Q1 2024 Cumberland Pharmaceuticals Inc Earnings Call
Operator: Good afternoon, and welcome to Cumberland Pharmaceutical's 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 one 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. Mollie, please go ahead.
Good afternoon, and welcome to Cumberland Pharmaceuticals, first quarter, 'twenty 'twenty, four financial report and company update.
Molly Aggas: This call is being recorded at Cumberland request and will be archived on the company's website for one year from today's date.
Molly Aggas: I would now like to turn it over to Molly I guess.
Molly Aggas: Supervisor at adult and agency, who handles Cumberland communications.
Molly Aggas: Please go ahead.
Molly Aggas: Hello, everyone. Thanks for joining us today.
Molly Aggas: Hello, everyone and thanks for joining us today.
Molly Aggas: This afternoon umbrella and issued a press release announcing the company's financial results with an operational update for the first quarter of 'twenty 'twenty four.
Molly Aggas: This afternoon, Cumberland issued a press release announcing the company's financial results and 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. Kazemi, Cumberland's Chief Executive Officer. Anthony, Vice President of Organizational Development, and John Hamm, Chief Financial Officer.
Molly Aggas: The release, which includes the related financial tables can be found on the company's website at www Dot Cumberland pharma dotcom.
Molly Aggas: Management will share an overview of those financial results during today's call.
Molly Aggas: Also provide an overall company update including a discussion of Cumberland brand pipeline and partners.
Molly Aggas: Participating in today's call are a J kazimi Cumberland Chief Executive Officer.
Molly Aggas: Anthony Vice President organizational development, and Jon Hamm, Chief Financial Officer.
Molly Aggas: Please keep in mind that their discussions may include forward-looking statements as defined in the Private Securities Reform Act. Those 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.
Molly Aggas: Please keep in mind that their discussion may include forward looking statements as defined in the private Securities Reform Act.
Molly Aggas: These statements reflect the company's current views and expectations concerning future events and may involve risks and uncertainties.
Molly Aggas: There are many factors that could affect <unk> future results, including natural disasters economic downturns public health epidemics international conflicts and others that are beyond the company's control.
Molly Aggas: Those issues are described under the caption Risk Factors and Cumberland's Form 10-K and any additional updates filed with SE. 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.
Molly Aggas: Those issues are described under the caption risk factors in Cumberland Form 10-K, and any additional updates filed with SEC.
Molly Aggas: Any forward looking statements made during today's call are qualified by those risk factors.
Molly Aggas: 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.
Molly Aggas: 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.
Molly Aggas: Please remember that the company is responsible for updating any forward looking statements, whether as a result of new information or due to future developments.
Molly Aggas: During today's call. There will also be references to several of Cumberland 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 Dot Cumberland pharma Dot com.
Molly Aggas: 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. Kazemi.
Molly Aggas: The company will be providing some non-GAAP financial measures with respect to its performance.
Molly Aggas: An explanation and reconciliation to GAAP measures can be found in the financial tables of the earnings release that was issued earlier this afternoon.
A.J. Kazemi: If you have any questions. Please hold them until the end of the call at which point, we'll be happy to answer them.
Molly Aggas: Management is also prepared to hold a follow up conversation after the call if you prefer.
A.J. Kazemi: With that introduction I'll turn the call over to Cumberland, Chief Executive Officer, a J kazimi.
A.J. Kazemi: Thank you, Molly, and good afternoon, everyone. We appreciate you joining us today as we share how the year has gone so far. As Polly mentioned during today's call, we'll provide a company update and a review of our financial results for the first quarter ending March 31st, 2024. The first quarter came in generally as expected, given the backdrop of a higher interest rate environment and the typical first quarter consumer buying pattern.
A.J. Kazemi: Thank you Mollie and good afternoon, everyone. We appreciate you joining us today as we share how the year has gone so far.
A.J. Kazemi: As Paul you mentioned during today's call, we'll provide a company update and reviews, our financial results for the first quarter ending March 31 2024.
