What changed in this filing

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Item 1. Business

2022-03-15 compared with 2021-03-11 · 85 added, 85 removed, 243 unchanged (41% of the section changed)

ANI Pharmaceuticals, Inc.

and its consolidated subsidiaries, ANIP Acquisition Company and ANI Pharmaceuticals Canada Inc.

(together, “ANI,” the “Company,” “we,” “us,” or “our”) is an integrated specialty pharmaceutical company focused on delivering value to our customers by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceuticals.

We focus on niche and high barrier to entry opportunities including controlled substances, oncology products (anti-cancer), hormones and steroids, and complex formulations.

Our three pharmaceutical manufacturing facilities, of which two are located in Baudette, Minnesota and one is located in Oakville, Ontario, are together capable of producing oral solid dose products, as well as semi-solids, liquids and topicals, controlled substances, and potent products that must be manufactured in a fully-contained environment.

Through product launches, acquisitions of Abbreviated New Drug Applications (“ANDAs”), New Drug Applications (“NDAs”), product rights, and entry into agreements to obtain the distribution rights for various products, we have a commercial portfolio of 65 products as of December 31, 2020.

In addition, in January 2016, we acquired the Cortrophin gel and Cortrophin-Zinc NDAs.

We continue to focus on the re-commercialization of these products while increasing our portfolio of generic and mature brand products.

and its consolidated subsidiaries (together, “ANI,” the “Company,” “we,” “us,” or “our”) is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceuticals, including for diseases with high unmet medical need.

Our team is focused on delivering sustainable growth by building a successful Purified Cortrophin Gel franchise, strengthening our generics business with enhanced development capability, innovation in established brands and leveraging our North American manufacturing capabilities.

Our four pharmaceutical manufacturing facilities, of which two are located in Baudette, Minnesota, one is located in East Windsor, New Jersey, and one is located in Oakville, Ontario, are together capable of producing oral solid dose products, as well as semi-solids, liquids and topicals, controlled substances, and potent products that must be manufactured in a fully-contained environment.

Through research and development, acquisitions of businesses, acquisitions of Abbreviated New Drug Applications (“ANDAs”), New Drug Applications (“NDAs”), product rights, and entry into agreements to obtain the distribution rights for various products, we have a commercial portfolio of 101 products with a wide variety of indications and a robust portfolio of pipeline products as of December 31, 2021.

Refer to our website at www.anipharmaceuticals.com for information on our products, including indications/treatments.

On August 6, 2018, our subsidiary, ANI Pharmaceuticals Canada Inc.

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In conjunction with the transaction, we acquired WellSpring’s pharmaceutical manufacturing facility, laboratory, and offices, its current book of commercial business, as well as an organized workforce.

Unless otherwise required by the context, references in this Annual Report on Form 10-K to the "Company,"

"we,"

and "our"

refer to ANI Pharmaceuticals, Inc., a Delaware corporation formed in April 2001.

On November 19, 2021, we completed the acquisition of Novitium Pharma LLC (“Novitium”).

With operations in East Windsor, New Jersey, and Chennai, India, Novitium is a pharmaceutical company that specializes in development, manufacturing, and distribution of niche generic products.

Founded in 2016, Novitium has since developed a growing commercial product portfolio spanning a diverse range of dosage forms and therapeutic categories.

Unless otherwise required by the context, references in this Annual Report on Form 10-K to the “Company,” “we,” “us,” and “our” refer to ANI Pharmaceuticals, Inc., a Delaware corporation formed in April 2001.

Our principal executive offices are located at 210 Main Street West, Baudette, Minnesota, 56623, our telephone number is (218) 634-3500, and our website address is www.anipharmaceuticals.com.

Our objective is to build a sustainable and growing biopharmaceutical company serving patients in need and creating long-term value for our investors.

Our objective is to build a sustainable and growth oriented biopharmaceutical company serving patients in need and creating long-term value for our investors.

Our growth strategy is driven by the following key pillars:

Building a successful Cortrophin Gel franchise.

We acquired the NDAs for Cortrophin gel and Cortrophin-Zinc in January 2016;

executed long-term supply agreements with a supplier of our primary raw material for corticotrophin active pharmaceutical ingredient (“API”), a supplier of corticotrophin API with whom we have advanced the manufacture of commercial scale batches of API, and a Cortrophin gel fill/finish contract manufacturer.

