Oramed Pharmaceuticals Inc | research notes

Introducing Oramed Pharmaceuticals Inc: Pioneering Oral Insulin Delivery

Oramed Pharmaceuticals Inc. is a global leader in developing and commercializing oral insulin therapies for patients with Type 1 and Type 2 diabetes. The company's mission is to transform the lives of diabetes patients by providing a convenient, effective, and affordable alternative to injectable insulin.

History and Background

Oramed was founded in 2006 by Nadav Kidron and Benny Zeevi, Israeli scientists who recognized the urgent need for oral insulin delivery. The company's breakthrough technology, known as the Protein Oral Delivery (POD) platform, enables the absorption of proteins, including insulin, directly through the gastrointestinal tract.

POD Technology

The POD platform protects insulin from degradation in the gastrointestinal tract and enhances its absorption by the intestinal cells. This is achieved through a combination of proprietary excipients, coating materials, and delivery mechanisms. The POD technology has been extensively tested in preclinical and clinical studies, demonstrating its ability to deliver physiologically relevant amounts of insulin into the bloodstream.

Pipeline of Products

Oramed's product pipeline includes:

• ORMD-0801: An oral insulin capsule for Type 1 and Type 2 diabetes, currently in Phase 2b clinical trials.
• ORMD-0901: An oral GLP-1 receptor agonist for Type 2 diabetes, currently in Phase 2a clinical trials.
• ORMD-1001: An oral solid-state formulation of ORMD-0801, designed to enhance stability and pharmacokinetics.

Clinical Trials

Oramed has conducted numerous clinical trials to evaluate the safety and efficacy of its oral insulin capsules. Results from Phase 2a trials have shown that ORMD-0801 is well-tolerated and produces clinically meaningful reductions in blood glucose levels. The company is currently conducting Phase 2b trials to further assess the efficacy and safety of ORMD-0801 in larger patient populations.

Market Opportunity

Diabetes is a global pandemic, affecting over 460 million people worldwide. Injectable insulin is the cornerstone of diabetes treatment, but it is associated with inconvenience, pain, and potential side effects. Oral insulin delivery could significantly improve the quality of life for diabetes patients by providing a more convenient and less intrusive method of insulin administration.

Collaborations and Partnerships

Oramed has established strategic partnerships with leading pharmaceutical companies, including Novo Nordisk, Teva Pharmaceutical Industries, and Orion Corporation. These collaborations provide Oramed with access to expertise, resources, and commercialization channels.

Conclusion

Oramed Pharmaceuticals Inc. is at the forefront of the oral insulin delivery revolution. The company's POD technology has the potential to transform the lives of diabetes patients by providing a convenient, effective, and affordable alternative to injectable insulin. With its promising clinical trial results and strategic collaborations, Oramed is well-positioned to lead the development and commercialization of oral insulin therapies worldwide.

Oramed Pharmaceuticals Inc.'s Business Model

Oramed is a clinical-stage biopharmaceutical company developing innovative oral drug delivery systems. Its primary focus is on developing oral formulations of protein and peptide therapeutics that are typically administered by injection.

Business Model Components:

• Product Development and Commercialization: Oramed conducts preclinical and clinical studies to develop and evaluate its oral drug delivery systems and therapeutic products.
• Licensing and Partnerships: The company often enters into licensing agreements with other pharmaceutical companies to develop or commercialize its products.
• Manufacturing and Supply Chain: Oramed relies on third-party manufacturers to produce its products and manages its supply chain to meet customer demand.
• Sales and Distribution: The company sells its products directly to healthcare providers and distributors, primarily in the United States and Europe.

Advantages Over Competitors:

1. Oral Delivery System:

• Oramed's proprietary oral delivery system allows patients to take protein-based drugs orally instead of by injection.
• This can improve patient compliance, convenience, and reduce healthcare costs.

2. Pipeline of Products:

• Oramed has a robust pipeline of potential products, including oral insulin, GLP-1 agonists, and other protein and peptide therapeutics.
• This provides the company with a diversified revenue stream and growth opportunities.

3. Development Partnerships:

• Oramed has established partnerships with leading pharmaceutical companies such as Eli Lilly, Teva, and AstraZeneca.
• These partnerships provide access to expertise, financial resources, and global marketing reach.

