About Societal CDMO

Societal CDMO, Inc. operates as a contract development and manufacturing organization (CDMO) providing development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market. The company is a bi-coastal contract development and manufacturing organization with capabilities spanning pre-investigational new drug development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms with a primary focus on small molecules. In addition to the company’s experience in handling the U.S. Drug Enforcement Agency (DEA)-controlled substances and developing and manufacturing modified-release dosage forms, it has the expertise to deliver on its clients’ pharmaceutical development and manufacturing projects, regardless of complexity level. The company does all of this in its three state-of-the-art facilities that, in the aggregate, total 145,000 square feet, in Gainesville, Georgia and San Diego, California. The company manufactures the following key products with its key commercial partners: Ritalin LA, Focalin XR, Verelan PM, Verelan SR, Verapamil PM, Verapamil SR and Donnatal liquids and tablets. It also supports numerous development stage products. The company’s manufacturing and development capabilities include product development from formulation through clinical trial and commercial manufacturing, and specialized capabilities for solid oral dosage forms, with specialization in modified release technologies and facilities to handle highly potent compounds and controlled substances, liposomes and nano/microparticles, topicals and oral liquids. In September 2022, the company announced a new state of the art, aseptic fill/finish and lyophilization suite in its San Diego facility to further its intention of offering end-to-end solutions to its clients. In addition to providing manufacturing capabilities, the company offers its customers clinical trial support, including over-encapsulation, comparator sourcing, packaging, labeling, storage and distribution. The company has a bi-coastal footprint from which to better serve clients within the U.S., as well as globally. In a typical collaboration between the company and its commercial partners, it continues to work with its partners to develop product candidates or new formulations of existing product candidates. The company also exclusively manufactures and supplies clinical and commercial supplies of these proprietary products and product candidates. Strategy The company’s strategy for growth in this market includes executing segment-specific sales and marketing strategies; building stronger visibility and an updated identity for the organization; and enhancing its customers’ experience working with and for the company. Services The company offers integrated solutions for formulation development, analytical method development, pharmaceutical manufacturing, regulatory support, and pharmaceutical packaging and logistics of both commercial and development stage products with a primary focus in the area of small molecules. The company’s facilities are located on both coasts of the United States and include: A 97,000 square foot manufacturing facility in Gainesville, Georgia that provides a full range of manufacturing capabilities from scale-up services to commercial manufacturing; A 24,000 square foot current Good Manufacturing Practices (cGMP) development and high-potency product facility in Gainesville, Georgia that focuses on development and clinical packaging; and A 24,500 square foot development facility in San Diego, California that focuses on development of advanced dosage forms (aseptic fill/finish, lyophilization and inhalation, etc.). The company’s end-to-end service capabilities allow its customers to start with it for early-phase projects and stay with it through late phase and commercial projects. Early-stage coordination with customers utilizing the company’s development and high-potency product facilities help assure streamlined technology transfer for final scale up and manufacturing at its commercial manufacturing site. The company’s capabilities include: Formulation Development: The company’s formulation services support the development of a range of pharmaceutical products and advanced dosage forms. The company has expertise in complex formulations, reformulation, physical characterization and excipient compatibility. It also conducts feasibility studies, identify critical variables and inefficiencies and optimize process. Analytical Methods Development: The company offers diverse analytical services designed to assess quality. Its advanced facilities offer a full range of analytical testing capabilities, including product testing, ICH stability, method development and validation, chromatography and spectroscopy equipment, stability chambers and microbial testing. Pharmaceutical Manufacturing: The company can serve clients from small, early-phase batches to clinical and commercial production. It offers structured tech transfer services and key technologies, including milling, blending, compression, spray and rotary granulation, particle and bead coating, encapsulation, liquids, lyophilization and sterile fill and finish. Regulatory Support: The company has extensive experience across all steps of the drug approval process. Its regulatory support services include handling communications with the U.S. Food and Drug Administration (FDA) on behalf of its sponsor companies and consultation and guidance for client FDA meetings and responses. The company utilizes industry best practices, including standardized reports for eCTD submission and pharmacovigilance reporting support. Pharmaceutical Packaging and Logistics: The company offers contract packaging and logistics to maintain the safety and integrity of its customers’ products. The company’s commercial-scale, single-line packaging operation has an annual maximum capacity of 2.5 million bottles per shift and can also serve late-phase clinical and development packaging needs. This line can package round or square bottles of various sizes and offers Drug Supply Chain Security Act, or DSCSA, compliant serialization services. The