A.J. Kazemi: The first quarter came in generally as expected given the backdrop of a higher interest rate environment and typical first quarter consumer buying patterns.
A.J. Kazemi: Recall that our first quarter sales are usually lighter as patients work through their new insurance deductibles before purchasing more expensive medicine. 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.
A.J. Kazemi: Call. Our first quarter sales are usually lighter as patients work through their new insurance deductibles before purchasing more expensive medicines.
A.J. Kazemi: Also our sales in Q1 this year were impacted by wholesaler buying patterns, which do fluctuate during the year.
A.J. Kazemi: However, it's important to note.
A.J. Kazemi: The overall demand for our brands was steady during the period.
A.J. Kazemi: That reason, we believe it's best to evaluate our financial performance on an annual basis.
A.J. Kazemi: 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.
A.J. Kazemi: We remain very optimistic about our company's fundamentals and future given the number of ongoing positive developments, which will elaborate on during todays call.
A.J. Kazemi: And finally, we believe we are still on track to post double digit revenue growth and positive cash flow from operations in 2024.
A.J. Kazemi: You see Camilla his build a portfolio of FDA approved brands with outstanding safety and efficacy profiles that can make a difference in patients' lives.
A.J. Kazemi: These are valuable brands with attractive margins.
A.J. Kazemi: 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. 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 within the medical community.
A.J. Kazemi: 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.
A.J. Kazemi: Our resulting diversified product line has enabled us to weather external challenges, while our team remains responsive to the evolving marketplace.
A.J. Kazemi: Next I'd like to share several updates regarding our products, including a number of growth opportunities.
A.J. Kazemi: We're implementing a strategy to increase the overall awareness of our products and their attributes throughout the medical community.
A.J. Kazemi: 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 Caudillor, 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 Caudillor in 2023 to include its use in patients from three Additionally, recall that the federal No Pain Act was passed last year, which is designed to provide special, favorable reimbursement for non-opioid products like Caldolor.
A.J. Kazemi: Mark.
A.J. Kazemi: <unk> 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 IV <unk> as a standard of care for the treatment of pain and fever in.
A.J. Kazemi: <unk> children and infants.
A.J. Kazemi: A reminder, FDA approved expanded labeling for <unk> in 2023 to include its use in patients from three to six months of age.
A.J. Kazemi: Additionally, recall that the federal no pain Act was passed last year, which desk ignite which is designed to provide special favorable reimbursement for non opioid products like caldolor.
A.J. Kazemi: We look forward to learning more this year regarding CalDelure's inclusion and reimbursement in preparation for the app's implementation in early 2025. This could be a very meaningful revenue growth opportunity for Cal Delore. 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 at 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.
A.J. Kazemi: We look forward to learning more this year regarding <unk> inclusion and reimbursement in preparation for the <unk> implementation in early 2025.
A.J. Kazemi: This could be a very meaningful revenue growth opportunity for caldolor.
A.J. Kazemi: Regarding vibe that is our potent antibiotic.
A.J. Kazemi: We're pleased to announce the launch this quarter of new product packaging.
A.J. Kazemi: Additional presentation is designed to overcome the barrier is 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.
A.J. Kazemi: Turning to Crystalose, 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. 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.
A.J. Kazemi: Turning to Chris <unk>, 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 saying cuso through our recently expanded oncology sales division in order to support patients.
A.J. Kazemi: Helping address certain side effects associated with their chemotherapy cancer treatments.
A.J. Kazemi: And Additionally, we continue to work with partners in their efforts to advance our potent antibiotic feed additive in several international markets, which can contribute to the brand's growth in the future.
A.J. Kazemi: Tabook Pharmaceuticals has obtained final approval for Vybative in Saudi Arabia and will next be discussing with them their plans for the product in that market. And Skyclone Pharmaceuticals, our partner for the Chinese market, continues to respond to regulatory inquiries there as they seek approval for Vybative in their country. DB Farm, our partner in South Korea who also distributes Caldor there, did receive an update during the first quarter on their submission to approve and distribute Phi Beta in their country.
