AMPHASTAR PHARMACEUTICALS, INC. The following is a discussion and analysis of the consolidated operating results, financial condition, liquidity and cash flows of our company as of and for the periods presented below. The following discussion and analysis should be read in conjunction with the audited consolidated financial statements and the related notes thereto included in Item 8 under the heading "Financial Statements and Supplementary Data." This discussion contains forward-looking statements that are based on the beliefs of our management, as well as assumptions made by and information currently available to, our management. Actual results could differ materially from those discussed in or implied by forward-looking statements. These risks, uncertainties and other factors include among others, those identified under the "Special Note About Forward-Looking Statements," above and described in greater detail elsewhere in this Annual Report on Form 10-K, particularly in Item 1A, "Risk Factors." In this section, we generally discuss the results of our operations for the year endedDecember 31, 2022 , compared to the year endedDecember 31, 2021 . For a discussion of the year endedDecember 31, 2021 , to the year endedDecember 31, 2020 , please refer to Part II, Item 7, "Management's Discussion and Analysis of Financial Condition and Results of Operations" in our Annual Report on Form 10-K for the year endedDecember 31, 2021 , filed with theSEC onMarch 11, 2022 , which discussion is hereby incorporated herein by reference.
Overview
We are a bio-pharmaceutical company focusing primarily on developing, manufacturing, marketing, and selling technically challenging generic and proprietary injectable, inhalation, intranasal, and insulin API products. We currently manufacture and sell over 20 products.
Our largest products by net revenues currently include Primatene MIST®, epinephrine, glucagon, lidocaine, phytonadione, and enoxaparin sodium. InApril 2022 , the FDA approved our ganirelix acetate injection 250mg/0.5mL prefilled syringe, which we launched inJune 2022 . InJuly 2022 , the FDA approved our vasopressin injection, USP 20 Units/mL, 1 mL single-dose vial, which we launched inAugust 2022 . InMay 2022 , the FDA approved our regadenoson injection, 0.08mg/mL, 5mL, single-dose prefilled syringe. The timing of the launch of this product is subject to a confidential settlement agreement with the product's innovator. We are currently developing a portfolio of generic abbreviated new drug applications, or ANDAs, biosimilar insulin product candidates, and proprietary product candidates, which are in various stages of development and target a variety of indications. Three of the ANDAs and one new drug application, or NDA, are currently on file with the FDA. To complement our internal growth and expertise, we have made several strategic acquisitions of companies, products, and technologies. These acquisitions collectively have strengthened our core injectable and inhalation product technology infrastructure by providing additional manufacturing, marketing, and research and development capabilities, including the ability to manufacture raw materials, API, and other components for our products. In 2021, we completed the restructuring of our Chinese subsidiary, ANP, resulting in the reduction of ANP's ownership ofHanxin Pharmaceutical Technology Co., Ltd , or Hanxin to 14%. See Note 3 in the accompanying "Notes to Consolidated Financial Statements" in this Annual Report on Form 10-K. As a result of the restructuring, we determined that we have significant influence over Hanxin and as such the retained non-controlling investment in Hanxin is accounted for as an equity method investment. Hanxin continues to be a related party subsequent to the restructuring.
COVID-19 Pandemic
The ongoing COVID-19 pandemic and the resulting containment measures that have
been in effect from time to time in various countries and territories since
early 2020 have had a number of substantial negative impacts on businesses
around the world and on global, regional, and national economies, including
widespread disruptions in supply chains for a wide variety of products and
resulting increases in the prices of many goods and services. Currently, our
production facilities in all of our locations continue to operate as they had
before the COVID-19 pandemic with few changes other than for enhanced safety
measures intended to prevent the spread of the virus.
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Some of our ongoing clinical trials experienced short-term interruptions in the recruitment of patients due to the COVID-19 pandemic, as hospitals prioritized their resources towards the COVID-19 pandemic and governments imposed travel restrictions. Some clinical trials experienced increased expenses due to new protocols to protect participants from COVID-19. Additionally, certain suppliers had difficulties meeting their delivery commitments, and we are experiencing longer lead times for components. For example, in the first quarter of 2022, increases in COVID-19 cases inShanghai, China , led to shutdowns and delays at the ports inShanghai , which led to temporary delays in shipping certain APIs and starting materials from our facility inChina to ourU.S. business. Future shutdowns could have an adverse impact on our operations. However, the extent of the impact of any future shutdown or delay is highly uncertain and difficult to predict. It is not possible at this time to estimate the complete impact that COVID-19 could have on our business, including our customers and suppliers, as the effects will depend on future developments, which are highly uncertain and cannot be predicted. Infections may resurge or become more widespread, including due to new variants and the limitation on our ability to travel and timely sell and distribute our products, as well as any closures or supply disruptions may be prolonged for extended periods, all of which would have a negative impact on our business, financial condition, and operating results. Even after the COVID-19 pandemic has subsided, we may continue to experience an adverse impact on our business due to the continued global economic impact of the COVID-19 pandemic. We cannot anticipate all of the ways in which health epidemics such as COVID-19 could adversely impact our business. See Item 1A, "Risk Factors" for further discussion of the possible impact of the COVID-19 pandemic on our business.
