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Note 13 - Revenue Recognition
6 Months Ended
Jun. 30, 2025
Revenue from Contract with Customer [Abstract]  
Revenue Recognition

NOTE 13 REVENUE RECOGNITION

We generate revenues from services, products and intellectual property as follows:

Revenue from services

Revenue for laboratory services is recognized at the time test results are reported, which approximates when services are provided and the performance obligations are satisfied. Services are provided to patients covered by various third-party payor programs including various managed care organizations, as well as the Medicare and Medicaid programs. Billings for services are included in revenue net of allowances for contractual discounts, allowances for differences between the amounts billed and estimated program payment amounts, and implicit price concessions provided to uninsured patients which are all elements of variable consideration.

The following are descriptions of our payors for laboratory services:

Healthcare Insurers. Reimbursements from healthcare insurers are based on negotiated fee-for-service schedules. Revenues consist of amounts billed, net of contractual allowances for differences between amounts billed and the estimated consideration we expect to receive from such payors, which considers historical denial and collection experience and the terms of our contractual arrangements. Adjustments to the allowances, based on actual receipts from the third-party payors, are recorded upon settlement.

Government Payors. Reimbursements from government payors are based on fee-for-service schedules set by governmental authorities, including traditional Medicare and Medicaid. Revenues consist of amounts billed, net of contractual allowances for differences between amounts billed and the estimated consideration we expect to receive from such payors, which considers historical denial and collection experience and the terms of our contractual arrangements. Adjustments to the allowances, based on actual receipts from the government payors, are recorded upon settlement.

Client Payors. Client payors include physicians, hospitals, employers, and other institutions for which services are performed on a wholesale basis, and are billed and recognized as revenue based on negotiated fee schedules.

Patients. Uninsured patients are billed based on established patient fee schedules or fees negotiated with physicians on behalf of their patients. Insured patients (including amounts for coinsurance and deductible responsibilities) are billed based on fees negotiated with healthcare insurers. Collection of billings from patients is subject to credit risk and ability of the patients to pay. Revenues consist of amounts billed net of discounts provided to uninsured patients in accordance with our policies and implicit price concessions. Implicit price concessions represent differences between amounts billed and the estimated consideration that we expect to receive from patients, which considers historical collection experience and other factors including current market conditions. Adjustments to the estimated allowances, based on actual receipts from the patients, are recorded upon settlement.

The complexities and ambiguities of billing, reimbursement regulations and claims processing, as well as considerations unique to Medicare and Medicaid programs, require us to estimate the potential for retroactive adjustments as an element of variable consideration in the recognition of revenue for the period during which the related services are rendered. Actual amounts are adjusted in the period those adjustments become known. For the six months ended June 30, 2025, we recorded $0.7 million of negative revenue adjustments due to changes in estimated implicit price concessions for services provided in prior

periods, primarily due to shifts in the composition of our client mix. For the six months ended June 30, 2024, we recorded $0.9 million of positive revenue adjustments due to changes in estimates of implicit price concessions for performance obligations satisfied in prior periods mainly due to the composition of client pay mix.

Third-party payors, including government programs, may decide to deny payment or recoup payments for testing they contend were improperly billed or not medically necessary, against their coverage determinations, or for which they believe they have otherwise overpaid (including as a result of their own error), and we may be required to refund payments already received. Our revenues may be subject to retroactive adjustment as a result of these factors among others, including without limitation, differing interpretations of billing and coding guidance and changes by government agencies and payors in interpretations, requirements, and “conditions of participation” in various programs. We have processed requests for recoupment from third-party payors in the ordinary course of our business, and it is likely that we will continue to do so in the future. If a third-party payor denies payment for testing or recoups money from us in a later period, reimbursement for our testing could decline.

As an integral part of our billing compliance program, we periodically assess our billing and coding practices, respond to payor audits on a routine basis, and investigate reported failures or suspected failures to comply with federal and state healthcare reimbursement requirements, as well as overpayment claims which may arise from time to time without fault on the part of the Company. We may have an obligation to reimburse Medicare, Medicaid, and third-party payors for overpayments regardless of fault. We have periodically identified and reported overpayments, reimbursed payors for overpayments and taken appropriate corrective action.

