Protagonist Therapeutics, Inc. (PTGX): Business Model Canvas [11-2024 Updated]

Protagonist Therapeutics, Inc. (PTGX) is at the forefront of innovative drug development, focusing on peptide-based therapeutics for hematology and immunology. This blog post delves into the company's Business Model Canvas, outlining its strategic partnerships, key activities, and value propositions that aim to revolutionize treatment options for patients. Discover how PTGX navigates the complex landscape of drug development and commercialization below.

Protagonist Therapeutics, Inc. (PTGX) - Business Model: Key Partnerships

Collaborations with Janssen (JNJ) and Takeda

Protagonist Therapeutics has established significant collaborations with Janssen Pharmaceuticals, a Johnson & Johnson company, and Takeda Pharmaceutical Company. Under the JNJ License and Collaboration Agreement, Protagonist received milestone payments totaling $172.5 million from the inception of the agreement in 2017 through September 30, 2024. Recent milestones included:

• $50.0 million upon the dosing of the third patient in the ICONIC-TOTAL Phase 3 trial in October 2023;
• $10.0 million for the dosing of the third patient in the ANTHEM Phase 2b trial in December 2023.

Protagonist is eligible for additional milestone payments up to $795.0 million, including:

• $115.0 million for meeting primary clinical endpoints in a Phase 3 trial;
• $35.0 million upon filing a New Drug Application (NDA) with the FDA;
• $50.0 million upon FDA approval of the NDA;
• $15.0 million for the dosing of the third patient in a Phase 3 trial for a second indication.

In April 2024, Protagonist entered into a Collaboration Agreement with Takeda, receiving a one-time, non-refundable upfront payment of $300.0 million, with potential future milestone payments totaling up to $975 million if certain conditions are met.

Partnerships with Contract Manufacturers for Drug Production

Protagonist relies on contract manufacturers to produce its drug candidates, which is critical for scaling up production to meet clinical trial and potential market demands. The operational costs associated with these partnerships are integrated into the overall research and development expenses, which totaled $103.2 million for the nine months ended September 30, 2024, reflecting a 13% increase compared to the previous year. These expenses include:

Category	Expense (2024)	Expense (2023)	Change (%)
Clinical and development expense - rusfertide	$74.7 million	$74.4 million	0%
Pre-clinical and drug discovery research expense	$28.3 million	$15.3 million	85%
Total R&D Expenses	$103.2 million	$91.3 million	13%

These partnerships ensure the production of high-quality drug candidates, which is essential for the success of Protagonist's clinical trials.

Engagements with Clinical Research Organizations (CROs) for Trial Management

Protagonist collaborates with various clinical research organizations (CROs) to manage its clinical trials efficiently. These partnerships are pivotal in streamlining operations and ensuring compliance with regulatory standards. The costs associated with CRO engagements are reflected in the company's operating expenses, which amounted to $137.7 million for the nine months ended September 30, 2024. This includes:

• Research and Development Expenses: $103.2 million
• General and Administrative Expenses: $34.5 million

Protagonist's strategic use of CROs enhances its capability to conduct trials effectively and efficiently, allowing the company to focus on its core competencies in drug development.

Protagonist Therapeutics, Inc. (PTGX) - Business Model: Key Activities

Conducting clinical trials for product candidates

Protagonist Therapeutics is actively engaged in conducting clinical trials for its product candidates, notably rusfertide and JNJ-2113. As of September 30, 2024, the company reported that it has earned a total of $172.5 million in non-refundable payments from its collaboration with Johnson & Johnson (JNJ) since the inception of the agreement in 2017. The company is eligible for further milestone payments totaling approximately $795.0 million, contingent upon the successful completion of clinical trials and regulatory approvals.

Specifically, Protagonist is focused on the Phase 3 VERIFY trial for rusfertide in polycythemia vera (PV). It anticipates a milestone payment of $25.0 million upon achieving the primary endpoint in this trial. Additionally, a milestone of $50.0 million is expected upon FDA approval of a New Drug Application (NDA) for rusfertide.

Research and development of peptide-based therapeutics

The company’s research and development (R&D) expenses for the nine months ended September 30, 2024, totaled $103.2 million, which reflects a 13% increase from $91.3 million in the same period of 2023. This increase is attributed to a $12.9 million rise in pre-clinical and drug discovery research program expenses. Protagonist currently has 98 full-time equivalent employees dedicated to R&D, up from 84 the previous year.

