About Antares Pharma

Antares Pharma, Inc. operates as a specialty pharmaceutical company that focuses primarily on the development and commercialization of pharmaceutical products and technologies that address patient needs in targeted therapeutic areas. The company has a portfolio of proprietary and partnered commercial products and ongoing product development programs in various stages of development. It has formed partnership arrangements with different pharmaceutical companies. Technology and Product Platforms Encompassing a variety of sizes and designs, the company’s technology operates by using pressure to force the drug, in solution or suspension, through the skin and deposits the drug into the subcutaneous or intramuscular tissue. The company has designed disposable, pressure assisted auto injector devices to address acute and chronic medical needs, such as rheumatoid arthritis and psoriasis, allergic reactions, migraine headaches, testosterone deficiency and maternal health. The company’s platforms include the VIBEX and the VIBEX QuickShot disposable pressure assisted auto injection systems, the Vai auto injector and disposable pen injection systems. VIBEX Auto Injectors The company’s proprietary VIBEX disposable auto injector systems combine a spring-based power source with a shielded needle, which delivers the needed drug solution subcutaneously or intramuscularly. To minimize the anxiety and perceived pain associated with injection-based technologies, the VIBEX system features a triggering collar that shields the needle from view. The patented retracting collar springs back and locks in place as a protective needle guard after the injection, making the device safe for general disposal. The primary goal of the VIBEX disposable pressure assisted auto injector is to provide a method of self-injection. This device is designed around conventional single dose pre-filled syringes, which is a primary drug container, offering ease of transition for potential pharmaceutical partners. The company’s proprietary product OTREXUP (product line, excluding the New Drug Application (NDA), sold to Otter (Otter Pharmaceuticals, LLC (a wholly-owned subsidiary of Assertio Holdings, Inc., together with Assertio Holdings, Inc., as guarantor, individually and collectively referred to as ‘Otter’) in December 2021) uses the VIBEX auto injector system for the delivery of methotrexate. The company also has two license agreements with Teva Pharmaceutical Industries, Ltd. (Teva) for its VIBEX system, one for Teva’s generic epinephrine auto injector and the other for its Sumatriptan Injection USP. VIBEX QuickShot Auto Injectors An advancement of the company’s proprietary line of VIBEX auto injectors is the VIBEX QuickShot auto injector system, which offers a dose capacity of 1 mL or greater in a compact design. VIBEX QuickShot achieves these advancements by incorporating a novel triggering mechanism and space-saving spring configuration. The design also accommodates the injection of highly viscous drug products that less-powerful conventional auto injectors are typically unable to deliver. Many self-injectable drugs that are marketed or in clinical development are of higher viscosity and are formulated to be administered in a 1 mL dose volume. The company’s proprietary product XYOSTED, and the Makena subcutaneous auto injector that the company developed with its partner Covis (Covis Group S.a.r.l. (CG), which acquired AMAG Pharmaceuticals, Inc. (AMAG) (collectively CG and AMAG are herein after referred to as ‘Covis’)), were developed using the VIBEX QuickShot auto injector platform. The company also has a development agreement with Pfizer Inc. (Pfizer) to develop a rescue pen utilizing its VIBEX QuickShot auto injector system with an undisclosed Pfizer drug. In addition, the company has a development agreement with Idorsia Pharmaceuticals Ltd (Idorsia) for a drug device combination product using a variation of its VIBEX QuickShot auto injector device with a new chemical entity selatogrel, which is being developed for the treatment of acute myocardial infarction. Vai Auto Injector The company developed the versatile Vai auto injector platform to meet evolving market needs. The Vai auto injector builds off the capabilities of the company’s VIBEX and QuickShot platforms adding automatic needle insertion, subcutaneous or intramuscular injections of up to 1 inch and delivered volumes of up to 2 mL. The Vai auto injector can accommodate 1 mL standard, 1 mL long, and 2.25 mL syringes. The auto-insert technology is intended to improve compliance for drug products requiring deep intramuscular injections. This device is convertible to different fill volumes and needle lengths and is designed specifically to meet the reliability requirements for emergency use applications, while maintaining the intuitive two-step process of administration of the QuickShot device. Pen