A.J. Kazemi: To book Pharmaceuticals has obtained final approval <unk> in Saudi Arabia, and we will next be discussing with them their plans for the product in that market.
A.J. Kazemi: Sky Crone pharmaceuticals, our partner for the Chinese market continues to respond to the regulatory inquiries there as they seek approval for <unk> in their countries.
A.J. Kazemi: DB Pharm partner in South Korea, who also distributes caldolor there did receive an update during the first quarter on their submission to approve and distribute five added in their country.
A.J. Kazemi: The Korean regulatory authorities did not yet approve the submission and indicated that some additional manufacturing information would be required and will work with DVFARM 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 of Organizational Development, to discuss our team and our brands.
A.J. Kazemi: The Korean regulatory authorities did not yet approved the submission and indicated that some additional manufacturing information that will be required and we will work with D V far to address.
Todd M. Anthony: Regarding our financial performance during the first quarter, we recorded $8 $5 billion in net revenues and again overall demand for our brands was steady during the period and we therefore continue suggest evaluating our performance on an annual basis, so with that overview.
Todd M. Anthony: I'd now like to turn to Todd Anthony Cumberland, Vice President organizational development to discuss our team and our branch Todd. Thank you AJ 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.
Todd M. Anthony: Thank you, AJ. In March, we hosted our Spring National Sales Meeting here in Nashville as we launched new marketing initiatives and equipped our sales teams in their efforts to build our brand. 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 clinics.
Todd M. Anthony: Our brands.
Todd M. Anthony: 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.
Todd M. Anthony: Cumberland oncology focuses on cancer clinics.
Todd M. Anthony: I'd now like to share an update on each of our major brands. Starting with Vibative, 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 Vibative in children 2 to 17 years of age. The results of the study suggest that a single dose of Vibativ is safe in children and that they experience a reduced exposure to Vibativ compared with the same body weight-based dose in adults.
Todd M. Anthony: I would now like to share an update on each of our major brands.
Todd M. Anthony: Starting with <unk> recall that last year, we announced a new publication and antimicrobial agents and chemotherapy detailing the results of the first clinical study investigating the safety and pharmacokinetics of buyback in children two to 17 years of age.
Todd M. Anthony: The results of this study suggests that a single dose of iPad, if it's safe in children.
Todd M. Anthony: And that they experienced reduced exposure to vivat, if compared with the same body weight based dosing in adults.
Todd M. Anthony: 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 therapy. 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.
Todd M. Anthony: By bad as an intravenous antibiotic approved by the FDA for the treatment of hospital acquired and ventilator associated bacterial pneumonia.
Todd M. Anthony: As well as complicated skin and skin structure infections caused by certain gram positive bacteria.
Todd M. Anthony: Anti microbial resistance continues to pose a significant challenge in the treatment of bacterial infections, which necessitates the development of new antibiotic therapies.
Todd M. Anthony: 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.
Todd M. Anthony: <unk> was specifically designed to kill drug resistant bacteria.
Todd M. Anthony: Additionally, as AJ 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 Chrysalose, our prescription strength laxative packaged in a convenient pre-measured powder dose that dissolves quickly in just four ounces of water for a clear, taste-free, and grit-free solution. Crystallose continues to be our largest selling product and is benefiting nicely from the support of our two co-promotion partners.
Todd M. Anthony: Additionally, as a J mentioned, we are launching a new package for the product this quarter.
Todd M. Anthony: 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.
Todd M. Anthony: Moving next to Crystal lows, our prescription strength laxative packaged in a convenient pre measured powder dose that dissolves quickly in just four ounces of water for a clear taste free and grit free solution.
Todd M. Anthony: <unk> continues to be our largest selling product and is benefiting nicely from the support of our two co promotion partners.
Todd M. Anthony: Moreover, we found that the brand performs best in states where we have Medicaid coverage. New York State recently added Crystalose to its Medicaid formulary, and we are implementing a special initiative to increase our presence and share a voice in this market. We believe that this new coverage is contributing to the growth of the product.
