Q4 2023 Cumberland Pharmaceuticals Inc Earnings Call

Participants

Todd Anthony; VP & Organizational Development; Cumberland Pharmaceuticals Inc.

Presentation

Operator

Good afternoon, and welcome to Cumberland Pharmaceuticals 2023 financial report and company. Our call is being recorded at Cumberland's request and will be archived on the company for one year from today. I would now like to turn it over to Molly Aggas, count supervisor at the door who handles Cumberland's communication model.

Scott, everyone, thanks for joining us today this afternoon, Cumberland issued a press release announcing the company's annual financial results, an operational update for the year ending December 31, 2023, the release, which includes the related financial tables can be found on the Company's website at www,Cumberland's pharma.com.
Management will share an overview of the 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 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 discussion 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 they 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 10K 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. Information shared on this call should be considered current as of today. 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 individual product websites. You can find links to those sites on the corporate website at www.Cumberland'spharma.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 today. 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's also prepare to hold a follow-up conversation after the call, if you prefer.
And with that introduction, I'll turn the call over to Cumberland's Chief Executive Officer, A.J. casino.

Thank you, Molly, and good afternoon, everyone. We appreciate you joining us as we recap our progress here at Cumberland. As Molly mentioned during today's call, we'll provide both a company update as well as a review of our 2023 financial results.
So let's begin in many ways. 2023 was a productive and important year for Cumberland as we were able to take key steps in laying the foundation for future success. We continue to integrate our newest products while also delivering a number of significant achievements, which will recap on today's call.
In 2023, Cumberland delivered net revenues of $40 million. Sam Crusoe has become a valuable addition to our product line with continued significant shipments during 2023, but also an unusual amount of sales deductions during that year. Meanwhile, Kristalose, caliber, Lord and vibe that have continued their steady contributions to our revenue mix. In fact, by the head of sales rebounded in 2023 with the brand and beginning to deliver an attractive return on the investment associated with this acquisition.
Our gross margins remained attractive in 2023, resulting in $6 million in cash generated from operations for the year. Our balance sheet also remains strong as we ended the year with $82 million in total assets including $20 million in cash, $53 million in liabilities and $30 million of shareholders' equity.
Now I'm pleased to share a series of exciting developments which occur in 2023, including several growth opportunities for our brands throughout the year. We continue to work with our partners in their efforts to register and launch by BAT is in several international markets. Which can provide significant catalyst for the brands in the future.
Guy clone Pharmaceuticals, our partner for the Chinese market has continued to respond to regulatory inquiries as they seek approval for a drug that is in their country. Their book Pharmaceuticals has updated, but that has approval in Saudi Arabia through manufacturing information as they plan to introduce the product into the Middle East and DB. pharm, our partner in South Korea, who also distributes capital or there isn't awaiting the approval of diabetes in their market. So we now await the clearance of these submissions associated with these three initiatives and look forward to the launch of Vibe Data in these three countries.
Meanwhile, following the FDA's approval to expand the labeling for capital or in 2023. Our non-opioid agent may now be administered for the treatment of pain and fever in patients, three to six months of age in early 2023. The federal no-pay Act was passed, which is expected to provide special favorable reimbursement for non-opioid products like Hallador, we submitted a request to CMS that capital would be included in the favorable reimbursement, and we look forward to learning more this year in preparation for the AX implementation in 2025.
During 2023, we also completed the expansion of our oncology sales division as we work to deliver our newest brands and to so to cancer patients and our largest selling product, Kristalose began benefiting from its listing on the New York State Medicaid formulary during the year.
So with that overview, I'd now like to turn to Todd Anthony, Cumberland's, Vice President, organizational development, to further discuss our brand, our brands and our team's Todd.

