Quarterly report pursuant to Section 13 or 15(d)

INTANGIBLES

v3.21.2
INTANGIBLES
9 Months Ended
Sep. 30, 2021
INTANGIBLES  
INTANGIBLES

NOTE 5. INTANGIBLES

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. Upon HSR acceptance, which was received on May 13, 2021, the Company paid the upfront fee of $12.5 million to Dermira. In addition, Dermira is eligible to receive 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. Trial in the Patent Litigation is scheduled for September 19, 2022. The Company cannot make any predictions about the final outcome of this matter or the timing thereof.

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 September 30, 2021 and December 31, 2020, respectively:

    

Estimated Useful

    

    

    

($in thousands)

    

Lives (Years)

    

September 30, 2021

    

December 31, 2020

(Unaudited)

Ceracade®

3

$

300

$

300

Luxamend®

3

 

50

 

50

Targadox®

3

 

1,250

 

1,250

Ximino®

7

 

7,134

 

7,134

Exelderm®

3

 

1,600

 

1,600

Accutane

5

 

4,727

 

4,727

Anti-itch product (1)

3

 

3,942

 

3,945

Total intangible assets

 

19,003

 

19,006

Accumulated amortization

 

(5,960)

 

(3,977)

Net intangible assets

$

13,043

$

15,029

(1) As of September 30, 2021, this asset has not yet been placed in service, therefore no amortization expense was recognized on this asset for the three or nine months ended September 30, 2021. Commercial launch of this product is expected in the first half of 2022.

The Company’s amortization expense for the three months ended September 30, 2021 and 2020 was approximately $0.7 million and $0.4 million, respectively. The Company’s amortization expense for the nine months ended September 30, 2021 and 2020 was approximately $2.0 million and $1.1 million, respectively. Amortization expense is recorded as a component of cost of goods sold in the Company’s unaudited condensed consolidated statements of operations.

The table below provides a summary for the nine months ended September 30, 2021, of the Company’s recognized expense related to its product licenses, which was recorded in costs of goods sold on the unaudited condensed consolidated statement of operations:

    

Intangible

($in thousands)

Assets, Net

Beginning balance at January 1, 2021

$

15,029

Reductions:

 

  

Anti-itch Product license acquisition adjustment

 

(3)

Amortization expense

 

(1,983)

Ending balance at September 30, 2021

$

13,043

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

    

    

    

Total

($in thousands)

    

Ximino®

    

Accutane®

Amortization

Three months ending December 31, 2021

$

255

$

236

$

491

Year ended December 31, 2022

 

1,019

 

946

 

1,965

Year ended December 31, 2023

 

1,019

 

945

 

1,964

Year ended December 31, 2024

 

1,019

 

946

 

1,965

Year ended December 31, 2025

 

1,019

 

945

 

1,964

Thereafter

 

595

 

157

 

752

Sub-total

$

4,926

$

4,175

$

9,101

Assets not yet placed in service:

 

  

 

  

 

  

Anti-itch product license acquisition

 

 

 

3,942

Total

$

4,926

$

4,175

$

13,043