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Cumberland Pharmaceuticals Reports 16% Sequential Revenue Growth in Second Quarter 2024

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Cumberland Pharmaceuticals (Nasdaq: CPIX) reported 16% sequential revenue growth in Q2 2024, with net revenue reaching $9.9 million. The company achieved adjusted earnings of $0.2 million, a $0.8 million improvement over Q1 2024. Key developments include:

1. Kristalose added to Wisconsin Medicaid formulary and recommended in AGA guidelines
2. New study supports Vibativ as an effective treatment for anthrax infections
3. Progress in ifetroban clinical trials for various indications
4. New manufacturing and supplies of Sancuso
5. Potential Medicare reimbursement for Caldolor under the NOPAIN Act

Cumberland's CEO expressed optimism about the company's future, projecting significant revenue growth and positive cash flow from operations in 2024.

Cumberland Pharmaceuticals (Nasdaq: CPIX) ha riportato una Crescita dei ricavi sequenziali del 16% nel secondo trimestre del 2024, con ricavi netti che hanno raggiunto 9,9 milioni di dollari. L'azienda ha raggiunto utili aggiustati di 0,2 milioni di dollari, un miglioramento di 0,8 milioni di dollari rispetto al primo trimestre del 2024. Le principali novità includono:

1. Kristalose inserito nel formulary del Medicaid del Wisconsin e raccomandato nelle linee guida AGA
2. Nuovo studio supporta Vibativ come trattamento efficace per le infezioni da antrace
3. Progresso nei trial clinici di ifetroban per varie indicazioni
4. Nuovo approvvigionamento e produzione di Sancuso
5. Potenziale rimborso Medicare per Caldolor ai sensi del NOPAIN Act

Il CEO di Cumberland ha espresso ottimismo riguardo al futuro dell'azienda, prevedendo una significativa crescita dei ricavi e un flusso di cassa positivo dalle operazioni nel 2024.

Cumberland Pharmaceuticals (Nasdaq: CPIX) reportó un crecimiento secuencial de ingresos del 16% en el segundo trimestre de 2024, con ingresos netos alcanzando 9,9 millones de dólares. La empresa logró ganancias ajustadas de 0,2 millones de dólares, una mejora de 0,8 millones de dólares en comparación con el primer trimestre de 2024. Los desarrollos clave incluyen:

1. Kristalose agregado al formulario de Medicaid de Wisconsin y recomendado en las guías de AGA
2. Nuevo estudio apoya a Vibativ como un tratamiento efectivo para infecciones de ántrax
3. Progreso en los ensayos clínicos de ifetroban para diversas indicaciones
4. Nueva fabricación y suministro de Sancuso
5. Posible reembolso de Medicare para Caldolor bajo la Ley NOPAIN

El CEO de Cumberland expresó optimismo sobre el futuro de la compañía, proyectando un crecimiento significativo de los ingresos y un flujo de efectivo positivo de las operaciones en 2024.

Cumberland Pharmaceuticals (Nasdaq: CPIX)는 2024년 2분기 16%의 순수익 성장을 보고하며, 순수익이 990만 달러에 도달했다고 발표했습니다. 회사는 조정된 순이익 20만 달러를 기록하며, 2024년 1분기보다 80만 달러 개선되었습니다. 주요 발전 사항은 다음과 같습니다:

1. Kristalose가 위스콘신 메디케이드 목록에 추가되었고 AGA 가이드라인에서 추천됨
2. 새로운 연구에서 Vibativ가 탄저균 감염에 효과적인 치료법으로 지지됨
3. 다양한 적응증을 위한 ifetroban 임상 시험 진행 중
4. Sancuso의 새로운 제조 및 공급
5. NOPAIN 법안에 따른 Caldolor의 Medicare 환급 가능성

Cumberland의 CEO는 회사의 미래에 대한 낙관적인 전망을 제시하며, 2024년에는 상당한 수익 성장과 긍정적인 운영 현금 흐름을 예상하고 있습니다.