Injector System The company’s multi-dose, disposable pen injector technology complements its portfolio of single-use pressure assisted auto injector devices. The disposable pen injector devices are designed to deliver drugs by injection through needles from multi-dose cartridges. Its disposable pen injectors are designed for chronic conditions, such as diabetes, which require daily injection of a product. Depending on dosage, the company’s pens can deliver up to thirty days of drug. It has licensed its pen injector device technology to Teva for two products in late-stage development, such as a multi-dose pen with teriparatide for the treatment of osteoporosis (a generic form of Forteo); and a multi-dose pen with exenatide for the treatment of diabetes (a generic version of BYETTA). In February 2022, Teva notified the company that it was terminating the exenatide program and related agreement due to a lack of commercial viability. The termination is effective August 23, 2022. Products The following includes the company’s approved and marketed commercial products, including proprietary and partnered products. XYOSTED (testosterone enanthate) Injection The company markets and sells in the U.S. its proprietary product XYOSTED (testosterone enanthate) injection for subcutaneous administration of testosterone replacement therapy (TRT) in adult males for conditions associated with a deficiency or absence of endogenous testosterone. XYOSTED is the U.S. Food and Drug Administration (FDA) approved subcutaneous testosterone enanthate product for once-weekly, at-home self-administration and is approved and marketed in three dosage strengths, 50 mg, 75 mg and 100 mg. XYOSTED provides a pain-free administration, low risk of transference and the ability to achieve and maintain steady levels of testosterone. OTREXUP (methotrexate) Injection Prior to December 2021, the company marketed and sold in the U.S. its proprietary product OTREXUP (methotrexate) injection. OTREXUP is a subcutaneous methotrexate injection for once weekly self-administration with a single dose, disposable auto injector, indicated for adults with severe active rheumatoid arthritis (RA), children with active polyarticular juvenile idiopathic arthritis and adults with severe recalcitrant psoriasis. In December 2021, the company sold certain assets used in the operation of the OTREXUP product to Otter under an Asset Purchase Agreement, subject to the finalization of changes in closing inventory to be transferred. Pursuant to a separate supply agreement, Otter is responsible for supplying the pre-filled syringe of methotrexate and the company will continue to manufacture and oversee the assembly and packaging of the final product, which is sold to Otter as a partnered product. Further, the company entered into a license agreement with Otter in which it granted Otter a worldwide, exclusive, fully paid-up license to certain patents relating to OTREXUP that may also relate to its other products for Otter to commercialize and otherwise exploit OTREXUP in the field as defined in the license agreement. The primary competitor in the RA market is Medexus Pharma, which markets and sells Rasuvo, a once-weekly, subcutaneous, single-dose auto-injector of methotrexate indicated for the treatment of rheumatoid arthritis, psoriasis and juvenile idiopathic arthritis (JIA), which is a direct competitor to OTREXUP. NOCDURNA (desmopressin acetate) Sublingual Tablets The company markets and sells NOCDURNA (desmopressin acetate) in the U.S., which is a sublingual tablet indicated for the treatment of nocturia due to nocturnal polyuria (NP) in adults who awaken at least two times per night to urinate. NOCDURNA is a sublingual tablet, marketed in two dosage strengths, which dissolves under the tongue without water and has been shown in clinical studies to reduce nighttime urination by nearly half (in patients who average three nighttime bathroom visits). The company licenses NOCDURNA from Ferring International Center S.A. and its affiliates (Ferring). It began detailing NOCDURNA with a soft launch in the fourth quarter of 2020 and reintroduced the product through a re-launch strategy to increase awareness and demand in the first quarter of 2021. Epinephrine Injection USP The company is the exclusive supplier of the device, which it developed, for Teva’s generic Epinephrine Injection USP products, indicated for the emergency treatment of severe allergic reactions, including those that are life threatening (anaphylaxis) in adults and certain pediatric patients. Teva’s Epinephrine Injection, utilizing the company’s patented VIBEX injection technology, was approved by the FDA as a generic drug product with an AB rating, meaning that it is therapeutically equivalent to the branded products EpiPen and EpiPen Jr and therefore, subject to state law, substitutable at the pharmacy. The company supplies the device and