In April 2020, the FDA issued a Refusal to File (“RTF”) letter for our Supplemental New Drug Application (“sNDA”) for Cortrophin Gel.

Currently, our efforts are focused on the preparation of a complete resubmission of sNDA.

We have retained a prominent regulatory consulting firm to support our efforts and augment the capabilities of our restructured internal Cortrophin development team.

Together, we have performed a comprehensive review of the original sNDA filing and prepared an internal gap assessment and execution plan to address these gaps.

Throughout, we have remained engaged with the FDA and plan to re-submit our supplemental NDA in the second quarter of 2021.

We have invested in leadership and expertise in the areas of commercialization of rare disease therapies to develop a launch strategy and commercial plan for this product.

We acquired the NDAs for Cortrophin gel and Cortrophin-Zinc in January 2016 and executed long-term supply agreements with a supplier of our primary raw material for corticotrophin active pharmaceutical ingredient (“API”), a supplier of corticotrophin API with whom we have advanced the manufacture of commercial scale batches of API, and a Cortrophin gel fill/finish contract manufacturer.

During the second quarter of 2021, we submitted a Supplemental New Drug Application (“sNDA”) to the FDA.

On October 29, 2021, the FDA approved the Company’s sNDA for Purified Cortrophin™ Gel (Repository Corticotropin Injection USP) for the treatment of certain chronic autoimmune disorders, including acute exacerbations of multiple sclerosis (“MS”) and rheumatoid arthritis (“RA”), in addition to excess urinary protein due to nephrotic syndrome.

Cortrophin Gel is an adrenocorticotropic hormone (“ACTH”), also known as purified corticotropin.

During 2021, we invested in leadership, expertise and infrastructure in the areas of commercialization of rare disease therapies and developed a launch strategy and commercial plan for this product.

In the fourth quarter of 2021 and first quarter of 2022, we hired a significant number of new employees and assembled and trained our rare disease field force.

On January 24, 2022, we announced the commercial launch of Cortrophin Gel in the U.S.

As a result of the build out of our rare disease team, our expenditures in support of these efforts are expected to materially increase in 2022 as compared to 2021.

Strengthening our generics business with enhanced research and development capability and increased focus on niche opportunities

We have grown our generics business through a combination of market share gains on existing products and new product launches.

We have also successfully acquired numerous ANDAs through asset acquisitions, including, most recently, the U.S.

portfolio of 23 generic products, including 10 commercial products at the time of the acquisition, from Amerigen Pharmaceuticals, Ltd.

We also focus on niche lower competition opportunities such as injectables and Paragraph IV filings.

Additionally, we will seek opportunities to enhance our research and development capabilities through strategic partnerships and acquisitions of businesses.

We have also successfully acquired numerous ANDAs through business and asset acquisitions, including, most recently, our acquisition of Novitium, including their portfolio of commercial and pipeline generic products, manufacturing and development facilities and expert workforce.

We have begun to increase our focus on niche lower competition opportunities such as injectables, Paragraph IV, and Competitive Generic Therapy designation filings.

Additionally, we will continue to seek opportunities to enhance our capabilities through strategic partnerships and acquisitions of assets and businesses.

Maximizing the value from our established brands through innovative “go-to-market” (“GTM”) strategies and continued programmatic acquisitions

We have acquired the NDAs for and market Atacand, Atacand HCT, Arimidex, Casodex, Lithobid, Vancocin, Inderal LA, Inderal XL, and InnoPran XL.

We have acquired the New Drug Applications (“NDAs”) for and market Atacand, Atacand HCT, Arimidex, Casodex, Lithobid, Vancocin, Inderal LA, Inderal XL, InnoPran XL, Oxistat, Veregen, and Pandel.

We are innovating in our GTM strategy through creative partnerships.

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Expansion of contract development and manufacturing organization (“CDMO”) business by leveraging our unique manufacturing capabilities

We built a CDMO business through our sites in Baudette and grew it through the acquisition of WellSpring Pharma Services Inc.

(“ANI Canada”).

We built a CDMO business through our sites in Baudette and grew it through the acquisition of Novitium and WellSpring.

Our North America based manufacturing and unique capabilities in high-potency, hormonal, steroid, and oncolytic products can be leveraged to expand our CDMO business.

The pillars of our strategy will be enabled by an empowered, collaborative, and purposeful team with high performance-orientation.

