Q1 2024 Cumberland Pharmaceuticals Inc Earnings Call

Participants

A. Kazimi; Chairman of the Board, Chief Executive Officer; Cumberland Pharmaceuticals Inc

Todd Anthony; Vice President - Organizational Development; Cumberland Pharmaceuticals Inc

John Hamm; Chief Financial Officer, Senior Director - Finance and Accounting; Cumberland Pharmaceuticals Inc

Molly Aggas; IR; Dalton Agency, LLC

Presentation

Operator

Good afternoon, and welcome to Cumberland Pharmaceuticals First Quarter 2024 financial report and company update. The call is being recorded. At Cumberland's request, it will be archived on the Company's website one year from today's date. I would now like to turn it over to Molly Angus account supervisor at the Dalton agency, he handles Cumberland's communications, Mollie. Please go ahead.

Molly Aggas

So everyone. Thanks for joining us today. This afternoon, Cumberland issued a press release announcing the Company's financial results with an operational update for the first quarter of 2024. The release which includes the related financial tables, can be found on the Company's website at www.cumberland pharma.com. Management will share an overview of those financial results during today's call. I'll also provide an overall company update, including a discussion of Cumberland's brands, pipeline and partners. Participating in today's call are Ajay Cassini, Cumberland's Chief Executive Officer; Todd Anthony, Vice President, Organizational Development; and John Hann, Chief Financial Officer.
Please keep in mind that their discussion may include forward-looking statements as defined in the Private Securities Reform Act. Such statements reflect the Company's current views and expectations concerning future events and may involve risks and uncertainties. There are many factors that could affect Cumberland's future results, including natural disasters, economic downturns, public health epidemics international conflicts and others that are beyond the Company's control issued are described under the caption Risk Factors in Cumberland's Form 10-K and any additional updates filed with the SEC.
Any forward-looking statements made during today's call are qualified by those risk factors by the Company's best efforts. Actual results may differ materially from expectations. Information shared on this call should be considered current as of today only. Please remember that the Company isn't responsible for updating any forward-looking statements, whether as a result of new information or due to future developments.
During today's call, there will also be references to several of Cumberland's marketed brands. Full prescribing and safety information for each brand is included on the individual product website, and you can find links to those sites on the corporate website, www.cumberlandpharma.com.
The Company will be providing some non-GAAP financial measures with respect to its performance. An explanation and reconciliation to GAAP measures can be found in the financial tables of the earnings release that was issued earlier this afternoon. If you have any questions, please hold them until the end of the call, at which point, we'll be happy to answer them. Management is also prepared to hold a follow-up conversation after the call, if you prefer.
With that introduction, I'll turn the call over to Cumberland's Chief Executive Officer, A.J. Kazim.