Teva is responsible for the drug, assembly and packaging, distribution and commercialization of the finished product, for which it also receives royalties on the Teva’s net sales. Epinephrine is used for the treatment of severe allergic reactions (anaphylaxis) to insect venom, foods, drugs and other allergens, as well as anaphylaxis to unknown substances or exercise-induced anaphylaxis. Viatris Inc.’s (Viatris’s) EpiPen, along with its own authorized generic of the product, continues to be the global market leader in the epinephrine auto injector market. Sumatriptan Injection USP The company, through its partner Teva, sells Sumatriptan Injection USP, indicated in the U.S. for the acute treatment of migraine headaches and cluster headache in adults. Sumatriptan Injection USP is a generic equivalent to Imitrex STATdose Pen, and available in the 4 mg/0.5 mL and 6 mg/0.5 mL single-dose pre-filled syringe auto-injectors. The company has a license, supply and distribution agreement with Teva, under which Teva is responsible for the manufacture and supply of the drug, and the company manufactures the device and complete assembly and packaging of the finished product. Teva is responsible for commercialization and distribution. Makena (hydroxyprogesterone caproate injection) Subcutaneous Auto Injector The company is the exclusive supplier of the device, a variation of its VIBEX QuickShot subcutaneous auto injector developed by it, for the progestin hormone drug Makena (hydroxyprogesterone caproate injection). The Makena subcutaneous auto injector drug-device combination product is a ready-to-administer treatment indicated to reduce the risk of preterm birth in women pregnant with one baby and who spontaneously delivered one preterm baby in the past. The product was approved by the FDA under the accelerated approval pathway. The company is the exclusive supplier of the devices and the final assembled and packaged commercial product. Makena is a progestin that belongs to a class of drugs called progestogens. In October 2019, Covis announced that the FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee met to understand and interpret the PROLONG (Progestin’s Role in Optimizing Neonatal Gestation) confirmatory clinical trial for Makena (hydroxyprogesterone caproate) injection. Nine advisory committee members voted to recommend that the FDA pursue withdrawal of approval for Makena and seven committee members voted to leave the product on the market under accelerated approval and require a new confirmatory trial. In October 2020, Covis received notice that the FDA is proposing to withdraw approval of Makena (hydroxyprogesterone caproate injection). In August 2021, Covis announced the FDA had granted the request for a public hearing. A date for such meeting has not been set or announced by either the FDA or Covis. Teriparatide Injection The company is the exclusive supplier of the multi-dose pen, which it developed, used in Teva’s generic teriparatide injection product. In 2020, its partner Teva launched Teriparatide Injection, the generic version of Eli Lilly’s branded product Forsteo featuring the company’s multi-dose pen platform, for commercial sale in several countries outside of the U.S. Under an exclusive development, license and supply agreement with Teva, the company is responsible for the manufacturing and supply of the multi-dose pen used in Teva’s generic teriparatide product and Teva is responsible for the sale and distribution of the product. The company is compensated for devices sold to Teva and is entitled to receive royalties on net product sales by Teva in the territories. Teriparatide is used for the treatment of osteoporosis in postmenopausal women and men at increased risk of fracture and for glucocorticoid induced osteoporosis in men and women. Products with Tentative Approval The following includes the company’s products with tentative approval from the FDA. TLANDO (testosterone undecanoate) Oral Formulation TLANDO (testosterone undecanoate) is a twice daily oral formulation of testosterone for testosterone replacement therapy (TRT) indicated for conditions associated with a deficiency or absence of endogenous testosterone, or hypogonadism in adult males. TLANDO was granted tentative approval from the FDA in December 2020 and will be eligible for final approval and marketing in the U.S. upon expiration of the exclusivity period previously granted to Clarus for JATENZO on March 27, 2022. In February 2022, the company announced the FDA’s acceptance of its NDA resubmission for TLANDO in which the FDA designated the NDA as a Class 1 resubmission with a two-month review goal period and set a target action date of March 28, 2022. The company continues to prepare for the launch of TLANDO in 2022 pending final FDA approval after the expiration of JATENZO’s exclusivity period. ATRS - 1901 The company has initiated the development of