Macroeconomic Trends and Uncertainties
TheRussia -Ukraine conflict and resulting sanctions and other actions againstRussia have led to uncertainty and disruption in the global economy. Although the conflict has not had a direct material adverse impact on our revenues or other financial results, one of our insulin API customers inWestern Europe , that previously bought our product and resold it intoRussia , did not purchase API from us this year. We are closely monitoring the events of theRussia -Ukraine conflict and its impact onEurope and throughout the rest of the world. It is not clear at this time how long the conflict will endure, or if it will escalate further, which could further compound the adverse impact to the global economy and consequently affect our results of operations. Certain other worldwide events and macroeconomic factors, such as international trade relations, new legislation and regulations, taxation or monetary policy changes, political and civil unrest, supply chain disruptions, inflationary pressures, and rising interest rates, among other factors, also increase volatility in the global economy. For example,the United States has recently experienced historically high levels of inflation. According to theU.S. Department of Labor , the annual inflation rate forthe United States was approximately 6.5% as ofDecember 2022 . The existence of inflation inthe United States , and global economy has and may continue to result in higher interest rates and capital costs, increased costs of labor, weakening exchange rates and other similar effects.
See Item 1A, "Risk Factors" for further discussion of the possible impact of the
Business Segments
As ofDecember 31, 2022 , our performance is assessed and resources are allocated based on the following two reportable segments: (1) finished pharmaceutical products and (2) API products. The finished pharmaceutical products segment manufactures, markets and distributes Primatene MIST®, epinephrine, glucagon, phytonadione, lidocaine, enoxaparin, naloxone, as well as various other critical and non-critical care drugs. The API segment manufactures and distributesRHI API and porcine insulin API for external customers and internal product development. Information reported herein is consistent with how it is reviewed and evaluated by our chief operating decision maker. Factors used to identify our segments include markets, customers and products. For more information regarding our segments, see "Part II - Item 8. Financial Statements and Supplementary Data - Notes to Consolidated Financial Statements - Segment Reporting Information." 84 Table of Contents Results of Operations
Year ended
Net revenues
Year Ended December 31, Change
2022 2021 Dollars %
(in thousands)
Net revenues
Finished pharmaceutical products $ 486,505 $ 419,570 $ 66,935 16 %
API 12,482 18,198 (5,716) (31) %
Total net revenues $ 498,987 $ 437,768 $ 61,219 14 %
Cost of revenues
Finished pharmaceutical products $ 229,795 $ 209,855 $ 19,940 10 %
API 20,332 28,174 (7,842) (28) %
Total cost of revenues $ 250,127 $ 238,029 $ 12,098 5 %
Gross profit $ 248,860 $ 199,739 $ 49,121 25 %
as % of net revenues 50 % 46 %
The increase in net revenues of finished pharmaceutical products for 2022 was primarily due to the following changes:
Year Ended December 31, Change
2022 2021 Dollars %
(in thousands)
Finished pharmaceutical products net revenues
Primatene MIST® $ 84,309 $ 73,113 $ 11,196 15 %
Epinephrine 74,204 57,530 16,674 29 %
Glucagon 55,322 47,639 7,683 16 %
Lidocaine 52,539 44,413 8,126 18 %
Phytonadione 49,500 45,498 4,002 9 %
Enoxaparin 34,950 35,962 (1,012) (3) %
Naloxone 26,269 27,540 (1,271) (5) %Other finished pharmaceutical products 109,412
87,875 21,537 25 %
Total finished pharmaceutical products net revenues
Primatene MIST® sales continued to grow in 2022 as a result of increased unit volumes, which was primarily a result of the continued success of our advertising campaign. The increase in sales of epinephrine was primarily due to an increase in unit volumes, due to an increase in demand caused by competitor shortages, contributing$9.0 million in sales, as well as a higher average selling price, which contributed$7.7 million to the increase in sales. The increase in sales of glucagon was primarily due to an increase in unit volumes as the prior year period did not include a full year of sales due to glucagon's launch in the first quarter of 2021. The increase in sales of lidocaine was primarily due to an increase in unit volumes, which contributed$4.4 million , as well as a higher average selling price, which contributed$3.8 million to the increase in sales. The increase in sales of phytonadione was due to a higher average selling price. The decrease in sales of naloxone was primarily due to a decrease in average selling price, which caused a decrease of$3.2 million , which was partially offset by an increase in unit volumes contributing$1.9 million . The increase in other finished pharmaceutical products was primarily due to higher unit volumes of calcium chloride, dextrose and sodium bicarbonate, due to increased demand caused by competitor shortages, as well as the launch of ganirelix and vasopressin inJune 2022 andAugust 2022 , respectively. We anticipate that sales of naloxone and enoxaparin will continue to fluctuate in the future as a result of changing levels of competition. We also anticipate that sales of epinephrine and other finished pharmaceutical products will continue to fluctuate depending on the ability of our competitors to supply
market demands.