Cumberland Pharmaceuticals (Nasdaq: CPIX) a signalé une croissance des revenus séquentiels de 16% au deuxième trimestre de 2024, avec des revenus nets atteignant 9,9 millions de dollars. L'entreprise a réalisé des bénéfices ajustés de 0,2 millions de dollars, soit une amélioration de 0,8 millions de dollars par rapport au premier trimestre de 2024. Les développements clés comprennent :

1. Kristalose ajouté au formulaire Medicaid du Wisconsin et recommandé dans les directives de l'AGA
2. Une nouvelle étude soutient Vibativ comme traitement efficace des infections à anthrax
3. Progrès dans les essais cliniques d'ifetroban pour plusieurs indications
4. Nouvelle fabrication et approvisionnement de Sancuso
5. Remboursement potentiel de Medicare pour Caldolor dans le cadre de la loi NOPAIN

Le PDG de Cumberland a exprimé son optimisme quant à l'avenir de l'entreprise, prévoyant une croissance significative des revenus et un flux de trésorerie positif provenant des opérations en 2024.

Cumberland Pharmaceuticals (Nasdaq: CPIX) berichtete von einem 16% sequenziellen Umsatzwachstum im 2. Quartal 2024, wobei der Nettoumsatz 9,9 Millionen US-Dollar erreichte. Das Unternehmen erzielte bereinigte Erträge von 0,2 Millionen US-Dollar, eine Verbesserung um 0,8 Millionen US-Dollar im Vergleich zum 1. Quartal 2024. Zu den wichtigsten Entwicklungen gehören:

1. Kristalose wurde in das Medicaid-Formular von Wisconsin aufgenommen und in den AGA-Richtlinien empfohlen
2. Neue Studie unterstützt Vibativ als wirksame Behandlung für Anthrax-Infektionen
3. Fortschritte bei den klinischen Studien zu Ifetroban für verschiedene Indikationen
4. Neue Herstellung und Versorgung von Sancuso
5. Potenzielle Medicare-Erstattung für Caldolor im Rahmen des NOPAIN-Gesetzes

Der CEO von Cumberland äußerte Optimismus hinsichtlich der Zukunft des Unternehmens und prognostizierte ein signifikantes Umsatzwachstum sowie einen positiven Cashflow aus den Betrieben im Jahr 2024.

Positive
  • 16% sequential revenue growth in Q2 2024, reaching $9.9 million
  • Adjusted earnings of $0.2 million, a $0.8 million improvement over Q1 2024
  • Kristalose added to Wisconsin Medicaid formulary and recommended in AGA guidelines
  • New study supports Vibativ as an effective treatment for anthrax infections
  • Progress in ifetroban clinical trials for various indications
  • New manufacturing facility approved by FDA for Sancuso
  • Potential Medicare reimbursement for Caldolor under the NOPAIN Act starting 2025
Negative
  • Net loss of $1.1 million ($0.08 per share) in Q2 2024
  • Year-to-date net loss of $3.0 million ($0.21 per share)
  • $16.1 million outstanding on the company's revolving line of credit

Cumberland Pharmaceuticals' Q2 2024 results show promising growth, with net revenue increasing 16% sequentially to $9.9 million. The company's adjusted earnings of $0.2 million represent a significant improvement over Q1. Key products like Kristalose and Vibativ are driving sales, with Kristalose benefiting from expanded Medicaid coverage and guideline recommendations.

The company's pipeline, particularly ifetroban, shows potential with ongoing Phase II trials. The balance sheet remains stable with $78.5 million in total assets and $26.3 million in shareholders' equity. However, investors should note the $16.1 million outstanding on the revolving line of credit. Overall, Cumberland's focus on specialty pharmaceuticals and potential growth drivers like the NOPAIN Act could position it well for future growth.

Cumberland's research efforts are noteworthy, particularly the study on Vibativ (telavancin) as a potential treatment for anthrax infections. The results showing 100% survival rate in animal studies and effectiveness against multiple anthrax strains are promising, especially in the context of antimicrobial resistance concerns.

The company's ifetroban pipeline is diverse, targeting rare diseases like Systemic Sclerosis, Duchenne Muscular Dystrophy and Idiopathic Pulmonary Fibrosis. The pending FDA designations for orphan drug and rare pediatric disease could significantly boost the development process if approved. These research initiatives demonstrate Cumberland's commitment to addressing unmet medical needs in niche markets, which could translate to long-term value if successful.

Cumberland's strategic positioning in the specialty pharmaceutical market is evident from its product portfolio and pipeline. The company's focus on hospital acute care, gastroenterology and oncology segments provides diversification. The addition of Sancuso to its portfolio and successful transition of manufacturing demonstrates Cumberland's ability to integrate acquisitions effectively.