a proprietary drug device combination product for the urology oncology market, identified as ATRS-1901, and conducted formulation development work and non-clinical studies to help advance this program. In 2020, it received a response from the FDA regarding its pre-IND (Investigational New Drug) submission. Its pre-clinical safety studies are ongoing. ATRS – 1902 The company has identified a program to develop a proprietary drug device combination product for the endocrinology market, an adrenal crisis pen, identified as ATRS-1902. The development program supports a proposed indication for the treatment of acute adrenal insufficiency, known as adrenal crisis, in adults and adolescents, using a novel proprietary auto-injector platform to deliver a liquid stable formulation of hydrocortisone. It has conducted initial formulation work and developed a working prototype of a new device to support this program. In June 2021, the company submitted an IND application with the FDA for the initiation of a Phase 1 clinical study of ATRS-1902 for adrenal crisis rescue. The IND application includes the protocol for an initial clinical study to compare the pharmacokinetic profile of its novel formulation of hydrocortisone versus Solu-Cortef, which is an anti-inflammatory glucocorticoid and is the current standard of care for the management of acute adrenal crises. In July 2021, the FDA accepted the company’s IND for ATRS-1902 enabling it to initiate its Phase 1 clinical study. The Phase 1 clinical study designed to evaluate the safety, tolerability and pharmacokinetics (PK) of a liquid stable formulation of hydrocortisone was initiated in September 2021. The study is a cross-over design to establish the PK profile of ATRS-1902 (100 mg). After this study is completed, the company expects to conduct a bioequivalence study and second human factor study utilizing its proprietary auto-injector technology. In January 2022, the company announced the positive results from the Phase 1 clinical study and were granted Fast Track designation by the FDA. The positive results support the advancement of its ATRS-1902 development program to a pivotal study for the treatment of acute adrenal insufficiency, known as adrenal crisis, using its Vai novel proprietary rescue pen platform to deliver a liquid stable formulation of hydrocortisone. The company anticipates starting this pivotal study in adults in the second quarter of 2022 and expects to submit a 505(b)(2) NDA with the FDA by the end of 2022 pending the success of the study, a further human factors study and confirmation of the product stability from its ongoing stability program. ATRS-1903 The company has initiated the development of a proprietary drug device combination product utilizing its rescue pen technology for a rare immunology disorder, identified as ATRS-1903. Formulation development work has been conducted and the company anticipates progressing this towards initial clinical testing to evaluate pharmacokinetics (PK) and tolerability in human subjects. Additional Development Programs The company continues to pursue and evaluate other potential new products and product extensions that address patient needs primarily in targeted therapeutic areas. It explores new development opportunities, including innovative delivery technologies and improved formulations of existing therapeutics. Partnered Development Projects The company, in collaboration with its pharmaceutical partners, engages in research and development activities utilizing its auto injectors and disposable pen injectors. The development programs typically consist of determination of the device design, the development of prototype tooling, the production of prototype devices for testing and clinical studies, and the development of commercial tooling and assembly. The following includes the development stages for select partnered products in development: Pen Injector with Teriparatide The company is developing with Teva, under a license, development and supply agreement, a multi-dose disposable pen injector device with teriparatide for the treatment of osteoporosis. Teva is working toward a regulatory approval with the FDA for a generic version of Forteo (teriparatide rDNA origin injection) using the abbreviated new drug application (ANDA) pathway. Pen Injector with Exenatide The company was developing with Teva a multi-dose pen injector device for use with a generic form of BYETTA (exenatide injection) for the treatment of diabetes. Teva was working through the U.S. regulatory approval process for its exenatide pen using the ANDA pathway. In February 2022, Teva notified the company that it was terminating the exenatide program and related agreement due to a lack of commercial viability. The termination is effective August 23, 2022. Rescue Pen (Drug Undisclosed) In 2018, the company entered into a development agreement with Pfizer and began developing