Protagonist's R&D strategy includes the development of constrained peptides that aim to combine the advantages of small molecules and injectable antibodies while overcoming their limitations. The company has announced a new oral Interleukin-17 peptide antagonist program, targeting multiple indications, which is expected to yield a development candidate ready for Investigational New Drug (IND) enabling studies by the end of 2024.

Regulatory submissions and compliance management

Protagonist Therapeutics is also focused on regulatory submissions and compliance management related to its product candidates. The company reported that it expects to file an NDA for rusfertide, with potential milestone payments of $50.0 million upon approval. As of September 30, 2024, Protagonist holds $583.3 million in cash, cash equivalents, and marketable securities, which is expected to support its operational and regulatory activities for at least the next 12 months.

In addition to its ongoing projects, Protagonist has incurred significant annual operating losses, totaling an accumulated deficit of $472.2 million as of September 30, 2024. The company’s regulatory efforts are crucial for the commercialization of its peptide-based therapeutics and involve extensive collaboration with regulatory bodies to ensure compliance with industry standards.

Activity	Details	Financial Impact
Clinical Trials	Conducting Phase 3 trials for rusfertide in PV	Eligible for $25.0 million upon primary endpoint achievement; $50.0 million upon NDA approval
R&D Expenses	Total R&D expenses for 2024: $103.2 million	13% increase from $91.3 million in 2023
Regulatory Submissions	Preparing NDA for rusfertide	Potential milestone of $50.0 million upon FDA approval
Cash Reserves	Cash, cash equivalents, and marketable securities	$583.3 million available as of September 30, 2024

Protagonist Therapeutics, Inc. (PTGX) - Business Model: Key Resources

Proprietary peptide technology platform for drug development

Protagonist Therapeutics has developed a proprietary discovery platform that focuses on engineering novel, structurally constrained peptides. This technology aims to combine the advantages of orally delivered small molecules with those of injectable antibody drugs, addressing the limitations of traditional peptides. The platform is strategically focused on therapeutic areas including hematology and blood disorders, inflammatory and immune diseases, and metabolic diseases such as obesity.

As of January 2024, Protagonist announced a new oral Interleukin-17 peptide antagonist program targeting multiple conditions, reflecting the ongoing development of its proprietary technology.

Experienced management and scientific teams

Protagonist Therapeutics is led by a seasoned management team and a highly skilled scientific workforce. As of September 30, 2024, the company employed 98 full-time equivalent research and development staff, an increase from 84 in the previous year. General and administrative personnel numbered 28 as of the same date. This experienced team is crucial for driving the company's research initiatives and advancing its clinical programs.

Financial resources including cash reserves and partnerships

As of September 30, 2024, Protagonist Therapeutics reported cash, cash equivalents, and marketable securities amounting to $583.3 million, a significant increase from $341.6 million at the end of 2023. This robust financial position is bolstered by collaborations, notably a $300.0 million upfront payment received from Takeda in April 2024 as part of their collaboration agreement. The company has also earned $263.8 million in license and collaboration revenue for the nine months ended September 30, 2024.

Protagonist's financial strategy includes additional potential milestone payments under its collaboration agreements with JNJ and Takeda, which could amount to approximately $795.0 million in future payments. This financial framework provides the necessary resources for continued investment in research and development activities.

Key Financial Metrics	As of September 30, 2024	As of December 31, 2023
Cash, Cash Equivalents, and Marketable Securities	$583.3 million	$341.6 million
Accumulated Deficit	$472.2 million	$615.7 million
License and Collaboration Revenue (Nine Months Ended September 30, 2024)	$263.8 million	$0
Number of R&D Employees	98	84
Number of G&A Employees	28	27

Protagonist Therapeutics, Inc. (PTGX) - Business Model: Value Propositions

Innovative peptide therapeutics targeting hematology and immunology

Protagonist Therapeutics focuses on developing peptide therapeutics specifically for hematology and immunology. Their lead product candidate, rusfertide, is designed for the treatment of polycythemia vera (PV) and aims to address significant unmet needs in this patient population. As of September 30, 2024, the company reported a significant milestone with a one-time, non-refundable upfront payment of $300.0 million received from Takeda under their collaboration agreement.