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Sales of API primarily depend on the timing of customer purchases. One of our
insulin API customers in Western Europe that previously bought our product and
resold it into Russia did not purchase API this year, which resulted in a
decline of $2.0 million in API sales.
In May 2021 , we amended the Supply Agreement with MannKind Corporation, whereby
MannKind's aggregate total commitment of RHI API under the Supply Agreement was
modified and extended for an additional year through 2027, which timeframe would
have previously lapsed after calendar year 2026. MannKind agreed to pay us an
amendment fee of $2.0 million . We received the first payment of the amendment
fee of $1.0 million in June 2021 , which we recognized in net revenues during the
year ended December 31, 2021 . The remaining $1.0 million of the amendment fee
was received in January 2022 , which we recognized in net revenues during the
year ended December 31, 2022 and relates to the amendments to the 2022 supply
level. We anticipate that sales of API will continue to fluctuate and may
decrease due to the inherent uncertainties related to sales to MannKind pursuant
to our supply agreement with them. In addition, most of our API sales are
denominated in euros, and the fluctuation in the value of euros versus the U.S.
dollar has had, and may continue to have, an impact on API sales revenues in the
near term.
A significant portion of our customer shipments in any period relate to orders
received and shipped in the same period, generally resulting in low product
backlog relative to total shipments at any time. However, as of December 31,
2022 , we experienced a backlog of approximately $7.0 million for various
products, partially as a result of competitor shortages, supplier constraints
and labor shortages at our facilities in California . We are currently working on
resolving backlog related issues and believe that we will be able to reduce the
backlog in the near future. Historically, our backlog has not been a meaningful
indicator in any given period of our ability to achieve any particular level of
overall revenue or financial performance.
Gross Margins
The increase in sales of Primatene MIST®, epinephrine and glucagon, which are higher-margin products, helped increase our gross margins for the year endedDecember 31, 2022 . These increases in gross margins were partially offset by an overall increase in labor and input costs. We are experiencing increased costs for labor and certain purchased components. Additionally, the cost of heparin may fluctuate, which could put downward pressure on our gross margins. However, we believe that this trend will be offset by increased sales of our higher-margin products, including Primatene MIST®, glucagon, vasopressin, ganirelix and our pipeline products.
Selling, distribution, and marketing, and general and administrative
Year Ended December 31, Change
2022 2021 Dollars %
(in thousands)Selling, distribution, and marketing$ 21,531 $
17,486$ 4,045 23 % General and administrative 45,061 51,434 (6,373) (12) %
The increase in selling, distribution and marketing expenses was primarily due
to increased freight expenses and an increase in advertising spending for
Primatene MIST®. The decrease in general and administrative expense was
primarily due to a decrease in legal expenses and a decrease in expenses in
We expect that selling, distribution and marketing expenses will continue to
increase due to the increase in marketing expenditures for Primatene MIST®.
Legal fees may fluctuate from period to period due to the timing of patent
challenges and other litigation matters.
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Research and development
Year Ended December 31, Change
2022 2021 Dollars %
(in thousands)
Salaries and personnel-related expenses $ 25,786 $ 27,461 $ (1,675) (6) %
Clinical trials 5,689 3,053 2,636 86 %
FDA fees 268 443 (175) (40) %
Materials and supplies 25,630 11,150 14,480 130 %
Depreciation 10,061 11,008 (947) (9) %
Other expenses 7,337 7,817 (480) (6) %
Total research and development expenses $ 74,771 $
60,932
The increase in research and development expenses is primarily due to an increase in materials and supplies as a result of an increase in expenditures on raw materials and components for our AMP-018 and insulin products. Additionally, clinical trial expense increased due to external studies related to our insulin and inhalation product pipeline. Reductions of salaries, depreciation and other expenses are related to the restructuring of our subsidiary inChina .