a combination drug device rescue pen. This rescue pen will use the company’s QuickShot auto injector and an undisclosed Pfizer drug. In 2021, the company continued to work on this development program, and it expects to continue the development of this product candidate. Rescue Device with Selatogrel In November 2019, the company entered into a new global agreement with Idorsia to develop a novel, drug-device product, including selatogrel. A new chemical entity, selatogrel, is being developed for the treatment of a suspected acute myocardial infarction (AMI) in adult patients with a history of acute myocardial infarction (AMI). Idorsia will pay for the development of the combination product and will be responsible for applying for and obtaining global regulatory approvals for the product. The parties intend to enter into a separate commercial license and supply agreement pursuant to which it will provide fully assembled and labelled product to Idorsia at cost plus mark-up. Idorsia will then be responsible for global commercialization of the product, pending FDA or foreign approval. The company will be entitled to receive royalties on the net sales of the commercial product. In 2020, the company completed the initial design phase of the selatogrel device and Idorsia conducted a clinical bridging study utilizing these devices. The company completed the usability and reliability studies for the device, which has been tailored for emergency use ahead of the Phase 3 study. Subcutaneous administration of selatogrel 8 mg and 16 mg has demonstrated a rapid onset of action, within 15 minutes, with the height of its effect extending over 4-8 hours, depending on the dose. Selatogrel was tolerated in both studies and there were no treatment-emergent serious bleeds. In December 2020, the FDA designated Idorsia’s investigation of selatogrel for the treatment of a suspected AMI in adult patients with a history of AMI as a ‘fast-track’ development program. This designation is intended to promote communication and collaboration between the FDA and pharmaceutical companies for drugs that treat serious conditions and fill an unmet medical need. In June 2021, Idorsia announced they initiated its Phase 3 registration study to evaluate the efficacy and safety of self-administered subcutaneous selatogrel, Idorsia’s P2Y12 receptor antagonist, in suspected AMI using the company’s QuickShot auto-injector. The study is an international, multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to assess the clinical efficacy and safety of 16 mg of selatogrel when self-administered (on top of standard-of-care) upon occurrence of symptoms suggestive of an acute myocardial infarction. The primary efficacy endpoint is the occurrence of death from any cause, or non-fatal AMI after any study treatment self-administration. Strategy The company’s strategy is to grow the business through targeted investments in internal and partnered product development and other corporate opportunities, as well as leverage its commercial infrastructure, primarily focused in certain therapeutic areas. An important part of the company’s growth strategy is its continued investment in its evolving research and development activities and new product pipeline. Manufacturing This segment includes a summary of the company’s key production, manufacturing, assembly and packaging arrangements with third-party manufacturers for products commercialized by the company and its partners: The company has contracted with Phillips-Medisize Corporation (Phillips), an international outsource provider of design and manufacturing services, to produce commercial quantities of its QuickShot auto injector device for XYOSTED, its QuickShot auto injector device for the Makena product with Covis, and its VIBEX epinephrine auto injector product with Teva. The company uses ComDel Innovation, Inc. (ComDel), a domestic provider of integrated solutions for product development, tooling, and manufacturing, to provide manufacturing services for the VIBEX sumatriptan auto injector product and for the teriparatide pen product with Teva. The company has contracted with Jabil Healthcare, an international manufacturing development company to supply commercial quantities of its VIBEX auto injector device for the OTREXUP product for Otter and the VIBEX epinephrine auto injector product with Teva. The company has contracted with Fresenius Kabi to supply commercial quantities of pre-filled syringes of testosterone for XYOSTED. The company has contracted with Ferring for the commercial supply of NOCDURNA. The company uses Sharp Corporation (Sharp), an international contract packaging company, to assemble and package XYOSTED, Sumatriptan Injection USP and the Makena auto injector products, and the OTREXUP auto injector product for Otter. The following includes the company’s key production, manufacturing, assembly and packaging