Potential for improved efficacy and safety profiles over existing treatments

Protagonist’s peptide therapeutics, including rusfertide, are designed to enhance treatment efficacy while maintaining a favorable safety profile. The potential for improved outcomes is underscored by ongoing clinical trials, which have shown promising results. For example, the company achieved a milestone payment of $50.0 million upon dosing the third patient in the Phase 3 clinical trial for rusfertide. The development expenses for rusfertide were reported at $74.7 million for the nine months ended September 30, 2024, indicating robust investment in ensuring its competitive edge.

Focus on patient-centric solutions with self-administration options

Protagonist is committed to developing patient-centric solutions that facilitate self-administration, thereby enhancing treatment adherence and convenience. This approach is particularly relevant in the context of chronic diseases where long-term treatment regimens are necessary. The company’s focus on self-administration options is part of its broader strategy to improve patient outcomes and satisfaction. As of September 30, 2024, Protagonist had 98 full-time equivalent research and development employees, emphasizing its commitment to innovative solutions.

Metric	Value
Cash, cash equivalents, and marketable securities (as of September 30, 2024)	$583.3 million
Accumulated deficit (as of September 30, 2024)	$472.2 million
Total operating expenses for nine months ended September 30, 2024	$137.7 million
License and collaboration revenue for nine months ended September 30, 2024	$263.8 million
Research and development expenses for nine months ended September 30, 2024	$103.2 million
General and administrative expenses for nine months ended September 30, 2024	$34.5 million

Protagonist Therapeutics, Inc. (PTGX) - Business Model: Customer Relationships

Building relationships with healthcare providers for product education

Protagonist Therapeutics emphasizes the importance of establishing strong relationships with healthcare providers (HCPs) to facilitate product education and ensure optimal treatment outcomes. As of September 30, 2024, the company has invested significantly in educational initiatives, with research and development expenses totaling $103.2 million for the nine months ended September 30, 2024, which includes substantial allocations for educating HCPs on the use of their products, particularly rusfertide.

Engaging with patient advocacy groups for awareness and support

Protagonist Therapeutics actively engages with patient advocacy groups to raise awareness about their therapeutic options. The company recognizes that collaboration with these groups is essential for understanding patient needs and improving treatment adherence. In 2024, the company has allocated resources towards outreach programs, which are part of their broader marketing strategy aimed at enhancing patient support systems.

Establishing trust through transparent communication regarding product development

Transparency in communication regarding product development is a cornerstone of Protagonist Therapeutics' customer relationship strategy. The company has maintained an open dialogue with stakeholders, providing updates on clinical trials and regulatory milestones. As of September 30, 2024, Protagonist has achieved several regulatory milestones under its collaboration agreements, including a $300 million one-time upfront payment received from Takeda in April 2024. This level of transparency not only builds trust but also fosters long-term relationships with both HCPs and patients.

Key Metrics	Value (as of September 30, 2024)
Cash, Cash Equivalents, and Marketable Securities	$583.3 million
Accumulated Deficit	$472.2 million
Research and Development Expenses	$103.2 million
License and Collaboration Revenue	$263.8 million
General and Administrative Expenses	$34.5 million
Net Income (Loss)	$143.5 million

Protagonist Therapeutics, Inc. (PTGX) - Business Model: Channels

Collaboration with pharmaceutical partners for distribution

Protagonist Therapeutics engages in strategic collaborations with major pharmaceutical companies to enhance its distribution channels. Notably, the company has a collaboration with Takeda, which includes a $300.0 million one-time, non-refundable upfront payment received in April 2024. This agreement allows Protagonist to leverage Takeda's extensive distribution network for its product candidates, including rusfertide, which is co-developed and co-commercialized under this partnership.

Direct engagement with healthcare professionals for clinical trial participation

Protagonist Therapeutics actively engages healthcare professionals to facilitate clinical trial participation. The company has structured its clinical trials, such as the ICONIC-TOTAL Phase 3 trial for JNJ-2113, to involve healthcare providers who can recruit suitable candidates. As of September 30, 2024, Protagonist has earned $172.5 million in non-refundable payments under the JNJ License and Collaboration Agreement, which underscores the financial stakes involved in these clinical engagements.

