To Our Shareholders, Employees & Partners:
We’ve continued to successfully manage our business as challenges continue to develop in a post-pandemic world – including workforce shortages at healthcare facilities, supply chain interruptions, rising interest rates, the overall economic downturn and a recent banking crisis. Despite these difficulties in our operating environment, our team has been dedicated to delivering our FDA-approved products for the patients who need them, while also advancing the development of new medicines for the future.
Our financial performance was steady during the first quarter of 2023 with revenues of $9.2 million compared with $11.2 million during the same period last year and similar to the $9.1 million of revenues in the fourth quarter of 2022. Adjusted earnings were $1.7 million for the first quarter, or $.11 a share. Total assets at the end of the period were $89 million, with total liabilities of $53 million and shareholders’ equity of $36 million.
Sancuso® has been a driver of this growth since it joined our key legacy brands - Caldolor®, Kristalose® and Vibativ® - in our product portfolio. During 2022, we acquired and successfully completed the transition of Sancuso from the U.S. affiliate of Japan-based Kyowa Kirin Co., Ltd. The FDA also approved moving the product’s manufacturer to a new facility which will be our source of future product supplies. Sancuso is the first FDA-approved dissolvable prescription patch used to prevent certain side effects experienced by oncology patients receiving chemotherapy treatments.
We are now settled into our new headquarter offices on the Broadwest campus in the Vanderbilt/West End corridor of Nashville. The location allows us to remain close to Vanderbilt Medical Center and continue our collaboration while also maintaining our presence in the Nashville healthcare community, which represents the nation’s largest concentration of healthcare companies.
Meanwhile, we continue to support our international partners in their efforts to register our brands in their countries:
- PiSA Pharmaceutical is preparing their submission for distribution of Caldolor in Mexico.
- Tabuk Pharmaceutical is updating the approval in Saudi Arabia in order to begin introducing Vibativ into the Middle East.
- SciClone Pharmaceuticals continues to address regulatory inquiries, as they seek approval for Vibativ in China.
- DB Pharm Korea Co. Ltd. is working towards approval of Vibativ in South Korea, where they also distribute Caldolor.
Additionally, we are continuing to sponsor a series of clinical programs to evaluate Ifetroban in patients with unmet medical needs. Enrollment continues in our Phase II studies of patients with Systemic Sclerosis and Duchenne Muscular Dystrophy. We closed and completed the initial analysis of the data from our Phase II study in patients with a severe form of asthma known as Aspirin Exacerbated Respiratory Disease. As previously mentioned, we will await results from all the Phase II clinical programs before deciding on the best path to further develop the product towards approval.
During the first quarter we learned that the FDA granted our request for a waiver and refund of nearly $2 million in fees that we previously provided. The rationale for our request was that the funds could be better used to support the development of our new product candidates. We also learned that the federal NOPAIN legislation was enacted. It’s designed to provide more favorable reimbursement for non-opioid pain relievers in the hospital outpatient and ambulatory care settings. We understand that our Caldolor, (ibuprofen) injection product will qualify for this special treatment, which is scheduled to begin in 2025.
I’d like to close by recognizing and thanking our Cumberland team for their efforts in advancing our mission, as we provide high-quality medicines to improve our patients’ quality of life. The first quarter provided a solid start to 2023, and we look forward to further new developments and updates throughout the remainder of the year.
All the best,
Chief Executive Officer
Please see our corporate web site at www.cumberland pharma.com for links to our product web sites for full prescribing and safety information on our brands and for our SEC filings that contain the risk factors associated with our business.