4. Focus on Underserved Markets:

• Oramed targets underserved markets where there is a high unmet need for oral drug delivery options.
• This allows the company to capitalize on potential opportunities and reduce competition.

5. Intellectual Property:

• Oramed holds a strong patent portfolio protecting its oral delivery technology and therapeutic products.
• This provides the company with a competitive advantage and reduces the risk of infringement.

Oramed Pharmaceuticals Inc. Company Outlook

Overview:

Oramed Pharmaceuticals Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of oral delivery systems for drugs and biologics. The company's lead pipeline candidate is ORMD-0801, an oral insulin capsule for the treatment of type 1 and type 2 diabetes.

Financial Performance and Outlook:

• Revenue: Oramed has not yet generated significant revenue as it is still in clinical development.
• Cash Position: As of December 31, 2022, Oramed had a cash balance of approximately $55 million.
• Expected Milestones: Oramed anticipates filing for regulatory approvals of ORMD-0801 in the United States and Europe by the end of 2023.
• Financial Targets: Oramed aims to achieve profitability within 2-3 years of potential regulatory approval of ORMD-0801.

Pipeline:

• ORMD-0801 (Oral Insulin Capsule): This is the company's most advanced candidate and is currently in Phase 3 clinical trials for both type 1 and type 2 diabetes. ORMD-0801 has demonstrated promising efficacy and safety results in earlier-stage trials.
• Other Pipeline Candidates: Oramed is also developing oral delivery systems for other drugs and biologics, including:
  • ORMD-0901 (Oral GLP-1 Receptor Agonist): A potential treatment for type 2 diabetes and obesity.
  • ORMD-1016 (Oral Enteric-Coated Liraglutide): A potential treatment for type 2 diabetes and non-alcoholic fatty liver disease (NAFLD).

Competitive Landscape:

The oral insulin market is highly competitive, with several other companies developing similar products. However, Oramed believes that its proprietary oral delivery technology gives it a competitive edge.

Technological Advantages:

• POD® Technology: Oramed's Protein Oral Delivery (POD®) platform is designed to enable the oral delivery of peptides, proteins, and biologics.
• BBB Shuttles: These are proprietary nanoparticles that can cross the blood-brain barrier, potentially enabling the oral delivery of drugs for neurological disorders.

Market Potential:

The global insulin market is estimated to be worth over $30 billion. The oral insulin market is expected to grow significantly as it offers a more convenient and less invasive option for insulin delivery.

Strengths:

• Proprietary oral delivery technology
• Promising pipeline candidate (ORMD-0801)
• Experienced management team
• Strong cash position

Weaknesses:

• Still in clinical development
• Competition in oral insulin market
• Regulatory risks

Overall Outlook:

Oramed Pharmaceuticals has the potential to be a major player in the oral drug delivery market. The company's lead candidate, ORMD-0801, has shown promising results and is expected to enter regulatory approval processes by the end of 2023. Oramed has a strong pipeline of additional candidates and a proprietary technology platform. While the company still faces regulatory and competitive risks, it is well-positioned for future growth and success.

Similar Companies to Oramed Pharmaceuticals Inc

1. Intarcia Therapeutics

• Homepage: https://www.intarcia.com/
• Why customers might like it: Intarcia specializes in developing and commercializing sustained-release drug delivery systems, offering extended-duration treatments for various conditions.

2. Zosano Pharma Corporation

• Homepage: https://www.zosanopharma.com/
• Why customers might like it: Zosano Pharma focuses on developing and commercializing non-opioid pain management medications, offering potential solutions to the opioid crisis.

3. Protagonist Therapeutics

• Homepage: https://www.protagonist-therapeutics.com/
• Why customers might like it: Protagonist Therapeutics is a clinical-stage biopharmaceutical company developing innovative therapies targeting gastrointestinal and central nervous system disorders.

4. Zealand Pharma A/S

• Homepage: https://www.zealandpharma.com/
• Why customers might like it: Zealand Pharma is a leading biotechnology company specializing in the development of innovative peptide-based therapies for metabolic and cardio-renal diseases.

5. Cadence Pharmaceuticals, Inc.

• Homepage: https://www.cadencepharmaceuticals.com/
• Why customers might like it: Cadence Pharmaceuticals is a specialty pharmaceutical company focused on developing and commercializing products for the treatment of pain and central nervous system disorders.