Digital platforms for disseminating research findings and product information

Protagonist utilizes digital platforms to disseminate its research findings and product information efficiently. The company reported a license and collaboration revenue of $263.8 million for the nine months ended September 30, 2024, which includes both direct communications and digital outreach efforts. These platforms not only enhance visibility but also facilitate engagement with both healthcare professionals and potential patients.

Channel Type	Description	Financial Impact
Pharmaceutical Partnerships	Collaboration with Takeda for distribution of rusfertide	$300.0 million upfront payment
Clinical Trials	Engagement with healthcare professionals for trials	$172.5 million in milestone payments from JNJ
Digital Platforms	Research dissemination and product information	$263.8 million in license and collaboration revenue

Protagonist Therapeutics, Inc. (PTGX) - Business Model: Customer Segments

Patients with hematologic disorders such as polycythemia vera

Protagonist Therapeutics, Inc. focuses on patients suffering from hematologic disorders, particularly polycythemia vera (PV). The market for PV treatments is significant, with an estimated prevalence of approximately 44,000 cases in the United States alone. The company’s lead product candidate, rusfertide, is being developed specifically for PV and is currently in Phase 3 clinical trials. The global market for PV treatment is projected to reach $3.5 billion by 2028, driven by the increasing diagnosis and awareness of the disease.

Healthcare providers and specialists in hematology and immunology

Healthcare providers, including hematologists and immunologists, represent a critical customer segment for Protagonist Therapeutics. These specialists play a crucial role in diagnosing and treating patients with PV and other related hematologic disorders. As of 2024, there are approximately 5,000 hematologists practicing in the U.S., and the number of specialists is expected to grow. Protagonist targets these providers to ensure that they are informed about the benefits and efficacy of rusfertide as a treatment option.

Pharmaceutical companies interested in collaboration and licensing

Protagonist Therapeutics actively engages with pharmaceutical companies for collaboration and licensing opportunities. The company has established significant partnerships, including a collaboration agreement with Johnson & Johnson (JNJ) and Takeda Pharmaceuticals. Through these collaborations, Protagonist has received substantial milestone payments, including:

• $300 million upfront payment from Takeda upon the closing of their collaboration agreement in March 2024.
• $172.5 million in non-refundable payments from JNJ since the inception of their collaboration agreement in 2017 through September 30, 2024.

Future development milestones under these collaborations include potential payments of up to $795 million from JNJ based on clinical trial successes and regulatory approvals. This demonstrates the strategic importance of pharmaceutical partnerships in Protagonist's business model.

Customer Segment	Target Population	Market Size	Collaboration Value
Patients with hematologic disorders	44,000 cases of PV in the U.S.	$3.5 billion by 2028	N/A
Healthcare providers	5,000 hematologists in the U.S.	N/A	N/A
Pharmaceutical companies	Multiple pharmaceutical partners	N/A	$300 million upfront + $172.5 million from JNJ

Protagonist Therapeutics, Inc. (PTGX) - Business Model: Cost Structure

Significant R&D expenses related to clinical trials and drug development

For the nine months ended September 30, 2024, Protagonist Therapeutics incurred $103.2 million in research and development expenses, an increase of $12.0 million or 13% compared to $91.3 million for the same period in 2023. This increase was driven primarily by:

• Clinical and development expense for rusfertide: $74.7 million in 2024 vs. $74.4 million in 2023.
• Pre-clinical and drug discovery research expense: $28.3 million in 2024 vs. $15.3 million in 2023.
• Clinical and development expense for PN-943: $121,000 in 2024 vs. $1.5 million in 2023 (a decrease of 92%).

Expense Category	2024 (in thousands)	2023 (in thousands)	Change (in thousands)
Clinical and development expense — rusfertide	$74,692	$74,387	$305
Clinical and development expense — PN-943	$121	$1,487	($1,366)
Pre-clinical and drug discovery research expense	$28,285	$15,327	$12,958
Total R&D Expenses	$103,224	$91,262	$11,962

Operational costs including general administration and facility maintenance

General and administrative expenses for the nine months ended September 30, 2024, totaled $34.5 million, representing a 36% increase from $25.4 million in the same period of 2023. This increase can be attributed to:

• A $4.6 million rise in advisory and legal fees related to the Takeda Collaboration Agreement.
• A $3.3 million increase in stock-based compensation expense.
• A $2.0 million increase in personnel-related expenses.

