FibroGen, Inc. (FGEN): Business Model Canvas [Dec-2025 Updated]

You're looking at FibroGen, Inc. after its major pivot, and honestly, the old model is gone; the company is now a lean, US-focused R&D shop centered on FG-3246 for metastatic prostate cancer and Roxadustat for anemia, banking on a $121.1 million cash pile as of September 30, 2025, which gives them a runway into 2028 thanks to that $220 million China divestiture in Q3. Their immediate game is pushing FG-3246 through Phase 2 while prepping the Roxadustat protocol for an FDA submission by Q4 2025, all while keeping 2025 operating costs tight, targeting only $50 million to $60 million. This canvas breaks down exactly how this newly streamlined entity plans to generate its projected $6 million to $8 million in 2025 collaboration revenue and manage its critical partnerships with Astellas and AstraZeneca; dive in to see the structure behind this focused biotech play.

FibroGen, Inc. (FGEN) - Canvas Business Model: Key Partnerships

You're looking at how FibroGen, Inc. structures its external relationships to get its assets, primarily roxadustat and FG-3246, to market and through the clinic. The strategy heavily relies on leveraging global pharmaceutical partners for commercial reach and specialized external research groups for trial execution and data generation.

Global Commercialization Alliances

FibroGen, Inc. has strategically parceled out the global rights for roxadustat, retaining the US, Canada, and Mexico rights while partnering for other major territories. This structure allows for focused internal development on its oncology pipeline, like FG-3246, supported by significant non-dilutive cash events.

The company completed the sale of its China subsidiary to AstraZeneca in the third quarter of 2025 for a total consideration of approximately $220 million, which consisted of an enterprise value of $85 million plus an estimated net cash of $135 million held in China at closing. This transaction was transformative, allowing FibroGen, Inc. to repay its term loan to Morgan Stanley Tactical Value for approximately $81 million and extending the company's cash runway into 2028.

Here's a breakdown of the key commercial partners for roxadustat:

External Research and Development Support

To run its clinical programs efficiently, FibroGen, Inc. relies on external expertise, particularly for its pipeline assets like the antibody-drug conjugate FG-3246. This outsourcing helps manage the operational load while the internal team focuses on strategic direction and data interpretation.

The company's pipeline development involves several key external research entities:

• Fortis Therapeutics for an exclusive license of FG-3246 (FOR46) starting in May 2023.
• UCSF for an investigator-sponsored study of FG-3246 in metastatic castration-resistant prostate cancer (mCRPC).
• UCSF for developing a PET-based biomarker (PET46) to select patients for FG-3246 therapy.

The expected readout for the investigator-sponsored study of FG-3246 in combination with enzalutamide, conducted by UCSF, is the fourth quarter of 2025. Furthermore, FibroGen, Inc. is preparing to initiate the Phase 2 monotherapy dose optimization trial for FG-3246 in mCRPC in the third quarter of 2025.

Beyond drug development, FibroGen, Inc. has also partnered for other platform technologies. For instance, in July 2021, Eluminex exclusively licensed global rights to develop and commercialize FibroGen, Inc.'s investigational biosynthetic cornea (EB-301).

The shift in focus post-China sale is clear: the company is using its strengthened balance sheet, with consolidated cash, cash equivalents, and accounts receivable at $142.1 million as of June 30, 2025, to fund these internal US development initiatives and external trial commitments.

Finance: review Q3 2025 CRO service provider contracts by end of month.

FibroGen, Inc. (FGEN) - Canvas Business Model: Key Activities

You're managing a biotech firm in a pivotal transition, so the focus on execution for your pipeline assets is everything right now. Here's how FibroGen, Inc. is deploying its resources across its core operational areas as of late 2025.

