- Valeant May Lawsuit
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Other revenues include alliance and service revenue from the licensing of products and contract service revenue primarily in the areas of dermatology and topical medication. Contract service revenue is derived primarily from contract manufacturing for third parties and is not material.
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Product Sales. The Company recognizes revenue when the customer obtains control of promised goods or services and in an amount that reflects the consideration to which the Company expects to be entitled to receive in exchange for those goods or services. To achieve this core principle, the Company applies the five-step revenue model to contracts within its scope: i identify the contract s with a customer, ii identify the performance obligations in the contract, iii determine the transaction price, iv allocate the transaction price to the performance obligations in the contract and v recognize revenue when or as the entity satisfies a performance obligation.
Where a contract with a customer contains more than one performance obligation, the Company allocates the transaction price to each distinct performance obligation based on its relative standalone selling price.
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The transaction price is adjusted for variable consideration which is discussed further below. The Company generally recognizes revenue for product sales at a point in time, when the customer obtains control of the products. Product Sales Provisions. As is customary in the pharmaceutical industry, gross product sales are subject to a variety of deductions in arriving at reported net product sales.
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The transaction price for product sales is typically adjusted for variable consideration, which may be in the form of cash discounts, allowances, returns, rebates, chargebacks and distribution fees paid to customers. The amount of variable consideration included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in the future period.
Provisions for these deductions are recorded concurrently with the recognition of gross product sales revenue and include cash discounts and allowances, chargebacks, and distribution fees, which are paid to direct customers, as well as rebates and returns, which can be paid to direct and indirect customers. Returns provision balances and volume discounts to direct customers are included in Accrued and other current liabilities. All other provisions related to direct customers are included in Trade receivables, net, while provision balances related to indirect customers are included in Accrued and other current liabilities.
Three Months Ended March 31, Reserve balance, January 1, Current year provision. Payments or credits. The Company continually monitors its variable consideration provisions and evaluates the estimates used as additional information becomes available. The Company is required to make subjective judgments based primarily on its evaluation of current market conditions and trade inventory levels related to the Company's products.
Why the Valeant-Walgreens deal could save you money - MarketWatch
This evaluation may result in an increase or decrease in the experience rate that is applied to current and future sales, or an adjustment related to past sales, or both. The Company applies this method consistently for contracts with similar characteristics. Cash Discounts and Allowances. Cash discounts are offered for prompt payment and allowances for volume purchases.
Provisions for cash discounts are estimated at the time of sale and recorded as direct reductions to trade receivables and revenue. Management estimates the provisions for cash discounts and allowances based on contractual sales terms with customers, an analysis of unpaid invoices and historical payment experience.
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Consistent with industry practice, customers are generally allowed to return product within a specified period of time before and after its expiration date, excluding European businesses which generally do not carry a right of return. The returns provision is estimated utilizing historical sales and return rates over the period during which customers have a right of return, taking into account available information on competitive products and contract changes.
The information utilized to estimate the returns provision includes: i historical return and exchange levels, ii external data with respect to inventory levels in the wholesale distribution channel, iii external data with respect to prescription demand for products, iv remaining shelf lives of products at the date of sale and v estimated returns liability to be processed by year of sale based on an analysis of lot information related to actual historical returns. In determining the estimate for returns, management is required to make certain assumptions regarding the timing of the introduction of new products and the potential of these products to capture market share.
In addition, certain assumptions with respect to the extent and pattern of decline associated with generic competition are necessary. These assumptions are formulated using market data for similar products, past experience and other available information.
These assumptions are continually reassessed, and changes to the estimates and assumptions are made as new information becomes available. The estimate for returns may be impacted by a number of factors, but the principal factor relates to the inventory levels in the distribution channel.
When management becomes aware of an increase in such inventory levels, it considers whether the increase may be temporary or other-than-temporary. Temporary increases in wholesaler inventory levels will not differ from original estimates of provision for returns. Other-than-temporary increases in wholesaler inventory levels, however, may be an indication that future product returns could be higher than originally anticipated, and, as a result, estimates for returns may need to be adjusted.
