Q3 2023 Cumberland Pharmaceuticals Inc Earnings Call

Speaker 1: Good afternoon and welcome to Cumberland from Asciuticals, Third quarter, 2023 company update and financial report. This call is being recorded at Cumberland's request and will be archived at the company's website for one year from today's date.

Good afternoon, and welcome to Cumberland Pharmaceuticals, third quarter, 2023 company update and financial report.

This call is being recorded at Cumberland to request and will be archived on the company's website for one year from today's date.

Speaker 1: I would now like to turn it over to Molly Agus, a Council supervisor at the Dalton Agency who handles Comberland Communications. Molly.

I would now like to turn it over to Molly I guess.

Supervisor at the adult and agency, who handles Cumberland Communications Mollie.

Molly Please go ahead.

Speaker 2: Hello everyone, good afternoon. Thanks for joining today's call.

Hello, everyone. Good afternoon, thanks for joining today's call.

Speaker 2: Earlier today, Cumberland issued a press release announcing the company's financial results with an operational update for the third quarter ending September 30, 2023. The release, which includes the related financial tables, can be found on the company's website at www.CumberlandFarma.com.

Earlier today Cumberland issued a press release announcing the company's financial results with an operational update for the third quarter ending September 30th 2023.

Release, which includes the related financial tables can be found on the company's website at www Dot Cumberland farm on Dot com.

Speaker 2: During today's call, management will share an overview of those financial results. They'll also provide an overall company update, including a discussion of its brand pipeline and partners.

During today's call management will share an overview of those financial results.

To provide an overall company update including a discussion of its brand pipeline and partners.

Speaker 2: Participating in today's call or AJ Kazini, Cumberland's Chief Executive Officer, Todd Anthony, Vice President, Organizational Development, and John Hamm, Chief Financial Officer.

Participating in today's call are a J Kazimi Cumberland, Chief Executive Officer, Todd Anthony Vice President organizational development, and Jon Hamm, Chief Financial Officer.

Speaker 2: Please keep in mind that their discussions may include forward-looking statements as defined in the Private Security's Reform Act. Those statements reflect the company's current views and expectations concerning future events, and they involve risks and uncertainties.

Please keep in mind that there are 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 they involve risks and uncertainties.

Speaker 2: 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.

There are many factors that could affect Cumberland feature 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 Form 10-K, and any additional updates filed with the SEC.

Speaker 2: Any forward-looking statements made during today's call are qualified by those risks.

Any forward looking statements made during today's call are qualified by those risk factors.

Speaker 2: 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 on the...

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 only.

Speaker 2: Please remember that the company isn't responsible for updating and forward-looking statements, whether as a result of new information or due to future development.

Please remember that the company is it responsible for updating its forward looking statements, whether as a result of new information or due to future developments.

Speaker 2: During today's call, there will be references to several of Cumberland's marketed brands. Full prescribing and safety information for each brand is included on the individual product websites. In the links to those sites can be found on the corporate website at www.cumberlandfarmla.com.

During today's call there'll be references to several of Cumberland marketed brands full prescribing and safety information for each brand is included on the individual product websites and the like.

Thanks to those sites can be found on our corporate website at www Dot Cumberland farms Dot com.

Speaker 2: The company will also provide some non-GAAP financial measures with respect to performance. An explanation and reconciliation to GAAP measures can be found in the financial tables of the earnings release that was issued earlier today.

The company will also provide some non-GAAP financial measures with respect to performance and explanation and reconciliation to GAAP measures can be found in the financial tables of the earnings release that was issued earlier today.

Speaker 2: If you have any questions, please hold them until the end of the call, at which point we'll be happy to answer them.

If you have any questions. Please hold them until the end of the call at which point, we'll be happy to answer them.

Speaker 2: Management is also prepared to hold a follow-up conversation after the call if that's your press.

Management also prepared to hold a follow up conversation after the call if that's your preference.

Speaker 2: So without overview, I'll turn the call over to Cumberland's Chief Executive Officer, AJ Kazumi.

With that overview I'll turn the call over to Cumberland, Chief Executive Officer, a J kazimi.

Speaker 3: Thank you, Molly, and good afternoon, everyone. I do have a slight cough today, so please bear with me. We appreciate you taking the time to join us today as we share how the year is going.

Thank you Mollie and good afternoon, everyone I do have a slight cough today. So please bear with me. We appreciate your taking the time to join US today as we share how the year's going.