Research and development costs consist primarily of costs associated with the research and development of our product candidates including the cost of developing APIs. We expense research and development costs as incurred.
We have made, and expect to continue to make, substantial investments in research and development to expand our product portfolio and grow our business. We expect that research and development expenses will increase on an annual basis due to increased clinical trial costs related to our insulin and inhalation product candidates. These expenditures will include costs of APIs developed internally as well as APIs purchased externally, the cost of purchasing reference listed drugs and the costs of performing the clinical trials. As we undertake new and challenging research and development projects, we anticipate that the associated costs will increase significantly over the next several quarters and years. Over the past year, some of our ongoing clinical trials experienced short term interruptions in the recruitment of patients due to the COVID-19 pandemic, as hospitals prioritized their resources towards the COVID-19 pandemic and trial sites changed their operating protocols to protect participants from COVID-19. These conditions may continue to increase the costs of clinical trials and also delay spending and results of these trials.
Other income (expense), net
Year Ended December 31, Change
2022 2021 Dollars %
(in thousands)
Other income (expenses), net
InJanuary 2022 , we received a settlement of$5.4 million in connection with the Regadenoson patent litigation. For more information regarding our litigation matters, see Note 19 in the accompanying "Notes to Consolidated Financial Statements" in this Annual Report on Form 10-K. In the third quarter of 2021, we completed the restructuring of ANP, whereby our ownership interest in ANP increased to 100% and ANP's ownership interest in Hanxin and its subsidiaries was reduced to approximately 14%. As a result of the loss in control over Hanxin, we deconsolidated Hanxin and recorded a$13.6 million gain on deconsolidation. For more information regarding our ANP restructuring, see Note 3 in the accompanying "Notes to Consolidated Financial Statements" in this Annual Report on Form 10-K.
Income tax provision
Year Ended December 31, Change
2022 2021 Dollars %
(in thousands)
Income tax provision $ 23,477 $ 20,630 $ 2,847 14 %
Effective tax rate 20 % 25 %
Our effective tax rate for the year ended December 31, 2022 decreased in
comparison to the year ended December 31, 2021 , primarily due to differences in
pre-tax income positions and excess tax benefit from share-based compensation.
For more information regarding our income taxes, see Note 15 to the consolidated
financial statements.
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Liquidity and Capital Resources
Cash Requirements and Sources
We need capital resources to maintain and expand our business. We expect our cash requirements to increase significantly in the foreseeable future as we sponsor clinical trials for, seek regulatory approvals of, and develop, manufacture and market our current development stage product candidates and pursue strategic acquisitions of businesses or assets. Our future capital expenditures include projects to upgrade, expand, and improve our manufacturing facilities inthe United States andChina , including a significant increase in capital expenditures in 2023 We plan to fund this facility expansion with cash flows from operations. Our cash obligations include the principal and interest payments due on our existing loans and lease payments, as described below and throughout this Annual Report on Form 10-K. As ofDecember 31, 2022 , our foreign subsidiaries collectively held$15.2 million in cash and cash equivalents. Cash or cash equivalents held at foreign subsidiaries are not available to fund the parent company's operations inthe United States . We believe that our cash reserves, operating cash flows, and borrowing availability under our credit facilities will be sufficient to fund our operations for at least the next 12 months. We expect additional cash flows to be generated in the longer term from future product introductions, although there can be no assurance as to the receipt of regulatory approval for any product candidates that we are developing or the timing of any product introductions, which could be lengthy or ultimately unsuccessful. We maintain a shelf registration statement on Form S-3 pursuant to which we may, from time to time, sell up to an aggregate of$250 million of our common stock, preferred stock, debt securities, depositary shares, warrants, subscription rights, purchase contracts, or units. If we require or elect to seek additional capital through debt or equity financing in the future, we may not be able to raise capital on terms acceptable to us or at all. To the extent we raise additional capital through the sale of equity or convertible debt securities, the issuance of such securities will result in dilution to our stockholders. If we are required and unable to raise additional capital when desired, our business, operating results and financial condition may be adversely affected.
Working capital increased
Cash Flows from Operations
The following table summarizes our cash flows from operating, investing, and
financing activities for the years ended
Year Ended December 31,
2022 2021
(in thousands)
Statement of Cash Flow Data:
Net cash provided by (used in)
Operating activities $ 89,181 $ 97,994
Investing activities (32,777) (28,672)
Financing activities (26,439) (37,018)
Effect of exchange rate changes on cash
(220) (223)
Net increase in cash, cash equivalents, and restricted cash
Sources and Use of Cash Operating Activities Net cash provided by operating activities was$89.2 million for the year endedDecember 31, 2022 , which included net income of$91.4 million . Non-cash items comprised primarily of$28.7 million of depreciation and amortization and$17.9 million of share-based compensation expense.