Advancing FG-3246 Phase 2 trial for metastatic prostate cancer is a major lift. The Phase 2 monotherapy dose optimization trial for FG-3246, which targets CD46 in metastatic castration-resistant prostate cancer (mCRPC), officially kicked off in the third quarter of 2025. This study is designed to enroll 75 patients with mCRPC in the post-ARSI and pre-chemotherapy setting. Remember, the Phase 1 study, which helped determine the maximum tolerated dose of 2.7 mg/kg every 3 weeks, involved 56 patients. You're also tracking the investigator-sponsored study of FG-3246 combined with enzalutamide, with topline results expected in the fourth quarter of 2025.

For Roxadudustat, the key activity is pushing the LR-MDS indication forward. FibroGen reached agreement with the U.S. Food and Drug Administration (FDA) on the design elements for a pivotal Phase 3 trial. The company intends to submit the full Phase 3 protocol in the fourth quarter of 2025. This planned trial will use a randomized, double-blind, placebo-controlled design and is set to enroll approximately 200 patients with LR-MDS and high red blood cell (RBC) transfusion burden. Anyway, FibroGen maintains its rights to roxadustat in the U.S., so this submission is critical for that market.

Managing the global intellectual property portfolio requires constant spend to keep those assets enforceable. While I don't have FibroGen's exact annual IP budget, you should know that keeping a patent alive in the U.S. incurs maintenance fees after issue, costing a large entity about $13,460 per patent at the 3.5, 8.5, and 11.5-year marks, plus ongoing annuities in other countries. That money protects the investment in the science.

Strategic business development is centered on the U.S. opportunity for roxadustat, as the company is actively assessing internal development or partnership options for that program. This follows the completion of a major transaction: the sale of FibroGen China to AstraZeneca for a total consideration of approximately $220 million, completed in the third quarter of 2025. That deal, plus the repayment of the term loan, has extended the cash runway into 2028.

Cost control is clearly a priority, especially following the corporate streamlining. For the three months ended June 30, 2025, total operating costs and expenses were $13.4 million, representing a 72% decrease year-over-year. Research and development (R&D) expenses specifically dropped by 82% year-over-year to $5.9 million for that quarter. That's real money saved to fund the pipeline.

Here are the key operational metrics driving these activities:

You need to keep an eye on the near-term data readouts, which are the immediate milestones for the R&D engine:

• Topline results from the investigator-sponsored FG-3246/enzalutamide study expected in Q4 2025.
• FDA submission for the pivotal Roxadustat Phase 3 protocol planned for Q4 2025.
• Interim analysis for the FG-3246 Phase 2 monotherapy trial anticipated in the second half of 2026.
• Cash runway extends into 2028 following the China sale.

Finance: draft 13-week cash view by Friday.

FibroGen, Inc. (FGEN) - Canvas Business Model: Key Resources

You're looking at the core assets that power FibroGen, Inc.'s operations as of late 2025. These aren't just things they own; they are the essential building blocks for their future value creation, especially after the recent China transaction.

The financial foundation is significantly bolstered by a recent, transformative event. The completion of the sale of FibroGen China to AstraZeneca in August 2025 provided a substantial capital infusion. This deal, with a total consideration of approximately $220 million, allowed FibroGen, Inc. to repay its senior secured term loan facility to Morgan Stanley Tactical Value for approximately $81 million. This action simplified the capital structure and directly contributed to the strong balance sheet position as of the end of the third quarter.

The current financial standing provides the necessary runway to execute on near-term clinical milestones. As of September 30, 2025, FibroGen, Inc. reported $121.1 million in cash, cash equivalents, investments, and accounts receivable in the U.S.. This financial strength is projected to extend the company's cash runway into 2028.

The true value, however, rests in the intellectual property and the expertise to develop it. FibroGen, Inc.'s core IP centers on two main programs:

This pipeline is supported by deep scientific and clinical development expertise focused specifically on oncology and anemia. The company's focus is on novel therapies at the frontiers of these two areas. The team is actively managing complex regulatory pathways, evidenced by reaching agreement with the U.S. Food and Drug Administration (FDA) on the design elements for the pivotal Phase 3 trial for roxadustat in LR-MDS. The leadership includes individuals like the Senior Vice President and Chief Financial Officer, David DeLucia, CFA. The company is on track to submit the Phase 3 protocol for roxadustat in the fourth quarter of 2025.