We will also retain our continued programmatic approach to inorganic growth initiatives.

The pillars of our strategy are enabled by an empowered, collaborative, and purposeful team with a high performance-orientation.

Product Development Considerations

We consider a variety of criteria in determining which products to develop or acquire, all of which relate to the level of potential competition and expected profitability upon product launch.

Below are the principal criteria we consider.

We consider a variety of criteria in determining which products to develop, all of which influence the level of competition upon product launch.

These criteria include:

● Formulation Complexity.

Our development and manufacturing capabilities enable us to manufacture pharmaceuticals that are difficult to produce, including highly potent, extended release, combination, and low dosage products.

This ability to manufacture a variety of complex products is a competitive strength that we intend to continue to leverage in selecting products to develop or manufacture.

This ability to manufacture a variety of complex products is a competitive strength that we intend to leverage in selecting products to develop or manufacture.

● Patent Status.

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● Manufacturing.

We generally seek to develop and manufacture products at our own manufacturing plants in order to optimize the utilization of our facilities, ensure quality control in our products, and maximize profit potential.

● Competition.

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A complete list of our generic and branded pharmaceutical products and descriptions is posted on our website, www.anipharmaceuticals.com.

In November 2021, we acquired Novitium which specializes in development, manufacturing, and distribution of niche generic products.

At the time of the acquisition, Novitium’s commercial portfolio consisted of 24 generic products.

In determining which products to pursue for development, we target products that are complex to manufacture and therefore have higher barriers to entry.

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Schedule II controlled substances are drugs considered to have a high abuse risk but that also have safe and accepted medical uses.

In addition to our four Schedule II products currently on the market, our pipeline includes two ANDAs in this market.

One of our manufacturing facilities in Baudette, Minnesota is licensed by the DEA for the manufacture of Schedule II controlled substances.

In addition to our Schedule II products currently on the market, our pipeline includes ANDAs in this market.

One of our manufacturing facilities in Baudette, Minnesota and our manufacturing facility in East Windsor, New Jersey is licensed by the DEA for the manufacture of Schedule II controlled substances.

Our manufacturing facility in Oakville, Ontario is licensed by Health Canada for the manufacture of Schedule II controlled substances.

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In particular, we are targeting products subject to priority review by the FDA, more specifically those with no blocking patents and no generic competition.

We currently have five oncology products on the market.

We currently have a variety of oncology products on the market.

Hormone and Steroid Drugs

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● The aging “baby boomer” population, of which women represent a majority, is expected to support continued growth in the HT market.

Our burgeoning injectable portfolio contains five injectable ANDA products encompassing several key therapeutic areas.

Additionally, Cortrophin Gel would be our first branded injectable product if we obtained approval for this product.

Our burgeoning injectable portfolio contains injectable ANDA products encompassing several key therapeutic areas.

Cortrophin Gel is our first branded injectable product.

We work with world-class manufacturing partners to support these efforts.

Complex Formulations

In addition to our 18 complex formulation products currently on the market, our pipeline includes 10 extended-release products and seven combination products.

We have a range of complex formulation products currently on the market and a pipeline that includes various extended-release products and combination products.

Competitive Generic Therapy

The FDA Reauthorization Act of 2017, or (“FDARA”), created a new pathway by which FDA may, at the request of the applicant, designate a drug with “inadequate generic competition” as a competitive generic therapy (“CGT”).

At the request of the applicant, the FDA may also expedite the review of an ANDA for a drug designated as a CGT.

Under the CGT pathway, the FDA provides a statutory provision for a 180-day exclusivity period for certain first to market applicants whose ANDA received a CGT designation.

Our Novitium subsidiary has developed a strong track record of obtaining CGT approvals and we expect to continue to develop generic drugs under the CGT pathway.

Contract Manufacturing

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Given our specialized manufacturing capabilities, we are focused on attracting niche contract manufacturing opportunities that offer high margins.

In conjunction with our acquisition of WellSpring Pharma Services Inc., we acquired WellSpring’s pharmaceutical manufacturing facility.

As a result of this transaction, we perform contract manufacturing in both our Baudette, Minnesota and Oakville, Ontario facilities.

In conjunction with our acquisitions of WellSpring and Novitium, we acquired WellSpring’s and Novitium’s pharmaceutical manufacturing facilities.