The potential impact of the NOPAIN Act on Caldolor's reimbursement could be a significant market opportunity. If approved for separate reimbursement under Medicare, it could drive adoption in hospital outpatient and ambulatory surgical settings. However, investors should be cautious as the final CMS decision is pending. Cumberland's ability to navigate regulatory changes and capitalize on market opportunities will be important for its future growth trajectory.

NASHVILLE, Tenn., Aug. 6, 2024 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company, today announced significantly improved financial results and a favorable overall company performance for the second quarter of 2024.

Highlights include:

  • $9.9 million in net revenue during the second quarter of 2024, an increase of 16% sequentially from the first quarter of 2024.
  • Adjusted earnings of $0.2 million, which represents a $0.8 million improvement over the prior period in 2024.
  • $78.5 million in assets, $52.5 million in liabilities and $26.3 million of shareholders' equity.

"We are very optimistic about our company's future, and we look forward to building on our second quarter success throughout the remainder of the year," said Cumberland's CEO, A.J. Kazimi. "Given the number of ongoing positive developments, we believe we're still on track to post significant revenue growth and positive cashflow from operations during 2024."

RECENT DEVELOPMENTS INCLUDE:

Kristalose® Medicaid Coverage & Gastroenterology Guidelines Recommendation

Wisconsin has added Kristalose, Cumberland's prescription-strength laxative, to its Medicaid formulary, and Cumberland is implementing a special initiative to announce this development in that market. Cumberland also has Medicaid coverage for the brand in New York state and Texas, two of the largest states for the product.

Additionally, the American Gastroenterological Association's ("AGA") guidelines include Kristalose as a first-line treatment option for opioid-induced constipation. As the guidelines state, "Constipation is by far the most common and debilitating gastrointestinal effect of opioids, and some degree of constipation is near universal in patients taking opioid medications." Cumberland believes the AGA's recommendation will support the use of Kristalose in those patients.

New Study Supports Vibativ® as an Effective Treatment for Anthrax Infections

In June, Antimicrobial Agents and Chemotherapy published a study evaluating Vibativ (telavancin) as a novel therapeutic against anthrax inhalation, the most dangerous form of those infections. Researchers were particularly interested in finding alternatives to current antibiotics in case anthrax bacteria become resistant to them.

Researchers tested telavancin against 17 different anthrax strains in the lab to determine how well it could stop their growth. Additionally, researchers tested telavancin in rabbits that were infected with a deadly dose of airborne anthrax spores and compared telavancin's effectiveness to another antibiotic (levofloxacin) and a placebo.

The results showed that:

  • Telavancin was very effective at killing all the anthrax strains tested in the lab.
  • In the preclinical study, all the animals treated with telavancin survived.
  • Telavancin was better at clearing anthrax from the blood and organs than levofloxacin.

Based on these results, the researchers concluded that telavancin could potentially be an effective new treatment option for anthrax infections, especially if current antibiotics become less effective due to resistance.

Antimicrobial resistance continues to pose a significant challenge in the treatment of bacterial infections, necessitating the development of new antibiotic therapies. While many recently introduced antibiotics are quickly losing the battle to fight the bacteria they were designed to kill because those bacteria have become drug-resistant, Vibativ was specifically designed to kill drug-resistant bacteria.

Product Pipeline

Cumberland has been evaluating its ifetroban product candidate, a selective thromboxane-prostanoid receptor antagonist, in a series of clinical studies. It has now been dosed in nearly 1,400 subjects and has been found to be safe and well tolerated in healthy volunteers and various patient populations. Cumberland has three Phase II clinical programs underway evaluating ifetroban in patients with 1) Systemic Sclerosis or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs, 2) cardiomyopathy associated with Duchenne Muscular Dystrophy, a rare, fatal, genetic neuromuscular disease results in deterioration of the skeletal, heart, and lung muscles and 3) Idiopathic Pulmonary Fibrosis, the most common form of progressive fibrosing interstitial lung disease. This third program is our newest, with enrollment now underway.

Cumberland recently applied for two U.S. Food and Drug Administration ("FDA") designations for its Duchenne Muscular Dystrophy  product candidate: 

          1) Orphan Drug Designation, which is granted to products that show promise in the treatment, prevention or diagnosis of rare – or orphan – diseases; such designation can result in a number of benefits associated with the FDA review process including exclusivity after approval of the product.

          2) Rare Pediatric Disease Designation, which is given to products intended to prevent or treat serious or life-threatening diseases that primarily affect children from birth to 18 years of age. Upon FDA approval this designation may result in a priority review voucher from the FDA for a different product.