A. Kazimi

Thank you, Molly, and good afternoon, everyone. We appreciate you joining us today as we share how the year has gone so far as Balu mentioned during today's call, we'll provide a company update and a review of our financial results for the first quarter ending March 31, 2024 first quarter came in generally as expected, given the backdrop of a higher interest rate environment and typical first quarter consumer buying patterns. Recall our first quarter sales are usually lighter as patients work through their new insurance deductibles before purchasing more expensive medicines.
Also, our sales in Q1 this year were impacted by wholesaler buying patterns, which do fluctuate during the year. However, it's important to note that the overall demand for our brands was steady during the period. And for that reason, we believe it's best to evaluate our financial performance on an annual basis.
We remain very optimistic about our company's fundamentals and future given the number of ongoing positive developments, which we'll elaborate on during today's call. And finally, we believe we are still on track to post double digit revenue growth and positive cash flow from operations in 2024.
You see Cumberland has built a portfolio of FDA-approved brands with outstanding safety and efficacy profiles that make it can make a difference in patients' lives. These are valuable brands with attractive margins, and we continue to build our portfolio of innovative and differentiated products through a multifaceted strategy that includes both the development of new candidates as well as the acquisition of established brands. Our resulting diversified product line has enabled us to weather external challenges. While our team remains responsive to the evolving marketplace.
And next, I'd like to share several updates regarding our products, including a number of growth opportunities. We're implementing a strategy to increase the overall awareness of our products and their attributes throughout the medical community. In March, a special report was published in anesthesiology, news, General Surgery News and pharmacy practice news, which presented the growing amount of clinical data supporting the use of capital or our IV program as a standard of care for the treatment of pain and fever in adults, children and infants. As a reminder, FDA approved expanded labeling for category 2023 to include its use in patients from three to six months of age.
Additionally, recall that the federal know pain Act was passed last year, which designation, which is designed to provide special favorable reimbursement for non-opioid products like Hallador. We look forward to learning more this year regarding Calloway's inclusion and reimbursement in preparation for the AX implementation in early 2025. This could be a very meaningful revenue growth opportunity for Caterpillar.
Regarding Vibe, that is our potent antibiotic.
We are pleased to announce the launch this quarter of new product packaging. This additional presentation is designed to overcome a barrier as smaller hospitals and infusion centers that use less of the product at a time in order to help them manage their investment and workflow associated with the product.
Turning to Kristalose, our prescription strength laxative, we continue to build on the growing number of states where has favorable Medicaid coverage. And meanwhile, we also continue to feature set to sell through our recently expanded oncology sales division in order to support patients by helping address certain side effects associated with their chemotherapy cancer treatments. And additionally, we continue to work with partners in their efforts to advance our potent antibiotic biobetters in several international markets, which can contribute to the brand's growth in the future to book Pharmaceuticals has obtained final approval from that is in Saudi Arabia, and we'll next be discussing with them their plans for the product in that market in Sky clone pharmaceuticals. Our partner for the Chinese market continues to respond to the regulatory inquiries there as they seek approval for five batteries in their country.
Db pharm, our partner in South Korea who also distribute capital were there did receive an update during the first quarter on their submission to approve and distribute five added in their country. The Korean regulatory authorities did not yet improve the submissions and indicated that some additional manufacturing information will be required and will work with the DV. farm to address regarding our financial performance during the first quarter, we recorded $8.5 million in net revenues.
And again, overall demand for our brands was steady during the period, and we therefore continue to suggest evaluating our performance on an annual basis.
So with that overview, I'd now like to turn to Todd Anthony Cumberland's, Vice President, Organizational Development, to discuss our team and our brands. Todd?

Todd Anthony

Thank you A.J. In March, we hosted our spring national sales meeting here in Nashville as we launched new marketing initiatives and equipped our sales teams and their efforts to build our brands as a reminder, we support our portfolio of FDA approved medicines through three national sales divisions. Our hospital sales division calls on key institutional accounts across the country. While our field sales division covers select office-based physicians. Our newest sales group, Cumberland oncology, focuses on cancer clinic.
I'd now like to share an update on each of our major brands, starting with my bet of Recall that last year we announced a new publication in Antimicrobial Agents and Chemotherapy detailing the results of the first clinical study investigating the safety and pharmacokinetics of buyback in children, 2 to 17 years of age.
The results of this study suggests that a single dose of buyback is safe in children and that they experience reduced exposure to vibe that have compared with the same body weight base dosing in adult. That is an intravenous antibiotic approved by the FDA for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia as well as complicated skin and skin structure infections caused by certain gram-positive bacteria. Antimicrobial Resistance continues to pose a significant challenge in the treatment of bacterial infections, which necessitates the development of new antibiotic therapies While many recently introduced antibiotics are quickly losing the battle to fight the bacteria they were designed to kill because those bacteria have become drug resistant by BAT and was specifically designed to kill drug resistant bacteria.
Additionally, as Ajay mentioned, we are launching a new package for the product this quarter. This new presentation is designed for smaller accounts that either don't have the space to store or don't have the patient volume to necessitate the investment in larger quantities.
Moving next to Kristalose, our prescription strength, laxative packaged in a convenient pre measured powder dose that dissolves quickly and just for ounces of water for a clear taste free and grip free solution. Kristalose continues to be our largest selling product and is benefiting nicely from the support of our two co-promotion partners. Moreover, we found that the brand performs best in states where we have Medicaid coverage. New York State recently added Kristalose to its Medicaid formulary and we are implementing a special initiative to increase our presence and share of voice in this market. We believe that this new coverage is contributing to the growth of the product shifting now to Camelot our intravenous IV frozen product. As Ajay mentioned, we recently shared a special report evaluating the growing amount of data supporting the use of capital or as a standard of care for the treatment of pain and fever in adults, children and infants as young as three months of age. Takeaways from the special report include that intravenous IV protein results in significant reductions in temperature compared to placebo in adults and to acetaminophen in pediatric patients. Also administration of the product prior to surgery leads to patients waking up in significantly less postsurgical pain while also lessening or even eliminating the need for opioids. The use of intravenous IV process in the hospital emergency department for acute pain can also minimize opioid requirements while achieving significant pain control finally candle or should be considered a foundation for any multimodal pain regimen. Pain management has become one of the most common health care problems in the United States. As this new report, states comprehensive multimodal pain regimens have become key in preventing pain and optimizing pain control while minimizing the need for opioids. A nonsteroidal anti-inflammatory drugs such as cold war can provide a cornerstone for many treatment protocols. And we are encouraged by the substantial database emerging from our studies in patients of all ages with its newly approved pediatric labeling caliber or is now the only non-opioid product approved to treat pain in infants that's delivered via an injection. The new indication was further supported by the publication of positive results from a clinical study investigating the safety and pharmacokinetics of caliber Lauren newborns. We are very pleased to have further expanded the product's labeling for use in patients of nearly all ages and have launched a marketing initiative highlighting this new indication.
Additionally, we expect capital or will be eligible for special Medicare reimbursement under the new non opioids prevent addiction in the nation for no pain legislation, which was enacted as part of the Consolidated Appropriations Act of 2023. The no pain Act requires Medicare to provide separate and more favorable reimbursement for non opioid products used to manage pain during surgeries conducted in both hospital outpatient departments as well as ambulatory surgical centers. This legislation applies in part to products that are indicated to provide analgesia without acting upon the body's opioid receptors. As a result, we do expect that the no pain act will affect Medicare reimbursement for Calpella. Cms requested that manufacturers with potentially applicable non-opioid products, submit comments and supporting clinical evidence regarding products that could be eligible for separate payment. We submitted a comment letter along with the requisite clinical information to CMS in September of 2023, explaining why capital or should be included and separately reimbursed. We now await information from CMS regarding the reimbursement status and the pricing for the product the act is scheduled to go into effect in early 2025 and will initially apply to products that are furnished between January first, 2025 and January first, 2028.
Moving on to Santa Cruz. So a new facility was approved by the FDA and we have completed the manufacturing of Cumberland packaged product there. We will be launching these new supplies of our Cumberland branded products. This year, we are supporting the product through our expanded oncology sales division to help cancer patients by addressing certain side effects associated with their chemotherapy treatments. And we're already seeing a favorable impact from the expanded sales division, which we plan to build upon to increase customer frequency and reach. Meanwhile, our new manufacturing and distribution partner for Vaprisol has successfully produced the product in their facility as we await FDA approval for making the branded products there. Our partner is providing a special supply of compounded product in support of critically ill patients. Vaprisol is the first and only intravenously administered Basil Preston receptor antagonist, and it's used to raise serum sodium load in hospitalized patients with hyponatremia, which is the most common electrolyte disorder among such patients.
This completes my update for today, and so I'll turn it back to you, A.J.