Additionally, for the year ended
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liabilities of$32.2 million , which resulted from an increase in accounts receivables; an increase in inventories, as we increased purchases of certain raw materials and components; as well as a decrease in accounts payable and accrued liabilities. Accounts payable and accrued liabilities decreased primarily due to the timing of payments. The increase in accounts receivables was due to both increases in sales and timing of sales. Net cash provided by operating activities was$98.0 million for the year endedDecember 31, 2021 , which included net income of$63.3 million . Non-cash items comprised primarily of$26.8 million of depreciation and amortization,$18.7 million of share-based compensation expense and a$13.6 million gain relating to the deconsolidation of Hanxin and its subsidiaries as result of the ANP restructuring during the third quarter of 2021. Additionally, for the year endedDecember 31, 2021 , there was a net cash outflow from changes in operating assets and liabilities of$2.0 million , which resulted from an increase in accounts receivable, which was partially offset by a decrease in inventory, as well as an increase in accounts payable and accrued liabilities. Accounts payable and accrued liabilities increased primarily due to the timing of payments. The increase in accounts receivable was due to both increases in sales and the timing of sales.
Investing Activities
Net cash used in investing activities was$32.8 million for the year endedDecember 31, 2022 , primarily as a result of$24.0 million in purchases of property, plant, and equipment, which included$15.4 million incurred inthe United States ,$1.4 million inFrance , and$7.2 million inChina . Additionally, net cash outflows from purchases and sales of short-term investments during the period was$7.8 million .
Net cash used in investing activities was
Financing Activities
Net cash used in financing activities was$26.4 million for the year endedDecember 31, 2022 , primarily as a result of purchases of$39.9 million of treasury stock, which was partially offset by$15.7 million in net proceeds from the settlement of share-based compensation awards under our equity plan. Additionally, we also made$1.8 million in principal payments on our long-term debt. Net cash used in financing activities was$37.0 million for the year endedDecember 31, 2021 , primarily as a result of$53.6 million in payments relating to the purchase of additional ANP ownership interest in connection with the ANP restructuring completed during the third quarter of 2021 (For more information, see Note 3 in the accompanying "Notes to Consolidated Financial Statements" in this Annual Report on Form 10-K). We borrowed$70.0 million in connection with a credit agreement withCapital One N.A. , which was partially offset by$37.9 million in principal payments on our long-term debt and lines of credit. We used$28.9 million to purchase treasury stock and received$15.9 million in net proceeds from the settlement of share-based compensation awards under our equity plans. Debt and Borrowing Capacity
Our outstanding debt obligations are summarized as follows:
December 31,
2022 2021 Change
(in thousands)
Short-term debt and current portion of long-term debt $ 3,046 $ 2,202 $ 844
Long-term debt 72,839 74,776 (1,937)
Total debt $ 75,885 $ 76,978 $ (1,093) As of
The weighted average interest rates on lines of credit as ofDecember 31, 2022 and 2021 were 5.2% and 1.8%, respectively. For our loans withCapital One N.A. andEast West Bank , we have entered into fixed interest rate swap contracts to exchange the variable interests for fixed interest rates. 89
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For more information regarding our outstanding indebtedness, see "Part II - Item 8. Financial Statements and Supplementary Data - Notes to Consolidated Financial Statements - Debt." Operating Lease Obligations As discussed in Note 18 to the consolidated financial statements, as ofDecember 31, 2022 we had a total of$32.4 million of minimum rental payments under operating leases. Of that amount,$4.1 million is due within 12 months as ofDecember 31, 2022 . Purchase obligations We have certain purchase obligations under which we are required to make minimum payments for items including, but not limited to, inventory and pharmaceutical manufacturing and laboratory equipment. As ofDecember 31, 2022 , we had an aggregate amount of approximately$58.2 million .
Critical Accounting Policies
We prepare our consolidated financial statements in accordance with accounting principles generally accepted inthe United States , or GAAP. The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates. In some cases, changes in the accounting estimates are reasonably likely to occur from period to period. Accordingly, actual results could differ materially from our estimates. To the extent that there are material differences between these estimates and actual results, our financial condition and results of operations will be affected. We base our estimates on past experience and other assumptions that we believe are reasonable under the circumstances, and we evaluate these estimates on an ongoing basis. We refer to accounting estimates of this type as critical accounting policies, which we discuss further below. While our significant accounting policies are more fully described in Note 2 to our audited consolidated financial statements, we believe that the following accounting policies are critical to the process of making significant judgments and estimates in the preparation of our audited consolidated financial statements.