Key operational capabilities tied to these resources include:

• Retaining U.S. rights for roxadustat, excluding territories licensed to Astellas, China, and South Korea.
• Advancing FG-3246 into a Phase 2 dose optimization trial.
• Reducing full year 2025 total operating costs and expenses (including stock-based compensation) to be between $50 million and $60 million at the midpoint, a 70% reduction from full year 2024.
• Reporting R&D expenses for Q3 2025 at $1.2 million, down 94% year-over-year.

Finance: draft 13-week cash view by Friday.

FibroGen, Inc. (FGEN) - Canvas Business Model: Value Propositions

You're looking at the core value FibroGen, Inc. (FGEN) is offering to patients and the market as of late 2025, which is heavily centered on its focused, U.S.-centric pipeline following a major corporate transaction.

Potential first-in-class Antibody-Drug Conjugate (ADC), FG-3246, for mCRPC

FG-3246, which targets CD46, is positioned as a potential first-in-class Antibody-Drug Conjugate (ADC) for metastatic castration-resistant prostate cancer (mCRPC), offering an androgen receptor agnostic and non-PSMA approach. The company initiated the Phase 2 monotherapy, dose-optimization study for FG-3246 in the third quarter of 2025.

Earlier Phase 1 data from study NCT03575819 provided a strong foundation for this value proposition. Here's a quick look at the numbers from that initial work:

The development path includes an investigator-sponsored study of FG-3246 in combination with enzalutamide, with topline results expected at a medical conference in the first quarter of 2026. Furthermore, interim results from the ongoing Phase 2 monotherapy trial are anticipated in the second half of 2026.

Oral treatment option (Roxadustat) for anemia in lower-risk MDS patients

FibroGen, Inc. is advancing Roxadustat as a potential oral treatment for anemia in lower-risk myelodysplastic syndromes (LR-MDS) patients with a high red blood cell (RBC) transfusion burden. This offers a differentiated mechanism of action and oral route compared to existing injectable agents.

• The company reached agreement with the U.S. Food and Drug Administration (FDA) on important design elements for the pivotal Phase 3 trial.
• Final Phase 3 protocol submission to the FDA is planned for the fourth quarter of 2025.
• In a post-hoc subgroup analysis from the MATTERHORN Phase 3 trial, 36% of LR-MDS patients with high transfusion burden achieved transfusion independence for at least 56 days, compared to only 7% on placebo.
• Lower-risk MDS patients represent approximately 77% of the total diagnosed MDS population in the U.S.
• Annual incidence rates of MDS in the U.S. are estimated at 4.9/100,000 adults.
• Approximately 80% of MDS patients have anemia at diagnosis.

Simplified, focused pipeline post-China sale to drive US development

The value proposition is underpinned by a significant financial restructuring completed in August 2025, which streamlined the company to focus on its wholly owned, late-stage U.S. assets. FibroGen, Inc. completed the sale of its China operations to AstraZeneca for a total consideration of approximately $220 million. This total consideration comprised $85 million in enterprise value and approximately $135 million in net cash held in China.

This transaction provided substantial financial breathing room. As of September 30, 2025, FibroGen, Inc. reported cash, cash equivalents, investments, and accounts receivable of $121.1 million, which is expected to fund operating plans into 2028. This focus is reflected in the cost structure:

• Total operating costs and expenses for the third quarter of 2025 were $6.5 million, an 86% decrease from $47.8 million in the third quarter of 2024.
• R&D expenses for Q3 2025 were $1.2 million, a 94% decrease year-over-year from $20 million in Q3 2024.
• Full year 2025 guidance for total operating costs and expenses is between $50 million and $60 million, representing a 70% reduction from full year 2024 at the midpoint.