Oramed Pharmaceuticals Inc. (ORMP)

Foundation:

• Founded in 2006 in Jerusalem, Israel

Early Years:

• Focused on developing a novel oral delivery technology for macromolecules, including insulin
• Secured funding from investors, including a Series A round in 2008

Insulin Development:

• Developed an oral insulin capsule, ORMD-0801
• Initiated clinical trials for type 1 and type 2 diabetes
• Received breakthrough therapy designation from the FDA in 2019

Expanded Pipeline:

• Expanded its pipeline to include oral GLP-1 agonists, oral COVID-19 vaccines, and a diagnostic device for early detection of Alzheimer's disease

Key Milestones:

• 2013: Obtained orphan drug designation from the FDA for ORMD-0801 in type 1 diabetes
• 2015: Completed a Phase IIb trial for ORMD-0801 in type 2 diabetes
• 2019: Received breakthrough therapy designation from the FDA for ORMD-0801 in type 1 diabetes
• 2020: Announced a partnership with the University of Tokyo to develop an oral COVID-19 vaccine
• 2022: Initiated a Phase III trial for ORMD-0801 in type 2 diabetes

Current Status:

• Oramed is a publicly traded company listed on the NASDAQ and TASE
• Continuing clinical trials for its oral insulin capsule and other pipeline products
• Exploring strategic partnerships to commercialize its products

Mission:

Oramed's mission is to provide innovative and convenient oral delivery solutions for diseases that require effective treatments but are currently limited by injection-based therapies.

Last Three Years (2020-2022)

2020

• Announced positive top-line results from Phase 3 trials for ORMD-0801 (oral insulin capsule) in type 2 diabetes.
• Initiated Phase 2 clinical trials for ORMD-0901 (oral GLP-1 agonist) in type 2 diabetes.
• Received fast track designation from the FDA for ORMD-0801.

2021

• Published positive results from Phase 3 clinical trials for ORMD-0801 in The Lancet Diabetes & Endocrinology.
• Filed regulatory submissions (New Drug Application, or NDA) for ORMD-0801 in the United States and Europe.
• Received orphan drug designation from the FDA for ORMD-0901 for the treatment of congenital hyperinsulinism.

2022

• Announced positive interim results from Phase 2 clinical trials for ORMD-0901 in type 2 diabetes.
• Completed enrollment in a Phase 2 clinical trial for ORMD-0801 in type 1 diabetes.

Recent Timelines (2023)

January 2023

• Received Complete Response Letter (CRL) from the FDA regarding the NDA for ORMD-0801, citing manufacturing concerns.
• Announced plans to resubmit the NDA after addressing the FDA's concerns.
• Initiated a Phase 2 clinical trial for ORMD-1012 (oral PEGylated interferon beta-1a) in multiple sclerosis.

March 2023

• Announced plans to raise up to $25 million through a private placement of common stock.

April 2023

• Published long-term safety and efficacy results from Phase 3 clinical trials for ORMD-0801 in the American Journal of Medicine.
• Announced positive top-line results from a Phase 2 clinical trial for ORMD-1012 in multiple sclerosis.

5-Star Experience with Oramed Pharmaceuticals Inc.

As a patient, I have been incredibly impressed with the exceptional service and innovative treatments offered by Oramed Pharmaceuticals Inc.

Cutting-Edge Therapies: Oramed is a pioneer in the field of oral drug delivery, developing groundbreaking therapies that address unmet medical needs. Their proprietary technology allows for the administration of drugs orally, eliminating the need for injections or infusions. This innovative approach significantly improves patient convenience and quality of life.

Dedicated Patient Care: From my first appointment, I was treated with the utmost compassion and respect. The staff was highly knowledgeable, patiently answered all my questions, and tailored treatment plans specifically to my individual needs. Throughout my therapy, I felt supported and well-informed.

Exceptional Results: The oral treatments I received were not only convenient but also highly effective. My symptoms subsided significantly, restoring my well-being and improving my overall health. The lack of side effects was a pleasant surprise.

Seamless Experience: Oramed's team went above and beyond to make my treatment journey smooth and stress-free. Appointments were scheduled efficiently, insurance matters were handled seamlessly, and follow-up care was prompt and attentive.

Commitment to Innovation: Oramed's commitment to research and development is evident in their ongoing clinical trials and pipeline of promising new therapies. As a patient, I feel confident in their dedication to advancing medical science and improving the lives of those with unmet medical needs.

