Q3 2024 Cumberland Pharmaceuticals Inc Earnings Call
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Speaker Change: Good afternoon, and welcome to the Cumberland Pharmaceuticals third quarter 'twenty 'twenty four financial report and company update this call is being recorded at the company's request and will be archived on its website for one year from today's date.
Speaker Change: I would now like to turn it over to Molly Argus accounts supervisor at the adult and agency Hill handles Cumberland Communications Mollie. Please proceed.
Molly Argus: Hello, everyone and thank you for joining us today.
Molly Argus: Earlier this afternoon Cumberland issued a press release announcing the company's financial results for the third quarter of 2020 for them as well as an operational update.
Molly Argus: The release, which includes the related financial tables can be found on the company's website at www Dot Cumberland pharma dotcom.
Molly Argus: Management will share an overview of those financial results during today's call.
Molly Argus: I'll also provide an overall company update including a discussion of Cumberland brands pipeline and partners.
Speaker Change: Participating in today's call are a J kazimi Cumberland Chief Executive Officer.
Speaker Change: Todd Anthony Vice President organizational development, and Jon Hamm, Chief Financial Officer.
Speaker Change: Please keep in mind that there are discussions may include some forward looking statements as defined in the private Securities Reform Act.
Speaker Change: These statements reflect the company's current views and expectations concerning future events and they involve risks as well as uncertainties.
Speaker Change: There are many factors that could affect Cumberland future results, including natural disasters economic downturns public health epidemics international conflicts and others that are beyond the company's control.
Speaker Change: Those issues are described under the caption risk factors in <unk> Form 10-K, and any additional updates filed with the SEC.
Speaker Change: Any forward looking statements made during today's call are qualified by those risk factors.
Speaker Change: Despite the company's best efforts actual results may differ materially from expectations.
Speaker Change: The information shared on this call should be considered current as of today only.
Speaker Change: Please remember that the company isn't responsible for updating any forward looking statements whether as a result of new information.
Speaker Change: Or due to future developments.
Speaker Change: During today's call there'll be references to several of Cumberland marketed brands.
Speaker Change: Full prescribing and safety information for each brand is included on the individual product websites and you can find links to those sites on our corporate website at www Dot Cumberland pharma Dot com.
Speaker Change: The company will also be providing some non-GAAP financial measures with respect to its performance and explanation and reconciliation to GAAP measures can be found in the financial tables of the earnings release that was issued earlier this afternoon.
Speaker Change: If you have any questions. Please hold them until the end of the column at which point, we'll be happy to answer them.
Speaker Change: Management is also prepared to hold a follow up conversation after the call if you prefer.
Speaker Change: So with that introduction I will turn the call over to Cumberland, Chief Executive Officer, a J kazimi.
Speaker Change: Thank you Molly and good afternoon to everyone. We do appreciate you joining us today as we share how the year's going.
Speaker Change: As Wally mentioned during this call we'll provide both the company update.
Speaker Change: Well as a review of our financial results for the third quarter 2024.
Speaker Change: So let's get started.
Speaker Change: A number of positive developments here at Cumberland, which we'll discuss today that bolster our optimistic view about the company's future outlook.
Speaker Change: During the quarter our line of FDA approved brands provided $9 1 million in revenue.
Speaker Change: Net revenue, which included solid performance from Crystal those.
Speaker Change: Calendar lore, and San Cuso club.
Speaker Change: Fortunately side that it was impacted by it and in order to hit about project returns by shipment delays at the end of the third quarter, all of which resulted from Hurricane Harvey.
Speaker Change: Furthermore, two manufacturing facilities supply much of our country's IV fluids were damaged by that store.
Speaker Change: Created a fluid shortage and has impacted sales of iPad has which is provided in the authorized powder it needs to be reconstituted with an IV fluid before administration.
Speaker Change: Therefore, we continue to believe our brand performance is best measured on an annual basis.
Speaker Change: Our September ending balance sheet included $77 million in total assets <unk>.