Companion diagnostic (FG-3180) to select patients for FG-3246

To enhance the precision and potential efficacy of FG-3246, the development program includes FG-3180, an associated CD46-targeted PET biomarker. This diagnostic agent is being evaluated to select patients and predict response to the ADC. The Phase 2 monotherapy trial for FG-3246 will assess the diagnostic performance of FG-3180, with an interim analysis for this combined program anticipated in the second half of 2026. This integrated approach aims to de-risk the oncology development pathway.

FibroGen, Inc. (FGEN) - Canvas Business Model: Customer Relationships

You're looking at how FibroGen, Inc. manages its critical external relationships, which are heavily weighted toward regulatory bodies and strategic pharma partners. It's a classic biotech model where external validation and collaboration drive the value chain.

Direct, high-touch engagement with the U.S. Food and Drug Administration (FDA) is paramount, especially given past regulatory hurdles with roxadustat. FibroGen, Inc. successfully reached agreement with the U.S. Food and Drug Administration (FDA) on important design elements for the pivotal Phase 3 trial for roxadustat for the treatment of anemia in patients with lower-risk myelodysplastic syndromes (LR-MDS) and high red blood cell (RBC) transfusion burden. This followed a Type-C meeting with the FDA in July 2025. The company plans to submit the final Phase 3 protocol to the FDA in the fourth quarter of 2025. That's the next big regulatory gate to clear.

Strategic management of existing licensing partnerships is currently dominated by the finalization of the China divestiture. The sale of FibroGen China to AstraZeneca was completed in the third quarter of 2025 for a total consideration of approximately $220 million. This total consideration consisted of an enterprise value of $85 million plus approximately $135 million in net cash held in China at closing. This was an increase from the initial estimate of approximately $160 million total consideration. FibroGen, Inc. maintains its rights to roxadustat in the U.S. and in all markets outside of China, South Korea, and those licensed to Astellas. The Astellas collaboration continues for roxadustat commercialization in territories including Japan, Europe, Turkey, Russia, and the Commonwealth of Independent States, the Middle East, and South Africa.

Investor relations communication centers on pipeline progression and financial stability following the China transaction. The company reported cash, cash equivalents, accounts receivable, and investments of $121.1 million as of September 30, 2025. The completion of the China sale is key, as it extended the company's cash runway into 2028. You can see the financial shift in the second quarter of 2025, where operating costs and expenses decreased by 72% year-over-year, with Research & Development (R&D) expenses down 82% and Selling, General & Administrative (SG&A) expenses down 53%.

Relationships with key opinion leaders (KOLs) and clinical investigators are tied directly to the FG-3246 program. The investigator-sponsored study of FG-3246 in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) is a major focus. Topline results from this investigator-sponsored study are expected to be presented at a medical conference in the first quarter of 2026.

Here's a quick view of the key financial and partnership metrics as of late 2025:

The Q2 2025 net loss from continuing operations was $13.7 million, on total revenue from continuing operations of $1.3 million. That's the cost of keeping the U.S. pipeline moving forward.

• Astellas collaboration territories include Japan, Europe, Turkey, Russia, and the Middle East.
• FibroGen, Inc. retains roxadustat rights in the U.S., Canada, and Mexico.
• The FG-3246 Phase 2 monotherapy trial initiation was expected in Q3 2025.

FibroGen, Inc. (FGEN) - Canvas Business Model: Channels

Licensing and collaboration agreements for ex-US commercialization.

Clinical trial sites and hospitals for drug development and testing.

• Investigator-sponsored Phase 1b/2 study of FG-3246 in combination with enzalutamide is being conducted at UCSF.
• Investigator-sponsored radiopharmaceutical marker trial using a zirconium-89 PET tracer for CD46 is also underway at UCSF.
• Initiation of the Phase 2 monotherapy dose optimization study of FG-3246 in metastatic castration-resistant prostate cancer (mCRPC) anticipated in the third quarter of 2025.
• Topline results from the Phase 2 portion of the investigator-sponsored study of FG-3246 in combination with enzalutamide expected in the fourth quarter of 2025.

Future commercial sales force or new partners for US market access.