Speaker 3: As Molly mentioned, during today's call, we'll provide both a company update as well as a review of our financial results for the third quarter of 2023.

As Mollie mentioned during todays call will provide both a company update as well as a review of our financial results for the third quarter 2023.

Speaker 3: I'd like to start by mentioning that we've recently refined our mission statement to better capture the spirit of what we endeavor to do here each day at Cumberland. And now, Reese's follows working together to provide unique products that improve the quality of patient care.

I'd like to start by mentioning that we've recently refined our mission statement to better capture the spirit of what.

We endeavored to do here each day at Cumberland.

Now reads as follows working together to provide unique products that improve the quality of patient care.

Speaker 3: In designing this statement, we took into account several factors. First, we wanted a mission that's designed to address the constituents we serve, which include the patients in need of care, health care providers, our employees, our shareholders, our partners, and our community.

In designing the statement we took into account several factors.

First we wanted a mission that's designed to address the constituents, we serve which include the patients in need of care health care providers, our employees, our shareholders our partners and our community.

Speaker 3: We also wanted to reflect cumberland's culture. Where teamwork is prized, emphasized, and expected in order to achieve our goals. Next, it needed to demonstrate our focus on developing, acquiring, and distributing differentiated brands. And finally, it emphasizes that the patient is at the core of everything we do.

We also wanted to reflect Cumberland as culture, where teamwork is prized emphasized unexpected in order to achieve our goals.

Next it needed to demonstrate our focus on developing acquiring and distributing differentiated brands and finally it emphasizes that the patient is at the core of everything we do.

Speaker 3: our collective efforts are directed at providing better alternatives for poorly met medical needs.

Our collective efforts are directed at providing better alternatives for poorly met medical needs.

Speaker 3: Our hope is that everyone across our organization will embrace our newly refined mission statement and use it not only as an inspiration but also as a guide in supporting the achievement of our goals.

Yeah.

Our hope is that everyone across our organization, we will embrace our newly refined mission statement and use it not only as an inspiration but also as a guide and supporting the achievement of our goals.

Speaker 3: Our strategy for fulfilling this mission is to build a portfolio of specialty pharmaceutical brands.

Our strategy for fulfilling this mission is to build a portfolio of specialty pharmaceutical brands.

Speaker 3: Our San Tuso patch is the only FDA-approved prescription patch for the prevention of certain side effects in oncology patients receiving chemotherapy treatment.

On a few.

Cuso patch is the only FDA approved prescription patch for the prevention of certain side effects college, he patients receiving chemotherapy treatment.

Speaker 3: Caldolores, the only injectable therapy approved in the US for the treatment of both pain and fever in a wide range of patients that includes children, adults, and now newborns. And crystalose is the only branded prescription laxative that combines the established safety and efficacy of lactulose with the convenience and portability of a pre-measured dose.

<unk> is the only injectable therapy approved in the U S for the treatment of both pain and fever in a wide range of patients that includes children and adults now newborns.

Christa alone is Crystal house as the only branded prescription laxative that combines the established safety and efficacy of Lactulose with the convenience and portability of a pre measured dose.

Speaker 3: So now as we reflect on the progress we've made throughout 2023, we are pleased to share a number of exciting updates and growth opportunities for our product portfolio.

So now as we reflect on the progress we've made throughout 2023, we are pleased to share a number of exciting updates and growth opportunities for our product portfolio.

Speaker 3: For example, we continue to work with our partners in their efforts to register and launch FIBATIVE in several international markets, which will provide significant future catalyst for the brand.

For example, we continue to work with our partners and their efforts to register and launch side that is in several international markets, which should provide significant future catalyst for the brand.

Speaker 3: To book pharmaceuticals has updated by by bad of approval in Saudi Arabia with new manufacturing information as they plan to introduce the product into the Middle East.

To book Pharmaceuticals, as updated by brands like that its approval in Saudi Arabia.

With me manufacturing information as they plan to introduce the product into the middle East.

Speaker 3: DB Farm, our partner in South Korea, who also distributes a cow to lore, is awaiting the approval of a bad of in their country. And Skycloan pharmaceuticals, our bad of partner for the Chinese market, has continued to respond to regulatory inquiries as they seek approval in their country.

D V farm, our partner in South Korea, who also distributes caldolor is awaiting the approval of that in.

In their country.

And Sky cone pharmaceuticals provide data partner for the Chinese market has continued to respond to regulatory inquiries.

Seek approval in their country.