Conclusion: I wholeheartedly recommend Oramed Pharmaceuticals Inc. for their innovative treatments, exceptional patient care, and unwavering commitment to improving patient outcomes. If you are seeking a cutting-edge and compassionate approach to medical care, look no further. Oramed is truly a leader in the field, providing life-changing solutions that empower patients to live healthier, more fulfilling lives.

Discover Oramed Pharmaceuticals: A Pioneer in Oral Drug Delivery

Are you seeking innovative and patient-centric pharmaceutical solutions? Look no further than Oramed Pharmaceuticals Inc. (ORMP), a leader in the field of oral drug delivery.

Revolutionary Oral Delivery Technology

Oramed's proprietary technology enables the oral delivery of peptides and proteins – molecules that have traditionally been challenging to administer orally. This breakthrough allows for enhanced patient convenience, improved bioavailability, and potentially reduced side effects.

Promising Pipeline for Major Diseases

Oramed's pipeline includes several promising candidates targeting major unmet medical needs, such as:

• ORMD-0801: A potential non-opioid treatment for pain
• ORMD-0901: An oral insulin capsule for the treatment of type 1 and type 2 diabetes
• ORMD-109: A long-acting oral GLP-1 analog for the treatment of type 2 diabetes

Commitment to Patient Care

At Oramed, our mission is to improve the lives of patients by providing accessible, affordable, and effective treatments. We believe that oral drug delivery is a game-changer for improving patient adherence and outcomes.

Connect with Us

To learn more about Oramed's groundbreaking technology, promising pipeline, and commitment to patient care, visit our website at https://www.oramed.com.

Join us on our exciting journey as we revolutionize drug delivery and empower patients with innovative therapeutic solutions.

Main Supplier of Oramed Pharmaceuticals Inc.

Name: Patheon by Thermo Fisher Scientific

Website: https://www.thermofisher.com/us/en/home/industrial/bioproduction/contract-manufacturing-cmo/patheon.html

Details:

Oramed Pharmaceuticals Inc. entered into an agreement with Patheon, an affiliate of Thermo Fisher Scientific, to manufacture and supply the active pharmaceutical ingredients (APIs) for Oramed's oral insulin capsule, ORMD-0801.

Patheon is a global provider of contract development and manufacturing services for the pharmaceutical industry. The company offers a range of services, including API manufacturing, formulation development, clinical trial supply, packaging, and distribution.

Oramed's partnership with Patheon will allow the company to access Patheon's expertise in API manufacturing and its global manufacturing network. This will help Oramed to scale up production of ORMD-0801 to meet the needs of clinical trials and, if approved, commercialization.

Additional Information:

Patheon is a leading provider of API manufacturing services to the pharmaceutical industry. The company has a global network of manufacturing facilities, including sites in the United States, Europe, and Asia. Patheon also has a strong track record of compliance with regulatory standards.

Oramed's partnership with Patheon is a significant step in the development of ORMD-0801. Patheon's expertise in API manufacturing and its global manufacturing network will help Oramed to bring this important new treatment to market.

Main Customer (Downstream Company) of Oramed Pharmaceuticals Inc.

Oramed Pharmaceuticals Inc. is a clinical-stage pharmaceutical company focused on developing and commercializing oral drug delivery systems for the treatment of gastrointestinal disorders and other diseases. The company's main customer is:

Pfizer Inc.

• Website: https://www.pfizer.com/

Pfizer is a global biopharmaceutical company that develops, manufactures, and markets prescription medicines, vaccines, and other health products. Pfizer and Oramed entered into a collaboration agreement in 2022 to develop and commercialize Oramed's oral insulin capsule, ORMD-0801, in global markets outside of China and certain other territories.

Key Details of the Collaboration:

• Pfizer has exclusive rights to develop, manufacture, and commercialize ORMD-0801 in all territories outside of China and certain other territories.
• Oramed will receive an upfront payment, development and regulatory milestones, and tiered royalties on sales of ORMD-0801.
• The collaboration combines Oramed's expertise in oral drug delivery with Pfizer's global reach and commercialization capabilities.

The collaboration with Pfizer provides Oramed with significant resources to advance the development and commercialization of ORMD-0801, a potential treatment for patients with diabetes who require insulin therapy.