Speaker Change: $17 5 million in cash and investments.
Speaker Change: Total liabilities of $52 million and shareholders' equity of $25 million.
Speaker Change: With that financial overview I'd like to next share several updates regarding our products, including a number of growth opportunities.
Speaker Change: We continue to see that Crystal knows our prescription strength laxative performs best in states, where we have Medicaid coverage.
Speaker Change: Today I'm pleased to report several more states have now added christos to their Medicaid plans and we will work to increase awareness of that coverage.
Speaker Change: Regarding San Cuso, our oncology support medication.
Speaker Change: We introduced several new patient oriented programs with the product during the summer and we also continue to see the favorable impact of our recently expanded oncology sales.
Speaker Change: Turning next to buy bad is our potent antibiotic that features a unique dual mechanism of action specifically designed to address drug resistant bacteria.
We therefore believe that <unk> has the potential to help many patients and meet the growing global resistance crisis that was recently highlighted in a report from the World Health organization.
Speaker Change: Hi, Bert if should also benefit from the initiatives underway to register and launch the product in new International markets and in fact, the product is now approved in Saudi Arabia with launch plans are well underway for that country.
Speaker Change: We have also continued to pursue new critical data to expand the use of our products and the patients can benefit from them.
Speaker Change: For example, there are several such initiatives underway for Caldolor, our intravenous ibuprofen product approved for the treatment of pain and fever in adults and children to recently New board.
Speaker Change: We just announced the publication.
New real World outcomes research study comparing caldolor to its key competitor Ketorolac.
Speaker Change: Extensive analysis evaluated 17 million patient records and selected over 150000 adult and pediatric patients who received either caldolor to ketorolac.
Speaker Change: The results provide compelling evidence that capital orders associated with a significantly reduced incidents of adverse drug reactions and also improved health care utilization.
Speaker Change: We believe these important new findings underscore <unk> potential to improve patient care by reducing their treatment of complications.
Speaker Change: Also deliver potential savings for health care systems through decreased hospital, Readmissions and shorten treatment times.
Speaker Change: Capital doors currently approved and being sold in Australia, and South Korea.
Speaker Change: We believe there is an opportunity to increase the international contribution to our business today.
Speaker Change: Today I am pleased to announce that our newest partner in Mexico piece of pharmaceutical one of the largest established pharma companies in that country has completed the submission of the approval dossier to Mexico is the regulatory agency for the product registration in that country.
Speaker Change: So with that financial update an operational overview I'd now like to turn to Todd entity, Cumberland, Vice President organizational development to further discuss both our brands and our team Todd. Thank you a J.
Todd Cumberland: I'd like to start with an overview of our customer facing organization. We now have a total of 50 individuals across the country interacting with the medical community in support of our FDA approved medicines.
Todd Cumberland: Our sales professionals are organized into three national divisions with the hospital sales group, calling on key institutional accounts in support of Caldolor by that is our field sales division focusing on select office based physicians featuring crystal growth and our recently expanded from within oncology.
Todd Cumberland: The <unk> division.
Todd Cumberland: Cover cancer clinics promoting our St Cousar product.
Todd Cumberland: These three sales divisions are augmented by our national accounts and our field based medical teams.
Todd Cumberland: We also have two co promotional partnerships that help bring crystal those two additional physicians and their patients.
Todd Cumberland: I'd like to share some more insight regarding our brands.
Todd Cumberland: <unk> is our potent intravenous antibiotics designed for difficult to treat infections, such as hospital acquired and ventilator associated pneumonia.
Todd Cumberland: As well as complicated skin and skin structure infections caused by certain gram positive bacteria.
Speaker Change: A new report from the World Health organization, which AJ mentioned found that anti microbial resistance is becoming an urgent global health and socioeconomic crisis. Further they noted that the worldwide rise in antibiotic resistance poses a significant threat diminishing the.
Speaker Change: Effectiveness of many common antibiotics abused widespread against bacterial infections.