Speaker 3: We now await the approval of these three initiatives and look forward to launch of our product in those markets.

We now await the approval of these three initiatives and look forward to launch of our product in those markets.

Speaker 3: We recently announced the publication of positive results from a clinical study investigating the safety and pharmacokinetics of our Caldwell or product in newborns, which supported the brand's FDA approval in infants of three to six months of age. And we're thrilled to further expand Caldwellers labeling the youngest of patients.

We recently announced the publication of positive results from our clinical study investigating the safety and pharmacokinetics of Caldolor product in newborns, which supported the brand's FDA approval and defense of three to six months of age.

Trilled to further expand counter labeling.

Speaker 3: Additionally, we expect Calder Law will be held triple for special Medicare reimbursement under the new no-paying legislation.

Hunger for patients.

Additionally, we expect Caldolor will be eligible for special Medicare reimbursement under the new no pain legislation.

Speaker 3: the Act is scheduled to into effect in early 2025, and we expect CMS to next issue regulations for implementing the Act and the amount of the separate reimbursement.

The App is scheduled to go into effect in early 2025, and we expect CMS to next issue regulations for implementing the act and the amount of the separate reimbursement.

Speaker 3: Meanwhile, we've completed the expansion of our oncology sales division, as we work to expand the use of our newest brand, San Puso, to help cancer patients tolerate the chemotherapy treatment.

Meanwhile, we have completed the expansion of our oncology sales division as we work to expand the use of our newest brand <unk> so to help cancer patients tolerate chemotherapy treatments.

Speaker 3: Our largest selling brand, Christelose, is now beginning to benefit from its listing on the New York State Medicaid formulary. And we're glad to share today that we now have now successfully transferred the manufacturing of our VAPRESOL product to a new facility.

Our largest selling brand Crystal House is now beginning to benefit from its listing on the New York State Medicaid formulary.

And we're glad to share today that we now have now successfully transferred the manufacturing of our Zap resolve product to a new facility.

Speaker 3: Following that successful production of the first batches, we're now planning to provide supplies of a special compounded conavaptant product on an interim basis to the market starting at the end of this year. We then expect a file for the approval of VAPRESOL at the new plant in order to then relaunch the branded version of the product in the future.

Following that successful production of the first batches were now planning to provide supplies of the special compound at kind of that product.

On an interim basis to the market starting at the end of this year.

We then expect to file for the approval of <unk> at the new plant in order to then relaunched the branded version of the product in the future.

Speaker 3: Turning next to some highlights on our financial performance, during the third quarter, our product portfolio of FDA-approved brands delivered combined revenues of $10.1 million and year-to-date revenues totaled $30.2 million.

Turning next to some highlights of our financial performance during the third quarter, our product portfolio of FDA approved brands delivered combined revenues of $10.1 million.

Year to date revenues totaled $32 million.

Speaker 3: Adjust the earnings for the quarter worth $260,000 or two cents a share. And the year-to-date adjusted earnings were totaled $4.2 million or 29 cents a share.

Adjusted earnings for the quarter were $260000 or <unk>, a share and the year to date adjusted earnings were totaled $4.2 million or 29 cents a share.

Speaker 3: Also, I'm pleased to report that cash flow from operations this year has totaled $5.1 million. We ended the third quarter with $88 million in total asset.

Also I'm pleased to report that cash flow from operations. This year has totaled $5 $1 million.

We ended the third quarter with $88 million in total assets.

Speaker 3: 52 million in liabilities at $36 million in Shear Holder's Equity.

Up to $2 million in liabilities at $36 million in shareholders' equity.

Speaker 3: Additionally, I'm very pleased to report that we entered into a new revolving credit loan agreement for a $20 million facility expandable to $25 million with a three-year term.

Additionally, I'm very pleased to report that we entered into a new revolving credit loan agreement for a 20 million dollar facility expandable to $25 million with a three year term.

Speaker 4: So with that overview, now I'd like to turn to Todd Anthony, Cumberland's Vice President, Organizational Development, to further discuss our brands. Todd? Thank you, A.J. Regarding our Vibative product, in October we announced a new publication in the journal Antimicrobial Agents and Chemotherapy, detailing the results of the first clinical study investigating the safety and pharmacokinetics of our Vibative injection in children 2 to 17 years of age.

So with that overview now I'd like to turn to Tortilla City, Cumberland, Vice President organizational development to further discuss our brands Todd. Thank you a J regarding our by battery product in October we announced a new publication in the journal anti microbial agents in chemotherapy detailing the results.