Cumberland expects to hear back from the FDA on both applications this year.

Cumberland's plan going forward is to complete each of its company-sponsored studies, analyze their final data, announce top-line results and decide on the best development path for the registration of ifetroban, which Cumberland continues to believe has the potential to benefit many patients with orphan diseases that represent unmet medical needs.

New Manufacturing & Supplies of Sancuso®

After acquiring U.S. rights to Sancuso, Cumberland successfully completed the transition from Kyowa Kirin to Cumberland in 2023, including the NDA transfer. A new manufacturing facility was approved by the FDA for Sancuso, and Cumberland has completed the first lots of Cumberland-packaged product there. Cumberland began shipping these new supplies of its Cumberland-branded product this summer.

Federal NOPAIN Act

Cumberland announced in April 2023 that it expected that Caldolor would be eligible for special Medicare reimbursement under the Non-Opioids Prevent Addiction in the Nation Act, which was enacted as part of the Consolidated Appropriations Act of 2023 (the "NOPAIN Act").

The NOPAIN Act requires Medicare to provide separate reimbursement for non-opioid products that are used to manage pain during surgeries conducted in hospital outpatient departments or in ambulatory surgical centers. The NOPAIN Act applies, in part, to products that are indicated to provide analgesia, without acting upon the body's opioid receptors. As a result, the Company expected that the NOPAIN Act would affect Medicare reimbursement for Caldolor, its non-opioid analgesic injection product.

The reimbursement for non-opioid pain alternatives under the NOPAIN Act will apply to those products that are furnished between January 1, 2025 and January 1, 2028.  It is anticipated that in late 2024, the Centers for Medicare & Medicaid Services ("CMS") will issue regulations implementing the NOPAIN Act and detailing the conditions for, and amount of, the separate reimbursement.

In July 2023, in the Medicare Hospital Outpatient Prospective Payment System ("OPPS") Proposed Rule, CMS requested that manufacturers with potentially applicable non-opioid products submit comments and supporting clinical evidence regarding products that they believe should be eligible for separate payment. Cumberland submitted a comment letter along with the requisite clinical information to CMS in September 2023, explaining why Caldolor should be included and separately reimbursed. In July the 2024 Medicare OPPS Proposed Rule, CMS proposed that, in 2025, several drugs that were previously eligible for separate payment via existing CMS policies continue to be eligible for separate payment in the hospital outpatient setting under the Consolidated Appropriation Act 2023 and solicited comments on whether there are additional drugs or biologicals that meet the statutory definition. In response, Cumberland plans to submit a comment letter along with the requisite information in September 2024 and will then await information from CMS regarding the reimbursement status and price for Caldolor in the CY 2025 OPPS Final Rule.

FINANCIAL RESULTS

Net Revenue: For the three months ended June 30, 2024, net revenues were $9.9 million, a 16% increase from the first quarter of the year.  Net revenue by product for the second quarter of 2024 included $4.1 million for Kristalose®, $2.5 million for Vibativ® $2.2 million for Sancuso® and $0.8 million for Caldolor®.

Year-to-date 2024 net revenues were $18.3 million. Year-to-date net revenues by product were $7.3 million for Kristalose, $4.1 million for Vibativ, $4.0 million for Sancuso and $2.3 million for Caldolor.

Operating Expenses: Total operating expenses were $10.9 million for the second quarter of 2024 and $21.2 million for the first half of the year.

Net Income (Loss): The net loss for the second quarter of 2024 was $1.1 million, or $0.08 a share and a net loss of $3.0 million year to date, or $0.21 a share.

Adjusted Earnings: Adjusted earnings for the second quarter of 2024 were $0.2 million, or $0.01 per share which is a $0.8 million improvement over the prior period in 2024. The adjusted earnings calculation does not include the benefit of the $0.6 million cost of goods for Vibativ and Sancuso during the quarter, which were received as part of each product's acquisition.

Balance Sheet: At June 30, 2024, Cumberland had $78.5 million in total assets, including $17.3 million in cash and cash equivalents.  Total liabilities were $52.5 million, including $16.1 million outstanding on the company's revolving line of credit. Total shareholders' equity was $26.3 million at the end of the quarter.

EARNINGS REPORT CALL: 

A conference call will be held on August 6, 2024, at 4:30 p.m. Eastern Time to provide a Company update  discuss the financial results. To participate in the call, please register at:
https://register.vevent.com/register/BIfa6a94515e5548c28e9d77d03c95a13e.