As a result of these transactions, we perform contract manufacturing in our Baudette, Minnesota, Oakville, Ontario, and East Windsor, New Jersey facilities.

Manufacturing, Suppliers, and Raw Materials

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While we also generally qualify a single source for non-API raw materials, the process required to qualify an alternative source of a non-API raw material is typically much less rigorous.

If we were to change the supplier of a raw material for a product, the cost for the material could be greater than the amount we paid

with the previous supplier.

If we were to change the supplier of a raw material for a product, the cost for the material could be greater than the amount we paid with the previous supplier.

Changes in suppliers are rare but could occur as a result of a supplier’s business failing, an issue arising from an FDA inspection, or failure to maintain our required standards of quality.

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Certain of the APIs for our drug products, including those that are marketed without approved NDAs or ANDAs, are sourced from international suppliers.

From time to time, we have experienced temporary disruptions in the supply of certain of such imported API due to FDA inspections.

From time to time, we have experienced temporary disruptions in the supply of certain of such imported API due to FDA inspections and customs delays.

In addition, certain of our products are manufactured, packaged, or manufactured and packaged by third parties.

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While we have experience with these regulations, there can be no assurance that we will be able to fully comply with all applicable regulations.

In April 2020, the FDA issued an RTF letter for our sNDA for Cortrophin Gel.

Since this time, our efforts have been focused on the preparation of a complete resubmission of the sNDA.

We immediately retained a prominent regulatory consulting firm to support our efforts and augment the capabilities of our internal Cortrophin development team.

In addition, we restructured the composition of the internal team.

We have performed a comprehensive review of the original sNDA filing and prepared an internal gap assessment and execution plan to address these gaps.

The resultant remediation activities are currently in-progress.

Branded and Generic Pharmaceutical Products

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Two of our products, EEMT and Opium Tincture, are marketed without approved NDAs or ANDAs.

Previously, the U.S.

Food and Drug Administrations (“FDA’s”) Unapproved Drug Initiative included publication of their policy with respect to the continued marketing of unapproved products in the September 2011 Compliance Policy Guide Sec.

440.100 titled “Marketed New Drugs without Approved NDAs or ANDAs.” Under this policy, the FDA had stated that it would follow a risk-based approach with regard to enforcement against marketing of unapproved products.

The guideline allowed the FDA to evaluate whether to initiate enforcement action on a case-by-case basis, while giving higher priority to enforcement action against products in certain categories, such as those with potential safety risks or that lack evidence of effectiveness.

In November 2020 (effective December 2020), the Department of Health and Human Services (“HHS”) published a notice in the Federal Register to terminate the FDA’s Unapproved Drug Initiative, which would include the withdrawal of this September 2011 Compliance Policy Guide.

Neither the HHS nor the FDA has provided any additional guidance, notice or statement regarding how they intend to approach enforcement against

marketing of unapproved products.

The FDA's policy with respect to the continued marketing of unapproved products appears in the FDA's September 2011

Compliance Policy Guide Sec.

440.100 titled “Marketed New Drugs without Approved NDAs or ANDAs.” Under this policy, the FDA has stated that it will follow a risk-based approach with regard to enforcement against marketing of unapproved products.

The FDA evaluates whether to initiate enforcement action on a case-by-case basis, but gives higher priority to enforcement action against products in certain categories, such as those with potential safety risks or that lack evidence of effectiveness.

We continue to believe that, so long as we comply with applicable manufacturing standards, the FDA will continue to operate on a risk-based approach and will not take action against us.

However, we can offer no assurance that the FDA will continue to follow this approach or that it will not take a contrary position with any individual product or group of products.

During the years ended December 31, 2020, 2019, and 2018, revenues for EEMT were 7%, 9%, and 11% of total revenue, respectively, and revenues from Opium Tincture were 1% of total revenue.

See “Risk Factors – Two of our products, which together comprised 7% of our total revenue in 2021, are marketed without approved NDAs or ANDAs and we can offer no assurances that the FDA will not require us to either seek approval for these products or withdraw them from the market.

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Medicaid and Medicare, both of which are U.S.

federal health care programs administered by CMS, are major purchasers of pharmaceutical products, including those we produce.

federal health care programs administered by CMS, are major payors of pharmaceutical products, including those we produce.

Medicaid is administered by the states and jointly funded by the federal and state governments.

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State drug coverage policies under Medicaid may vary significantly state by state.