So the first clinical study investigating the safety and pharmacokinetics of our buyback of injection in children two to 17 years of age.

Speaker 4: The results of this study suggest that a single dose of vivative can be safely administered to children to fight certain serious skin and lung infections in those patients.

The results of this study suggests that a single dose of <unk> can be safely administered to children to fight certain serious skin and lung infections in those patients.

Speaker 4: By bad 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 grand positive bacteria.

By bad 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.

Speaker 4: Antommycrobial resistance poses a significant challenge in the treatment of bacterial infections, necessitating the development of new antibiotic therapies. We are pleased to see that Vibadibs' sales continue to improve and are up 13% year to date as we have a number of new initiatives underway to improve the brand's performance.

Anti microbial resistance poses a significant challenge in the treatment of bacterial infections, necessitating the development of new antibiotic therapies. We are pleased to see that by that if sales continue to improve and are up 13% year to date as we have a number of new initiatives underway to improve.

The brand's performance.

Speaker 4: Turning next to chrysalose, our prescription strength-laccidive 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.

Turning next to crystallize, our prescription strength laxative packaged in a convenient pre measured powder dose the dissolve quickly in just four ounces of water for a clear taste free and grit free solution.

Speaker 4: It continues to be our largest selling product and is benefiting nicely from the support of our two co-promotion partners with this year's sales up 8% over the prior year period.

It continues to be our largest selling product and is benefiting nicely from the support of our two co promotion partners with this year's sales up 8% over the prior year period. Additionally.

Speaker 4: Additionally, we found that the brand performs best in states where we have Medicaid coverage. New York State recently added Christalow's to its Medicaid formulary, and we are implementing a special initiative to increase our presence and our share of voice in that state. We believe that this new coverage is contributing to the growth of the product.

Additionally, 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 our share of voice in that state. We believe that this new coverage is contributing to the growth of the.

Speaker 4: As AJ mentioned, we believe Cavalore, our non-opioid analogies of injection product, 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.

Yeah.

As a J mentioned, we believe caldolor, our non opioid analgesic injection product 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.

Speaker 4: The NOPE pain act requires Medicare to provide separate and more favorable reimbursement for non-obuloid products that are used to manage pain during surgeries conducted in hospital outpatient departments or ambulatory surgical centers.

There are no paint 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 ambulatory surgical centers.

Speaker 4: 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-paying act will affect Medicare reimbursement for caldolor.

This legislation applies to products that are indicated to provide analgesia without acting upon the bodies opioid receptors. As a result, we believe that the no panic will affect Medicare reimbursement for Caldolor.

Speaker 4: In the Medicare Hospital outpatient prospective payment system proposed rule, the CMS requested that manufacturers with potentially applicable non-obioid products submit comments in supporting clinical evidence regarding products that should be eligible for separate payments.

In the Medicare Hospital outpatient prospective payment system proposed rule CMS requested that manufacturers of with potentially applicable non opioid products submit comments and supporting clinical evidence regarding products that should be eligible for separate payment.

Speaker 4: We submitted a comment letter along with the requisite clinical information to the CMS in September of 2023 explaining why Calvallor should be included in separately reimbursed.

We submitted a comment letter along with the requisite clinical information to the CNS in September of 2023, explaining why caldolor should be included and separately reimbursed.

Speaker 4: The act is scheduled to go into effect in early 2025 and will apply to those products that are furnished between January 1st, 2025 and January 1st, 2028.

The act is schedule to go into effect in early 2025 and will apply to those products that are furnished between January one 2025 in January one 2028.

Speaker 4: Also, with the newly approved labeling, AJ noted, Calvallors now the only non-opioid product to prove the treat pain and infants that's delivered through injection.

Also with the newly approved labeling a J noted caldolor is now the only non opioid product approved to treat pain in infants that's delivered through injection.

Speaker 4: Other products in this class, such as Catoralact and Moloxicam, are not approved for use in children. As the safety and efficacy of those drugs have not been established for pediatric patients.

Other products in this class such as Ketorolac in Meloxicam are not approved for use in children as the safety and efficacy of those drugs have not been established for pediatric patients.

Speaker 4: A seat of minifin 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 newborn infants.

Acetaminophen injection is not approved for treating pain in children less than two years of age is the safety and efficacy of that drug has not been established for treating pain in those newborn infants.

