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FibroGen Reports Fourth Quarter and Full Year 2023 Financial Results

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FibroGen, Inc. (FGEN) reports positive financial results for FY 2023, with a 5% increase in total net revenue. The company anticipates topline data from pivotal pancreatic cancer trials in 2Q 2024 and additional data from a Phase 1 study in 1Q 2024. FibroGen also regains rights to roxadustat from AstraZeneca in certain territories, showing robust volume growth in China. The company's cost reduction plan has been successful, with a cash runway into 2026.
Positive
  • FY 2023 total net revenue of $147.8 million, up 5% YoY
  • Anticipated topline data from pivotal pancreatic cancer trials in 2Q 2024
  • Additional data from Phase 1 study of FG-3246 in mCRPC expected in 1Q 2024
  • FibroGen regains rights to roxadustat from AstraZeneca in certain territories
  • Robust roxadustat volume growth of 41% in China in FY 2023
  • Successful execution of cost reduction plan
  • $248.1 million in cash provides cash runway into 2026
Negative
  • None.

The announcement from FibroGen regarding the anticipation of topline data from pivotal pancreatic cancer trials and additional data from a Phase 1 study in mCRPC represents a significant milestone. The data could potentially lead to new treatment options and expand the company's portfolio. From a financial perspective, the robust 41% volume growth of roxadustat in China is a strong indicator of the drug's market acceptance and the company's ability to capitalize on the Chinese market. The increase in total net revenue by 5% year over year, despite the challenges in the pharmaceutical industry, reflects a positive trend in the company's revenue-generating capabilities.

Furthermore, the regaining of rights to roxadustat from AstraZeneca in the U.S. and other territories, with the exception of China and South Korea, could provide FibroGen with a greater share of future revenues from this drug, assuming it maintains market performance. However, investors should be aware of the costs associated with marketing and distribution that FibroGen will now incur. The successful execution of a cost reduction plan and the reported cash runway into 2026 offer a cushion that may support the company's strategic initiatives and mitigate financial risk in the short to medium term.

The expected topline data from the pamrevlumab trials could be a game-changer in the treatment of pancreatic cancer, a disease with historically limited options and low survival rates. If the results are positive, it could lead to significant shifts in treatment protocols and market dynamics. The Phase 1 study data for FG-3246 in mCRPC, a condition that currently has few effective treatments, also holds promise for addressing unmet medical needs. The ability of FibroGen to regain rights to roxadustat presents an opportunity to directly influence the drug's commercial strategy in the lucrative U.S. market.

It's important for stakeholders to understand that the clinical success of these drugs can significantly enhance the company's valuation and market position. However, the path from clinical data to market success is fraught with regulatory hurdles and commercialization challenges. Positive trial results could lead to increased investor confidence and potentially attract partnership opportunities or buyout interest.

Regaining control over roxadustat in various territories outside of China and South Korea allows FibroGen to potentially increase its market share and strengthen its position in the anemia treatment market, especially for patients with chronic kidney disease. This strategic move could have a ripple effect on competitors and alter market forecasts. The cash runway into 2026 indicates that FibroGen is in a position to invest in marketing and sales efforts for roxadustat without immediate financial strain.

However, it's critical to monitor how FibroGen will manage the transition and whether it can effectively leverage its regained rights to maximize profitability. The company's ability to navigate the competitive landscape, regulatory environment and pricing pressures will be key determinants of its success in capitalizing on these developments.

•  Topline data from two pivotal pamrevlumab pancreatic cancer trials anticipated in 2Q 2024

•  Additional data from Phase 1 monotherapy study of FG-3246 in metastatic castration-resistant prostate cancer (mCRPC) expected in 1Q 2024

•  FibroGen regains rights to roxadustat from AstraZeneca in the United States and other AstraZeneca territories, except China and South Korea

•  FY 2023 total net revenue of $147.8 million, an increase of 5% year over year

•  Robust roxadustat volume growth of 41% in China in FY 2023 compared to FY 2022

•  Successful execution of cost reduction plan; $248.1 million in cash provides cash runway into 2026

SAN FRANCISCO, Feb. 26, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for the fourth quarter and full year 2023 and provided an update on the company’s recent developments.