Registered participants can dial in from their phone using a dial-in and PIN number that will be provided to them. Alternatively, they can choose a "Call Me" option to have the system automatically call them at the start of the conference.

A replay of the call will be available for one year and can be accessed via Cumberland's website or by visiting:
https://edge.media-server.com/mmc/p/h9bx4zn8.

ABOUT CUMBERLAND PHARMACEUTICALS:

Cumberland Pharmaceuticals Inc. is the largest biopharmaceutical company founded and headquartered in Tennessee and is focused on providing unique products that improve the quality of patient care. The company develops, acquires, and commercializes products for the hospital acute care, gastroenterology and oncology market segments.

The company's portfolio of FDA-approved brands includes:

  • Acetadote® (acetylcysteine) injection, for the treatment of acetaminophen poisoning;
  • Caldolor® (ibuprofen) injection, for the treatment of pain and fever;
  • Kristalose® (lactulose) oral, a prescription laxative, for the treatment of constipation;
  • Sancuso® (granisetron) transdermal, for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment;
  • Vaprisol® (conivaptan) injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia; and
  • Vibativ® (telavancin) injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections.

The company also has a series of Phase II clinical programs underway evaluating its ifetroban product candidate in patients with cardiomyopathy associated with Duchenne Muscular Dystrophy, Systemic Sclerosis and Idiopathic Pulmonary Fibrosis.

For more information on Cumberland's approved products, including full prescribing information, please visit links to the individual product websites, which can be found on the company's website www.cumberlandpharma.com.

About Acetadote® (acetylcysteine) Injection

Acetadote, administered intravenously within 8 to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen, is indicated to prevent or lessen hepatic injury. Used in the emergency department, Acetadote is approved in the United States to treat overdose of acetaminophen, a common ingredient in many over-the-counter medications. Acetadote is contraindicated in patients with hypersensitivity or previous anaphylactoid reactions to acetylcysteine or any components of the preparation. For full prescribing and safety information, visit www.acetadote.com.

About Caldolor® (ibuprofen) Injection

Caldolor is indicated in adults and pediatric patients for the management of mild to moderate pain and management of moderate to severe pain as an adjunct to opioid analgesics, as well as the reduction of fever. It was the first FDA-approved intravenous therapy for fever. Caldolor is contraindicated in patients with known hypersensitivity to ibuprofen or other NSAIDs, patients with a history of asthma or other allergic type reactions after taking aspirin or other NSAIDs. Caldolor is contraindicated for use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery. For full prescribing and safety information, including boxed warning, visit www.caldolor.com.

About Kristalose® (lactulose) Oral Solution

Kristalose is indicated for the treatment of acute and chronic constipation. It is a unique, proprietary, crystalline form of lactulose, with no restrictions on length of therapy or patient age. Kristalose is contraindicated in patients who require a low-galactose diet. Elderly, debilitated patients who receive lactulose for more than six months should have serum electrolytes (potassium, chloride, carbon dioxide) measured periodically. For full prescribing and safety information, visit www.kristalose.com.

About Sancuso® (granisetron) Transdermal System

Sancuso is the only skin patch approved by the FDA for the prevention of chemotherapy-induced nausea and vomiting ("CINV") in patients receiving moderately and/or highly emetogenic chemotherapy. When applied 24 to 48 hours before receiving chemotherapy, the Sancuso patch slowly and continuously releases the medicine contained in the adhesive through clean and intact skin areas into the patient's bloodstream. It can prevent CINV for chemotherapy regimens of up to five consecutive days. For full prescribing and safety information, visit www.sancuso.com.

About Vaprisol® (conivaptan hydrochloride) Injection

Vaprisol is an intravenous treatment for hyponatremia used in the critical care setting. Hyponatremia is an electrolyte disturbance in which sodium ion concentration in blood plasma is lower than normal. This can be associated with a variety of critical care conditions including congestive heart failure, liver failure, kidney failure and pneumonia. The product is a vasopressin receptor antagonist that raises serum sodium levels and promotes free water secretion. Vaprisol is contraindicated in patients with hypovolemic hyponatremia. The coadministration of Vaprisol with potent CYP3A inhibitors, such as ketoconazole, itraconazole, clarithromycin, ritonavir and indinavir, is contraindicated. For full prescribing and safety information, including boxed warning, visit www.vaprisol.com.