Speaker 4: We are thrilled to further expand the products labeling for use in patients of nearly all ages and believe the product is beginning to benefit with sales up 8% so far this year.

We are thrilled to further expand the product labeling for use in patients of nearly all ages and believe the product is beginning to benefit with sales up 8%. So far this year.

Speaker 4: Moving now to Sankuso, which is the only FDA-approved prescription patch for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment.

Moving now to St Cuso, which is the only FDA approved prescription patch for the prevention of nausea, and vomiting in patients receiving certain types of chemotherapy treatment.

Speaker 4: We assumed commercial responsibility for the product in the United States, including its marketing, promotion, distribution, manufacturing, and medical support activities early last year, and as of September 2023, have fully completed the transition of Sankuso to Cumberland.

We assumed commercial responsibility for the product in the United States, including its marketing promotion distribution manufacturing and medical support activities early last year and as of September 2023 have fully completed the transition of Santa Cruz So to Cumberland.

Speaker 4: As we previously reported, the FDA approved moving the product's manufacturer to a new facility, and the production of supplies for cumulurant at this plant is now underway.

As we previously reported the FDA approved moving the products manufacturer to a new facility and the production of supplies for combo room at this plant is now underway.

Speaker 4: St. Cuso sales are significantly lower than those we experienced last year, due to an inordinate amount of sales deduction.

<unk> sales are significantly lower than those we experienced last year due to an inordinate amount of sales deductions. We are working to improve that performance and are also now supporting the brand through our expanded oncology sales division, which is comprised of both field based and insights.

Speaker 4: We are working to improve that performance and are also now supporting the brand through our expanded oncology sales division, which is comprised of both field-based and inside sales personnel.

Sales personnel.

As we've reported previously the packager four hour of macro box pack brand suspended their operations due to supply issues that facility is now under new ownership and new management and we're currently awaiting availability of a potential supply from their operations.

Speaker 4: That facility is now under new ownership and new management, and we're currently awaiting availability of a potential supply from their operations. We're also exploring other alternatives to restart the products package.

We're also exploring other alternatives to restart the products packaging.

Speaker 4: 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 healthcare crisis.

Demand for our bap or salt 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 we're not currently available.

Speaker 4: We then shipped all remaining inventory of the product and notified the FDA that supplies of the product were not currently available.

Speaker 4: As AJ mentioned, we have since transferred the products manufacturing to a new facility. Our new manufacturing partner is working with the FDA to address several form 483 and warning letter issues in a timely manner. Meanwhile, we're planning to provide interim supplies of a special compounded conovaptant product to the market in support of critically ill patients.

Jay mentioned, we have since transferred products manufacturing to a new facility, our new manufacturing partner is working with the FDA to address several form 483 and warning letter issues in a timely manner.

Meanwhile, we're planning to provide interim supplies of the special compounded Kona VAT and product to the market in support of critically ill patients.

Speaker 4: The companies will share in sales of this interim compounded product, which is expected to be available in the coming months.

The companies will share in the sales of this interim compounded product, which is expected to be available in the coming months.

Speaker 4: We then expect to file for the approval to manufacture branded vapers tall once all FDA issues at this new site are resolved.

We then expect to file for the approval to manufacture branded fab or saw once all FTA issues at this new site are resolved.

Speaker 3: That completes my updates for today, and I'll turn it back over to you, AJ. Thank you, Todd. Before we turn to the financial report, I'd like to provide an update on our ongoing clinical pipeline.

That completes my updates for today and I'll turn it back over to you a J. Thank you Todd.

Before we turn to the financial report I'd like to provide an update on our ongoing clinical pipeline.

Speaker 3: Throughout the third quarter, we continue to progress our phase two clinical trials evaluating ifitriban, a potent and selective thromboxane receptor antagonist, for patients with a series of unmet medical needs.

Throughout the third quarter, we continued to progress our phase two clinical trials evaluating <unk>, our potent and selective thromboxane receptor antagonist for patients with a series of unmet medical needs.

Speaker 3: It has now been dosed to nearly 1,400 subjects and is bound to be safe and well tolerated in those individuals. Patient enrollment is a well underway in two company sponsored phase two clinical program.

It has now been dosed in nearly 1400 subjects and has been found to be safe and well tolerated in those individuals.

Patient enrollment is well underway in two company sponsored phase II clinical programs.

