Societal CDMO, Inc. - SCTL STOCK NEWS

Societal CDMO (SCTL) has announced a significant agreement to provide contract manufacturing services for a novel oral anti-viral drug candidate aimed at treating HIV. This partnership highlights the company’s position in the growing trend of onshoring contract manufacturing to the U.S. Under the agreement, Societal CDMO will perform technology transfer and cGMP manufacturing of clinical trial materials for upcoming Phase 2 studies in Europe. The firm continues to leverage its CDMO services to expand its market presence and support the drug development process.

Societal CDMO, Inc. (SCTL) announced an amendment to its agreement with Lannett for Verapamil PM and Verelan SR, increasing the profit share by 10% amid declining sales. The new terms also include scheduled increases in manufacturing prices and potential new GMP manufacturing agreements for injectable products. CEO David Enloe highlighted the collaborative effort with Lannett to enhance financial outcomes and explore new revenue streams through the partnership. The amendment aims to create a mutually beneficial relationship as Societal seeks to stabilize its financial results following a drop in sales.

Societal CDMO (SCTL) announced the hiring of new employees to fill various open roles. In connection with this, the board approved inducement stock option grants totaling 87,690 shares, aimed at incentivizing the new hires. These options are priced at the closing stock price on June 30, 2022, vesting over four years. The company specializes in providing comprehensive manufacturing solutions in small molecule therapeutic development, with facilities across the U.S.

Additionally, the press release includes a cautionary note on forward-looking statements and various operational risks.

Societal CDMO (NASDAQ: SCTL) announced a new project with a Japan-based biopharmaceutical company to support the clinical development of a novel cancer therapeutic. The project will utilize Societal's automated fill/finish line and lyophilization unit in San Diego for sterile GMP manufacturing. The company aims to enhance its revenue streams through these expanded capabilities, which include filling up to 2,000 vials per hour and lyophilization capacity for approximately 9,000 vials every 3-5 days.

Societal CDMO (SCTL) has been selected by AmyriAD Pharma for CDMO services supporting the clinical development of AD101, a novel treatment for Alzheimer’s disease, currently in Phase 3 trials. The contract, valued at nearly $1.0 million, includes clinical trial services such as packaging and distribution of the compound and its placebo. This collaboration highlights Societal's bi-coastal footprint, enhancing operational capabilities from its facilities in Georgia and California. The agreement signifies a critical growth opportunity for Societal's Clinical Trial Services segment.

Societal CDMO (SCTL) has announced participation in three upcoming investor conferences, aimed at showcasing its capacity as a contract development and manufacturing organization. The conferences include the H.C. Wainwright Global Investment Conference from May 23-25, 2022; the 19th Annual Craig-Hallum Institutional Investors Conference on June 1, 2022; and the William Blair 42nd Annual Growth Stock Conference from June 6-9, 2022. Notably, Societal CDMO specializes in small molecule therapeutic development and offers comprehensive manufacturing solutions.

Societal CDMO has introduced a new service model, the 20/80 Second Source Technical Transfer, aimed at enhancing supply chain preparedness for pharmaceutical companies. Launched on May 17, 2022, during the CPhI North America meeting, this model allows companies to execute planning and sourcing activities ahead of time, potentially reducing supply disruption response time by a year while only committing 20% of total technical transfer costs initially. This proactive approach addresses critical supply chain vulnerabilities heightened by global disruptions, offering cost and time savings, and aligns with the need for trusted second suppliers.

Societal CDMO (SCTL) reported Q1 2022 revenue of $21 million, a 26% increase from the prior year. This growth was driven by new business agreements and an expanded customer base. The company is launching aseptic fill-finish and lyophilization services in Q2 2022, bolstering its operational capabilities. However, a revenue decline from a major partner, Lannett, is noted as a concern. Net loss improved to $4.3 million or $0.08 per share, compared to the previous year's loss of $6.8 million. Cash reserves decreased to $15.3 million.

Societal CDMO has secured a three-year manufacturing and supply agreement with InfectoPharm for Ritalin LA® capsules in Europe, effective through April 2025. This establishes Societal as the exclusive supplier in Europe after Novartis divested European rights. In 2021, revenue from Novartis constituted approximately 24% of Societal's total revenue, with €30% from the European Ritalin LA market. CEO David Enloe highlights the company’s expertise in Ritalin’s formulation and anticipates continued high-quality supply support for InfectoPharm's commercialization efforts.