XML 22 R8.htm IDEA: XBRL DOCUMENT v3.26.1
Revenue and Accounts Receivable
3 Months Ended
Mar. 31, 2026
Accounting Policies [Abstract]  
Revenue and Accounts Receivable Revenue and Accounts Receivable
Concentrations
The following table summarizes net revenue from each of the Company’s customers, who individually represent at least 10% of total revenue.
Three Months Ended
March 31,
20262025
Customer A24%78%
Customer B23%14%
Customer C30%0%
The following table summarizes accounts receivable concentrations for each of the Company’s customers, who individually represent at least 10% of gross total accounts receivable.
March 31,
2026
December 31,
2025
Customer A18%20%
Customer B31%23%
Customer C37%41%
For DefenCath, the Company currently has one FDA-approved source (contract manufacturing organization, or “CMO”) for each of its two key active pharmaceutical ingredients (“APIs”), taurolidine and heparin sodium, respectively. With regards to taurolidine, the Company has a drug master file (“DMF”) filed with the FDA. There is a master commercial supply agreement between a third-party manufacturer that has been in place since August 2018. With respect to heparin sodium API, the Company has identified an alternate third-party supplier and may qualify such supplier under the DefenCath NDA over the next twelve months.
The Company received FDA approval of DefenCath with finished dosage production from its European based CMO, Rovi Pharma Industrial Services. The Company believes this CMO has adequate capacity to produce the volumes needed to meet near-term projected demand for DefenCath. In addition, the Company also qualified Siegfried Hameln as an alternate finished dosage manufacturing site and is in the process of scaling up production at the facility.
Each of the products in the Melinta Portfolio has one FDA-approved CMO, primarily in Europe or in the United States. The Company has ongoing technology transfers intended to reduce costs of goods sold as well as to onshore the manufacture of several of its products, which it expects to complete over the next two to three years.
Accounts Receivable and Sales Allowances
Allowances recorded for credit losses as of March 31, 2026 and December 31, 2025 were approximately $0.6 million with no write-offs or recoveries during the three months ended March 31, 2026.
Variable consideration associated with net product sales, or "Sales Allowances," totaled $189.0 million and $19.3 million for the three months ended March 31, 2026, and March 31, 2025, respectively. As of March 31, 2026 and December 31, 2025, total accrued reserves and allowances to accounts receivable on the balance sheet were $98.2 million and $132.4 million, respectively.
A roll forward of the significant categories of Sales Allowances and the related accrual balances on the Condensed Consolidated Balance Sheet for the three months ended March 31, 2026 is as follows:
Volume
Incentive
Rebates
MedicaidDistribution
Service Fees
Accrued
Shelf-
stock
Liability
Accrued
Returns
Allowance
Chargebacks
Balance at December 31, 202586,001 12,418 5,780 2,255 18,291 4,304 
Provisions related to sales recorded in the period45,778 2,348 17,878 4,983 1,699 26,535 
Credits/payments issued during the period(86,193)(735)(15,549)(2,175)(924)(19,389)
Effect of change in estimate(3,187)(5,796)
Balance at March 31, 202645,586 10,844 8,109 5,063 13,270 11,450 
During the quarter ended March 31, 2026, the Company recorded a change in estimate related to variable consideration for Medicaid rebates and product returns. During the three months ended March 31, 2026, the Company obtained new information regarding Medicaid utilization and updated its assumptions based on substantially completed historical claims data. Such estimates are subject to uncertainty due to the timing and completeness of claims processing. In addition, the Company updated its estimate of product returns as initial rate of return history for DefenCath recently became available, which was lower than previously estimated. For the quarter ended March 31, 2026, the resulting changes in accounting estimates positively impacted net sales by $9.0 million and positively impacted income from continuing operations and net income by $6.2 million, net of taxes, and increased basic and diluted earnings per share by $0.08 and $0.07 per share, respectively.