For roxadustat in anemia associated with lower-risk myelodysplastic syndromes (LR-MDS) in the U.S., FibroGen is exploring options for either internal development or partnership opportunities following agreement with the FDA on pivotal Phase 3 trial design elements.

The company's financial position, supported by the China sale proceeds, extends the cash runway into 2028, which funds U.S. development initiatives. Operating costs were slashed by 72% and R&D expenses by 82% year-over-year as of Q2 2025. The market cap contextually stood at $34 million as of Q2 2025.

FibroGen, Inc. (FGEN) - Canvas Business Model: Customer Segments

You're looking at the specific groups of people or organizations that FibroGen, Inc. (FGEN) is trying to reach and serve with its late-stage pipeline assets as of late 2025. This is where the value of their assets is realized, so the numbers here are critical for understanding their focus.

The primary customer segments for FibroGen, Inc. (FGEN) are defined by the indications for their two main clinical programs: FG-3246 in oncology and roxadustat in hematology, alongside the strategic segment of global pharma entities.

For the LR-MDS indication, the target patient population in the U.S. is substantial, though FibroGen is focusing on a specific, high-need subset. Roughly 75K patients live with Myelodysplastic Syndrome (MDS) in the U.S., and about 77% of those, or approximately 58K patients, are diagnosed with lower-risk MDS (LR-MDS). Of these, around 85% have anemia, meaning approximately 49K patients in the U.S. have anemia in LR-MDS. The specific group targeted for the pivotal Phase 3 trial of roxadustat requires a high transfusion burden, defined as patients needing $\ge$ 4 pRBC units in two consecutive 8-week periods and being refractory to, intolerant to, or ineligible for prior Erythropoiesis-Stimulating Agents (ESAs). The planned Phase 3 trial aims to enroll approximately 200 patients.

In oncology, the segment is Patients with metastatic castration-resistant prostate cancer (mCRPC). FibroGen is advancing FG-3246, an Antibody-Drug Conjugate (ADC) targeting CD46, which has potential in multiple lines of mCRPC and other solid tumors. The company initiated the Phase 2 monotherapy trial for FG-3246 in Q3 2025, and topline results from the investigator-sponsored study combining FG-3246 with enzalutamide are expected in Q4 2025.

The third segment involves Global pharmaceutical partners, which is a key customer base for potential out-licensing or strategic alliances, especially for the U.S. development of roxadustat in LR-MDS. FibroGen recently completed a major transaction with one such partner. The sale of FibroGen China to AstraZeneca was expected to have a total consideration of approximately $210 million, which included an enterprise value of $85 million plus estimated net cash held in China at closing of approximately $125 million (based on Q2 2025 updates). This transaction is expected to extend the company's cash runway into 2028.

Here's a quick look at the patient population scale and key financial events shaping these segments:

FibroGen, Inc. (FGEN) is clearly prioritizing these specific patient groups where their novel mechanism of action drugs, FG-3246 and roxadustat, aim to address significant unmet needs.

The company's focus areas for these customer segments include:

• Patients with metastatic castration-resistant prostate cancer (mCRPC).
• Patients with lower-risk Myelodysplastic Syndromes (LR-MDS) anemia and high transfusion burden.
• Global pharmaceutical partners seeking oncology and anemia assets.

For the LR-MDS segment, the oral convenience of roxadustat is a key differentiator against existing injectable Standard of Care (SOC) agents. For the mCRPC segment, FG-3246 offers a novel mechanism by binding a unique epitope on CD46 present on cancer cells. The company's cash position, extended into 2028 post-China sale, provides flexibility to pursue these segments internally or via partnership.

Finance: draft 13-week cash view by Friday.

FibroGen, Inc. (FGEN) - Canvas Business Model: Cost Structure

You're looking at the cost structure for FibroGen, Inc. (FGEN) as of late 2025, post-China transaction, which has clearly reshaped their expense profile. Here's the quick math on the key cost components based on the Q3 2025 reporting period.

The company has aggressively streamlined its operating expenses. Total operating costs and expenses for the third quarter of 2025 were reported at only $6.5 million, a significant drop from $47.8 million in the third quarter of 2024, representing an 86% year-over-year decrease.