Speaker 3: One is evaluating a fitter band in systemic sclerosis or scleroderma. It's a dehabilitating autoimmune disorder characterized by the fused fibrosis of the skin and internal organs. Enrollment in that study is

One is evaluating I picture ban in systemic sclerosis or scleroderma.

It's a debate dehabilitation.

<unk> autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs.

Enrollment in that study is well underway.

Speaker 3: The other ongoing clinical program involves the 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.

The other ongoing clinical program involves the cardiomyopathy associated with Duchenne muscular dystrophy or D. M D.

It's a rare and fatal genetic neuromuscular disease that results in deterioration of the <unk>.

Little heart and lung muscles.

Speaker 3: We're sponsoring the FITE DMD trial, a multi-center, randomized, placebo-controlled phase 2 study enrolling patients across 10 centers in the United States that specialize in DMD.

Sponsoring the fight DMD trial, a multicenter randomized placebo controlled phase two study enrolling patients across 10 centers.

The United States that specialize in DMD.

Speaker 3: We have completed enrollment in the younger age group of patients and now are working to finish enrollment in the older patient group with DMD.

We have completed enrollment in the younger age group of patients and now are working to finish enrollment in the older patient group with DMD.

Speaker 3: Meanwhile, earlier this year, we announced that the FDA cleared the investigational new drug application for a Phase II study in patients with idiopathic pulmonary fibrosis, or IPF.

Meanwhile, earlier this year, we announced that the FDA cleared the investigational new drug application for a phase II study in patients with idiopathic pulmonary fibrosis or IPF.

Speaker 3: It's the most common form of progressive fibrosing interstitial lung disease. And as a result, we're in the process of initiating our Fighting Fibrosis trial designed to enroll 128 patients in over 20 medical centers of excellence across the U.S.

The most common form of progressive fibrosis, interstitial lung disease and as a result, we are in the process of initiating our fighting fibrosis trial designed to enroll 128 patients in over 20 medical centers of excellence across the U S.

Speaker 3: Recent studies have shown I fit true band can both prevent and enhance resolution of lung fibrosis in multiple preclinical models.

Recent studies have shown I think Japan can both prevent and enhance resolution of lung fibrosis in multiple preclinical models.

Speaker 3: In addition to these sponsored studies, there are several other preclinical and pilot patient studies that are underway, including several investigator-initiated trials. Our plan going forward is to complete each of our company-sponsored studies.

Yeah.

In addition to these sponsored studies there are several other preclinical and pilot patient studies of a hit to ban underway, including several investigator initiated trials.

Our plan going forward is that.

Complete each of our company sponsored studies.

Speaker 3: Analyze the resulting data, announce the top line results, and then decide on the best development path for the registration of ifitriban. And we continue to believe it has the potential to benefit many patients with orphan diseases that represent unmet medical needs.

Analyzing there was analyzed the resulting data.

Announced the topline results and then decide on the best development path for the registration of a fisherman.

And we continue to believe it has the potential to benefit many patients with orphan diseases that represent unmet medical needs.

Speaker 3: 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 third quarter financial results. John . Thank you.

So with that update on our ongoing clinical trials and now I'd like to turn it over to our Chief Financial Officer, Jon Hamm to review, our third quarter financial results John.

Thank you a J for the three months ended September 32023, net revenue from continuing operations were $10 $1 million.

Speaker 4: For the three months and its September 30th, 2023, net revenue from continuing operations were $10.1 million.

Speaker 4: Net revenue by product for the third quarter of 2023 included $3.9 million for Crystalos, $2.8 million for Vibadov, $1.9 million. So, and $1.2 million for Coutalore.

Net revenue by product for the third quarter of 2023 included $3 $9 million for Crystal Rose $2 8 million provide bad of one $9 million increase so and $1 2 million for Caldolor.

Speaker 5: total year-to-date net revenue were $30.2 million, including $12.3 million for Christalow's, $6.8 million for Vibadav, $5.7 million for Siancuso, and $3.3 million for Calvallore.

Total year to date net revenue were $32 million, including $12 $3 million for Crystal Rose six $8 million for Vivat us $5 $7 million for San Cuso, and $3 3 million for Caldolor.

Each of these brands has experienced growth in sales this year with the exception of sand Coosa. Unfortunately, the brand has seen sales deductions associated with the product transition.

Speaker 5: We are working to address these issues and believe over time Sancuso's performance will improve and therefore it's best evaluated on an annual basis.

We are working to address these issues and believe over time <unk> performance will improve and therefore, its best evaluated on an annual basis.

