Quarterly report pursuant to Section 13 or 15(d)

Discontinued Operations

v3.23.3
Discontinued Operations
9 Months Ended
Sep. 30, 2023
Discontinued Operations and Disposal Groups [Abstract]  
Discontinued Operations

4) Discontinued Operations

In March 2023, the Company entered into an Asset Transfer Agreement with Alkermes Pharma Ireland Limited (“Alkermes”) (the “Transfer Agreement”). Under the terms of the Transfer Agreement, the Company transferred the rights to certain patents, trademarks, equipment, data and other rights related to ANJESO (the “Assets”) to Alkermes. The Company also withdrew the New Drug Application (“NDA”) related to ANJESO and agreed, if elected by Alkermes at a later date, to transfer such withdrawn NDA to Alkermes at no additional cost.

Additionally, under the Transfer Agreement, the Company granted Alkermes a non-exclusive, perpetual and irrevocable, royalty-free and fully paid-up worldwide license, to the additional intellectual property owned by the Company necessary to or useful to exploit ANJESO. In consideration of the transfer of the Assets, the parties agreed to the termination of (i) the Purchase and Sale Agreement, dated March 7, 2015 by and among Alkermes, the Company and the other parties thereto (as amended, the “PSA”), (ii) the Asset Transfer and License Agreement, dated April 10, 2015 by and among Alkermes, the Company and the other parties thereto (as amended, the “ATLA”); and (iii) the Development, Manufacturing and Supply Agreement, dated as of July 10, 2015 by and between the Company and Alkermes (as amended, the “Manufacturing Agreement”) between the parties related to ANJESO (the PSA, ATLA and Manufacturing Agreement, collectively, the “ANJESO Agreements”). In connection with the termination of the ANJESO Agreements, no further payments of any kind pursuant to the ANJESO Agreements are payable by the Company to Alkermes.

The accounting requirements for reporting the abandonment of ANJESO as a discontinued operation were met when the agreements with Alkermes were executed. Accordingly, the accompanying consolidated financial statements for all periods presented reflect this business as a discontinued operation.

The historical consolidated balance sheet and statements of operations of the Company and the related notes to the consolidated financial statements have been presented as discontinued operations in the consolidated financial statements and prior periods have been recast. Discontinued operations include results of the Company’s commercial business except for certain corporate overhead costs, which are included in continuing operations.

There were no assets or liabilities of discontinued operations as of September 30, 2023. The following table shows amounts included in assets and liabilities of discontinued operations, respectively, on the Company’s Consolidated Balance Sheet at December 31, 2022:

 

 

 

December 31, 2022

 

 

 

 

 

Current assets of discontinued operation:

 

 

 

Accounts receivable, net

 

$

336

 

Prepaid expenses and other current assets

 

 

449

 

Total current assets of discontinued operation

 

 

785

 

Non-current assets of discontinued operation:

 

 

 

Property and equipment, net

 

 

695

 

Total non-current assets of discontinued operation

 

 

695

 

Total assets of discontinued operation

 

$

1,480

 

 

 

 

 

Current liabilities of discontinued operation:

 

 

 

Accounts payable

 

$

730

 

Accrued expenses and other current liabilities

 

 

365

 

Current portion of contingent consideration

 

 

9,203

 

Total current liabilities of discontinued operation

 

 

10,298

 

Non-current liabilities of discontinued operation:

 

 

 

Long-term portion of contingent consideration

 

 

10,697

 

Total non-current liabilities of discontinued operation

 

 

10,697

 

Total liabilities of discontinued operation

 

$

20,995

 

 

The results of operations from discontinued operations for the three and nine months ended September 30, 2023 and 2022, have been reflected as discontinued operations in the consolidated statements of operations and consist of the following:

 

 

 

For the Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Revenue, net

 

$

—

 

 

$

238

 

 

$

16

 

 

$

959

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of sales

 

 

43

 

 

 

1,208

 

 

 

552

 

 

 

2,217

 

Research and development

 

 

—

 

 

 

23

 

 

 

—

 

 

 

654

 

Selling, general and administrative

 

 

—

 

 

 

855

 

 

 

—

 

 