Todd Anthony

Thank you.
May J.
There certainly was a lot of activity at Cumberland throughout 2023. So I'd like to offer a further update on each of our major brands in October, we announced a new publication in Antimicrobial Agents and Chemotherapy detailing the results of the first clinical study investigating the safety and pharmacokinetics of our Vibex product in children, 2 to 17 years of age.
By that, it 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. The results of this study suggests that a single dose of I bet it is safe in children and that they experienced reduced exposure to buyback of compared with the same body weight based dosing in adults. Antimicrobial Resistance continues to pose posed a significant challenge in the treatment of bacterial infections, necessitating the development of new antibiotic therapies. We are pleased to see that buyback of sales continue to improve and were up 18% in 2023, reflecting the several new initiatives underway to improve the brand's performance.
Touching next on Kristalose, which is our first prescription strength, laxative packaged in a convenient pre measured powder dose. It dissolves quickly interest 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 with 2023 sales up 5% over the prior year.
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 that market. We believe that this new coverage is contributing to the growth of the product.
Moving next to capital or non-opioid analgesic injection products with the newly approved pediatric labeling. Ajay mentioned, it's now the only non-opioid product approved to treat pain in infants that's delivered via an injection. Other products in this class such as Qatar, lack and meloxicam, are not approved for use in children as the safety and efficacy of those drugs have not been established for pediatric patients. Additionally, acetaminophen injection is not approved for treating pain in children less than two years of age as the safety and efficacy of that drug has not been established for treating pain in those younger children.
In 2023, we also shared the positive results from a clinical study investigating the safety and pharmacokinetics of cattle or in newborns. The study evaluated the safety and drug exposure profile of calendar or in 2024 hospitalized infants between the ages of one and six months who require treatment for pain or fever.
The results of this study, which were published in the journal pediatric drugs supports the growing body of evidence that demonstrates Calibre is safe, therapeutic option available to practitioners for the treatment of fever in pain in infants, children and adults. We're 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 believe capital will be eligible for special Medicare reimbursement under the new non-opioid prevent addiction in the nation or 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 that are used to manage pain during surgeries conducted in hospital outpatient departments or in ambulatory surgical centers.
This legislation applies to products that are indicated to provide analgesia without acting upon the body's opioid receptors as a result, we believe that the NO pain act will affect Medicare reimbursement for catalog in the Medicare hospital outpatient prospective payment system proposed rule.
The CMS requested that manufacturers with potentially applicable non-opioid products, submit comments and supporting clinical evidence regarding products that should be eligible for separate payments. We submitted a comment letter along with the requisite clinical information to the CMS in September of 2023, explaining why Calvo or should be included and separately reimbursed.
We are now awaiting further information from CMS expected this year, including the potential new reimbursement level for CalBear. The Act itself is scheduled to go in effect in early 2025 and will initially apply to those products that are furnished between January 1, 2025 and January 1, 2028, shifting now to same crew.
So the first and only FDA approved prescription patch for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy after acquiring US rights to the brand in 2022, we successfully completed the transition from Kyowa Kirin to Cumberland in 2023, which included the NDA transfer.
We also successfully transferred manufacturing of the product to a new facility following FDA approval of that site. We have now received new supplies of Cumberland packaged product, which we will begin shipping this year. I'd like to note that 2023 includes So net sales were significantly lower than those we experienced in the prior year due to an inordinate amount of sales deductions we are working to address and improve those deductions, which include fees, rebates and product returns.
During the year, we expanded our oncology sales division as we work to deliver the brand to help cancer patients tolerate their chemotherapy treatments. We are already seeing a favorable impact from this expanded sales division, which we plan to build upon to increase customer frequency and reach in 2024 demand for our Vaprisol product increased during the pandemic, and we work to support the expanded use of the product in hospitals and clinics during that health care crisis, we then shipped all remaining inventory of the product and notified the FDA that supplies of the product were not currently available.
We have since transferred the product manufacturing to a new facility in our new manufacturing partners, working with the FDA to address several form four A. three warning letter issues in a timely manner. Meanwhile, we've been working with them to support a special interim supply of compounded product for critically ill patients, which we will introduce to the market, which we introduced to the market in late 2023 and will begin selling in early 2024 companies will share in the sales of this interim compounded product, and then we will expect to file for the approval to manufacture branded Vaprisol once all the issues at the new site are resolved.
As for ready Trex, a line of prefilled syringes. Recall that we amended our agreement with Nordic pharma who previously provided us with the license for the US rights for the product line. As of July 1, 2023, Nordic has assumed responsibility for the product in the United States. We support our portfolio of FDA approved medicines through three national sales divisions, including our newest Cumberland oncology, which is comprised of both field-based and inside sales personnel. Our hospital division calls on key institutional accounts across the country. And our field sales division covers select space physicians.
And lastly, I'd like to highlight Cumberland's ongoing focus and our commitment to sustainability. We have updated our metrics. And today, I'm pleased to announce the key findings for 2023, which include providing 3 million doses of our products to patients safely disposing of nearly 6,000 pounds of damaged an expired product and having no products recalled and no clinical trials terminated due to failure to practice good clinical standards.
That completes my update for today and so now I'll turn it back over to you, A.J.