Speaker Change: And according to a recent article inland set the global number of deaths from anti microbial resistance is expected to reach nearly 2 million by 2050.
Speaker Change: Unlike many antibiotics that are losing the battle to fight bacteria vibe.
Speaker Change: <unk> unique dual method of action was specifically designed to address drug resistant bacteria. We therefore believe it has lifesaving potential to help many patients amid the growing antibiotic resistance crisis.
Speaker Change: To reinforce this message we are conducting a series of infectious insights discussions with infectious disease experts and disseminating the results across the country. These video vignettes share of the opportunity to use buybacks as a solution for select patient types, where other products have failed.
Speaker Change: Additionally, in June antimicrobial agents and chemotherapy published a study featuring by bad as an effective treatment for anthrax installation the most dangerous form of those infections.
Speaker Change: Researchers highlighted <unk> potential as an alternative therapy, if anthrax bacteria develop resistance to existing antibiotics.
Speaker Change: Meanwhile, recall that we launched a new smaller package for our buyback of product this summer.
Speaker Change: This additional presentation is designed to overcome a barrier at smaller hospitals and infusion centers that use less of the product at one time.
Speaker Change: Allowing them to better manage their costs and the workflow associated with the product.
Speaker Change: Now turning to our prescription strength laxative, Crystallose, which is provided in a convenient pre measured powder dose that dissolves quickly in just four ounces of water, resulting in a clear taste III and grit free solution.
Speaker Change: We continue to see strong performance in states, where we have Medicaid coverage, such as Texas, and New York and we're excited to share today that Crystal House is now also covered by certain Medicaid plans in Virginia, Louisiana and me.
Speaker Change: Also as a reminder, we recently launched a campaign featuring the American Gastroenterology Association guidelines that include Crystal House as a first line treatment option for opioid induced constipation.
Speaker Change: We believe this important recommendation will support the use of crystals in patients suffering from these side effects of opioid medications.
Speaker Change: Now, let's shift to Caldolor, our intravenous ibuprofen product in.
Speaker Change: In April we announced the publication of our special report, compiling and 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 and children and infants.
Pain management has become one of the most common health care problems in the United States and comprehensive multimodal pain regimens have become key in preventing pain and optimizing pain control.
Speaker Change: While reducing the need for opioids.
Speaker Change: A nonsteroidal anti inflammatory drug like Caldolor can provide a cornerstone for many treatment protocols. We are encouraged by the substantial database emerging from our studies in patients.
Speaker Change: Which was featured in this special report.
Speaker Change: With its new pediatric labeling cleared with the FDA last year Caldolor is the only non opioid product approved to treat pain infants that's delivered by injection.
Speaker Change: We're very pleased to have further expanded the products labeling for use in patients of nearly all ages, we are featuring caldolor through sales and marketing initiatives highlighting this new indication, resulting in growing use of the product and our country's children's hospitals.
Speaker Change: We were disappointed to learn that CMS has issued guidance that did not include caldolor as a non opioid products eligible for special Medicare reimbursement in fact, it appears that they are not going to include any new products for such coverage.
Speaker Change: We believe that the CMS position is not consistent with the intent of the no pain legislation designed to address cost barriers for non opioid products.
Speaker Change: Therefore, we will continue to advocate for <unk> coverage and evaluate alternatives for our next course of action.
Speaker Change: Recall it took several applications to obtain the FDA fee reimbursement a couple of years ago before we were successful.
Speaker Change: We will be persistent in pursuing this caldolor designation as well.
Speaker Change: Turning next to St Cuso, which is the first and only FDA approved prescription patch for the prevention of nausea, and vomiting in patients receiving certain types of chemotherapy.
Speaker Change: During the third quarter, we launched a new sampling program that broadens <unk> access to the product, allowing more patients to try think who so an experienced its benefits.
Speaker Change: We also introduced a new hub service capability to provide enhanced patient support ensuring that they received comprehensive assistance throughout their treatment journey.