Speaker 5: Turning to our expenditures, total operating expenses for the third quarter were $12 million, slightly more than the $11.7 million for the prior year period. Year-to-date expenses totaled $33.6 million.

Turning to our expenditures total operating expenses for the third quarter were $12 million slightly more than the $11 $7 million for the prior year period year to date expenses totaled 33 6 million net loss for the third quarter was one.

Speaker 5: Net loss for the third quarter was $1 million, and when the non-cash expenses are added back, the resulting adjusted earnings were $260,000, or $0.02 a share.

Yeah.

And when the noncash expenses are added back the resulting adjusted earnings were $260000 or <unk> a share.

Speaker 5: The year-to-date adjusted earnings were $4.2 million or $0.29 a share. Both net income and adjusted earnings have improved significantly over the last year.

The year to date adjusted earnings.

$2 million or 29 cents a share both net income and adjusted earnings have improved significantly over the last year.

Speaker 5: Also, please note that the adjusted earnings calculations do not include the additional benefit of the $0.8 million cost of goods for Vybadov and Sancuso during the quarter. Year-to-date, the benefit is $1.7 million.

Also please note that the adjusted earnings calculations do not include the additional benefit of the $8 million cost of goods provide data ensign cuso during the quarter year.

Year to date, the benefit is $1 $7 million.

Speaker 5: That inventory was received as part of each product's acquisition. The total cash flow from operations was $5.1 million.

Inventory was received as part of each products acquisition.

Total cash flow from operations was $5 $1 million.

Speaker 5: As a reminder, the additions of Vybatev and Tinkuso to our product portfolio have continued to significantly impact our financial statement.

As a reminder.

The additions of <unk> to our product portfolio have continued to significantly impact our financial statements. As a result of the buy back of acquisition a total of $34 million in new assets were added including approximately $21 million in inventory.

Speaker 5: 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.

$12 million of intangible assets and $1 million of goodwill.

Speaker 5: The financial terms for the Vivado 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.

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

Speaker 5: BiBATF was our largest acquisition, and I am pleased to report that since we assumed responsibility for the product in late 2018, it has delivered a total cash contribution of $37.2 million to our business, and therefore is now generating a return on our $25 million investment.

<unk> was our largest acquisition and I am pleased to report that since we assumed responsibility for the product in late 2018. It has delivered a total cash contribution of $37 2 million to.

To our business and therefore is now generating a return on our $25 million investment.

Speaker 5: Sancuso added a total of $19 million in new assets, including approximately $4 million in inventory and $14 million of intangibles. The estimated value of these assets was $13.6 million at the end of the third quarter. We provided $13.5 million at closing for the Sancuso acquisition. There are also royalties that we pay based on the brand sale.

<unk> added a total of $19 million in new assets, including approximately $4 million in inventory and <unk>.

$14 million of intangibles.

Estimated value of these assets was $13 6 million at the end of the third quarter, we provided $13 $5 million at closing for the San Cuso acquisition.

There are also royalties that we pay based on the brand sales.

Speaker 5: Since we started shipping Sancuso in early 2022, the product has already provided a total cash contribution of approximately $12.2 million. And we believe it will soon begin to generate a return on our $14.5 million investment.

Since we started shipping sand crusoe in early 2022.

<unk> has already provided a total cash contribution of approximately $12 $2 million and we believe it will soon begin to generate a return on our $14 $5 million investment.

Speaker 5: Turning to our balance sheet as of September 30, 2023, we had $88 million in total assets, including $18.5 million in cash and cash equivalents.

Turning to our balance sheet as of September 32023, we had $88 million in total assets, including $18 $5 million in cash and cash equivalents liabilities totaled $52 million and total shareholders' equity was $36 million.

Speaker 5: Liabilities totaled $52 million, and total shareholders' equity was $36 million.

Speaker 5: On September 5, 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 million. It provides an initial revolving credit line with $20 million of availability and the ability of Cumberland to increase the amount to $25 million under certain conditions.

On September five 2023, we entered into a new revolving credit loan.

Pinnacle Bank grade three year term. The agreement provides for an aggregate principal funding amount of up to $25 million. It provides an initial revolving credit line with $20 million 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 sofa and is subject to one financial covenant determined on a quarterly basis.

Speaker 5: The interest rate is based on benchmark term SOFR and is subject to one financial covenant determined on a quarterly basis.

Speaker 5: Also, during the third quarter of 2023, we continued our share repurchase program.