About Vibativ® (telavancin) Injection

Vibativ is a patented, FDA-approved injectable anti-infective for the treatment of certain serious bacterial infections, including hospital-acquired and ventilator-associated bacterial pneumonia, and complicated skin and skin structure infections. It addresses a range of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant. Intravenous unfractionated heparin sodium is contraindicated with Vibativ administration due to artificially prolonged activated partial thromboplastin time (aPTT) test results for up to 18 hours after Vibativ administration. Vibativ is contraindicated in patients with a known hypersensitivity to telavancin. For more information, please visit www.vibativ.com.

ABOUT CUMBERLAND EMERGING TECHNOLOGIES:

Cumberland Emerging Technologies, Inc. (www.cet-fund.com) is a joint initiative between Cumberland Pharmaceuticals Inc., Vanderbilt University, LaunchTN and WinHealth. The mission of CET is to advance biomedical technologies and products conceived at Vanderbilt University and other regional research centers toward the marketplace.

CET helps manage the development and commercialization process for select projects, and provides expertise on intellectual property, regulatory, manufacturing and marketing issues that are critical to successful new biomedical products. CET's Life Sciences Center provides laboratory space, equipment and infrastructure for CET's activities and other early-stage life sciences ventures.

FORWARD LOOKING STATEMENTS:

This press release contains forward-looking statements, which are subject to certain risks and reflect Cumberland's current views on future events based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. Forward-looking statements include, among other things, statements regarding the company's intent, belief or expectations, and can be identified by the use of terminology such as "may," "will," "expect," "believe," "intend," "plan," "estimate," "should," "seek," "anticipate," "look forward" and other comparable terms or the negative thereof. As with any business, all phases of Cumberland's operations are subject to factors outside of its control, and any one or combination of these factors could materially affect Cumberland's operation results. These factors include macroeconomic conditions, including rising interest rates and inflation, competition, an inability of manufacturers to produce Cumberland's products on a timely basis, failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers, natural disasters, public health epidemics, maintaining an effective sales and marketing infrastructure, and other events beyond the company's control as more fully discussed in its most recent annual report on Form 10-K as filed with the U.S. Securities and Exchange Commission ("SEC"), as well as the company's other filings with the SEC from time to time. There can be no assurance that results anticipated by the company will be realized or that they will have the expected effects. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. The company does not undertake any obligation to publicly revise these statements to reflect events after the date hereof.

 

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(Unaudited)



June 30, 2024


December 31, 2023

ASSETS




Current assets:




Cash and cash equivalents

$              17,336,446


$              18,321,624

Accounts receivable, net

11,619,763


9,758,176

Inventories, net

4,302,159


4,609,362

Prepaid and other current assets

2,322,725


3,025,248

Total current assets

35,581,093


35,714,410

Non-current inventories

11,868,487


12,804,529

Property and equipment, net

337,089


367,903

Intangible assets, net

20,458,835


22,607,918

Goodwill

914,000


914,000

Operating lease right-of-use assets

6,365,790


6,674,394

Other assets

2,993,881


2,692,921

Total assets

$              78,519,175


$              81,776,075

LIABILITIES AND EQUITY




Current liabilities:




Accounts payable

$              12,508,026


$              14,037,629

Operating lease current liabilities

376,780


348,092

Other current liabilities

11,871,363


13,596,528

Total current liabilities

24,756,169


27,982,249

Revolving line of credit

16,091,592


12,784,144

Operating lease non-current liabilities

5,100,260


5,296,247

Other long-term liabilities

6,538,970


6,453,566

Total liabilities

52,486,991


52,516,206

Equity:




Shareholders' equity:




Common stock—no par value; 100,000,000 shares authorized; 14,083,183
and 14,121,833 shares issued and outstanding as of June 30, 2024 and
December 31, 2023, respectively

46,869,026


47,091,602

Accumulated deficit

(20,520,036)


(17,488,161)

Total shareholders' equity

26,348,990


29,603,441

Noncontrolling interests

(316,806)


(343,572)

Total equity

26,032,184


29,259,869

Total liabilities and equity

$              78,519,175


$              81,776,075

 

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations

(Unaudited)



Three months ended June 30,


Six months ended June 30,


2024


2023


2024


2023

Net revenues

$     9,848,849


$   10,888,877


$   18,346,550


$   20,113,515

Costs and expenses:








