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Societal CDMO, Inc. - SCTL STOCK NEWS

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.

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Societal CDMO (NASDAQ: SCTL) announced its participation in the 35th Annual Roth Conference from March 12-14, 2023, at The Ritz Carlton, Laguna Niguel, California. The company focuses on contract development and manufacturing for small molecule therapeutics, offering solutions for complex formulation challenges. At the conference, management will engage in 1-on-1 meetings with potential partners. With facilities in Gainesville, Georgia, and San Diego, California, Societal CDMO provides comprehensive services, including regulatory support and clinical manufacturing, aimed at delivering high-quality pharmaceutical products.

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Societal CDMO (NASDAQ: SCTL) reported a Q4 2022 revenue of $24.3 million, marking a 9% increase year-over-year. The clinical trial materials development sector grew by 58% in 2022, expanding the customer base significantly. The company executed a strategic multi-step plan that strengthened its financial position, including raising approximately $35.6 million from public offerings and securing a $36.9 million debt facility with improved terms. However, a net loss of $9.2 million was recorded for Q4 2022 compared to a $2.4 million loss in the previous year, attributed to refinancing costs.

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Societal CDMO (NASDAQ: SCTL) will release its financial results for Q4 and the full year 2022 on March 1, 2023, after market close. A webcast to discuss these results and operational highlights is scheduled for 4:30 p.m. Eastern Time the same day. The company's operations focus on complex formulation and manufacturing challenges in small molecule therapeutic development, serving the global pharmaceutical market with services ranging from pre-IND development to commercial manufacturing.

Societal CDMO operates in two primary facilities located in Gainesville, Georgia, and San Diego, California, totaling 145,000 square feet.

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Societal CDMO, Inc. (SCTL) has announced over $6 million in work orders signed with existing customers during Q4 2022. These orders encompass a wide range of its contract development and manufacturing organization (CDMO) services, including tech transfer, formulation, and fill/finish operations. The projects will take place across the company's facilities in Georgia and California, which total 145,000 square feet. CEO David Enloe emphasized that nurturing existing customer relationships is a crucial part of their growth strategy. This initiative demonstrates the company's capability to adapt to evolving customer needs and enhances its market position.

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Societal CDMO (NASDAQ: SCTL) has announced the hiring of new employees across various roles. To incentivize these hires, the firm's compensation committee has approved stock option grants totaling 70,960 shares, awarded under NASDAQ's inducement grant exception. The options were granted on December 30, 2022, with an exercise price reflecting the closing stock price that day, and will vest monthly over four years. Societal CDMO specializes in contract development and manufacturing, focusing on small molecule therapeutic development.

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Societal CDMO (SCTL) has successfully completed a series of capital financings, raising over $100 million. This has significantly reduced its outstanding debt from $100 million to $36.9 million, achieved through two non-dilutive transactions and a new loan from the Royal Bank of Canada. The refinancing improves the company's net debt leverage ratio from over six times to just above two times EBITDA, reducing annual interest costs by approximately $6 million. The new debt facility has a more favorable interest rate and extended maturity compared to its previous obligations.

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Societal CDMO, Inc. (NASDAQ: SCTL) has completed its public offerings of 27,841,737 common shares at $1.10 and 450,000 Series A convertible preferred shares at $11.00, raising approximately $35.6 million in gross proceeds. The funds will primarily be used for repaying the debt facility with Athyrium, with remaining proceeds allocated for general corporate and working capital needs. RBC Capital Markets acted as the sole book-running manager for the offerings, which were made under a previously filed SEC registration statement.

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Societal CDMO, Inc. (NASDAQ: SCTL) has priced concurrent public offerings of 27,841,737 shares of common stock at $1.10 each and 450,000 shares of Series A preferred stock at $11.00 each, aiming for gross proceeds of approximately $35.6 million. The offerings are set to close by December 14, 2022. The funds will primarily be used to repay an outstanding debt facility, while any remaining proceeds will support general corporate and working capital needs. RBC Capital Markets is the sole book-running manager for this transaction.

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Societal CDMO (NASDAQ: SCTL) announced plans for two concurrent public offerings of common stock and Series A convertible preferred stock. The proceeds will primarily be used to repay its debt facility with Athyrium and associated refinancing costs, which includes a sale-leaseback transaction for its Gainesville facility. The offerings are subject to market conditions and will be made under a previously effective shelf registration statement with the SEC.

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Societal CDMO (SCTL) has signed a $39 million sale and leaseback agreement with Tenet Equity for its Gainesville, Georgia, manufacturing site, aiming to reduce outstanding debt. Concurrently, it entered a credit agreement with Royal Bank of Canada for a new Term A Loan of up to $37.5 million, contingent upon raising at least $32.5 million in equity. The proceeds from both transactions are intended to strengthen the company’s capital structure and lower annual interest payments, extending debt maturity to December 2025.

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FAQ

What is the market cap of Societal CDMO (SCTL)?

The market cap of Societal CDMO (SCTL) is approximately 116.1M.

What does Societal CDMO, Inc. specialize in?

Societal CDMO specializes in solid dosage form development, clinical and commercial manufacturing, and packaging and logistics services.

What recent expansion has Societal CDMO undertaken?

The company has expanded its work across facilities in California and Georgia to include analytical method development, validation, dissolution testing, and manufacturing of prototype, surrogate, and engineering batches.

What is the significance of the strategic realignment by Societal CDMO?

The strategic realignment aims to right-size the organization to address macro pharma market financing challenges and increase operational efficiency in areas of historical strength.

What is the role of Benuvia Operations, LLC in Societal CDMO's portfolio?

Benuvia specializes in the development and manufacturing of controlled substance APIs and drug products, focusing on cannabinoids and psychedelics. It owns the FDA-approved cannabinoid drug product SYNDROS.

What is SYNDROS, and what is it used for?

SYNDROS is an FDA-approved cannabinoid drug product designed to alleviate chemotherapy-induced nausea and vomiting (CINV) and anorexia in AIDS patients.

What makes Societal CDMO a reliable partner in pharmaceutical development?

The company offers integrated services from research and route scouting to commercial products, adhering to current Good Manufacturing Practices (cGMP).

How large is Benuvia's manufacturing facility?

Benuvia operates an 83,000-square-foot, FDA-registered manufacturing facility.

What kind of substances does Societal CDMO handle in their manufacturing processes?

Societal CDMO deals with extended-release solid dose and DEA-controlled substances.

Does Societal CDMO have a focus on any specific drug forms?

Yes, they specialize in extended-release solid dosage forms and complex finished dosage forms.

What measures does Societal CDMO take to ensure innovation?

The company is committed to innovation by expanding its portfolio of DMFs and pursuing new intellectual property avenues for its drug products.

Societal CDMO, Inc.

Nasdaq:SCTL

SCTL Rankings

SCTL Stock Data

116.13M
57.79M
45.32%
57.56%
0.26%
Drug Manufacturers - Specialty & Generic
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