A. Kazimi

Thank you, Todd. I'd now like to provide an update on our ongoing clinical activities. We continue to progress our pipeline of innovative products, which are designed to improve patient care and patient quality of life.
Our IC tri-band product candidate, which is our first new chemical entities, is being evaluated in a number of Phase two clinical trials for patients with a series of unmet medical needs. It's now been dosed in over 1,400 subjects, and it's been found to be both safe and well tolerated in those individuals. We've initiated our newest clinical programs in medical centers across the country and enrollment has now begun in patients with pulmonary fibrosis, the most common form of progressive fibrosis in interstitial lung disease.
This fighting fibrosis study is designed to enroll 128 patients in over 20 medical centers of excellence across the United States and recent studies have shown that a future band can help both prevent and enhance resolution of lung fibrosis. In multiple preclinical models.
Meanwhile, patient enrollment is already well underway in our other two company-sponsored Phase two clinical programs. The first involves patients with systemic sclerosis or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs. And the other study is evaluating our future band in patients with the cardiomyopathy associated with Duchenne muscular dystrophy or DMD a rare and fatal genetic neuromuscular disease. It results in deterioration of the skeletal Heart and Lung muscles. We're sponsoring that phase DMD trial, which is US multicenter, randomized, placebo-controlled Phase two study, which is actively enrolling patients across 10 centers in the United States with those centers specializing in DMD. Also note, we've received over $1 million now in grant awards from the FDA to support this study.
Enrollment in the younger patient group is complete, and we're now working to finish enrollment in the older patient cohort for this study.
In addition to these company-sponsored studies. There are several other preclinical and pilot studies about future being underway, including several investigator initiated trials. We do expect to have data available this year, and we look forward to then sharing the results from these studies underway as they emerge and then deciding on the best path for our future band, the best development path for a future band which we believe has the potential to benefit many patients.
So with that update on our clinical studies, I'd now like to turn it over to our Chief Financial Officer, John Hamm, to review our first quarter financial results.
John?