Cost of products sold

1,710,944


1,520,774


3,286,486


2,771,038

Selling and marketing

4,248,401


4,672,075


8,402,989


8,949,393

Research and development

1,059,187


1,145,038


2,217,440


2,644,708

General and administrative

2,757,148


2,369,883


5,125,055


4,868,876

Amortization

1,099,857


1,158,248


2,210,518


2,388,319

Total costs and expenses

10,875,537


10,866,018


21,242,488


21,622,334

Operating income (loss)

(1,026,688)


22,859


(2,895,938)


(1,508,819)

Interest income

61,841


57,061


158,587


107,251

Other income


981,806



2,828,871

Interest expense

(126,347)


(192,635)


(244,873)


(378,988)

Income (loss) before income taxes

(1,091,194)


869,091


(2,982,224)


1,048,315

Income tax expense

(11,443)


(6,937)


(22,885)


(13,875)

Net income (loss)

(1,102,637)


862,154


(3,005,109)


1,034,440

Net loss (income) at subsidiary attributable to
noncontrolling interests

17,025


10,046


(26,766)


29,944

Net income (loss) attributable to common shareholders

$   (1,085,612)


$         872,200


$   (3,031,875)


$     1,064,384

Earnings (loss) per share attributable to common
shareholders








- basic

$             (0.08)


$               0.06


$             (0.21)


$               0.07

- diluted

$             (0.08)


$               0.06


$             (0.21)


$               0.07

Weighted-average shares outstanding








- basic

14,118,091


14,393,711


14,107,852


14,376,260

- diluted

14,118,091


14,554,264


14,107,852


14,570,798









 

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Cash Flows

(Unaudited)



Six months ended June 30,


2024


2023

Cash flows from operating activities:




Net income (loss)

$           (3,005,109)


$             1,034,440

Adjustments to reconcile net income (loss) to net cash provided by operating
activities:




Depreciation and amortization expense

2,290,130


2,456,590

Amortization of operating lease right-of-use assets

570,369


468,359

Share-based compensation

150,712


188,034

Decrease in non-cash contingent consideration

(442,321)


(476,606)

Increase in cash surrender value of life insurance policies over premiums
paid

(101,538)


(95,997)

Increase in noncash interest expense

8,654


7,809

Net changes in assets and liabilities affecting operating activities:




Accounts receivable

(1,861,587)


944,925

Inventories

1,243,245


(232,110)

Other current assets and other assets

424,684


808,699

Operating lease liabilities

(429,064)


(1,042,792)

Accounts payable and other current liabilities

(1,925,886)


386,614

Other long-term liabilities

85,404


(630,813)

Net cash provided by (used in) operating activities

(2,992,307)


3,817,152

Cash flows from investing activities:




Additions to property and equipment

(48,799)


(179,453)

Additions to intangible assets

(56,191)


(91,808)

Net cash used in investing activities

(104,990)


(271,261)

Cash flows from financing activities:




Borrowings on line of credit

22,000,000


16,000,000

Payments on line of credit

(18,692,552)


(19,051,875)

Cash settlement of contingent consideration

(813,478)


(1,652,990)

Payments made in connection with repurchase of common shares

(381,851)


(349,910)

Net cash provided by (used in) financing activities

2,112,119


(5,054,775)

Net decrease in cash and cash equivalents

(985,178)


(1,508,884)

Cash and cash equivalents at beginning of period

$          18,321,624


$          19,757,970

Cash and cash equivalents at end of period

$          17,336,446


$          18,249,086

 

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Reconciliation of Net Income (loss) Attributable to Common Shareholders to Adjusted Earnings (loss) and
Adjusted Diluted Earnings (loss) Per Share

(Unaudited)












Three months ended June 30,


Three months ended June 30,



2024


2024


2023


2023



Earnings
impact


Earnings per
share impact


Earnings
impact


Earnings per
share impact

Net income (loss) attributable to common
shareholders


$    (1,085,612)


$              (0.08)


$         872,200


$                0.06

Less: Net income (loss) at subsidiary attributable to
noncontrolling interests


17,025



10,046


Net income (loss)


(1,102,637)


(0.08)


862,154


0.06

Adjustments to net income (loss)









Income tax expense


11,443



6,937


Depreciation and amortization


1,139,445


0.08


1,200,915


0.08

Share-based compensation (a)


71,958


0.01


97,878


0.01

Interest income


(61,841)



(57,061)