Thank you, Todd. But now I'd like to take a few minutes to provide an update on our clinical programs. We continue to progress our pipeline of innovative products designed to improve patient care, patients' quality of life.
Our fit to a central vein product candidate could have potent and selective thromboxane receptor antagonist it's being evaluated in three Phase two clinical studies for patients with a series of unmet medical need. It's now been dosed in nearly 1,400 subjects and been found to be safe and well tolerated in those individuals. Patient enrollment is well underway in two of those company-sponsored Phase two clinical programs.
The first involves patients with systemic sclerosis or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis, skin and internal organs. The other is evaluating a future ban in patients with cardiomyopathy associated with Duchenne muscular dystrophy or DMD.
It's a rare and fatal genetic neuromuscular disease that results in deterioration of the skeletal Heart and Lung muscles. We're sponsoring the fight CMV trial, a multicenter, randomized placebo-controlled Phase two study, which is enrolling patients across 10 centers across the United States and a centers that specialize in DMD. We've completed enrollment in the younger age group of patients and are now working to finish enrollment in the older patient cohort with DMD for the whole, the FDA has provided grant awards of over $1 million to support the study.
We're also developing an oral capsule of a future band to treat idiopathic pulmonary fibrosis or IPF. The most common form of progressive fibrosis is interstitial lung disease following FDA clearance of our investigational new drug application in May of 2023.
We're now in the process of initiating our Phase two finding fibrosis trials designed to enroll 128 patients in over 20 medical centers of excellence across the US. Recent studies have shown Petrobank can both prevent and enhance resolution of lung fibrosis in multiple preclinical models. Well, in addition to the sponsored studies, there are several other preclinical and pilot patient studies at a future been underway, including several investigator initiated study.
We believe that Trubion has the potential to benefit many patients, and we look forward to sharing the results from our company-sponsored studies as they emerge. Our plan is to then decide on the best development path for the product, which represents our first new chemical entity.
So with that update on our ongoing clinical trials.
I'd now like to turn it over to our Chief Financial Officer, John Hamm, to review our 2023 financial results. Johnson?