Todd M. Anthony: Moreover, we found that the brand performs best in states, where we have Medicaid coverage, New York State recently added crystals to its Medicaid formulary and we are implementing a special initiative to increase our presence and share of voice in this market.
Todd M. Anthony: We believe that this new coverage is contributing to the growth of the product.
Todd M. Anthony: Moving now to Calvilor, our intravenous ibuprofen product. As AJ mentioned, we recently shared a special report evaluating the growing amount of data supporting the use of Calvilor 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 ibuprofen results in significant reductions in temperature compared to placebo in adults and to acetaminophen in pediatric patients.
Todd M. Anthony: Shifting now to Caldolor, our intravenous ibuprofen product.
Todd M. Anthony: 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 and children and infants as young as three months of age.
Todd M. Anthony: Takeaways from this special report include.
Todd M. Anthony: That intravenous ibuprofen results in significant reductions in temperature compared to placebo in adults and to acetaminophen in pediatric patients.
Todd M. Anthony: Also, administration of the product prior to surgery leads to patients waking up with significantly less post-surgical 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.
Todd M. Anthony: So administration of the product prior to surgery leads to patients waking up and significantly less post surgical pain, while also lessening or even eliminating the need for opioids.
Todd M. Anthony: The use of intravenous ibuprofen in the hospital emergency Department for acute pain can also minimize opioid requirements, while achieving significant pain control.
Todd M. Anthony: Finally, Cavalor 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 non-steroidal anti-inflammatory drug, such as Calvilor, 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.
Todd M. Anthony: Finally capital or should be considered a foundation for any multimodal pain regimen.
Todd M. Anthony: 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 and preventing pain.
Todd M. Anthony: And optimizing pain control, while minimizing the need for opioids.
Todd M. Anthony: A nonsteroidal anti inflammatory drugs, 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.
Todd M. Anthony: 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 Calvilorin in newborns.
Todd M. Anthony: 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.
Todd M. Anthony: The new indication was further supported by the publication of positive results from our clinical study.
Todd M. Anthony: <unk>, the safety and pharmacokinetics of Caldolor in newborns.
Todd M. Anthony: 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 Caldor will be eligible for special Medicare reimbursement under the new opioids 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 used to manage pain during surgeries conducted in both hospital outpatient departments as well as ambulatory surgical centers.
Todd M. Anthony: 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.
Todd M. Anthony: Additionally, we expect Caldolor will be eligible for special Medicare reimbursement under the new non opioids prevent addiction in the nation or no pain legislation, which was enacted as part of the consolidated Appropriations Act of 2023.
Todd M. Anthony: There are no pain act requires Medicare to provide separate and more favorable reimbursement for non opioid product used to manage pain. During surgeries conducted in both hospital outpatient departments as well as ambulatory surgical centers.
Todd M. Anthony: 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 Caldellor. The CMS requested that manufacturers with potentially applicable non-opioid products submit comments with supporting clinical evidence regarding products that could 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 CalDELOR should be included and separately reimbursed.
Todd M. Anthony: This legislation applies in part to products that are indicated to provide analgesia without acting upon the bodies opioid receptors.
Todd M. Anthony: As a result, we do expect that the no pain act will affect Medicare reimbursement for Caldolor.
Todd M. Anthony: The CMS requested that manufacturers with potentially applicable non opioid products submit comments is supporting clinical evidence regarding products that could be eligible for separate payment.
Todd M. Anthony: We submitted a comment letter along with the requisite clinical information to the CMS in September of 2023, explaining why caldolor should be included in separately reimbursed.
Todd M. Anthony: 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 1st 2025 and January 1st 2028. Moving on to Sancuso, a new facility was approved by the FDA, and we have completed the manufacturing of Cumberland packaged products there. We will be launching these new supplies of our Cumberland-branded products this year.
Todd M. Anthony: We now await information from CMS regarding the reimbursement status and the pricing for the product.
Todd M. Anthony: The act is schedule to go into effect in early 2025, and we will initially apply to products that are furnished between January one 2025 and January one 2028.
Todd M. Anthony: Moving onto same cuso.