arrangements with third-party manufacturers for TLANDO: The company uses Pfizer to supply the active pharmaceutical ingredient (API). The company has contracted with NextPharma, an international pharmaceutical manufacturing company, to supply the bulk capsule product. The company uses PCI Pharma Services (PCI), an international contract packaging company, to assemble and package TLANDO. Commercial Operations The company has built an internal commercial organization, including specialty sales representatives, management and support staff, to market and sell its proprietary products XYOSTED, OTREXUP and NOCDURNA in the U.S. As of December 2021, commercialization and distribution of OTREXUP is the responsibility of Otter in accordance with the Asset Purchase Agreement. The company has entered into agreements with vendors for certain commercialization services, such as third-party logistics, distribution, data analytics and claims processing. It has and may continue to enter into licensing and or additional distribution arrangements for the commercialization of its products outside the U.S. Distribution The company has contracted with a third-party logistics provider, Cardinal Health 105, Inc., also known as Specialty Pharmaceutical Services (Cardinal), for key services related to logistics, warehousing and inventory management, distribution, contract administration and chargeback processing, accounts receivable management and call center management. It also uses a division of Cardinal for sample administration. In addition, the company uses third parties to perform various other services for it relating to regulatory monitoring, including adverse event reporting, safety database management and other product maintenance services. Trade The company contracts with numerous wholesale distributors, including Cardinal, McKesson Corporation (McKesson) and AmerisourceBergen Corporation to distribute its proprietary products to retail pharmacies, as well as the Veterans Administration and other governmental agencies. In addition to shipping its product, these distributors provide inventory and sales reports, as well as other services. The company has also contracted with several specialty pharmacies to support fulfillment of certain prescriptions. International Distribution The company is contracting with a third-party logistics provider, Cardinal, for key services related to logistics, warehousing and inventory management, international shipping, export and customs administration to support its international distributor, Lunatus. It entered into an exclusive distribution agreement with Lunatus in August 2020 to distribute and promote the sale of XYOSTED in Saudi Arabia and the United Arab Emirates. Lunatus is responsible for obtaining regulatory approval and, assuming approval, for the promotion and commercialization of the product in the territories. Sales, Marketing & Distribution of Partnered Products Epinephrine Injection USP: The company is the exclusive supplier of the device used in Teva’s epinephrine injection product. It receives payment for each device sold to Teva and royalties on the Teva’s commercial sales of the product. Teva’s epinephrine injection was approved as a generic drug product with an AB rating, meaning that it is therapeutically equivalent to Viatris Inc.’s branded products EpiPen and EpiPen Jr and therefore, subject to state law, is substitutable at the pharmacy. Teva is solely responsible for the commercialization and distribution of the finished product. Makena Subcutaneous Auto Injector: The company is the exclusive supplier of the device used in the Makena subcutaneous auto injector. It receives payment for each device sold to Covis and royalties on the Covis’ commercial sales of the product. Covis primarily sells Makena to specialty pharmacies, specialty distributors, home infusion companies and pharmacies which, in turn, sell Makena to healthcare providers, hospitals, government agencies and integrated delivery systems. Covis is solely responsible for the commercialization and distribution of the finished product. Sumatriptan Injection USP: The company is the exclusive supplier of the product containing sumatriptan, which is commercialized by Teva. Teva is solely responsible for commercialization and distribution of the finished product. Teriparatide Injection: The company is the exclusive supplier of the pen injection device used in Teva’s Teriparatide Injection product outside the U.S. Teva launched its generic version of Forsteo in certain territories outside the U.S. in 2020. The company receives payment for each device sold to Teva and royalties on the Teva’s commercial sales of the product in the territories. Teva is solely responsible for the commercialization and distribution of the finished product. OTREXUP (methotrexate) Injection: Pursuant to the Asset Purchase Agreement, license agreement and supply agreement, the