Revenue Recognition
Our net revenues consist principally of revenues generated from the sale of our pharmaceutical products. We also generate a small amount of revenues from contract manufacturing services. Generally, we recognize revenues at the time of product delivery to our customers in accordance with ASC, 606 Revenue from Contracts with Customers. In some cases, revenues are recognized at the time of shipment when stipulated by the terms of the sale agreements. Revenues derived from contract manufacturing services are recognized when third-party products are shipped to customers, after the customer has accepted test samples of the products to be shipped. The consideration we receive in exchange for our goods or services is only recognized when it is probable that a significant reversal will not occur. The consideration to which we expect to be entitled includes a stated list price, less various forms of variable consideration. We make significant estimates for related variable consideration at the point of sale, including chargebacks, rebates, product returns, other discounts and allowances.
Provision for estimated chargebacks, rebates, discounts, product returns and credit losses is made at the time of sale and is analyzed and adjusted, if necessary, at each balance sheet date.
If actual future payments for the discounts, returns, fees, rebates and
chargebacks exceed the estimates we made at the time of sale, our financial
position, results of operations and cash flows would be negatively impacted. As
discussed under "Accrual for Product Returns" below, we are generally obligated
to accept from our customers the return of pharmaceuticals that have reached or
will soon reach their expiration dates. We establish reserves for such amounts
based on historical experience and other information available at the time of
sale, but the actual returns will not occur until several years after the sale.
Although we believe that our estimates and assumptions are reasonable as of the
date when made, actual results may differ significantly from these estimates.
Our financial position, results of operations and cash flows may be materially
and negatively impacted if actual returns exceed our estimated allowances for
returns.
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We establish allowances for estimated chargebacks, rebates and product returns based on a number of qualitative and quantitative factors, including:
? contract pricing and return terms of our agreements with customers;
? wholesaler inventory levels and turnover;
? historical chargeback and product return rates;
? shelf lives of our products, which is generally two years, as is the case with
enoxaparin;
? direct communication with customers;
? anticipated introduction of competitive products or authorized generics; and
? anticipated pricing strategy changes by us and/or our competitors.
Service revenues derived from research and development contracts is recognized over time based on progress toward completion of the performance obligation. For each performance obligation satisfied over time, we assess the proper method to be used for revenue recognition, either an input method to measure progress toward the satisfaction of services or an output method of determining the progress of completion of performance obligation. For the years endedDecember 31, 2022 and 2021, revenue from research and development services at ANP were$4.3 million and$5.1 million , respectively.
Provision for Chargebacks and Rebates
The provision for chargebacks and rebates is a significant estimate used in the recognition of revenue. Wholesaler chargebacks relate to sales terms under which we agree to reimburse wholesalers for differences between the gross sales prices at which we sell our products to wholesalers and the actual prices of such products that wholesalers resell them under our various contractual arrangements with third parties such as hospitals and group purchasing organizations inthe United States . Rebates include primarily amounts paid to retailers, payers, and providers inthe United States , including those paid to state Medicaid programs, and are based on contractual arrangements or statutory requirements. We estimate chargebacks and rebates using the expected value method at the time of sale to wholesalers based on wholesaler inventory stocking levels, historic chargeback and rebate rates, and current contract pricing. The provision for chargebacks and rebates is reflected as a component of net revenues. The following table is an analysis of the chargeback and rebate provision: Year Ended December 31, 2022 2021 (in thousands) Beginning balance$ 20,167 $ 20,380
Provision for chargebacks and rebates 208,081 201,133
Credits and payments issued to third parties (201,642) (201,346) Ending balance
$ 26,606 $ 20,167 Changes in the chargeback provision from period to period are primarily dependent on our sales to its wholesalers, the level of inventory held by wholesalers, and the wholesalers' customer mix. Changes in the rebate provision from period to period are primarily dependent on retailer's and other indirect customers' purchases. The approach that we use to estimate chargebacks and rebates has been consistently applied for all periods presented. Variations in estimates have been historically small. We continually monitor the provision for chargebacks and rebates and make adjustments when we believe that the actual chargebacks and rebates may differ from the estimates. The settlement of chargebacks and rebates generally occurs within 20 days to 60 days after the sale to wholesalers. Accounts receivable and/or accounts payable and accrued liabilities are reduced and/or increased by the chargebacks and rebate amounts depending on whether we have the right to offset with the customer. Of the provision for chargebacks and rebates as ofDecember 31, 2022 and 2021,$20.5 million and$15.6 million were included as a reduction to accounts receivable, net, on the 91 Table of Contents consolidated balance sheets, respectively. The remaining provision as ofDecember 31, 2022 and 2021, was$6.1 million and$4.6 million , respectively, were included in accounts payable and accrued liabilities on the consolidated balance sheets. Accrual for Product Returns We offer most customers the right to return qualified excess or expired inventory for partial credit; however, API product sales are generally non-returnable. Our product returns primarily consist of the returns of expired products from sales made in prior periods. Returned products cannot be resold. At the time product revenue is recognized, we record an accrual for product returns estimated using the expected value method. The accrual is based, in part, upon the historical relationship of product returns to sales and customer contract terms. We also assesses other factors that could affect product returns including market conditions, product obsolescence, and new competition. Although these factors do not normally give our customers the right to return products outside of the regular return policy, we realize that such factors could ultimately lead to increased returns. We analyze these situations on a case-by-case basis and make adjustments to the product return reserve as appropriate.