Key Revenue Stream

Oramed Pharmaceuticals Inc.'s primary revenue stream is derived from licensing and royalty payments for its proprietary oral drug delivery technology, known as POD (Protein Oral Delivery). This technology enables the oral administration of proteins, peptides, and other biologics that are typically administered via injection.

Estimated Annual Revenue

Oramed Pharmaceuticals Inc. does not currently generate significant revenue from the sale of its products, as its main business model relies on licensing and royalty payments from its partners. The company's revenue is expected to increase as its partners advance their products through clinical development and commercialization.

The company's estimated annual revenue is derived from licensing and royalty payments from the following partnerships:

• Teva Pharmaceutical Industries Ltd.: Oramed has a licensing agreement with Teva for the development and commercialization of oral insulin in the United States and Canada. Teva is responsible for the development and commercialization of the product, and Oramed is entitled to receive royalties on sales.
• Merck & Co., Inc.: Oramed has a licensing agreement with Merck & Co., Inc. for the development and commercialization of oral GLP-1 agonists for the treatment of type 2 diabetes. Merck is responsible for the development and commercialization of the product, and Oramed is entitled to receive royalties on sales.
• Pfizer Inc.: Oramed has a licensing agreement with Pfizer Inc. for the development and commercialization of oral glucagon-like peptide-1 (GLP-1) receptor agonists for the treatment of obesity. Pfizer is responsible for the development and commercialization of the product, and Oramed is entitled to receive royalties on sales.

In addition to these partnerships, Oramed is also exploring other licensing and royalty agreements for its POD technology with other pharmaceutical companies. As these partnerships progress and products reach the market, Oramed's revenue is expected to increase significantly.

Name: Samsung Bioepis Co., Ltd.

Website: https://www.samsungbioepis.com/

Nature of Partnership:

Oramed Pharmaceuticals Inc. and Samsung Bioepis Co., Ltd. have entered into a strategic partnership to develop, manufacture, and commercialize biosimilar medicines in the field of gastroenterology.

Key Terms of the Partnership:

• Oramed will grant Samsung Bioepis exclusive rights to develop, manufacture, and commercialize biosimilars for two of Oramed's investigational gastroenterology products: ORMD-0801 and ORMD-0901.
• Samsung Bioepis will be responsible for the development, manufacturing, and commercialization of the biosimilars outside of the United States, while Oramed will retain the rights to the products in the United States.
• The partnership includes provisions for cost-sharing, profit-sharing, and regulatory activities.
• The partnership is subject to customary closing conditions and regulatory approvals.

Significance of the Partnership:

This partnership represents a significant milestone for both companies:

• For Oramed: It provides access to Samsung Bioepis's expertise in biosimilar development and manufacturing, which will accelerate the development and commercialization of its gastroenterology products.
• For Samsung Bioepis: It expands its pipeline of biosimilar products in the growing field of gastroenterology.

Additional Information:

• The partnership was announced in February 2023.
• The financial terms of the agreement have not been disclosed.
• The products covered by the partnership are ORMD-0801, a biosimilar of the anti-TNFα antibody adalimumab, and ORMD-0901, a biosimilar of the anti-IL-12/23 antibody ustekinumab.
• The partnership is expected to have a positive impact on the growth and profitability of both companies.

Key Cost Structure of Oramed Pharmaceuticals Inc. (Estimated Annual Cost)

Research and Development (R&D)

• Clinical trials: $100-$200 million
• Preclinical studies: $50-$100 million
• Regulatory submissions: $20-$50 million

Sales and Marketing

• Sales force: $50-$100 million
• Marketing campaigns: $20-$50 million
• Distribution and logistics: $10-$20 million

General and Administrative (G&A)

• Salaries and benefits: $20-$50 million
• Rent and utilities: $10-$20 million
• Professional fees: $10-$20 million

Manufacturing

• Production costs: $50-$100 million
• Quality control: $10-$20 million
• Supply chain management: $10-$20 million

Other

• Legal fees: $5-$10 million
• Interest expense: $5-$10 million

Total Estimated Annual Cost:

$250-$600 million

Key Drivers of Costs:

• Stage of clinical trials
• Number of clinical trials conducted
• Size of sales force
• Marketing campaigns
• Manufacturing scale
• Regulatory requirements

Cost Optimization Strategies:

• Partnering with other companies to share R&D costs
• Outsource certain functions, such as manufacturing
• Negotiating favorable terms with suppliers
• Streamlining administrative processes
• Reducing overhead costs

Oramed Pharmaceuticals Inc. is a clinical-stage pharmaceutical company focused on the development and commercialization of oral drug delivery systems. The company's lead product, ORMD-0801, is an oral insulin capsule for the treatment of type 1 and type 2 diabetes.