Todd M. Anthony: Our new facility was approved by the FDA and we have completed the manufacturing of Cumberland packaged product there.
Todd M. Anthony: We will be launching these new supplies of our Cumberland branded products this year.
Todd M. Anthony: We are supporting the product through our expanded Oncology Sales Division to help cancer patients by addressing certain side effects associated with their chemotherapy treatment, 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 the compounded product in support of critically ill patients. Vaprosol is the first and only intravenously administered vasopressin receptor antagonist, and it's used to raise serum sodium levels in hospitalized patients with hyponatremia, which is the most common electrolyte disorder among such patients.
Todd M. Anthony: We're supporting the product through our expanded oncology sales division to help cancer patients by addressing certain side effects associated with their chemotherapy treatments and.
Todd M. Anthony: And we're already seeing a favorable impact from the expanded sales division, which we plan to build upon to increased customer frequency and reach.
Todd M. Anthony: Meanwhile, our new manufacturing and distribution partner for Viper Sol has successfully produced the product in their facility.
Todd M. Anthony: 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.
Todd M. Anthony: <unk> is the first and only intravenously administered vasopressin receptor antagonist and its used to raise serum sodium levels in hospitalized patients with hyponatremia, which is the most common electrolyte disorder among such patients.
Todd M. Anthony: This completes my updates for today, and so I'll turn it back to you, AJ.
Speaker Change: This completes my updates for today, and so I'll turn it back to you a J. Thank.
A.J. Kazemi: 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 patients' quality of life. Our IFITRABAN 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.
Speaker Change: Thank you Todd.
A.J. Kazemi: 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.
A.J. Kazemi: Our <unk> product candidate, which is our first new chemical entities is being evaluated in a number of phase III clinical trials for patients with a series of unmet medical needs. It's now been dosed in over 1400 subjects and it's been found to be safe and well tolerated and those individuals.
A.J. Kazemi: 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 ifitriban 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 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.
A.J. Kazemi: We've initiated our newest clinical program and medical centers across the country and enrollment has now begun in patients with pulmonary fibrosis. The most common form of progressive fibrosis interstitial lung disease.
A.J. Kazemi: This fighting fibrosis study is designed to enroll 128 patients in over 20 medical centers of excellence across the United States.
A.J. Kazemi: And recent studies have shown that <unk> can help both prevent and enhance resolution of lung fibrosis in multiple preclinical models.
A.J. Kazemi: 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 inter.
A.J. Kazemi: And the other study is evaluating IFITRA ban 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 FITE-DMD trial, which is a multicenter, randomized, placebo-controlled phase 2 study that is actively enrolling patients across 10 centers in Also note we've received over a million dollars now in grant awards from the FDA to support this study.
A.J. Kazemi: Oregon's.
A.J. Kazemi: And the other study is evaluating <unk> in patients with the 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, where.
A.J. Kazemi: We're sponsoring that fight DMD trial, which is a multicenter randomized placebo controlled phase III study, which is actively enrolling patients across 10 centers in the United States with those centers specializing in DMD.
A.J. Kazemi: Also note we have received over $1 million now in Grant awards from the FDA to support this study.
A.J. Kazemi: 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 IFITRABAN 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 ongoing studies as they emerge. And then deciding on the best path for IFITRABAN, the best development path for IFITRABAN, 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.
A.J. Kazemi: Enrollment in the younger patient group is complete and we're now working to finish enrollment in the older patient cohort of this study.
John Michael Hamm: In addition to these company sponsored studies there are several other preclinical and pilot studies of <unk> underway, including several investigator initiated trials.
John Michael Hamm: We do expect to have data available this year and we look forward to them sharing the results from these studies underway.
John Michael Hamm: As they emerge and then deciding on the best path for our future band the best development path for <unk>, which we believe has the potential to benefit many patients.
John Michael Hamm: So with that update on our clinical studies I'd now like to turn it over to our Chief Financial Officer, Jon Hamm to review, our first quarter financial results shot. Thank you a J for the three months ended March 31, 2024, net revenue from continuing operations were $8 $5 million net revenue.