Thank you, A.J. For the three months ended December 31, 2023, net revenue from continuing operations were $9.4 million, an increase over the $9.1 million in revenue recorded during the prior year period. Net revenue by product for the fourth quarter of 2023 included $2.4 million for Santos of $3.7 million for Kristalose, $2 million share buyback and $1 million for calendar law. As a reminder, due to quarterly fluctuation in our customers' purchases, we believe our performance should be assessed based on annual sales results. With that in mind, I'm pleased to report that net revenue for the full year 2023 were $40 million. Full year product revenue totaled $16 million for Kristalose, $8.1 million for CNQ, so $8.8 million for buyback of $4.3 million for Capital One.
Turning to our expenditures, total operating expenses for the fourth quarter were $15.5 million compared to $11.4 million for the prior year period. Total operating expenses for 2023 were $49.1 million, up from $47.7 million during the prior year.
The net loss for the quarter and the year was approximately $6.3 million, which includes a $3.3 million one-time write-down of Omeclamox intangible assets when non-cash expenses are added back, the resulting adjusted earnings for the year were $2.4 million or $0.17 a share. Also, please note that the adjusted earnings calculations do not include the benefit of the $0.6 million of buyback of NCQ. So cost of goods during the fourth quarter, which was at $2.3 million benefit for the full 2023 year.
Those goods are received as part of each products acquisition. As a result, we're taking into account all these items, total cash flow from operations was $6 million in 2023. As a reminder, the additions of buyback of instant crusade to our product portfolio has continued to significantly 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. The financial terms for the buyback of 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. By that it was our largest acquisition, and I'm pleased to report that since we assumed responsibility for the product in late 2018, it has delivered a total cash contribution of $38.4 million to our business and therefore is now generating a return on our $25 million investment Suku, so added a total of $19 million in new assets, including approximately $4 million in inventory and $14 million of intangibles. The estimated value of those assets was $13.3 million. At the end of 2023, we provided $13.5 million at closing for the CMQ, so acquisition and there are also royalties that we pay based on the brand sales.
Since we started shipping sand Crusoe in early 2022, the product has already provided a total cash contribution of approximately $13.3 million and therefore, is expected to begin generating a return on our $14.5 million investment in 2024.
Turning to our balance sheet. As of December 31, 2023, we had $82 million in total assets, including $18 million in cash and cash equivalents. Liabilities totaled $53 million, including $12.8 million on our credit facility. Total shareholders' equity was $30 million at the end of 2023. In September 2023, we entered into a new revolving credit loan agreement with Pinnacle Bank for a three year term, the agreement provides for an aggregate principal funding amount of up to $25 billion. It provides an initial revolving credit line with $20 million event of availability and the ability of Cumberland 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 determined on a quarterly basis. We continued our corporate share repurchase program in 2023 and through the end of December, we repurchased a total of 444,000 shares. These repurchases included those on the open market as well as those needed to fund the taxes associated with employee vested restricted shares. We also continued the process of implementing new training plans for our Board members who purchased Cumberland shares throughout 2023 to increase their holdings in the Company.
Lastly, I'd like to note that Cumberland continues to hold over $51 million in tax net operating loss carry forwards, primarily resulting from the prior exercise of stock options. And that completes our financial report for the final quarter and year end of 2023. Back to you, A.J.

Thank you, John. Well, as you may recall, in 2023, we took a fresh look at our mission statement and we refined it to better capture the spirit of what we do each day here at Cumberland. Our mission is now working together to provide unique products that improve the quality of patient care. In designing this statement, we considered several factors. First, we wanted to address the constituencies we serve, which includes patients in need of care as well as the health care providers, our employees, shareholders, partners and our community. We also sought to reflect Cumberland's culture where teamwork is priced, emphasized and expected in order to achieve our goals.
Next, I needed to demonstrate our focus on developing, acquiring and distributing differentiated brands. And finally, we wanted to emphasize that the patient is at the core of everything we do. Our collective efforts are directed at providing unique products that serve as better alternatives poorly met medical needs. We remain committed to fulfilling this mission by building a portfolio of specialty pharmaceutical brands, which we do by maximizing the potential of our commercial brands, progressing our pipeline and also pursuing select acquisitions.
Overall, it was a good year and we are encouraged by the developments that we've shared with you today. It's been particularly encouraging to see the recent growth in our Kristalose business, along with the rebound in out of sales. We're excited about the expansion of our oncology sales division and the opportunity to further help cancer patients.
And we believe the special reimbursement associated with the federal no pain that can have a meaningful impact on Calloway's future growth. We're pleased to share the recent pediatric studies involving favorable results for both VIBE additive and capital or in children as well as FDA's approval of the expanded labeling for capital or to now include infants.
So with that, let's open the call to any questions you may have. Operator, please proceed.

Operator

Ladies and gentlemen, that concludes the company's presentation, and we will open the call for question. (Operator Instructions)

Question and Answer Session

Well, thank you, everyone, for joining today's call. We do understand many of you prefer a private discussion with management and if so, please just reach out and would be happy to get a call scheduled with you and hold such a discussion. As always, we appreciate your time and interest in our company, and we look forward to providing another update in the coming months.

Operator

This concludes today's program. Thank you. All for participating. You may now disconnect.