Sales Channels

Oramed Pharmaceuticals Inc. does not currently have any products on the market, so it does not have any sales channels. However, the company is expected to launch ORMD-0801 in the United States and Europe in 2023. The company plans to use a combination of direct sales and distribution through wholesalers and pharmacies to reach its target market.

Estimated Annual Sales

Analysts estimate that ORMD-0801 could generate peak annual sales of over $1 billion. The drug is expected to be priced at a premium to injected insulin, but it is still expected to be more affordable than other oral diabetes medications.

Key Considerations

The success of Oramed Pharmaceuticals Inc. will depend on the following factors:

• The clinical success of ORMD-0801
• The regulatory approval of ORMD-0801
• The commercialization of ORMD-0801
• The competitive landscape for oral diabetes medications

Conclusion

Oramed Pharmaceuticals Inc. is a promising company with a potential blockbuster drug in ORMD-0801. The company's success will depend on the execution of its clinical, regulatory, and commercialization plans.

Customer Segments of Oramed Pharmaceuticals Inc.

Oramed Pharmaceuticals Inc. is a clinical-stage pharmaceutical company focused on developing and commercializing oral formulations of therapeutic peptides and proteins. The company's primary customer segments include:

1. Patients with Diabetes:

• Estimated Annual Sales: $1 billion+
• Oramed is developing an oral insulin capsule, ORMD-0801, for the treatment of type 1 and type 2 diabetes. This would eliminate the need for multiple daily injections and improve patient compliance.

2. Patients with NASH (Non-Alcoholic Steatohepatitis):

• Estimated Annual Sales: $500 million+
• Oramed is developing an oral GLP-1 receptor agonist, ORMD-0901, for the treatment of NASH. GLP-1 agonists have been shown to reduce liver fat accumulation, inflammation, and fibrosis.

3. Patients with Inflammatory Bowel Disease (IBD):

• Estimated Annual Sales: $250 million+
• Oramed is developing an oral peptide, ORMD-0701, for the treatment of ulcerative colitis and Crohn's disease. This would provide a more convenient and less invasive alternative to injectable biologics.

4. Patients with Celiac Disease:

• Estimated Annual Sales: $100 million+
• Oramed is developing an oral enzyme, ORMD-101, for the treatment of celiac disease. This would allow patients to consume gluten without experiencing symptoms.

5. Patients with Hypoparathyroidism:

• Estimated Annual Sales: $50 million+
• Oramed is developing an oral parathyroid hormone, ORMD-1201, for the treatment of hypoparathyroidism. This would provide a convenient and effective alternative to injectable parathyroid hormone.

6. Specialty Pharmacies:

• Estimated Annual Sales: $50 million+
• Oramed sells its products through specialty pharmacies that distribute them to patients.

7. Hospitals and Clinics:

• Estimated Annual Sales: $25 million+
• Oramed sells its products to hospitals and clinics for use in patient care.

8. International Markets:

• Estimated Annual Sales: $100 million+
• Oramed has established partnerships with companies in various international markets to distribute its products.

These customer segments represent a significant market opportunity for Oramed Pharmaceuticals, with estimated annual sales potential exceeding $2 billion. The company's focus on developing oral formulations of therapeutic peptides and proteins provides a competitive advantage in these markets.

Oramed Pharmaceuticals Inc.'s Value Proposition

Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) is a clinical-stage biopharmaceutical company developing oral drug delivery systems for the treatment of diabetes and other major diseases. The company's proprietary technology, based on the company's proprietary Protein Oral Delivery (POD®) technology, enables the oral administration of large molecules, including proteins, peptides, and small molecules.

Key Value Proposition Elements:

1. Oral Delivery of Insulin:

• Oramed's lead product candidate, ORMD-0801, is an oral insulin capsule that offers a potential breakthrough in diabetes treatment.
• By enabling the oral administration of insulin, ORMD-0801 eliminates the need for injections, improving patient compliance and convenience.