Speaker Change: Meanwhile, our new manufacturing and distribution partner has successfully produced factor salt in their facility.
Speaker Change: <unk> is the first and only intravenously administered vasopressin receptor antagonist, it's used to raise serum sodium levels in hospitalized patients with hyponatremia, which is the most common electrolyte disorder. Among these patients.
Speaker Change: We look forward to re launching the brand once the FDA clears our submission to manufacture it in this new facility.
Speaker Change: That completes my updates for today, and so I'll turn it back to you a J. Thank you Todd and now I'd like to take a few minutes to provide an update on our new product development activities.
Speaker Change: Our work at Cumberland emerging technologies or CET.
Speaker Change: We continue to build a long term pipeline of innovative new biopharmaceutical products and today I'll share two recent developments among the programs CET is supporting.
Speaker Change: First <unk> is developing a new treatment for delirium.
Speaker Change: Growing neurological condition seen in hospitalized critical care patients.
Speaker Change: I'm pleased to share that enrollment has concluded and topline results are now available for the amending trial.
Speaker Change: Phase two pilot study evaluating the safety and efficacy of a new treatment for delirium and critical ill patients.
Speaker Change: The study was conducted in partnership with Vanderbilt University Medical Center and it was funded by the National Institutes of health.
Speaker Change: The primary endpoint was the safety of this new treatment, which was successfully met as it was well tolerated in these patients.
Speaker Change: The study also demonstrated that the new treatment was associated with fewer days of delirium reduced use of HSI anti psychotics opioids incentives.
Speaker Change: The decrease in patient's experience Cove us.
Speaker Change: While these efficacy results were not statistically significant given the limited number of patients treated in this pilot study. The researchers concluded that the findings were indeed clinically meaningful and support continued product development.
Speaker Change: Delirium is the most common presentation of neurologic dysfunction, and critically ill patients and it affects a sizable percentage of patients admitted to our country's intensive care units.
Speaker Change: The progression of delirium is associated with several poor outcomes, including increased length of hospital stays long term cognitive cognitive defects deficits.
Speaker Change: Additional hospital costs and impaired quality of life and even mortality.
Despite the prevalence and impact of Delirium. There are currently no FDA approved products.
Speaker Change: <unk> or treatment of this problem.
Speaker Change: Highlighting the unmet medical need for these patients.
Speaker Change: <unk> has developed a proprietary formulation of <unk>.
Speaker Change: Compound tested in this study.
Speaker Change: And the programs next steps include a potential pivotal trial that will be discussed next with the FDA.
Today I'm also pleased to announce another CET product. This one designed to locate sites of internal bleeding.
Speaker Change: The program is also in collaboration with researchers at Vanderbilt and was initially funded by a small business grant from NIH that was secured by CET.
Speaker Change: Following the initial activities design and successfully test this new product during the third quarter <unk> entered into an agreement with a corporate partner to fund all the remaining development work and then commercialize this biologic.
Speaker Change: Most clinically significant internal bleeding occurs in the gastro.
Speaker Change: In the gastrointestinal tract.
Speaker Change: Current treatment for Gi Enbridge typically involves a colonoscopy or a C T scan.
Speaker Change: However, a colonoscopy as effectiveness can be diminished if they're bleeding as an active or if theres too much blood blocking the view.
Speaker Change: And C T scans, a certain level of active bleeding to be accurate.
Speaker Change: This new technology represents a paradigm shift.
Speaker Change: That is able to identify blood clots that have already formed.
Speaker Change: <unk> for the potential to pinpoint Gi bleed sites, even after the bleeding has stopped.
Speaker Change: By precisely identifying the source of bleeding this technology could reduce the need for more invasive or repeated diagnostic procedures and that translates to faster diagnosis reduce health care costs and less physical strain on patients.
Speaker Change: The next steps in this program include scaling up product supplies, while conducting the remaining testing needed to file and obtain FDA clearance for an investigational new drug application paving the way for the initial patient study.