“We are extremely excited about the company’s prospects in 2024,” said Thane Wettig, Chief Executive Officer, FibroGen. “In this year alone, we will obtain data read-outs from our two late-stage pancreatic cancer trials, start a Phase 2 metastatic castration-resistant prostate cancer trial, file an immuno-oncology IND, and potentially receive approval for roxadustat in chemotherapy-induced anemia in China. Furthermore, the continued strength of our China business, accelerated realization of our corporate cost reduction program, and our strong balance sheet provide us a cash runway into 2026. These unique and exciting programs, combined with the quality of our talented colleagues, provide a strong foundation to create significant value for shareholders relative to our current valuation.”

Upcoming Milestones:

    Pamrevlumab

  • Topline data from the PanCAN Precision Promise℠ Phase 2/3 study of pamrevlumab in metastatic pancreatic cancer expected in 2Q 2024.
  • Topline data from the LAPIS Phase 3 study of pamrevlumab in locally advanced unresectable pancreatic cancer (LAPC) expected in 2Q 2024.

    Roxadustat

  • Expect approval decision for roxadustat in chemotherapy-induced anemia (CIA) in China in mid-2024. If approved, FibroGen will receive a $10M milestone payment from AstraZeneca.

    Oncology Pipeline

  • Additional data from Phase 1 monotherapy study of FG-3246 in metastatic castration-resistant prostate cancer (mCRPC) expected in 1Q 2024.
  • Anticipate the initiation of a Phase 2 study of FG-3246 in mCRPC in 2H 2024.
  • Anticipate the filing of two INDs: FG-3165 (anti-Gal9 antibody) in 1Q 2024 and FG-3175 (anti-CCR8 antibody) in 2025.

Recent Developments and Key Highlights of 2023:

    Pamrevlumab

  • Announced graduation and completion of the pamrevlumab arm in Precision Promise℠, Pancreatic Cancer Action Network’s Phase 2/3 adaptive platform trial for metastatic pancreatic cancer.
    • Pamrevlumab, in Stage 1 of the trial, achieved a protocol pre-specified ≥ 35% predictive probability of success for the primary endpoint of overall survival at the completion of the trial.

    Roxadustat

  • Regained all rights to roxadustat from AstraZeneca in the United States and other AstraZeneca territories, except China and South Korea.
  • Presented data from Phase 3 MATTERHORN study of roxadustat in patients with anemia of lower risk transfusion-dependent myelodysplastic syndromes at American Society of Hematology Annual Meeting.

    Corporate

  • Thane Wettig appointed Chief Executive Officer.
  • Successful execution of cost reduction plan, resulting in a reduction of total annualized expenses of $120 million.

China:

  • Fourth quarter FibroGen’s net product revenue under U.S. GAAP from the sale of roxadustat in China was $23.5 million compared to $23.4 million in the fourth quarter of 2022.
  • Full year 2023 FibroGen’s net product revenue under U.S. GAAP from the sale of roxadustat in China was $100.9 million compared to $82.9 million in the full year 2022, an increase of 22%.
  • Fourth quarter total roxadustat net sales in China¹ by FibroGen and the distribution entity jointly owned by FibroGen and AstraZeneca (JDE) was $66.5 million, compared to $53.1 million in the fourth quarter of 2022, an increase of 25%.
  • Full year 2023 total roxadustat net sales in China¹ by FibroGen and the JDE was $284.1 million, compared to $208.8 million in the full year 2022, an increase of 36%, driven by over 41% growth in volume.
  • Roxadustat continues to be the number one brand based on value share in the anemia of CKD market in China and has secured renewal on the National Reimbursement Drug List.
  • For 2024, we anticipate FibroGen’s full year net product revenue under U.S. GAAP to range between $120 million to $135 million, representing full year roxadustat net sales in China¹ by FibroGen and the JDE to range between $300 million to $340 million.

Financial:

  • Total revenue for the fourth quarter of 2023 was $27.1 million, as compared to $34.4 million for the fourth quarter of 2022. Reduction primarily driven by the change in net product revenue assumptions under U.S. GAAP and drug product revenue shipment timing.
  • Total revenue for full year 2023 was $147.8 million as compared to $140.7 million in 2022.
  • Net loss for the fourth quarter of 2023 was $56.2 million, or $0.57 net loss per basic and diluted share, compared to a net loss of $66.2 million, or $0.70 net loss per basic and diluted share one year ago.
  • Net loss for the year was $284.2 million, or $2.92 net loss per basic and diluted share, compared to a net loss of $293.7 million, or $3.14 net loss per basic and diluted share one year ago.
  • At December 31, 2023, FibroGen had $248.1 million in cash - defined as cash, cash equivalents, investments, and accounts receivable.
  • We expect our cash, cash equivalents, investments, and accounts receivable to be sufficient to fund our operating plans into 2026.