 

9,242

 

Amortization of intangible assets

 

 

—

 

 

 

644

 

 

 

—

 

 

 

1,932

 

Change in contingent consideration valuation

 

 

—

 

 

 

1,222

 

 

 

(19,900

)

 

 

(1,254

)

Loss on impairment of property and equipment

 

 

—

 

 

 

3,663

 

 

 

485

 

 

 

3,662

 

Impairment of Intangible Asset

 

 

—

 

 

 

17,746

 

 

 

 

 

 

17,746

 

Total operating expenses

 

 

43

 

 

 

25,361

 

 

 

(18,863

)

 

 

34,199

 

Operating gain (loss) from discontinued operation

 

 

(43

)

 

 

(25,123

)

 

 

18,879

 

 

 

(33,240

)

Other expense:

 

 

 

 

 

 

 

 

 

 

 

 

Other expense, net

 

 

—

 

 

 

3

 

 

 

(206

)

 

 

320

 

Net income (loss) from discontinued operation

 

$

(43

)

 

$

(25,120

)

 

$

18,673

 

 

$

(32,920

)

 

The Company sold ANJESO in the U.S. through a single third-party logistics provider (“3PL”), which took title to and control of the goods, and was considered the customer. The Company recognized revenue from ANJESO product sales at the point the title to the product is transferred to the customer and the customer obtains control of the product. The transaction price that was recognized as revenue for products includes an estimate of variable consideration for reserves, which result from discounts, returns, chargebacks, rebates, and other allowances that were offered within contracts between the Company and end-user customers, wholesalers, group purchasing organizations and other indirect customers. The Company’s payment terms were generally between thirty to ninety days.

Historically, the Company’s intangible asset was classified as an asset resulting from R&D activities. The Company determined the useful life of its asset resulting from R&D activities to be approximately 10 years, which was based on the remaining patent life, and was amortized on a straight-line basis. The Company performed an impairment test as of December 31, 2022 after identifying indicators of impairment, such as a decline in share price, the termination of the dedicated commercial team, sustained impacts of COVID-19 on the market and the discontinuation of commercialization of ANJESO, and based on the quantitative analysis an impairment loss of $19,681 was recorded during the year ended December 31, 2022, eliminating the remaining carrying value of the intangible asset.

On April 10, 2015, Societal CDMO, Inc. (“Societal CDMO”), formerly Recro Pharma, Inc., completed the acquisition of a manufacturing facility in Gainesville, Georgia and the licensing and commercialization rights to injectable meloxicam (the “Alkermes Transaction”). Pursuant to the purchase and sale agreement and subsequent amendment with Alkermes, as amended, governing the Alkermes Transaction, the Company agreed to pay to Alkermes up to an additional $140,000 in milestone payments including $60,000 upon regulatory approval payable over a seven-year period, as well as net sales milestones related to injectable meloxicam and royalties on future product sales of injectable meloxicam.

Historically, the contingent consideration consisted of four separate components. The first component was (i) a $5,000 payment made in the first quarter of 2019 and (ii) a $5,000 payment made in the second quarter of 2019. The second components became payable upon regulatory approval in February 2020 and included (i) a $5,000 payment, which was paid in three installments during 2020 and 2021, and (ii) $45,000 payable in seven equal annual payments of approximately $6,400 beginning on the first anniversary of such approval, of which the first payment was made in the first quarter of 2021. The Company paid $1,200 of the second payment in 2022. The third component consisted of three potential payments, based on the achievement of specified annual revenue targets. The fourth component consists of a royalty payment between 10% and 12% (subject to a 30% reduction when no longer covered by patent) for a defined term on future injectable meloxicam net sales, which was paid quarterly. In connection with the Transfer Agreement, the Company was relieved of its milestone payments previously owed to Alkermes in connection with the transaction and in the first quarter of 2023 reversed its contingent consideration balance, which was $19,900.

Additionally as part of the Transfer Agreement, the Company wrote off its inventory balance as of March 31, 2023, which was fully reserved for as of December 31, 2022, and the remaining property and equipment balance related to equipment at the Alkermes facility that was transferred as part of the Transfer Agreement of $485.