Good afternoon, and welcome to Cumberland Pharmaceuticals First Quarter 2024 Financial Report and Company Update. This call is being recorded at Cumberland's request and will be archived on the company's website for 1 year from today's date. .

I would now like to turn it over to Molly Aggas, Account Supervisor at the Dalton Agency, who handles Cumberland's Communications. .

Molly, please go ahead. .

Hello, 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.cumberlandpharma.com. .

Management will share an overview of those financial results during today's call. They'll also provide an overall company update, including a discussion of Cumberland's brands, pipeline and partners. .

Participating in today's call are A.J. Kazimi, Cumberland's chief Executive Officer; Todd Anthony, Vice President, Organizational Development; and John Hamm, Chief Financial Officer. .

Please keep in mind that their discussions may include forward-looking statements as defined in the Private Securities Reform Act. These 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. Those issues 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. .

Despite the company's best efforts, actual results may differ materially from expectations. So 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 websites and you can find links to those sites on the corporate website at 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. 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 Molly 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. .

The 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 can make a difference in patients' lives. These are valuable brands with attractive margins.

And we continue to build our portfolio of innovated 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. I'd next 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 Caldolor our ibuprofen 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 Caldolor in 2023 to include its use in patients from 3 to 6 months of age. .

Additionally, recall that the Federal NOPAIN Act was passed last year, which is designed to provide special, favorable reimbursement for non-opioid products like Caldolor. We look forward to learning more this year regarding Caldolor's inclusion and reimbursement in preparation for the Act's implementation in early 2025.

This could be a very meaningful revenue growth opportunity for Caldolor. .

Regarding Vibativ, our potent antibiotic, we're 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 it has favorable Medicaid coverage.

And meanwhile, we also continue to feature Sancuso 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 Vibativ in several international markets, which can contribute to the brand's growth in the future.

To book Pharmaceuticals has obtained final approval for Vibativ in Saudi Arabia and will next be discussing with them their plans for the product in that market. .

In SciClone Pharmaceuticals, our partner for the Chinese market continues to respond to the regulatory inquiries there as they seek approval for Vibativ in their country.

DB Pharm, our partner in South Korea, who also distributed Caldolor there, did receive an update during the first quarter on their submission to approve and distribute Vibativ in their country.

The Korean regulatory authorities did not yet approve the submission and indicated that some additional manufacturing information will be required and will work with the DB Pharm 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?.

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 3 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 clinics. .

I'd now like to share an update on each of our major brands. Starting with Vibativ. Recall that last year, we announced a new publication in antimicrobial agents in chemotherapy, detailing the results of the first clinical study investigating the safety and pharmacokinetics of Vibativ in children 2 to 17 years of age.

The results of this study suggest that a single dose of Vibativ is safe in children and that they experience reduced exposure to Vibativ compared with the same body weight-based dosing in adults.

Vibativ 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.

Vibativ was specifically designed to kill drug-resistant bacteria. .

Additionally, as A.J. 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 premeasured powdered dose that dissolves quickly in just 4 ounces of water for a clear, taste-free and grit-free solution. Kristalose continues to be our largest selling product and is benefiting nicely from the support of our 2 co-promotion partners.

Moreover, we found that the brand performs best in the 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 Caldolor, our intravenous ibuprofen product. As A.J. mentioned, we recently shared a special report evaluating the growing amount of data supporting the use of Caldolor as a standard of care for the treatment of pain and fever in adults, children and infants as young as 3 months of age. .

Takeaways from the special report include that intravenous ibuprofen results in significant reductions in temperature compared to placebo in adults and 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 ibuprofen in the hospital emergency department for acute pain can also minimize opioid requirements while achieving significant pain control. .

Finally, Caldolor 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 drug such as Caldolor 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.

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With its newly approved pediatric labeling, Caldolor 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 Caldolor in newborns.

We are very pleased to have further expanded the product labeling for use in patients of nearly all ages and have launched a marketing initiative highlighting this new indication. .

Additionally, we expect Caldolor will be eligible for special Medicare reimbursement under the new Non-Opioids Prevent Addiction in the Nation "NOPAIN" legislation, which was enacted as part of the Consolidated Appropriations Act of 2023. .

The NOPAIN 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 NOPAIN Act will affect Medicare reimbursement for Caldolor. The CMS requested that manufacturers with potentially applicable non-opioid products, submit comments in supporting clinical evidence regarding products that could be eligible for separate payment. .