Conference Call and Webcast Details

FibroGen will host a conference call and webcast today, Monday, February 26, 2024, at 5:00 PM Eastern Time to discuss financial results and provide a business update. Interested parties may access a live audio webcast of the conference call via the “Investor Relations” page of the Company’s website at www.fibrogen.com. To access the call by phone, please go to this link (registration link), and you will be provided with dial in details. To avoid delays, we encourage participants to dial into the conference call fifteen minutes ahead of the scheduled start time. A replay of the webcast will also be available for a limited time at the following link (webcast replay).

About Pamrevlumab

Pamrevlumab is a potential first-in-class antibody being developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF). Pamrevlumab is in Phase 3 clinical development for the treatment of locally advanced unresectable pancreatic cancer (LAPC) and in Phase 2/3 for the treatment of metastatic pancreatic cancer. The U.S. Food and Drug Administration has granted Orphan Drug Designation, and Fast Track designation to pamrevlumab for the treatment of patients with LAPC. Pamrevlumab has demonstrated a safety and tolerability profile that has supported ongoing clinical investigation in LAPC and metastatic pancreatic cancer. Pamrevlumab is an investigational drug and not approved for marketing by any regulatory authority. For information about our pamrevlumab studies please visit www.clinicaltrials.gov.

About Roxadustat

Roxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin. Roxadustat is in clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted by the China Health Authority.

Roxadustat is approved in China, Europe, Japan, and numerous other countries for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). Several other licensing applications for roxadustat have been submitted by partners, Astellas and AstraZeneca, to regulatory authorities across the globe, and are currently under review. Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories including Japan, Europe, Turkey, Russia, and the Commonwealth of Independent States, the Middle East, and South Africa. AstraZeneca and FibroGen continue to collaborate on the development and commercialization of roxadustat in China.

About FibroGen

FibroGen, Inc. is a biopharmaceutical company focused on accelerating the development of novel therapies at the frontiers of cancer biology. Pamrevlumab, an anti-CTGF fully human monoclonal antibody, is in clinical development for the treatment of metastatic pancreatic cancer and locally advanced unresectable pancreatic cancer (LAPC). Roxadustat (爱瑞卓®, EVRENZO™) is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. Roxadustat is in clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted for review by the China Health Authority. FibroGen recently expanded its research and development portfolio to include antibody-drug conjugate (ADC) and immuno-oncology product candidates for the treatment of solid tumors. For more information, please visit www.fibrogen.com.

Forward-Looking Statements

This release contains forward-looking statements regarding FibroGen’s strategy, future plans and prospects, including statements regarding the development and commercialization of roxadustat, including its commercial potential, and the potential safety and efficacy profile of roxadustat. These forward-looking statements include but are not limited to statements about FibroGen’s plans and objectives and typically are identified by use of terms such as “may,” “will”, “should,” “on track,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. FibroGen’s actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of its various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in FibroGen’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, as filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and FibroGen undertakes no obligation to update any forward-looking statement in this press release, except as required by law.

Condensed Consolidated Balance Sheets
(In thousands)

  December 31, 2023  December 31, 2022
  (Unaudited)  (1)
Assets     
Current assets:     
Cash and cash equivalents $113,688  $155,700 
Short-term investments  121,898   266,308 
Accounts receivable, net  12,553   16,299 
Inventory  41,565   40,436 
Prepaid expenses and other current assets  41,855   14,083 
Total current assets  331,559   492,826 
      
Restricted time deposits  1,658   2,072 
Long-term investments     4,348 
Property and equipment, net  13,126   20,605 
Equity method investment in unconsolidated variable interest entity  5,290   5,061 
Operating lease right-of-use assets  68,093   79,893 
Other assets  3,803   5,282 
Total assets $423,529  $610,087 
      
Liabilities, stockholders’ equity and non-controlling interests     
Current liabilities:     
Accounts payable $17,960  $30,758 
Accrued and other liabilities  172,891   219,773 
Deferred revenue  12,740   12,739 
Operating lease liabilities, current  14,077   10,292 
Total current liabilities  217,668   273,562 
      
Product development obligations  17,763   16,917 
Deferred revenue, net of current  157,555   185,722 
Operating lease liabilities, non-current  66,537   79,593 
Senior secured term loan facilities, non-current  71,934    
Liability related to sale of future revenues, non-current  51,413   49,333 
Other long-term liabilities  2,858   6,440 
Total liabilities  585,728   611,567 
      
Redeemable non-controlling interests  21,480    
Total stockholders’ deficit attributable to FibroGen  (204,166)  (21,447)
Nonredeemable non-controlling interests  20,487   19,967 
Total deficit  (183,679)  (1,480)
Total liabilities, redeemable non-controlling interests and deficit $423,529  $610,087 
 

(1) The condensed consolidated balance sheet amounts at December 31, 2022 are derived from audited financial statements.