company is the exclusive supplier of the device used in OTREXUP beginning in December 2021. The company receives payment for each device sold to Otter. Otter is solely responsible for the commercialization and distribution of the finished product. Lipocine Agreement In October 2021, the company entered into an exclusive license agreement with Lipocine Inc. (Lipocine) for the product TLANDO (testosterone undecanoate) in the U.S., a twice-daily oral formulation of testosterone for testosterone replacement therapy indicated for conditions associated with a deficiency or absence of endogenous testosterone, or hypogonadism in adult males. TLANDO was granted tentative approval from the FDA in December 2020 and will be eligible for final approval and marketing in the U.S. upon expiration of the exclusivity period previously granted to Clarus Therapeutics, Inc. (Clarus) for JATENZO in March 2022. In February 2022, the company announced the FDA’s acceptance of its NDA resubmission for TLANDO with a target action date set for March 28, 2022. The company continues to prepare for the launch of TLANDO in 2022 pending final FDA approval after the expiration of JATENZO’s exclusivity period. The company will be responsible for the manufacturing and commercialization of TLANDO. The license agreement also grants the company the option to license and develop LPCN 1111 (TLANDO XR) in the U.S., a potential once daily oral testosterone product, including testosterone tridecanoate in development for the treatment of hypogonadism in adult males. Results of the Phase 2b study for TLANDO XR met its primary endpoints, including identifying the dose expected to be tested in a Phase 3 study. TLANDO XR was tolerated with no drug-related severe or serious adverse events reported and the target Phase 3 dose also met its primary and secondary endpoints in the Phase 2b study. TLANDO XR is an investigational drug, including tridecanoate and has not been approved by the FDA, nor has the name been approved. In addition, the company will be responsible for completing the development program, including the conduct of a Phase 3 clinical trial and applying for regulatory approval in the U.S. Seasonality Customer purchases have historically been lower in the first quarter (year ended December 2021) of the year due to the resetting of high-deductible health insurance plans. Intellectual Property, Patents, Trade Secrets and Proprietary Information The company holds a portfolio of patents with expirations ranging from 2021 to 2038, and numerous patent applications pending in the U.S. and other countries. These patents consist primarily of design, formulation and method-of-use patents. Regulation For its products and product candidates, the company must ensure they are manufactured in accordance with FDA’s current Good Manufacturing Practices (cGMPs) for drug products and FDA’s current Quality System Regulations (QSRs) for medical devices and equivalent provisions in the European Union (EU) and elsewhere, which are required as part of the overall obligations necessary. Any potential products discovered, developed and manufactured by the company or its collaborative partners must comply with comprehensive regulation by the FDA in the U.S. and by comparable authorities in other countries. Certain of the company’s drug products are considered ‘controlled substances’ as defined in the Controlled Substances Act (CSA) and implementing regulations, which, depending on the controlled substance schedule, establish certain registration, security, monitoring, reporting, storage, distribution, importation, inventory, quota, record keeping, prescribing, dispensing, and other requirements administered by the Drug Enforcement Agency (DEA). The company’s Minneapolis Quality Management System has ISO 13485: 2003 certification, the medical device industry standard for its quality systems. The Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, which the company refers to together as the Healthcare Reform Act, expanded healthcare coverage within the U.S., primarily through the establishment of state insurance exchanges and the expansion of the Medicaid program. In addition to regulations enforced by the FDA, the company must comply with regulations under the Occupational Safety and Health Act, the Environmental Protection Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act and other federal, state and local regulations. Competition The company’s competitors include established specialty pharmaceutical companies, major brand name and generic manufacturers of pharmaceuticals, such as Teva, Viatris, Eli Lilly and Endo International plc (Endo). The company’s competitors also include third party contract medical device design and development companies, such as Scandinavian Health Ltd.; Ypsomed AG; West Pharmaceutical; and Owen Mumford Ltd. History Antares Pharma, Inc. was incorporated in 1979.