John Hamm

Thank you, A.J. For the three months ended March 31, 2024, net revenue from continuing operations were $8.5 million. Net revenue by product for the first quarter of 2024 included $3.2 million for Kristalose, $1.8 million pursuant to So $1.6 million provide backup and $1.5 million for calendar oh four.
Turning to our expenditures, total operating expenses for the first quarter were $10.4 million. Net loss for the quarter was $1.9 million in wind, the non-cash expenses are added back through resolving loss was $0.6 million.
Also, please note that the adjusted earnings calculations do not include the additional benefit of the $0.5 million of buy back and say it too. So cost of goods during the first quarter, those goods are received as part of each product acquisition. As a reminder, the additions of buyback of InSync Crusoe to our product portfolio continue to positively impact our financial statements as a result of the buyback of acquisition, a total of $34 million in new assets were added, including approximately $21 million in inventory, $12 million of intangible assets and $1 million of goodwill financial terms for the buyback transaction included a $20 million payment upon closing the subsequent $5 million milestone payment. We also continue to provide royalties tied to product sales.
Buyback was our largest acquisition, and I'm pleased to report that since we assumed responsibility for the product in late 2018, delivered a total cash contribution of $39 million to our business. And therefore, is generating return on our $25 million investment. Suku, so added a total of $19 million in new assets, including $4 million in inventory and $40 million of intangibles. The estimated value of those assets was $12 million. At the end of the first quarter, we provided $13.5 million at closing for the same Crusoe acquisition, and we also paid $1.5 million in milestone payments. There are ongoing royalties that we pay based on the brand sales. Since we started shipping sand Crusoe in early 2022. The product has provided a total cash contribution of approximately $14.8 million and therefore is expected to begin generating return on our $15 million investment this year.
Turning to our balance sheet. As of March 31, 2024, we had $82 million in total assets, including $19 million in cash and cash equivalents. Liabilities totaled $54 million including $16 million on our credit facility. Total shareholders' equity was $27 million at the end of the quarter. We continue to hold a bank line of credit, which holds up to $20 million in capital and provides the ability for Carboline to increase the amount to $25 million under certain conditions.
The interest rate is based on benchmark terms so far and is subject to one financial covenant covenant determined on a quarterly basis. During the first quarter, we continued our corporate share repurchase program, buying a total of 126,000 shares. These repurchases included those on the open market at those needed to fund the taxes associated with employee vested restricted shares. We are also continuing the process of implementing new training plans for our Board members who will purchase Cumberland shares throughout the year to increase their holdings in the Company.
Lastly, I'd like to note that Cumberland continues to hold over $52 million in tax net operating loss carry forwards, primarily resulting from the prior exercise of stock options. And that completes our financial report in the first quarter of 2024. Back to you, A.J.

A. Kazimi

Thank you, John. We recently released our 2023 Annual Report, which includes last year's financial results and milestones as well as updated sustainability metrics.
You can find a copy of the report on our website under the Investor Relations tab. We've also recently held our annual shareholder meeting all the proposals presented in our Proxy were approved, including the reappointment of Martin Brown and James Jones as Cumberland board directors.
Overall, it's been a productive start to the year. We remain dedicated to our mission of working together to provide unique products that improve the quality of patient care.
And we're doing that by building the portfolio of FDA approved brands with outstanding safety and efficacy profiles that can truly make a difference in patients' lives. We're particularly encouraged to see the impact of our sales and marketing initiatives that are supporting SAINT two sold and Vibe Data. We're optimistic about the opportunity to further expand the use of Kristalose in the growing number of states where the product has favorable Medicaid coverage.
We're pleased to share this special report featuring the use of capital or for the treatment of pain and fever across a wide range of patient populations. And we're thrilled to have expanded capital towards labeling to the youngest of patients. We also believe the special reimbursement associated with the know pain act can have a meaningful impact on capital towards future growth. And we look forward to providing updates on our further developments as the year progresses.
So that concludes our remarks and as open the call to any questions you may have. Operator, please proceed.

Question and Answer Session

Operator

Thank you, sir. (Operator Instructions)

A. Kazimi

Okay. Well, we appreciate everybody joining us for today's call. And we know many of you prefer a private discussion with management. So please just reach out and we're happy to have follow up and answer any questions you have and hold a discussion. As always, we appreciate your time and interest in Cumberland, and we do look forward to providing another update in the coming months.

Operator

Thank you, sir. Ladies and gentlemen, that concludes today's call. If you would like to listen to a replay of the discussion, please visit investor relations section on Cumberland's website. I'd like to thank you for your participation, and you may disconnect.