company also offers smaller-scale primary and secondary packaging, labeling and kitting options suited for clinical trial materials and development packaging needs across a wide range of dosage forms. Commercial Partners The company is party to agreements with each of its commercial partners governing the development, formulation and/or supply services it provides, as well as any applicable intellectual property licenses. Each commercial partner remains responsible for distributing, marketing and promoting their respective products. The company is dependent on a small number of commercial partners, with its four largest customers (Teva Pharmaceutical Industries, Inc., or Teva, Novartis Pharma AG, or Novartis, Lannett Company, Inc., or Lannett, and InfectoPharm Arzneimittel und Consilium GmbH, or InfectoPharm) having generated 77% of its revenues for the year ended December 31, 2022, of which Teva generated 34%, Novartis generated 18%, Lannett generated 16%, and InfectoPharm generated 9%. Agreements with Key Commercial Partners Teva The company is party to a License and Supply Agreement with Watson Laboratories, Inc., a subsidiary of Teva, or the Teva Agreement, pursuant to which it is the exclusive supplier of Verapamil SR to Teva. The company owns the authorized generic for Verapamil SR and, pursuant to the Teva Agreement, have granted Teva an exclusive license to commercialize and sell Verapamil SR in the United States. The Teva Agreement expires on December 31, 2024, after which it will renew for additional one-year periods unless terminated by either party. Under the Teva Agreement, Teva pays the company a share of profits on sales of Verapamil SR. Novartis The company is party to a Manufacturing and Supply Agreement with Novartis, or the Novartis Agreement, pursuant to which it continued its long-standing relationship with Novartis as the exclusive global supplier to Novartis of Ritalin LA and Focalin XR capsules. The Novartis Agreement has an original term expiring December 31, 2023, and will renew automatically thereafter for successive one-year periods unless terminated by either party at least 24 months prior. Lannett The company is party to a License and Supply Agreement with Kremers Urban Pharmaceutical, Inc., a subsidiary of Lannett, or the Lannett Agreement, pursuant to which it supplies Verelan PM and SR and Verapamil PM to Lannett. The company owns the new drug application, or NDA, related to Verelan and license commercialization rights to Lannett under the Lannett Agreement. The Lannett Agreement expires on December 31, 2024 and will renew thereafter for successive two-year periods. Under the Lannett Agreement, Lannett pays us a share of profits on sales of Verelan PM and SR and Verapamil PM. Additionally, the amendment awarded the company potential new GMP manufacturing agreements targeting injectable products for multiple additional Lannett development projects. Advanz The company is party to an Amended and Restated Manufacturing and Supply Agreement with AmdiPharm Ltd., a subsidiary of Advanz Pharma Corp, Ltd. (collectively Advanz), pursuant to which it continued its multi-year relationship as the exclusive supplier of Donnatal to Advanz for sale in the United States. Under the agreement, the company is Advanz's exclusive manufacturer of Donnatal and its authorized generic version until February 3, 2025. Both the company and Advanz may terminate this Agreement for any reason at any time by giving the other party not less than twenty-four months prior written notice. InfectoPharm The company is party to a Commercial Manufacturing and Supply Agreement with InfectoPharm Arzneimittel und Consilium GmbH, or InfectoPharm, pursuant to which it is the exclusive supplier to InfectoPharm of Ritalin LA capsules in Europe through December 31, 2023. The agreement has a term of three years, expiring April 30, 2025, and is subject to auto-renewal. Permits and Regulatory Approvals In particular, the company is subject to laws and regulations concerning research and development, testing, manufacturing processes, equipment and facilities, including compliance with cGMPs, labeling and distribution, import and export, and product registration and listing, and compliance with post-marketing reporting obligations. As a result, the company’s facilities are subject to regulation by the FDA, as well as regulatory bodies of other jurisdictions in which it operates. The company also holds cGMP certifications for the European Union (EU), importation of products made in Gainesville for sale in the EU and an ANVISA certification for sale in Brazil. The company holds the approved NDAs (New Drug Applications) for Verelan SR and Verelan PM, which it licenses to Lannett and Teva, respectively. Verapamil SR and Verapamil PM are authorized generics. Government Regulation Any drug products developed or manufactured by the company is subject to pervasive and continuing regulation by the FDA, including compliance with current Good Manufacturing Practices, or cGMP, which impose procedural and documentation requirements. Certain products that the company manufactures are regulated as ‘controlled substances’ as defined in the Controlled Substances Act of 1970, or CSA, which establishes registration, security, recordkeeping, reporting, storage, distribution and other requirements administered and enforced by the DEA. Certain of the products the company manufactures and/or develops are regulated as Schedule II controlled substances. Competition The company competes with other CDMOs, such as Adare Pharma Solutions, Aenova Alcami, Avara Pharmaceutical Services, Corden Pharma, CoreRx, Pharmaceutics International, Quotient Sciences and Recipharm, segments of larger companies, such as Patheon (a segment of ThermoFisher Scientific), Lonza and Catalent, as well as other development and manufacturing service providers. History The company was founded in 2007. It was incorporated under the laws of the Commonwealth of Pennsylvania in 2007. The company changed its name to Recro Pharma, Inc. in 2008. Further, the company changed its name to Societal CDMO, Inc. in March 2022.