Settlements with third-party payors for retroactive adjustments due to audits, reviews or investigations are also considered variable consideration and are included in the determination of the estimated transaction price for providing services. These settlements are estimated based on the terms of the payment agreement with the payor, correspondence from the payor and our historical settlement activity, including an assessment of the probability a significant reversal of cumulative revenue recognized will occur when the uncertainty is subsequently resolved. Estimated settlements are adjusted in future periods as adjustments become known (that is, new information becomes available), or as years are settled or are no longer subject to such audits, reviews, and investigations. As of June 30, 2025 and December 31, 2024, we had liabilities of approximately $2.6 million and $2.0 million, respectively, within Accrued expenses and Other long-term liabilities related to reimbursements for payor overpayments.

The composition of revenue from services by payor for the three and six months ended June 30, 2025 and 2024 was as follows:

 

 

 

Three months ended June 30,

 

 

Six months ended June 30,

 

(In thousands)

 

2025

 

 

2024

 

 

2025

 

 

2024

 

Healthcare insurers

 

$

58,478

 

 

$

78,808

 

 

$

116,130

 

 

$

153,416

 

Government payers

 

 

17,102

 

 

 

21,234

 

 

 

34,257

 

 

 

43,193

 

Client payers

 

 

23,168

 

 

 

25,061

 

 

 

48,448

 

 

 

50,749

 

Patients

 

 

2,353

 

 

 

4,292

 

 

 

5,110

 

 

 

8,928

 

Total

 

$

101,101

 

 

$

129,395

 

 

$

203,945

 

 

$

256,286

 

 

Revenue from products

We recognize revenue from product sales when a customer obtains control of promised goods or services. The amount of revenue recorded reflects the consideration that we expect to receive in exchange for those goods or services. Our estimates for sales returns and allowances are based upon the historical patterns of product returns and allowances taken, matched against the sales from which they originated, and our evaluation of specific factors that may increase or decrease the risk of product returns. Product revenues are recorded net of estimated rebates, chargebacks, discounts, co-pay assistance and other deductions (collectively, “Sales Deductions”) as well as estimated product returns which are all elements of variable consideration. Allowances are recorded as a reduction of revenue at the time product revenues are recognized. The actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from our estimates, we will adjust these estimates, which would affect revenue from products in the period such variances become known.

Rayaldee is distributed in the U.S. principally through the retail pharmacy channel, which initiates with the largest wholesalers in the U.S. (collectively, “Rayaldee Customers”). In addition to distribution agreements with Rayaldee Customers, we have entered into arrangements with many healthcare providers and payors that provide for government-mandated or privately-negotiated rebates, chargebacks and discounts with respect to the purchase of Rayaldee.

We recognize revenue for shipments of Rayaldee at the time of delivery to customers after estimating Sales Deductions and product returns as elements of variable consideration utilizing historical information and market research projections. For the three and six months ended June 30, 2025, we recognized $7.2 million and $13.5 million, respectively, in net product revenue

from sales of Rayaldee. For the three and six months ended June 30, 2024, we recognized $7.2 million and $14.1 million, respectively, in net product revenue from sales of Rayaldee.

The following table presents an analysis of Rayaldee product sales allowances and accruals for the three and six months ended June 30, 2025 and 2024:

 

(In thousands)

 

Chargebacks,
discounts,
rebates and
fees

 

 

Governmental

 

 

Returns

 

 

Total

 

Balance at March 31, 2025

 

$

1,228

 

 

$

3,851

 

 

$

2,478

 

 

$

7,557

 

Provision related to current period sales

 

 

3,173

 

 

 

3,858

 

 

 

291

 

 

 

7,322

 

Credits or payments made

 

 

(3,161

)

 

 

(3,583

)

 

 

(452

)

 

 

(7,196

)