Factors that suggest increases in wholesaler inventory levels are temporary include: i recently. Conversely, factors that suggest increases in wholesaler inventory levels are other-than-temporary include: i declining sales trends based on prescription demand; ii introduction of new products or generic competition; iii increasing price competition from generic competitors; and iv recent changes to the U.
Rebates and Chargebacks. Product sales made under governmental and managed-care pricing programs in the U. The Company participates in state government-managed Medicaid programs, as well as certain other qualifying federal and state government programs whereby rebates are provided to participating government entities. The calculation of the Medicaid rebate reserve also requires other estimates, such as estimates of sales mix, to determine which sales are subject to rebates and the amount of such rebates.
Quarterly, the Medicaid rebate reserve is adjusted based on actual claims paid. Due to the delay in billing, adjustments to actual claims paid may incorporate revisions of that reserve for several periods. Chargebacks relate to contractual agreements to sell products to government agencies, group purchasing organizations and other indirect customers at contractual prices that are lower than the list prices the Company charges wholesalers. When these group purchasing organizations or other indirect customers purchase products through wholesalers at these reduced prices, the wholesaler charges the Company for the difference between the prices they paid the Company and the prices at which they sold the products to the indirect customers.
In estimating provisions for rebates and chargebacks, management considers relevant statutes with respect to governmental pricing programs and contractual sales terms with managed-care providers and group purchasing organizations. Management estimates the amount of product sales subject to these programs based on historical utilization levels.
Changes in the level of utilization of products through private or public benefit plans and group purchasing organizations will affect the amount of rebates and chargebacks that the Company is obligated to pay. Rebate provisions are based on factors such as timing and terms of plans under contract, time to process rebates, product pricing, sales volumes, amount of inventory in the distribution channel and prescription trends.
Accordingly, the Company generally assumes that adjustments made to rebate provisions relate to sales made in the prior years due to the delay in billing. However, the Company assumes that adjustments made to chargebacks are generally related to sales made in the current year, as these amounts are settled within a few months of original sale.
Patient Co-Pay Assistance Programs are patient discount programs offered in the form of coupon cards or point of sale discounts which patients receive certain discounts off their prescription at participating pharmacies, as defined by the specific product program. That estimate is based on historical experience and other relevant factors. Distribution Fees.
The Company sells product primarily to wholesalers, and in some instances to large pharmacy chains such as CVS and Wal-Mart. Under the DSAs, the wholesalers agree to provide services, and the Company pays the contracted DSA distribution service fees for these services based on product volumes. Under such contracts, the Company is entitled to credits from such wholesalers for the impact of that WAC increase on inventory currently on hand at the wholesalers.
Such credits are offset against the total distribution service fees paid to each such wholesaler. The variable consideration associated with price appreciation credits is reflected in the transaction price of products sold when it is determined to be probable that a significant reversal will not occur. Contract Assets and Contract Liabilities. There are no contract assets for any period presented.
Contract liabilities consist of deferred revenue, the balance of which is not material to any period presented. Sales Commissions. The Company expenses sales commissions when incurred because the amortization period would have been less than one year.
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Sales commissions are included in selling, general and administrative expenses. Financing Component. The Company has elected not to adjust consideration for the effects of a significant financing component when the period between the transfer of a promised good or service to the customer and when the customer pays for that good or service will be one year or less.
The Company's global payment terms are generally between thirty to ninety days. In , the Company divested certain businesses and assets, which, in each case, were not aligned with its core business objectives. Dendreon Pharmaceuticals LLC. Dendreon was part of the Branded Rx segment and was reclassified as held for sale as of December 31, Obagi Medical Products, Inc.
Obagi is a global specialty skin care pharmaceutical business with products focused on premature skin aging, skin damage, hyperpigmentation, acne and sun damage which are primarily available through dermatologists, plastic surgeons and other skin care professionals.
The Obagi business was part of the U.
Diversified Products segment and was reclassified as held for sale as of March 31, Sprout Pharmaceuticals, Inc.