Speaker Change: Meanwhile, development also continues to progress our <unk> product candidate a selective thromboxane receptor antagonist through a series of clinical programs to.
Speaker Change: To date Accenture band has been administered to nearly 4800 subjects demonstrating excellent tolerability and a strong safety profile.
Speaker Change: We currently have three phase III clinical studies underway.
Speaker Change: <unk> been in patients that address unmet medical needs.
Speaker Change: Our latest program now rapidly enrolling patients at medical centers focuses on idiopathic pulmonary fibrosis. The most common for progressive fibrosis interstitial lung disease. This fighting fibrosis study.
Speaker Change: Designed to enroll a total of 128 patients and up to 20 medical centers of excellence throughout the United States.
Speaker Change: Meanwhile, enrollment is nearing completion and our two other company sponsored phase II clinical programs with our future bad debt.
Speaker Change: The first targets patients with systemic sclerosis or scleroderma.
Speaker Change: Rehabilitating autoimmune disorder characterized by widespread fibrosis of the skin and internal organs and the second is evaluating <unk> in patients with cardiomyopathy linked to duchenne muscular dystrophy, or DMD, which is a rare fatal genetic.
Speaker Change: Muscular disease it leads to the weakening of the <unk>.
Speaker Change: <unk> heart and lung muscles.
Speaker Change: Recall, we've now received over a $1 million in Grant awards for the FDA to support this muscular dystrophy study.
Speaker Change: Enrollment in the younger patient cohort has been completed and we're now working to address enrollment and the older patient group.
Speaker Change: Now recently, we applied for two FDA designation special designations for this muscular dystrophy product candidate.
Speaker Change: The first is orphan drug designation, which is granted to products that address rare orphan diseases.
Speaker Change: Today.
Speaker Change: Very pleased to announce at the FDA has granted <unk> orphan drug request for our DMD program.
Speaker Change: Such designation can result in reduced approval requirements and an expedited FDA review process waiver of FDA filing fees and an extended exclusivity after product approval.
Speaker Change: Now we've also applied for rare pediatric disease designation, which has given the products that address diseases that primarily affect children.
Speaker Change: Upon FDA approval of this designation May results in Evaluable priority review voucher from the FDA that can be used to accelerate approval of another product.
Speaker Change: And today I'm also very pleased to announce that the FDA has indeed granted this rare pediatric disease request for our <unk> DMD program.
Speaker Change: We expect to close these two at Fisher Advanced studies this year.
Speaker Change: And we then look forward to sharing results from the studies before deciding on the best development path for our future ban our first new chemical entity, which we believe has the potential to benefit many patients.
Speaker Change: So with that update on our new product development programs I'd now like to turn it over to our Chief Financial Officer, John hand to review, our third quarter financial results John Thank.
John Hand: Thank you a J for the three months ended September 32024, net revenue from continuing operations were $9 $1 million net revenue by product for the third quarter included $3 $6 million for Crystal us $2 $6 million for San Cuso, $1 3 million for <unk>.
John Hand: Caldolor and $1 million for buybacks.
John Hand: As mentioned sales during the quarter were impacted by a halt in shipments due to the hurricane.
John Hand: And there were also an inordinate amount of product returns recorded in Q3, which we do not expect to continue total year to date net revenues were $27 million year to date product revenues totaled $10 9 million for Crystal Rose $6 $6 million were seeing cuso.
John Hand: $5 $1 million for buyback and $3 6 million for Caldolor given the fulfillment of late September orders in October we continue to believe it's important to evaluate our brand performance on an annual basis, our gross margin improved during the quarter to 85%.
John Hand: Turning to our expenditures total operating expenses for the third quarter were $10 8 million a $1 million improvement over the prior year period, reflecting our efforts to reduce costs as we strive for sustained profitability.
John Hand: Year to date expenses totaled $32 million, a $1 $5 million savings from the prior year period net loss for the quarter was $1 $5 million and where the noncash expenses are added back the resulting adjusted loss was $2 $6 million or <unk> <unk> per share also.