The Patient Protection and Affordable Care Act (“PPACA”), as amended by the Health Care and Education and Reconciliation Act of 2010, together known as the Affordable Care Act ("ACA"), required states to expand their Medicaid programs to individuals with incomes up to 138% of the federal poverty level.

Although the United States Supreme Court in 2011 made the Medicaid expansion optional, many states are expanding their Medicaid programs.

The Patient Protection and Affordable Care Act (“PPACA”), as amended by the Health Care and Education and Reconciliation Act of 2010, together known as the Affordable Care Act (“ACA”), originally required states to expand their Medicaid programs to individuals with incomes up to 138% of the federal poverty level.

Although the United States Supreme Court in 2011 made the Medicaid expansion optional, many states have expanded their Medicaid programs.

The ACA also made changes to Medicaid law that has negatively impacted our business.

In particular, pharmaceutical manufacturers must enter into rebate agreements with state Medicaid agencies, which require manufacturers to pay rebates based on their drugs dispensed to Medicaid beneficiaries.

Pharmaceutical manufacturers that want their drug products covered by state Medicaid programs must enter into a rebate agreement with CMS and pay rebates to state Medicaid agencies on utilization of their drugs dispensed to Medicaid beneficiaries.

The ACA raised the rebate percentages for both generic and branded pharmaceuticals effective January 1, 2010.

The required rebate is currently 13% of the average manufacturer price for sales of Medicaid-reimbursed products marketed under ANDAs.

The basic rebate is currently 13% of the average manufacturer price for sales of Medicaid-reimbursed products marketed under ANDAs.

Sales of Medicaid-reimbursed products marketed under NDAs require manufacturers to rebate the greater of 23.1% of the average manufacturer price or the difference between the average manufacturer price and the “best price” (as defined in the Medicaid statute) during a specific period.

In addition, there is an additional rebate if the average manufacturer price of the drug is rising faster than inflation.

Federal and/or state governments may continue to enact measures aimed at reducing the cost of drugs to the Medicaid program.

Medicare is run by the federal government and is largely focused on the elderly and disabled.

The Medicare Modernization Act of 2003 (“MMA”) created Medicare Part D to provide prescription drug coverage for Medicare beneficiaries.

The MMA has increased usage of pharmaceuticals, a trend that we believe will continue to benefit the generic pharmaceutical industry.

The Medicare Modernization Act of 2003 (“MMA”) created Medicare Part D to provide voluntary prescription drug coverage for Medicare beneficiaries.

The MMA has increased the amount of reimbursement for pharmaceuticals, a trend that we believe will continue to benefit the generic pharmaceutical industry.

The ACA made some changes to Part D to make it easier for Medicare beneficiaries to obtain drugs, such as reducing coinsurance amounts.

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Under the Medicare Coverage Gap Discount Program, any pharmaceutical product marketed under an NDA, regardless of whether the product is marketed as a “generic,” is subject to the discount requirement.

Our Candesartan Hydrochlorothiazide, Fenofibrate, Fluvoxamine, Hydrocortisone Enema, Lithium Carbonate ER, Mesalamine, Propranolol ER, Terbutaline, and Vancomycin products, while marketed as “generics,” are marketed under approved NDAs and, therefore, are subject to the discount requirement.

Our Candesartan Hydrochlorothiazide, Fenofibrate, Fluvoxamine, Hydrocortisone Enema, Lithium Carbonate ER, Mesalamine, Propranolol ER, Terbutaline, and Vancomycin products, while marketed as “generics,” are sold under approved NDAs and, therefore, are subject to the discount requirement.

Since its enactment, there have been judicial, administrative, executive and Congressional legislative challenges to certain aspects of the ACA.

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Azar, which challenges the constitutionality of the ACA.

Pending resolution of the litigation, all of the ACA, except for the individual mandate to buy health insurance remains in effect.

Were the Supreme Court to invalidate the ACA, that could have far-reaching consequences of an uncertain nature for our industry.

However, the Biden administration and Democratically-controlled Congress are expected to take significant action to mitigate any ruling against the Affordable

Further, the administration and Congress are expected to take steps towards expanding health care coverage beyond the ACA, which could have ramifications for the pharmaceutical industry.

There are a number of additional bills pending in Congress and healthcare reform proposals at the state level that would affect drug pricing in the Medicare and Medicaid programs.