We submitted a comment letter along with the requisite clinical information to the CMS in September of 2023, explaining why Caldolor 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 1, 2025, and January 1, 2028. .

Moving on to Sancuso. A new facility was approved by the FDA, and we have completed the manufacturing of Cumberland package 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 product 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 vasopressin receptor antagonist, and it's used to raise serum sodium level, hospitalized patients with hyponatremia, which is the most common electrolyte disorder among such patients. This completes my updates for today. .

And so I'll turn it back to you, A.J. .

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's quality of life.

Our ifetroban product candidate, which is our first new chemical entity, is being evaluated in a number of Phase II clinical trials for patients with a series of unmet medical needs. It's now been dosed in over 1,400 subjects and has been found to be both safe and well tolerated in those individuals. .

We've initiated our newest clinical program in medical centers across the country and enrollment has now begun in patients with pulmonary fibrosis, the most common form of progressive fibrosing 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 ifetroban can help both prevent and enhance resolution of lung fibrosis in multiple preclinical models. .

Meanwhile, patient enrollment is already well underway in our other 2 company-sponsored Phase II 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 ifetroban in patients with a cardiomyopathy associated with Duchenne Muscular Dystrophy or DMD, a rare and fatal genetic neuromuscular disease that results in deterioration of the skeletal, heart and lung muscles.

We're sponsoring that FIGHT DMD trial, which is a multicenter, randomized, placebo-controlled Phase II 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 of this study. In addition to these company-sponsored studies, there are several other preclinical and pilot studies of ifetroban underway, including several investigator-initiated trials.

We do expect to have data available this year, and we look forward to them sharing the results from these studies underway as they emerge and then deciding on the best path for ifetroban, the best development path for ifetroban, 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?.

Thank you, A.J. For the 3 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 for Sancuso; $1.6 million for Vibativ and $1.5 million for Caldolor. .

Turning to our expenditures. Total operating expenses for the first quarter were $10.4 million. Net loss for the quarter was $1.9 million and when the noncash expenses are added back, the 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 Vibativ and Sancuso cost of goods during the first quarter. Those goods were received as part of each product's acquisition.

As a reminder, the additions of Vibativ and Sancuso to our product portfolio continue to positively impact our financial statements. As a result of the Vibativ 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. .

The financial terms for the Vibativ transaction included a $20 million payment upon closing and a subsequent $5 million milestone payment. We also continue to provide royalties tied to product sales.

Vibativ was our largest acquisition, and I'm pleased to report that since we assume responsibility for the product in late 2018, it has delivered a total cash contribution of $39 million to our business and therefore, is generating return on our $25 million investment. .

Sancuso added a total of $19 million in new assets, including $4 million in inventory and $14 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 Sancuso 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 Sancuso 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 Cumberland to increase the amount of $25 million under certain conditions. .

The interest rate is based on benchmark term SOFR and is subject to one financial covenant to determine 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 and those needed to fund the taxes associated with employee vested restricted shares. .

We are also continuing the process of implementing new trading 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 carryforwards, primarily resulting from the prior exercise of stock options. And that completes our financial report for the first quarter of 2024. Back to you, A.J. .

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 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 of 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 Sancuso and Vibativ. We're optimistic about the opportunity to further expand the use of Kristalose in the growing number of states where the product is favorable Medicaid coverage.

We're pleased to share the special report, featuring the use of Caldolor for the treatment of pain and fever across a wide range of patient populations, and we're thrilled to have expanded Caldolor's labeling to the youngest of patients. .

We also believe the special reimbursement associated with the NOPAIN Act can have a meaningful impact on Caldolor's future growth. And we look forward to providing updates on our further developments as the year progresses. So that concludes our remarks and let's open the call to any questions you may have. .

Operator, please proceed. .

[Operator Instructions] At this time... .

Well, thank you, everyone. .

Go ahead. Sorry. .

Go ahead. .

I was just going to turn it back to management for any closing remarks. .

We do have a question that just came up. Let me move them up..

I'm seeing an error now. I had a question from Evan and I apologize, it is now not showing. .

Okay. Well, we appreciate everybody who's 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 a 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. .

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 the Investor Relations section on Cumberland's website. I'd like to thank you for your participation, and you may now disconnect..