Balance at June 30, 2025

 

$

1,240

 

 

$

4,126

 

 

$

2,317

 

 

$

7,683

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total gross Rayaldee sales

 

 

 

 

 

 

 

 

 

 

$

14,528

 

Provision for Rayaldee sales allowances and accruals as a percentage of gross Rayaldee sales

 

 

 

 

 

 

 

 

 

 

 

50

%

 

(In thousands)

 

Chargebacks,
discounts,
rebates and
fees

 

 

Governmental

 

 

Returns

 

 

Total

 

Balance at December 31, 2024

 

$

2,070

 

 

$

5,365

 

 

$

2,465

 

 

$

9,900

 

Provision related to current period sales

 

 

6,258

 

 

 

7,292

 

 

 

553

 

 

 

14,103

 

Credits or payments made

 

 

(7,088

)

 

 

(8,531

)

 

 

(701

)

 

 

(16,320

)

Balance at June 30, 2025

 

$

1,240

 

 

$

4,126

 

 

$

2,317

 

 

$

7,683

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total gross Rayaldee sales

 

 

 

 

 

 

 

 

 

 

$

27,638

 

Provision for Rayaldee sales allowances and accruals as a percentage of gross Rayaldee sales

 

 

 

 

 

 

 

 

 

 

 

51

%

 

(In thousands)

 

Chargebacks, discounts, rebates and fees

 

 

Governmental

 

 

Returns

 

 

Total

 

Balance at March 31, 2024

 

$

2,494

 

 

$

4,475

 

 

$

2,215

 

 

$

9,184

 

Provision related to current period sales

 

 

4,400

 

 

 

6,416

 

 

 

368

 

 

 

11,184

 

Credits or payments made

 

 

(4,151

)

 

 

(4,900

)

 

 

(389

)

 

 

(9,440

)

Balance at June 30, 2024

 

$

2,743

 

 

$

5,991

 

 

$

2,194

 

 

$

10,928

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total gross Rayaldee sales

 

 

 

 

 

 

 

 

 

 

$

18,424

 

Provision for Rayaldee sales allowances and accruals as a percentage of gross Rayaldee sales

 

 

 

 

 

 

 

 

 

 

 

61

%

 

(In thousands)

 

Chargebacks, discounts, rebates and fees

 

 

Governmental

 

 

Returns

 

 

Total

 

Balance at December 31, 2023

 

$

2,578

 

 

$

6,150

 

 

$

2,192

 

 

$

10,920

 

Provision related to current period sales

 

 

8,219

 

 

 

10,548

 

 

 

672

 

 

 

19,439

 

Credits or payments made

 

 

(8,054

)

 

 

(10,707

)

 

 

(670

)

 

 

(19,431

)

Balance at June 30, 2024

 

$

2,743

 

 

$

5,991

 

 

$

2,194

 

 

$

10,928

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total gross Rayaldee sales

 

 

 

 

 

 

 

 

 

 

$

33,582

 

Provision for Rayaldee sales allowances and accruals as a percentage of gross Rayaldee sales

 

 

 

 

 

 

 

 

 

 

 

58

%

 

Taxes collected from customers related to revenues from services and revenues from products are excluded from revenues.

Revenue from intellectual property and other

We recognize revenues from the transfer of intellectual property generated through license, development, collaboration and/or commercialization agreements. The terms of these agreements typically include payment to us for one or more of the following: non-refundable, up-front license fees; development and commercialization milestone payments; funding of research and/or development activities; and royalties on sales of licensed products. Revenue is recognized upon satisfaction of a performance obligation by transferring control of a good or service to the customer.

For research, development and/or commercialization agreements that result in revenues, we identify all material performance obligations, which may include a license to intellectual property and know-how, and research and development activities. In order to determine the transaction price, in addition to any upfront payment, we estimate the amount of variable consideration at the outset of the contract either utilizing the expected value or most likely amount method, depending on the facts and circumstances relative to the contract. We constrain (reduce) our estimates of variable consideration such that it is probable that a significant reversal of previously recognized revenue will not occur throughout the life of the contract. When determining if variable consideration should be constrained, we consider whether there are factors outside our control that could result in a significant reversal of revenue. In making these assessments, we consider the likelihood and magnitude of a potential reversal of revenue. These estimates are re-assessed each reporting period as required.