John Michael Hamm: Thank you, AJ. For the three months ended March 31st, 2024, net revenue from continuing operations was $8.5 million. Net revenue by product for the first quarter of 2024 included $3.2 million for Crystallos, $1.8 million for Ciancuso, $1.6 million for ViBATF, and $1.5 million for Caldelon. Turning to our expenditures, total operating expenses for the first quarter were $10.4 million. The net loss for the quarter was $1.9 million, and when the non-cash expenses are added back, the resolving loss was $0.6 million.
John Michael Hamm: By product for the first quarter of 2024 included $3 $2 million for Crystal us $1 $8 million for San Cuso, $1 6 million provide battles and $1 5 million for Caldolor turning to our expenditures total operating expenses for the first quarter were $10 four.
John Michael Hamm: Net loss for the quarter was $1 $9 million and when the noncash expenses are added back to resolving loss was <unk> $6 million also please note that the adjusted earnings calculations do not include the additional benefit of the <unk> $5 million.
John Michael Hamm: Also, please note that the adjusted earnings calculations do not include the additional benefit of the $0.5 million of Vybatov 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 Vybatov and Sancuso to our product portfolio continue to positively impact our financial statements. As a result of the Vybatov 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 Vybatov transaction included a $20 million payment upon closing and a subsequent $5 million milestone payment.
John Michael Hamm: The buyback cuso cost of goods during the first quarter. So those goods are received as part of each products acquisition.
John Michael Hamm: As a reminder, the additions of <unk> and <unk> to our product portfolio continue to positively impact our financial statements. As a result of the <unk> acquisition, a total of $34 million in new assets were added including approximately $21 million in inventory $12 million of.
John Michael Hamm: Intangible assets and $1 million of goodwill the financial terms for the Vivat transaction included a $20 million payment upon closing and the subsequent $5 million milestone payment. We also continue to provide royalties tied to product sales by battery was our largest acquisition and I'm pleased to rip.
John Michael Hamm: We also continue to provide royalties tied to product sales. Vybatov was our largest acquisition, and I'm pleased to report that since we assumed responsibility, 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.
John Michael Hamm: Port it since we assumed 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.
John Michael Hamm: So <unk> 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 <unk> acquisition.
John Michael Hamm: We provided $13.5 million at closing for the Sancuso acquisition, and we also paid $1.5 million in milestone payments. Additionally, 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 a 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.
John Michael Hamm: 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 <unk> in early 2022. The product has provided a total cash contribution of approximately $14 $8 million and therefore as <unk>.
John Michael Hamm: Spector 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 $90 million in cash and cash equivalents liabilities totaled $54 million, including 16 million.
John Michael Hamm: Royalties 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 to $25 million under certain conditions. The interest rate is based on the benchmark term SOFR and is subject to one financial covenant to be determined on a quarterly basis.
John Michael Hamm: 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 <unk> to increase the amount of $25 million under certain conditions. The interest rate is based on benchmark.
John Michael Hamm: Terms. So it is subject to one financial covenant are determined on a quarterly basis. During the first quarter. We continued our corporate share repurchase program buying a total of 126000 shares these repurchases, including those on the open market if those needed to fund the taxes associated with employee.
John Michael Hamm: 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 carry-forwards, primarily resulting from the prior exercise of stock options. And that concludes our financial report for the first quarter of 2024. Back to you, AJ.
John Michael Hamm: <unk> 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 would like to note that covenant continues to hold over $52 million in tax net operating loss carry.
AJ: Forwards, 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.
A.J. Kazemi: 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 Directors.
A.J. Kazemi: As well as updated sustainability metrics you can find a copy of the report on our website under the Investor Relations tab.
A.J. Kazemi: We also recently held our annual shareholder meeting.
A.J. Kazemi: All of the proposals presented in our proxy were approved including the redeployment of Martin Brown and James Jones as cover Lin Board of directors overall, it's been a productive start to the year.