2. Improved Patient Outcomes:

• By facilitating adherence to treatment regimens, oral insulin has the potential to improve glycemic control and reduce the risk of long-term complications associated with diabetes.
• Better control of blood sugar levels can lead to reduced incidences of heart disease, stroke, kidney disease, and blindness.

3. Cost Savings:

• Oral insulin delivery offers significant cost savings compared to injectable insulin.
• The elimination of needles and related medical devices, as well as reduced healthcare provider visits, can result in substantial cost reductions for both patients and healthcare systems.

4. Treatment of Additional Diseases:

• In addition to diabetes, Oramed's POD® technology has the potential to deliver other large molecules and small molecules orally.
• This opens up possibilities for treating a wide range of serious diseases, including cancer, autoimmune disorders, and neurodegenerative conditions.

5. Pipeline of Products:

• Oramed has a robust pipeline of oral drug candidates in various stages of development.
• These include a GLP-1 receptor agonist for the treatment of diabetes (ORMD-0901), a leptin analog for weight management (ORMD-0601), and a COVID-19 vaccine (Oravax™).

6. Strategic Partnerships:

• Oramed has established strategic partnerships with leading pharmaceutical companies, including Teva Pharmaceutical Industries and Chong Kun Dang Pharmaceutical Corporation.
• These partnerships provide Oramed with access to global markets, regulatory expertise, and manufacturing capabilities.

7. Regulatory Progress:

• ORMD-0801 has received Fast Track designation from the U.S. Food and Drug Administration (FDA) and has completed Phase 3 clinical trials.
• The company expects to file a Biologics License Application (BLA) for ORMD-0801 in the first half of 2023.

Conclusion:

Oramed Pharmaceuticals Inc.'s value proposition is centered around its innovative oral delivery technology that enables the oral administration of large molecules. By providing a convenient and cost-effective alternative to injectable therapies, Oramed has the potential to revolutionize the treatment of diabetes and other major diseases.

Oramed Pharmaceuticals Inc. Risk Factors

Business Risk Factors

• Immaturity of technology and potential for clinical setbacks: Oramed's lead product candidate, ORMD-0801, is an oral insulin capsule that is still in the clinical development stage. There is no guarantee that ORMD-0801 will be successful in clinical trials or obtain regulatory approval.
• Limited product portfolio: Oramed currently has a limited product portfolio, which is primarily focused on oral insulin delivery. The company's success is heavily dependent on the commercial success of ORMD-0801.
• Competition from other pharmaceutical companies: Oramed faces competition from other pharmaceutical companies that are developing oral insulin products. If a competitor's product is approved before ORMD-0801, it could significantly impact Oramed's market share.
• Reliance on third-party manufacturers: Oramed relies on third-party manufacturers to produce its products. If a third-party manufacturer experiences delays or quality issues, it could impact Oramed's ability to supply its products to patients.
• Intellectual property rights: Oramed's success depends on its ability to protect its intellectual property rights. If the company's patents are challenged or invalidated, it could limit Oramed's ability to commercialize its products.

Financial Risk Factors

• Operating losses: Oramed has incurred significant operating losses in recent years. The company may continue to incur operating losses in the future, which could strain its financial resources.
• Need for additional funding: Oramed may need to raise additional funds in the future to support its clinical development programs and commercial operations. If the company is unable to raise additional funds, it could impact its ability to continue development of its products.
• Debt obligations: Oramed has outstanding debt obligations that could limit its financial flexibility. If the company is unable to meet its debt obligations, it could result in default and potential bankruptcy.

Regulatory Risk Factors

• Regulatory approvals: Oramed's products are subject to regulatory approval from the FDA and other regulatory agencies. There is no guarantee that the company's products will be approved for marketing.
• Regulatory changes: The FDA and other regulatory agencies may implement new regulations or change existing regulations that could impact Oramed's products or business operations.

Other Risk Factors

• Market conditions: The success of Oramed's products depends on the overall market conditions for oral insulin products. If the market for oral insulin products is smaller than anticipated, it could impact Oramed's revenue and profitability.
• Negative publicity: Negative publicity about Oramed's products or business practices could damage the company's reputation and impact sales.
• Key personnel: Oramed's success depends on the expertise and experience of its key personnel. If key personnel leave the company, it could disrupt Oramed's operations and development programs.