This changing federal landscape has both positive and negative impacts on the U.S.

healthcare industry with much remaining uncertain as to how various provisions of federal law, and potential modification or repeal of these laws, will ultimately affect the industry.

Most of our products are covered by Medicaid and Medicare.

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For example, there have been several recent Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drug products.

For example, the last Presidential administration released a “Blueprint”, or plan, to lower drug prices and reduce out of pocket costs of drugs that contains additional proposals to increase drug manufacturer competition, increase the negotiating power of certain federal healthcare programs, incentivize manufacturers to lower the list price of their products, and reduce the out of pocket costs of drug products paid by consumers.

For example, a recent Presidential administration released a “Blueprint”, or plan, to lower drug prices and reduce out of pocket costs of drugs that contains additional proposals to increase drug manufacturer competition, increase the negotiating power of certain federal healthcare programs, incentivize manufacturers to lower the list price of their products, and reduce the out of pocket costs of drug products paid by consumers.

At the state level, individual states are increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

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Patents, Trademarks, and Licenses

We own the trademark names for most of our branded products, including Cortenema, Cortrophin gel, Cortrophin-Zinc, Inderal LA, Inderal XL, InnoPran XL, Lithobid, Reglan, and Vancocin.

We license the trademark names for Atacand, Atacand HCT, Arimidex, and Casodex.

With the exception of a license for patent technology for InnoPran XL and Inderal XL, we do not own or license any patents associated with these products.

Further, patent protection and market exclusivity for these branded products have expired, with the exception of the InnoPran XL and Inderal XL products, which have market exclusivity until 2022.

We own the trademark names for most of our branded products, including Apexicon, Cortenema, Purified Cortrophin Gel, Cortrophin-Zinc, Inderal LA, Inderal XL, InnoPran XL, Lithobid, Reglan, Vancocin, and Veregen.

We license the trademark names for Atacand, Atacand HCT, Arimidex, Casodex, Oxistat, and Pandel.

With the exception of a license for patent technology for Inderal XL, InnoPran XL, and Veregen, we do not own or license any patents associated with these products.

Further, patent protection and market exclusivity for these branded products have expired, with the exception of the Veregen product, which has three patents that expire in 2022, 2025, and 2026.

Therefore, we consider the trademark names to be of material value and we act to protect these rights from infringement.

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We believe that sales of our branded products have benefited and will continue to benefit from the value of the product name.

In addition, we receive royalties from a license for patent rights initially owned by Cell Genesys, Inc., which merged with BioSante in 2009.

The royalties are received as a result of sales and milestones related to the Yescarta® product.

In 2020, we recorded $1.4 million of royalties related to the license of these patent rights.

We formerly received royalties from a license for patent rights initially owned by Cell Genesys, Inc., which merged with BioSante in 2009.

The royalties were received as a result of sales and milestones related to the Yescarta® product.

These royalties ceased after a final payment in 2021.

Description of Business and Summary of Significant Accounting Policies, in the notes to the consolidated financial statements in Part II, Item 8.

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As a result of these strategic partnerships between wholesalers and pharmacy chains, we have experienced, and expect to continue to experience, increases in net sales to the wholesalers, with corresponding decreases in net sales to the pharmacy chains.

In the rare disease business there is a limited distribution network and a select group of specialty pharmacies which can dispense product to appropriate patients.

We are in the process of contracting with largest health insurance payers across the appropriate channels and classes of trade.

Consistent with industry practice, we maintain a return policy that allows customers to return product within a specified period prior to and subsequent to the expiration date.

Generally, product may be returned for a period beginning six months prior to its expiration date to up to one year after its expiration date.

See "Management’s Discussion and Analysis of Results of Operations and Financial Condition—Critical Accounting Estimates"

for a discussion of our accruals for chargebacks, rebates, returns, and other allowances.

See “Management’s Discussion and Analysis of Results of Operations and Financial Condition—Critical Accounting Estimates” for a discussion of our accruals for chargebacks, rebates, returns, and other allowances.

Sales, Marketing, and Distribution

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● Group Purchasing Organizations.

We have contracts with group purchasing organizations in the United States, such as ClarusONE, Rx Sourcing Strategies, Walgreens Boots Alliance Development Group, Red Oak Sourcing, Premier Inc., Managed Health Care Associates Inc., Innovatix, MedAssets, Minnesota Multi-State, Optisource, The Premier Group, and Kaiser Permanente Purchasing Organization.