The provision for product returns is reflected as a component of net revenues. The following table is an analysis of the product return liability:
Year Ended
December 31,
2022 2021
(in thousands)
Beginning balance $ 21,677 $ 14,204 Provision for product returns 4,405 15,005 Credits issued to third parties (6,631) (7,532) Ending balance
$ 19,451 $ 21,677 Of the provision for product returns as ofDecember 31, 2022 and 2021,$14.9 million and$16.0 million were included in accounts payable and accrued liabilities on the consolidated balance sheets, respectively. The remaining provision as ofDecember 31, 2022 and 2021, of$4.6 million and$5.7 million were included in other long-term liabilities, respectively. For the years endedDecember 31, 2022 and 2021, our aggregate product return rate was 1.4% and 1.7% of qualified sales, respectively.
Inventory
Inventories consist of currently marketed products and products manufactured under contract. Inventories are stated using the first-in, first-out method, on a consistent basis. Inventory is stated at the lower of cost or net realizable value. We adjust inventories to their net realizable value: (i) if a launch of a new product is delayed and inventory may not be fully utilized and could be subject to impairment, (ii) when a product is close to expiration and not expected to be sold, (iii) when a product has reached its expiration date, (iv) when a product is not expected to be sellable, and (v) when the estimated net realizable value is below cost. In determining the estimated net realizable value of an inventory item, we consider factors such as the forecasted average net selling price, the amount of inventory on hand, its remaining shelf life, its regulatory approval status, and current and expected market conditions, including management forecasts and levels of competition. The largest adjustment to the net realizable value of our inventory has historically been related to enoxaparin. The adjustment of enoxaparin inventory to its net realizable value has been driven primarily by increases in the prices of heparin, the starting material for the production of the API in our enoxaparin product. Other cost increases relate to labor and overhead also impacted the cost of producing enoxaparin. Additionally, fluctuations in the forecasted average net selling price impact this estimate. The average net selling price has fluctuated due to competitor entries and exits from the market.
Impairment of Intangible and Long-Lived Assets
We review long-lived assets and definite-lived identifiable intangible assets or
asset groups for impairment whenever events or changes in circumstances indicate
that the carrying amount of an asset may not be recoverable. Such events and
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circumstances include decisions by the FDA regarding evidence of effectiveness
of proprietary drug candidates or bioequivalence (sameness) of our generic
product candidates as compared to the reference drug, communication with the
regulatory agencies regarding the safety and efficacy of our products under
review, the use of the asset in current research and development projects, any
potential alternative uses of the asset in other research and development
projects in the short-to-medium term, clinical trial results and research and
development portfolio management options. Determination of recoverability is
based on an estimate of undiscounted future cash flows resulting from the use of
the asset or asset groups and its eventual disposition. If the sum of the
expected future undiscounted cash flows is less than the carrying amount of the
asset or asset groups, further impairment analysis is performed. An impairment
loss is measured as the amount by which the carrying amount exceeds the fair
value of the asset or asset groups (assets to be held and used) or fair value
less cost to sell (assets to be disposed of). All of our impairments relate
primarily to the isolated write-off of certain manufacturing equipment related
to abandoned projects. Since we periodically assess our product candidates and
make changes to product development plans, we incur impairment charges from time
to time which can fluctuate significantly from period to period.
The indefinite-lived intangible asset, the Primatene® trademark acquired in June
2008 , and goodwill are tested for impairment annually, in the fourth quarter, or
more frequently if indicators of impairment are present. An impairment loss is
recorded if the asset's fair value is less than its carrying value. We also
periodically review the Primatene® trademark to determine if events and
circumstances continue to support an indefinite useful life. When we choose to
perform a qualitative assessment, we evaluate economic, industry and
company-specific factors as an initial step. If we determine it is more likely
than not that the Primatene® trademark is impaired or the fair value of a
reporting unit is less than its carrying amount, further quantitative impairment
process is then performed; otherwise, no further testing is required. If the
life is no longer indefinite, the asset is tested for impairment, and the
carrying value, after recognition of any impairment loss, is amortized over its
remaining useful life. No impairment of indefinite-lived intangible asset and
goodwill was recorded during the years ended December 31, 2022 , 2021, or 2020,
respectively.