Condensed Consolidated Statements of Operations
(In thousands, except per share data)

  Three Months Ended December 31,  Years Ended December 31,
  2023  2022  2023  2022
  (Unaudited)  (Unaudited)  (1)
Revenue:           
License revenue $  $  $9,649  $22,590 
Development and other revenue  2,575   4,517   18,401   24,189 
Product revenue, net  23,510   23,374   100,949   82,869 
Drug product revenue, net  1,052   6,476   18,753   11,086 
Total revenue  27,137   34,367   147,752   140,734 
            
Operating costs and expenses:           
Cost of goods sold  5,406   4,924   18,848   20,280 
Research and development  51,702   61,628   282,861   296,791 
Selling, general and administrative  24,224   33,966   115,252   124,688 
Restructuring charge        12,606    
Total operating costs and expenses  81,332   100,518   429,567   441,759 
Loss from operations  (54,195)  (66,151)  (281,815)  (301,025)
            
Interest and other, net:           
Interest expense  (5,068)  (1,119)  (15,532)  (1,440)
Interest income and other income (expenses), net  2,496   923   10,480   7,596 
Total interest and other, net  (2,572)  (196)  (5,052)  6,156 
            
Loss before income taxes  (56,767)  (66,347)  (286,867)  (294,869)
Provision for (benefit from) income taxes  80   108   3   358 
Investment income in unconsolidated variable interest entity  615   280   2,638   1,573 
Net loss $(56,232) $(66,175) $(284,232) $(293,654)
            
Net loss per share - basic and diluted $(0.57) $(0.70) $(2.92) $(3.14)
            
Weighted average number of common shares used to calculate net loss per share - basic and diluted  98,496   94,032   97,303   93,582 
 

(1) The condensed consolidated statement of operations amounts for the year ended December 31, 2022 are derived from audited financial statements.

Contacts:
FibroGen, Inc.

Investors:
David DeLucia, CFA
Vice President of Corporate FP&A / Investor Relations
ir@fibrogen.com

Media:
Meichiel Keenan
Director, Investor Relations and Corporate Communications
media@fibrogen.com

_________________________________
¹ Total roxadustat net sales in China includes sales made by the distribution entity as well as FibroGen China’s direct sales, each to its own distributors. The distribution entity jointly owned by AstraZeneca and FibroGen is not consolidated into FibroGen’s financial statements.


FAQ

When is the anticipated topline data from the pivotal pancreatic cancer trials expected?

The topline data from the pivotal pancreatic cancer trials is anticipated in 2Q 2024.

What additional data is expected in 1Q 2024?

Additional data from a Phase 1 monotherapy study of FG-3246 in metastatic castration-resistant prostate cancer (mCRPC) is expected in 1Q 2024.

Which company did FibroGen regain rights to roxadustat from?

FibroGen regained rights to roxadustat from AstraZeneca in the United States and other AstraZeneca territories, except China and South Korea.

What was the total net revenue for FY 2023 and how does it compare to the previous year?

The total net revenue for FY 2023 was $147.8 million, showing an increase of 5% year over year.

What was the roxadustat volume growth in China for FY 2023 compared to FY 2022?

There was a robust roxadustat volume growth of 41% in China in FY 2023 compared to FY 2022.

How much cash does FibroGen have as per the recent report, and until when does it provide a cash runway?

FibroGen reported $248.1 million in cash, providing a cash runway into 2026.

FibroGen, Inc.

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About FGEN

fibrogen is a research-based biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics to treat serious unmet medical needs. the company has built upon its extensive research experience in fibrosis and hypoxia-inducible factor (hif) biology to generate clinical programs targeting multiple therapeutic areas. fibrogen's most advanced product candidate, roxadustat (fg-4592), is an oral small molecule inhibitor of hif prolyl hydroxylases (hif-phs), in phase 3 clinical development for the treatment of anemia in chronic kidney disease (ckd). our second product candidate, fg-3019, is a monoclonal antibody in phase 2 clinical development for the treatment of idiopathic pulmonary fibrosis (ipf), pancreatic cancer and liver fibrosis. for more information please visit: www.fibrogen.com.