Expense Category	2024 (in thousands)	2023 (in thousands)	Change (in thousands)
General and Administrative Expenses	$34,508	$25,439	$9,069

Costs associated with regulatory compliance and intellectual property protection

Protagonist Therapeutics faces costs related to regulatory compliance and intellectual property protection, which are part of their operational expenditures. These costs are included within the general administrative expenses and are significant for maintaining compliance with FDA regulations and safeguarding their intellectual property rights.

As of September 30, 2024, the company had an accumulated deficit of $472.2 million and total liabilities of $71.9 million. The total future minimum lease payments under their operating lease obligations are projected to be $12.8 million.

Type of Cost	Amount (in thousands)
Accrued Expenses and Other Payables	$1,061
Income Tax Expense	$2,230
Total Future Minimum Lease Payments	$12,819

Protagonist Therapeutics, Inc. (PTGX) - Business Model: Revenue Streams

Milestone payments from collaboration agreements with JNJ and Takeda

Protagonist Therapeutics has established significant revenue streams through collaboration agreements with Johnson & Johnson (JNJ) and Takeda. Under the JNJ License and Collaboration Agreement, the company has earned a total of $172.5 million in non-refundable payments since inception in 2017 through September 30, 2024. Recent milestone payments include:

• $50.0 million upon the dosing of the third patient in the ICONIC-TOTAL Phase 3 trial in late October 2023, received in December 2023.
• $10.0 million upon the dosing of the third patient in the ANTHEM Phase 2b trial in December 2023, received in January 2024.

Future potential milestones under this agreement include:

• $115.0 million upon a Phase 3 clinical trial meeting its primary endpoint.
• $35.0 million upon the filing of a New Drug Application (NDA) for a second-generation compound.
• $50.0 million upon FDA approval of the NDA for a second-generation compound.
• $15.0 million upon the dosing of the third patient in a Phase 3 trial for a second indication.

In addition, from the Takeda Collaboration Agreement, Protagonist received a one-time, non-refundable upfront payment of $300.0 million in April 2024. The agreement includes potential milestone payments of up to $330.0 million for rusfertide and tiered royalties of 10% to 17% on net sales.

Future product sales upon successful commercialization of therapeutics

Protagonist Therapeutics is focused on commercializing its therapeutic candidates. Successful commercialization of rusfertide and other product candidates will generate revenue through direct sales. The company is in the process of completing clinical trials and seeking regulatory approvals, which are essential steps before generating revenue from product sales. The anticipated product candidates include:

• Rusfertide for polycythemia vera (PV).
• JNJ-2113 for multiple indications under the JNJ collaboration.

Protagonist expects to nominate a development candidate ready for Investigational New Drug (IND) enabling studies by the end of 2024, which could further enhance its revenue potential.

Potential royalties from partnered product candidates post-approval

Post-approval, Protagonist Therapeutics stands to gain royalties on net product sales from its collaboration agreements. Specifically, under the JNJ collaboration, the company is eligible for tiered royalties ranging from 6% to 10% on net sales, increasing to 10% for net sales over $4.0 billion. Additionally, if Protagonist exercises its opt-out right, it may receive royalties of 14% to 29% on worldwide net sales of licensed products.

Revenue Stream	Amount	Details
JNJ Collaboration Payments	$172.5 million	Total non-refundable payments earned through September 30, 2024
Recent Milestones from JNJ	$60.0 million	$50 million (ICONIC-TOTAL) + $10 million (ANTHEM)
Takeda Upfront Payment	$300.0 million	Received in April 2024
Potential Future Milestones from Takeda	$330.0 million	Various developmental and regulatory milestones
Tiered Royalties from JNJ	6% - 10%	On net sales, increasing to 10% over $4 billion
Tiered Royalties from Takeda	14% - 29%	On net sales if opt-out right is exercised

Updated on 16 Nov 2024

Resources:

1. Protagonist Therapeutics, Inc. (PTGX) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of Protagonist Therapeutics, Inc. (PTGX)' financial performance, including balance sheets, income statements, and cash flow statements.
2. SEC Filings – View Protagonist Therapeutics, Inc. (PTGX)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.