Deferred Income Taxes
We utilize the liability method of accounting for income taxes under which deferred taxes are determined based on the temporary differences between the financial statements and the tax basis of assets and liabilities using enacted tax rates. A valuation allowance is recorded when it is more likely than not that the deferred tax assets will not be realized. A number of years may elapse before an uncertain tax position for which we have established a tax reserve is audited and finally resolved. The number of years for which we can be subject to audit varies depending on the tax jurisdiction. While it is often difficult to predict the final outcome or the timing of the resolution of an audit, we believe that our reserves for uncertain tax benefits reflect the outcome of tax positions that is more likely than not to occur. The resolution of a matter could be recognized as an adjustment to our provision for income taxes and our effective tax rate in the period of resolution, and may also require a use of cash. Share-Based Compensation Options issued under our 2015 Equity Incentive Award Plan, or the 2015 Plan, and our Amended and Restated 2005 Equity Incentive Award Plan, or 2005 Plan, are granted at exercise prices equal to or greater than the fair value of the underlying common shares on the date of grant and vest based on continuous service. There have been no awards with performance conditions and no awards with market conditions. The options have a contractual term of five to ten years and generally vest over a three- to five-year period. We use the Black-Scholes option pricing model to determine the fair value of options awards. The Black-Scholes option pricing model has various inputs such as the common share price on the date of grant, exercise price, the risk-free interest rate, volatility, expected life and dividend yield, all of which are estimates. We used the risk free rate onU.S. Treasury securities at the time of grant for instruments with maturities commensurate with the expected term of the stock option. Our volatility estimate was based on the weighted average historical volatility of our stock price since IPO. Our dividend yield was assumed to be 0%, because we have no plans to pay dividends. We estimate the expected term of options with consideration of vesting date, contractual term, and historical experience for employee exercise and post-vesting employment termination behavior after our common stock has been publicly traded. The expected term of "plain vanilla" options is estimated based on the midpoint between the vesting date and the end of the contractual term under the simplified method. 93 Table of Contents The fair value of each share-based compensation award is amortized into compensation expense on a straight-line basis between the grant date for the option and the vesting date net of expected forfeitures. We estimate forfeitures at the time of grant and revise those estimates in subsequent periods if actual numbers differ from such estimates. The change of any of these inputs could significantly impact the determination of the fair value of our options as well as significantly impact our results of operations.
Recent Accounting Pronouncements
There have been no recent accounting pronouncements or changes in accounting
pronouncements during the year ended
Off Balance Sheet Arrangements
We do not have any relationships or financial partnerships with unconsolidated entities, such as entities often referred to as structured finance or special purpose entities, which would have been established for the purpose of facilitating off balance sheet arrangements or other contractually narrow or limited purposes. In addition, we do not engage in trading activities involving non-exchange traded contracts.
Government Regulation
Our products and facilities are subject to regulation by a number of federal and state governmental agencies. The FDA in particular, maintains oversight of the formulation, manufacture, distribution, packaging, and labeling of all of our products. TheDrug Enforcement Administration , or DEA, maintains oversight over our products that are considered controlled substances. FromMay 17 through May 25, 2022 , our IMS facility inSouth El Monte, California was subject to routine cGMP inspection by the FDA. The inspection included a review of compliance with FDA regulations relating to Good Manufacturing Practices. The inspection resulted in one observation on Form 483. We responded to that observation. We believe that our response to the observation will satisfy the requirements of the FDA and that no significant further actions will be necessary.
From
OnJune 21, 2022 , our IMS facility inSouth El Monte, California was subject to routine inspection by the DEA. The inspection included a review of manufacture, storage and handling of our controlled substances. The inspection resulted in no findings. No further actions will be necessary. FromJuly 18 through July 21, 2022 , our Amphastar facility inRancho Cucamonga, California was subject to a remote pre-approval inspection by the FDA. The inspection included a review of the analytical clinical trial sample testing data to support one of our pending applications. The inspection resulted in no Form 483 findings. No further actions will be necessary. FromNovember 22 through November 25, 2022 , our AFP facility inFrance was subject to a GMP inspection from ANSM, theFrench Health Authority . The inspection included a review of compliance with French regulations relating to Good Manufacturing Practices. The inspection resulted in three observations that were provided during the inspection. A final report from ANSM is forthcoming at which time we will provide a response. 94
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