Upfront License Fees: If a license to our intellectual property is determined to be functional intellectual property distinct from the other performance obligations identified in the arrangement, we recognize revenue from nonrefundable, upfront license fees based on the relative value prescribed to the license compared to the total value of the arrangement. The revenue is recognized when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are not distinct from other obligations identified in the arrangement, we utilize judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time. If the combined performance obligation is satisfied over time, we apply an appropriate method of measuring progress for purposes of recognizing revenue from nonrefundable, upfront license fees. We evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition.

Research and Development Activities: If we are entitled to reimbursement from our customers for specified research and development expenses, we account for them as separate performance obligations if distinct. We also determine whether the research and development funding would result in revenues or an offset to research and development expenses in accordance with provisions of gross or net revenue presentation. The corresponding revenues or offset to research and development expenses are recognized as the related performance obligations are satisfied.

BARDA Contract: Revenue from the BARDA Contract is generated under terms that are cost plus fee. We recognize revenue using the incurred costs output method to measure progress. Revenue will only be recognized when research and development services are performed to the extent of actual costs incurred.

Sales-based Milestone and Royalty Payments: Our customers may be required to pay us sales-based milestone payments or royalties on future sales of commercial products. We recognize revenues related to sales-based milestone and royalty payments upon the latter to occur of (i) achievement of the customer’s underlying sales or (ii) satisfaction of any performance obligation(s) related to these sales, in each case assuming the license to our intellectual property is deemed to be the predominant item to which the sales-based milestones and/or royalties relate.

Other Potential Products and Services: Arrangements may include an option for license rights, future supply of drug substance or drug product for either clinical development or commercial supply at the licensee’s election. We assess if these options provide a material right to the licensee and if so, they are accounted for as separate performance obligations at the inception of the contract and revenue is recognized only if the option is exercised and products or services are subsequently delivered or when the rights expire. If the promise is based on market terms and not considered a material right, the option is accounted for if and when exercised. If we are entitled to additional payments when the licensee exercises these options, any additional payments are generally recorded in license or other revenues when the licensee obtains control of the goods, which is upon delivery.

Revenue from intellectual property and other increased by $2.7 million to $15.0 million for the three months ended June 30, 2025, from $12.3 million in the same period last year. This growth was primarily driven by a $1.5 million increase from the BARDA Contract (as defined and described in Note 14), with revenue of $6.5 million for the three months ended June 30, 2025 compared to $5.0 million in the 2024 period. Additionally, contract manufacturers' commercial milestones contributed a $2.0 million increase for the three months ended June 30, 2025, rising to $2.3 million from $0.3 million in the prior year. These gains

were partially offset by a $0.2 million reduction in gross profit share and royalty payments from NGENLA (Somatrogon) and Pfizer's Genotropin® (Somatropin), which totaled $6.1 million for the three months ended June 30, 2025 compared to $6.3 million in 2024.

Revenue from intellectual property and other grew by $6.2 million to $27.2 million for the six months ended June 30, 2025, from $21.1 million in the same period last year. This increase was primarily driven by a $6.3 million increase from the BARDA Contract (as defined and described in Note 14), with revenue recognized under the contract totaling $13.5 million for the six months ended June 30, 2025 compared to $7.2 million in the 2024 period. Additionally, contract manufacturers' commercial milestones contributed a $2.5 million increase for the six months ended June 30, 2025, rising to $2.9 million from $0.4 million in the prior year. These gains were partially offset by a $1.3 million reduction in gross profit share and royalty payments from NGENLA (Somatrogon) and Pfizer's Genotropin® (Somatropin), which totaled $10.6 million for the six months ended June 30, 2025 compared to $11.9 million in 2024.