We have contracts with group purchasing organizations in the United States, such as ClarusONE, Walgreens Boots Alliance Development Group, Red Oak Sourcing, Econdisc, Optisource, Rx Sourcing Strategies, The Premier Group, Topco, The Buyer’s Consortium, Managed Health Care Associates Inc., Asembia, Premier Inc, and Kaiser Permanente.

Certain of our products face limited competition due to complexities in formulation, active pharmaceutical ingredient sourcing, materials handling and manufacturing, and regulatory hurdles.

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If competitors introduce new products with therapeutic or cost advantages, our products can be subject to progressive price reductions and/or decreased volume of sales.

Principal competitors for the pharmaceutical market in which we do business include Amneal Pharmaceuticals, Inc., Alvogen, Inc., Apotex Inc., Glenmark Pharmaceuticals Ltd, Hikma Pharmaceuticals plc, Method Pharmaceuticals, LLC, Mylan N.V., Par Pharmaceutical, Inc., Perrigo Company plc, Rising Pharmaceuticals, Inc., Sun Pharmaceutical Industries Ltd., and Teva Pharmaceuticals USA, Inc.

Principal competitors for the pharmaceutical market in which we do business include Amneal Pharmaceuticals, Inc., Alvogen, Inc., Apotex Inc., Glenmark Pharmaceuticals Ltd, Hikma Pharmaceuticals plc, Method Pharmaceuticals, LLC, Viatris Inc., Par Pharmaceutical, Inc., Perrigo Company plc, Rising Pharmaceuticals, Inc., Sun Pharmaceutical Industries Ltd., and Teva Pharmaceuticals USA, Inc.

Product Liability

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Human Capital

As of January 2021, we have 369 employees, of which 250 are located in the United States and another 119 are located in Canada.

We occasionally use a small number of part-time and consultant resources to meet our operational

needs and are generally not impacted by significant turnover year-to-year.

As of January 2022, we have 601 employees, of which 457 are located in the United States, 123 are located in Canada, and 21 are located in India.

We occasionally use a small number of part-time and consultant resources to meet our operational needs and are generally not impacted by significant turnover year-to-year.

We are committed to creating a diverse and inclusive work environment within all levels of the business.

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Our total compensation program includes competitive base salaries, comprehensive benefits, and employee equity programs.

and Canada facilities are committed to the safety and health of our employees, patient-customers and the general public.

Our U.S., Canada, and India facilities are committed to the safety and health of our employees, patient-customers and the general public.

It is critical within our mission to ensure we keep our employees and customers safe while accomplishing our business goals.

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and Canada facilities quickly responded to the COVID-19 pandemic by establishing a COVID-19 action plan to protect the health and safety of our employees as they performed their duties, as all of our facilities have remained open during the pandemic.

Measures include social distancing requirements, increased and expanded sanitation for both employees and our property, face covering requirements for employees and visitors, staggered work schedules to minimize contact, flexible and work-from-home schedules, and employee illness and exposure protocols.

Measures include social distancing requirements, increased and expanded sanitation for both employees and our property, staggered work schedules to minimize contact, flexible and work-from-home schedules, and employee illness and exposure protocols.

These measures also seek to comply with all county, state, province, and/or city mandates as they relate to COVID-19.

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“Management’s Discussion and Analysis of Financial Condition and Results of Operations” of this Annual Report on Form 10-K for further discussion.

Available Information

We file annual, quarterly and current reports, proxy statements and other information required by the Securities Exchange Act of 1934, as amended (the “Exchange Act”), with the Securities and Exchange Commission (“SEC”).

We make available free of charge on our website (www.anipharmaceuticals.com) our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, proxy statements and any amendments to those filings as soon as reasonably practicable after such material is electronically filed with or furnished to the SEC.

Also posted on our website in the “Investors – Corporate Governance” section are our Corporate Governance Guidelines, Code of Ethics and the charters for the Audit and Finance, Compensation, and Nominating and Corporate Governance Committees.

Information on, or accessible through, our website is not a part of, and is not incorporated into, this report or any other SEC filing.

Copies of our SEC filings or corporate governance materials are available without charge upon written request to Investor Relations, c/o ANI Pharmaceuticals, Inc., 210 Main Street West, Baudette, Minnesota, 56623.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business