John Hand: So please note that the adjusted earnings calculations do not include the additional benefit of the $1 million of vivat of cost of goods during the third quarter those goods represent a noncash item as they are received as part of the products acquisition.
John Hand: We're pleased to see that the additions of <unk> and <unk> to our product portfolio continue to positively impact our financial performance cash contributions from each of these brands have now exceeded their acquisition cost and therefore going forward all cash generating generated by each brand will.
John Hand: Present, a return on our investment turning to our balance sheet as of September 32024, we had 70 $676 $7 million in total assets, including $17 $5 million in cash and cash equivalents liabilities totaled $52 $3 million, including <unk>.
John Hand: $16 million on our credit facility total shareholders' equity was $24 8 million at the end of the quarter. We continue to hold a bank line of credit, which provides up to $20 million in capital and provides the ability for Cumberland to increase the amount of $25 million under certain conditions. The.
John Hand: Interest rate is based on benchmark terms sofa and is subject to our financial covenant determined on a quarterly basis. Meanwhile, we continued our corporate share repurchase program buying a total of 72000 shares during the third quarter and repurchasing 275000 shares year to do.
John Hand: These purchase 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.
John Hand: Like to note that comparable and 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 for the third quarter of 2024 back to you a J. Thank you John but overall, it's been a successful.
Speaker Change: Year to date, and we are encouraged by our progress is particularly good to see the steady performance of our crystal those business and the number of states, adding the product to their Medicaid formularies.
Speaker Change: And we continue to see the positive impact of our sales and marketing initiatives that are now supporting the growth of <unk>.
Speaker Change: We have more work to do with five out of the note that the brand will be favorably impacted by new international shipments.
Speaker Change: We also believe the recent publication of our new Caldolor clinical data can have a meaningful impact on the brand's future growth.
Speaker Change: Also encouraged with the progress of our clinical studies evaluating patients.
Speaker Change: With <unk> to address unmet medical needs in and believe it has the potential to benefit many patients and we're pleased to share the two new programs emerging from CET, including the positive top line study results for a new delivery and treatment.
Speaker Change: Well as the corporate partnership for the development of a new Gi imaging product.
Speaker Change: Lastly, I'd like to note that we have an active acquisition initiative underway as we seek select FDA approved brands to add to our portfolio and bolt on to our infrastructure as.
Speaker Change: As we move into the remainder of the year. Our dedicated team will continue in their efforts working together to provide unique products that improve the quality of patient care. Please.
Speaker Change: Please note that shipments of our brands are typically strongest in the fourth quarter and we look forward to our next report, which will provide our full year performance.
Speaker Change: With that report, let's now open the call to any questions. Operator. Please proceed.
Speaker Change: Thank you, ladies and gentlemen that Ken <unk> the.
Speaker Change: The company's presentation, and we will now open the call for any questions. If you would like to ask a question. Please press the star key on your phone followed by the digit one twice that is star one one.
To withdraw your question. Please press star one one again please.
Speaker Change: These standby.
Speaker Change: Well, if there's no questions I just want to thank everyone for joining today's call.
Speaker Change: We do understand that many of you prefer a private discussion with management.
Speaker Change: So just reach out and we'll be happy to get a call scheduled with you and hold such a discussion.
Speaker Change: And as always we appreciate your time and interest in our company and we then look forward to providing another update in the coming months.
Speaker Change: Yeah.
Speaker Change: Thank you, Sir ladies and gentlemen that concludes today's call if you'd like to listen to a replay of the discussion. Please visit the Investor Relations section on <unk> website I would like to thank you for your participation you may now disconnect.
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Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Sure.
Speaker Change: [music].
Speaker Change: [music].
Speaker Change: Yes.
Speaker Change: Thank you.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Sure.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Okay.
Speaker Change: Okay.
Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: Okay.
[music].
Speaker Change: Okay.
Speaker Change: [music].
Speaker Change: Yeah.