Welcome to our dedicated page for Societal CDMO news (Ticker: SCTL), a resource for investors and traders seeking the latest updates and insights on Societal CDMO stock.
Societal CDMO, Inc. (SCTL) is a prominent player in the pharmaceutical manufacturing industry, specializing in solid dosage form development, clinical and commercial manufacturing, and packaging and logistics services. Under its subsidiary Recro Gainesville, LLC, the company provides expert solutions for extended-release solid dose and DEA-controlled substances. Their state-of-the-art, 97,000-square-foot manufacturing facility is equipped to handle the most complex pharmaceutical development and manufacturing projects.
The company recently announced additional work across its facilities in California and Georgia, which now includes analytical method development and validation, dissolution testing, and manufacturing of prototype, surrogate, and engineering batches. This expansion aims to enhance their service offerings and increase operational efficiency.
In response to macro pharmaceutical market financing challenges, Societal CDMO has initiated a strategic realignment to right-size its organization. This move is designed to boost efficiency in areas of historical strength and ensure long-term sustainability.
The company’s recent acquisition, Benuvia Operations, LLC, specializes in the development and manufacturing of controlled substance APIs and drug products, focusing on cannabinoids and psychedelics. Benuvia owns the FDA-approved cannabinoid drug product SYNDROS, aimed at alleviating chemotherapy-induced nausea and vomiting (CINV) and anorexia in AIDS patients. Operating out of an 83,000-square-foot, FDA-registered manufacturing facility, Benuvia adheres to cGMP standards, offering both APIs and complex finished dosage forms.
With a commitment to innovation, Societal CDMO continues to expand its portfolio of DMFs and is actively pursuing new intellectual property avenues for its drug products. The company's integrated services extend from research and route scouting to the commercialization of high-value, low-volume products, making it a reliable partner for end-to-end pharmaceutical development.
Societal CDMO (NASDAQ: SCTL) reported Q3 2022 revenue of $21.6 million, a 19% increase year-over-year. The company entered into a real estate sales agreement expected to generate over $9 million to improve its financial standing, alongside signing the highest number of new business agreements in its history. A favorable amendment with Lannett improved profit share by 10%. Despite these gains, the company reported a net loss of $3.3 million, or $0.06 per diluted share, while EBITDA, as adjusted, fell to $4.8 million.
Societal CDMO, Inc. (SCTL) will announce its third-quarter 2022 financial results after the market close on November 9, 2022. The management will discuss the results and operational highlights during a webcast at 4:30 p.m. ET on the same day. Interested parties can access the live event via the Investor Events page on Societal's website. The archived webcast will be available for 30 days post-event. Societal CDMO specializes in contract development and manufacturing, focusing on small molecule therapeutic development.
Societal CDMO (NASDAQ: SCTL) announced new CDMO service agreements with two clients to support their therapeutic programs. The first contract involves a clinical-stage oral biologic for pancreatic insufficiency, with a focus on Phase 3 trials in the U.S. The second contract is for a preclinical IL-2 analog cancer treatment. CEO David Enloe emphasized the significance of these contracts in diversifying the customer base and potential revenue growth.
Societal CDMO (NASDAQ: SCTL) has announced new hires to fill various roles within the organization. To incentivize these new employees, the compensation committee approved inducement stock option grants totaling 136,070 shares. This was done in accordance with NASDAQ rules, with options granted on September 30, 2022, at a price equal to the stock's closing value on that date. Options will vest monthly over four years, contingent on continued employment with the company. Societal CDMO specializes in complex therapeutics development and manufacturing.
Societal CDMO (NASDAQ: SCTL) announced on September 29, 2022, multiple new contracts expanding its CDMO services with existing and new clients in the pharmaceutical sector. These agreements focus on analytic methods, tech transfer, formulation, manufacturing, and packaging, aimed at supporting clinical developments and upcoming commercial activities. One notable contract involves manufacturing a novel ADHD treatment using unique formulation techniques, requiring specialized equipment. The company emphasizes its growth in business backlog and aims to diversify its customer base while enhancing revenue from current clients.
Societal CDMO recently appointed Elena Cant to its board of directors, bringing over 20 years of experience in biopharmaceuticals. Ms. Cant's career spans senior roles at companies like Takeda Pharmaceuticals and TwinStrand Biosciences, focusing on operational strategy and commercial activities. Her insights into customer perspectives will enhance Societal CDMO's value in the contract development and manufacturing space. With a commitment to delivering high-quality services, the company continues to solidify its reputation as a trusted partner in drug development.
Societal CDMO has announced agreements with two new customers to provide a range of CDMO services, supporting their clinical development programs. The first contract involves analytical methods and cGMP manufacturing for an investigational compound aimed at neurodegenerative diseases, while the second focuses on a topical gel candidate for hair loss. CEO David Enloe highlighted increased demand for their services, noting agreements with five new customers recently. SCTL plans to assist these customers in advancing their clinical-stage programs.
Societal CDMO has signed a sales agreement to sell approximately 121 acres of lakefront land in Gainesville, Georgia, to David Weekley Homes for $9,075,000. The company intends to use proceeds for debt reduction, aiming to strengthen its balance sheet amidst a challenging economy. The sale is expected to close in the second half of 2023. Additionally, Societal is pursuing a second real estate transaction to further enhance its financial standing, with total proceeds from both sales anticipated to be between $40 million and $50 million.
Societal CDMO (SCTL) reported Q2 revenue of $23.2 million, a 29% increase from the previous year, driven by new business agreements and increased customer demand. Notable developments include the launch of the “20/80 Second Source Technical Transfer” program for enhanced supply chain security and a favorable amendment to the agreement with Lannett, improving profit-sharing on Verapamil PM sales. However, net loss for the quarter was $3.1 million compared to a net income of $1.2 million in the same period last year.
Societal CDMO, Inc. (NASDAQ: SCTL) has secured CDMO service contracts from three new clients, enhancing its offerings in clinical trial services, formulation development, and cGMP manufacturing. Key activities include supporting a Phase 2 clinical study for a melatonergic antidepressant, developing a liquid formulation for pediatric neurological diseases, and conducting clinical trial services for a novel cancer treatment. These agreements highlight the company's growth momentum and its critical role in drug development.
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