

The Company’s amortization expense for the years ended December 31, 2022 and 2021 was approximately $4.3 million and $2.5 million, respectively. Amortization expense is recorded as a component of cost of goods sold in the Company’s consolidated statements of operations.

Future amortization of the Company’s intangible assets is as follows:

    

Total

For the years ended

    

Amortization

December 31, 2023

$

4,277

December 31, 2024

 

4,277

December 31, 2025

 

4,277

December 31, 2026

 

3,064

Thereafter

 

7,360

Subtotal

23,255

Asset not yet placed in service

 

3,942

Total

$

27,197