A.J. Kazemi: 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 a portfolio of FDA-approved brands with outstanding safety and advocacy 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 Vybative. We're optimistic about the opportunity to further expand the use of Crystallose in the growing number of states where the product is favorable Medicaid coverage.
A.J. Kazemi: We remain dedicated to our mission of working together to provide unique products that improve the quality of patient care.
A.J. Kazemi: And we're doing that by building a portfolio of FDA approved brands with outstanding safety and efficacy profiles that can truly make a difference in patients' lives.
A.J. Kazemi: We're particularly encouraged to see the impact of our sales and marketing initiatives that are supporting <unk> and <unk>.
A.J. Kazemi: We're optimistic about the opportunity to further expand the use of crystal lows and the growing number of states, where the product is favorable Medicaid coverage.
A.J. Kazemi: We're pleased to share this 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 No Pain Act can have a meaningful impact on Cal Delors' future growth, and we look forward to providing updates on our further developments as the year progresses.
A.J. Kazemi: We're pleased to share the special report.
A.J. Kazemi: 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 calendar the words labeling to the youngest of patients.
A.J. Kazemi: We also believe this special reimbursement associated with the no pain Act can have a meaningful impact on <unk> future growth and we look forward to providing updates on our further developments as the year progresses.
A.J. Kazemi: So that concludes our remarks, and let's open the call to any questions you may have. Operator, please proceed. Thank you, sir.
Speaker Change: So that concludes our remarks and let's open the call to any questions. You may have operator. Please proceed.
Operator: 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 it. [inaudible] Hold on, please. I'm seeing an error now. I had a question from Evan, and I apologize it is now not showing.
Operator: Thank you, sir. Ladies and gentlemen, that concludes the company's presentation, and we will now open the call for any questions. If you'd like to ask a question, please press the star key on your phone, followed by the digit 1 twice. That's star one one, will hold, please, for any questions.
Operator: Well, thank you, everyone. Go ahead, sorry. Oh, go ahead. I was just going to turn it back to management for any.
Speaker Change: Thank you, Sir ladies and gentlemen that concludes the company's presentation and we will now open the call for any questions if you'd like to ask a question. Please press the star key on your phone followed by the digit one twice.
Operator: At Star one one.
Operator: Well hold please for any questions.
Operator: Okay.
Operator: Okay.
Operator: Well, thank you everyone.
Speaker Change: Go ahead, sorry go ahead.
Operator: Ill turn it back to management for any closing remarks or would you have a question that Jeff.
Speaker Change: Hey, Matt let me move them.
Operator: Good question.
Speaker Change: Your line please.
Speaker Change: Zane and are now I had a question from.
Operator: And I apologize it is now nationally.
A.J. Kazemi: 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 follow up and answer any questions you have and have 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.
A.J. Kazemi: 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.
A.J. Kazemi: 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 the investor relations section on Cumberland's website. I'd like to thank you for your participation, and you may now disconnect.
Speaker Change: 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 <unk> website.
Operator: I'd like to thank you for your participation and you may now disconnect.
Operator: Yes.
Operator: Yes.
Operator: Okay.
Operator: Okay.
Operator: [music].
Operator: Yes.
Operator: Yeah.
Operator: Okay.
Operator: Okay.
Operator: Okay.
Operator: Okay.
Operator: Okay.
Operator: [music].
Operator: Okay.
Operator: Okay.
Operator: Sure.
Operator: Okay.
Operator: Okay.
Operator: Okay.
Operator: [music].
Operator: Okay.
Operator: [music].
Operator: Okay.
Operator: No.
Operator: Okay.
Operator: [music].
Operator: Yes.
Operator: Okay.
Operator: Okay.
Operator: [music].
Operator: Okay.
Operator: Okay.
Operator: Okay.
Operator: Okay.
Operator: Sure.
Operator: Yeah.
Operator: Yes.
Operator: Yes.
Operator: Okay.
Operator: Okay.
Operator: Okay.
Operator: Okay.
Operator: Okay.
Operator: [music].
Operator: Okay.
Operator: [music].
Operator: Okay.