During the third quarter of 2023, we continued our share repurchase program buying a total of 117000 shares. These repurchases included dose on the open market as well as those needed to fund the taxes associated with employee vested restricted.

Speaker 5: vying a total of 117,000 shares.

Speaker 5: These repurchases included those on the open market, as well as those needed to fund the taxes associated with employee-vested restricted shares.

Speaker 5: We are also continuing the process of implementing new trading plans for our board members who will purchase Cumberland shares over the remainder of 2023 to increase their holdings in the company.

Shares. We are also continuing the process of implementing new trading plans for our board members, who will purchase Cumberland shares over the remainder of 2023 to increase their holdings in the company.

Speaker 5: Cumberland continues to hold over $53 million in tax net operating loss carry-forwards, primarily resulting from the prior exercise of stock options.

Cumberland continues to hold over $53 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 2023 back to you a J. Thank you John.

Speaker 5: and that completes our financial report for the third quarter of 2023. Back to you, A.J. Thank you, John .

Speaker 3: Overall, Cumberland has had a successful year to date and we are encouraged by our progress.

Overall Cumberland has had a successful year to date and we are encouraged by our progress it's been particularly good to see the recent growth in our crystal those in Casualwear business, along with the rebound in by battery sales and we're pleased to share. The recent pediatric studies involving favorable results with both by bad is.

Speaker 3: It's been particularly good to see the recent growth in our chrysalis and caudillor business along with the rebound in vibative sales. And we're pleased to share the recent pediatric studies involving favorable results with both vibative and caudillor in children. We're also optimistic about the opportunity with our new manufacturing partner to provide initial supplies of compounded Vaprizol to help critically ill patients.

<unk> and Caldolor in children.

We're also optimistic about the opportunity with our new manufacturing partner to provide initial supplies of compounded that resolved to help critically ill patients and we're excited about the expansion of our oncology sales division and opportunity to further help cancer patients.

Speaker 3: And we're excited about the expansion of our Oncology Sales Division and opportunity to further help cancer patients.

Speaker 3: It's good to be on the New York State Medicaid formulary for Crystalose, and we believe that the special reimbursement associated with the No Pain Act can have a meaningful impact on Caldwellers' future growth.

It's good to be on the New York State Medicaid formulary for crystals, and we believe that the special reimbursement associated with the no pain Act can have a meaningful impact on <unk> future growth.

Speaker 3: As we move into the remainder of the year, we remain committed to our strategy, seeking to maximize the potential of our commercial brands, progressing our pipeline, and also pursuing select acquisitions.

As we move into the remainder of the year, we remain committed to our strategy seeking to maximize the potential of our commercial brands progressing our pipeline and also pursuing select acquisitions.

Speaker 3: As always, I'd like to extend a special thanks to the entire Cumberland team for their dedication and many fine contributions as we continue in our mission of working together to provide unique products that improve the quality of patient care.

As always I'd like to extend a special thanks to the entire Cumberland team for their dedication and many fund contributions as we continue in our mission of working together.

To provide unique products that improve the quality of patient care.

Speaker 3: So with that, let's open the call to any questions. Operator, please proceed.

So with that let's open the call to any questions. Operator. Please proceed.

Speaker 1: Ladies and gentlemen, that concludes the company's presentation, and we will now open the call for any questions.

Thank you Sir.

Ladies and gentlemen that concludes the Companys presentation, and we will now open the call for any questions.

Speaker 1: If you'd like to ask a question, please press star key on your phone, followed by the digit one twice. That's star one one.

If you'd like to ask a question please press <unk>.

Sorry key on your phone followed by the digit one twice that star one one please.

Please standby.

Okay.

Okay.

Yes.

Speaker 3: Well, thank you, everyone, for joining today's call. We do understand that many of you prefer a private discussion with management. And if so, please just reach out, and we'll be happy to get such a call scheduled with you and hold such a discussion.

Well. Thank you everyone for joining today's call. We do understand that many of you prefer a private discussion with management and if so please just reach out and we'll be happy to get such a call scheduled with you and hold such a discussion.

Speaker 3: as always we appreciate your time and your interest in Cumberland and we look forward to providing another update in the coming months.

As always we appreciate your time and your interest in Cumberland, and we look forward to providing another update in the coming months.

Speaker 1: 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 would like to thank you for your participation. You may now disconnect.

Yes.

Thank you Sir.

Ladies and gentlemen that concludes today's call if you would.

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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