The primary drivers of this cost reduction are evident in the breakdown of R&D and SG&A spending.

The R&D expense reduction was substantial, falling from $20 million in Q3 2024 to just $1.2 million in Q3 2025, a 94% decrease year-over-year. This reduction was achieved through steps to lower fixed cost infrastructure across both project and FTE (Full-Time Equivalent) spend.

General and Administrative (G&A) expenses, reported as SG&A, also saw a major cut, decreasing by 43%, from $9.4 million in Q3 2024 to $5.3 million in Q3 2025. For the full year 2025, FibroGen, Inc. is guiding total operating costs and expenses, including stock-based compensation, to be between $50 million and $60 million, which is a 70% reduction from full year 2024 at the midpoint.

Regarding clinical trial costs, the focus is on pipeline advancement:

• FG-3246 Phase 2 monotherapy trial initiation occurred in the third quarter of 2025.
• Interim analysis for the FG-3246 Phase 2 trial is anticipated in the second half of 2026.
• Roxadustat Phase 3 protocol submission for LR-MDS is anticipated in the fourth quarter of 2025.

Specific dollar amounts for the clinical trial costs themselves aren't itemized in the Q3 2025 data provided, but the activities are clearly underway. What this estimate hides is the future spend required to complete these trials.

A major, non-recurring cost event was the debt settlement. Upon closing the sale of FibroGen China in August 2025, FibroGen, Inc. successfully repaid its senior secured term loan with Morgan Stanley Tactical Value (MSTV). This resulted in a cash outflow of approximately $80.9 million. That outflow covered the $75 million principal balance accrued and unpaid interest, plus an applicable prepayment penalty.

Finance: draft 13-week cash view by Friday.

FibroGen, Inc. (FGEN) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of FibroGen, Inc. (FGEN) as of late 2025, and it's heavily shaped by a major, recent, one-time event alongside ongoing partnership contributions. The core business model relies on past licensing deals for its key asset, roxadustat, which is approved outside the U.S.

Collaboration revenue from partners like Astellas and AstraZeneca.

FibroGen, Inc. maintains rights to roxadustat in the U.S., Canada, and Mexico, while Astellas and FibroGen, Inc. collaborate on commercialization in territories including Japan, Europe, Turkey, Russia, the Commonwealth of Independent States, the Middle East, and South Africa. AstraZeneca is the partner for the China operations sale. Revenue from continuing operations, which largely reflects these collaborations outside of the China sale impact, was reported as follows:

• Q3 2025 total revenue from continuing operations: $1.1 million.
• Q2 2025 total revenue from continuing operations: $1.3 million.
• For the three months ended June 30, 2025, amounts recognized as license revenue and development revenue under the Astellas Japan Agreement were not material.

Full-year 2025 revenue guidance is between $6 million and $8 million.

Despite the low quarterly revenue from continuing operations, the company reiterated its forecast for the entire fiscal year 2025.

Potential future milestone payments from existing licensing deals.

While specific future milestone amounts for late 2025 aren't detailed as firm guidance, the progression of clinical assets suggests potential triggers. For instance, topline results from the investigator-sponsored study of FG-3246 in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) are expected in the fourth quarter of 2025. Also, the final protocol submission for the pivotal Phase III trial for roxadustat is anticipated in the fourth quarter of 2025.

One-time cash inflow of approximately $220 million from the China sale in Q3 2025.

The most significant financial event impacting the balance sheet was the completion of the sale of FibroGen China to AstraZeneca in August 2025. This transaction provided a substantial, non-recurring cash infusion, which was used to pay down debt and extend the cash runway into 2028.

• Total consideration received: approximately $220 million.
• Enterprise value component: $85 million.
• Net cash held in China at closing: approximately $135 million.
• This total consideration was an increase of $60 million from the initial net cash guidance provided in February 2025.

This deal fundamentally reset the company's financial footing, though it is not part of the recurring revenue stream.