Interest expense


126,347


0.01


192,635


0.01

Adjusted Earnings (Loss) and Adjusted Diluted
Earnings (Loss) Per Share


$         184,715


$                0.01


$      2,303,458


$                0.16










Diluted weighted-average common shares outstanding:




14,227,139




14,554,264





















Six months ended June 30,


Six months ended June 30,



2024


2024


2023


2023



Earnings
impact


Earnings per
share impact


Earnings
impact


Earnings per
share impact

Net income (loss) attributable to common
shareholders


$    (3,031,875)


$              (0.21)


$     1,064,384


$               0.07

Less: Net income (loss) at subsidiary attributable to
noncontrolling interests


(26,766)



29,944


Net income (loss)


(3,005,109)


(0.21)


1,034,440


0.07

Adjustments to net income (loss)









Income tax expense


22,885



13,875


Depreciation and amortization


2,290,130


0.16


2,456,590


0.17

Share-based compensation (a)


150,712


0.01


188,034


0.01

Interest income


(158,587)


(0.01)


(107,251)


(0.01)

Interest expense


244,873


0.02


378,988


0.03

Adjusted Earnings (Loss) and Adjusted Diluted
Earnings (Loss) Per Share


$       (455,096)


$              (0.03)


$     3,964,676


$               0.27










Diluted weighted-average common shares outstanding:




14,107,852




14,570,798

The Company provided the above adjusted supplemental financial performance measures, which are considered "non-GAAP" financial measures under applicable SEC rules and regulations. These financial measures should be considered supplemental to, and not as a substitute for, financial information prepared in accordance with Generally Accepted Accounting Principles ("GAAP"). The definition of these supplemental measures may differ from similarly titled measures used by others.

Because these supplemental financial measures exclude the effect of items that will increase or decrease the Company's reported results of operations, management encourages investors to review the Company's consolidated financial statements and publicly filed reports in their entirety. A reconciliation of the supplemental financial measures to the most directly comparable GAAP financial measures is included in the tables accompanying this release.

Cumberland's management believes these supplemental financial performance measures are important as they are used by management, along with financial measures in accordance with GAAP, to evaluate the Company's operating performance.  In addition, Cumberland believes that they will be used by certain investors to measure the Company's operating results. Management believes that presenting these supplemental measures provides useful information about the Company's underlying performance across reporting periods on a consistent basis by excluding items that Cumberland does not believe are indicative of its core business performance or reflect long-term strategic activities.  Certain of these items are not settled through cash payments and include: depreciation, amortization, share-based compensation expense and income taxes.  Cumberland utilizes its net operating loss carryforwards to pay minimal income taxes.  In addition, the use of these financial measures provides greater transparency to investors of supplemental information used by management in its financial and operational decision-making, including the evaluation of the Company's operating performance.

The Company defines these supplemental financial measures as follows:

  • Adjusted Earnings (loss): net income (loss) adjusted for the impact of income taxes, depreciation and amortization expense, share-based compensation, interest income and interest expense.

(a) Represents the share-based compensation of Cumberland.

  • Adjusted Diluted Earnings (loss) Per Share: Adjusted Earnings (loss) divided by diluted weighted-average common shares outstanding.

 

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SOURCE Cumberland Pharmaceuticals Inc.

FAQ

What was Cumberland Pharmaceuticals' (CPIX) revenue in Q2 2024?

Cumberland Pharmaceuticals (CPIX) reported net revenue of $9.9 million in Q2 2024, representing a 16% increase from the first quarter of 2024.

How did Cumberland Pharmaceuticals' (CPIX) adjusted earnings change in Q2 2024?

Cumberland Pharmaceuticals (CPIX) achieved adjusted earnings of $0.2 million in Q2 2024, which represents a $0.8 million improvement over the prior period in 2024.

What new developments were reported for Cumberland Pharmaceuticals' (CPIX) product Kristalose in Q2 2024?

Kristalose was added to Wisconsin's Medicaid formulary and was recommended in the American Gastroenterological Association's guidelines as a first-line treatment option for opioid-induced constipation.

What progress did Cumberland Pharmaceuticals (CPIX) report on its ifetroban clinical trials in Q2 2024?

Cumberland Pharmaceuticals (CPIX) reported ongoing Phase II clinical programs evaluating ifetroban in patients with Systemic Sclerosis, cardiomyopathy associated with Duchenne Muscular Dystrophy, and Idiopathic Pulmonary Fibrosis.

Cumberland Pharmaceuticals Inc

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