FibroGen Reports Fourth Quarter and Full Year 2020 Financial Results

Rhea-AI Summary

FibroGen reported Q4 2020 net sales of $29.2 million for roxadustat in China, contributing to full-year sales of $72.5 million. The FDA plans to hold an advisory meeting for the roxadustat NDA. Despite a net loss of $58.6 million in Q4 and $189.3 million for the year, company leadership remains confident in roxadustat’s efficacy, citing successful clinical programs. Cash reserves stand at $732.1 million. Future data releases from various studies are expected to impact FibroGen’s trajectory.

Positive

• Q4 2020 revenue increased to $65.0 million from $8.0 million YoY.
• Roxadustat sales in China support strong market presence.
• Positive results from global Phase 3 program with over 8,000 patients.

Negative

• Net loss of $58.6 million in Q4 2020.
• Annual net loss increased to $189.3 million from $77.0 million in 2019.

• Strong Fourth Quarter China Roxadustat Net Sales of $29.2 Million and 2020 full-year Net Sales of $72.5 Million

• FDA to hold Advisory Committee Meeting on Roxadustat New Drug Application

SAN FRANCISCO, March 01, 2021 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for the fourth quarter and full year 2020 and provided an update on the company’s recent developments.

“While disappointed with the news today, FibroGen and AstraZeneca remain confident in the efficacy and safety profile of roxadustat based on positive results from a global Phase 3 program encompassing more than 8,000 patients,” said Enrique Conterno, Chief Executive Officer, FibroGen. “With strong roxadustat commercial results in China, we continue to drive forward in our three main areas of focus: ensuring the regulatory and commercial success of roxadustat; accelerating the development of pamrevlumab in the three high-value indications of locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and idiopathic pulmonary fibrosis (IPF); and building our research capabilities in both hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology while adding to our clinical development pipeline.”

Key Events in 2020 and Other Developments

Roxadustat

• Regulatory:
  • The Cardiovascular and Renal Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will hold an advisory committee (AdCom) meeting to review the new drug application (NDA) for roxadustat in the U.S. The companies have not received a confirmed AdCom meeting date from the FDA.
  • In November 2020, Japan's Ministry of Health, Labour and Welfare (MHLW) approved EVRENZO^® (roxadustat) for the treatment of anemia of CKD in adult patients not on dialysis.
  • The Marketing Authorization Application (MAA) for roxadustat for the treatment of anemia in adult patients with CKD was accepted for regulatory review by the European Medicines Agency (EMA) in May 2020, with an expected decision by mid-2021.

• Clinical:
  • Enrollment was completed in the WHITNEY US Phase 2 roxadustat clinical trial in chemotherapy-induced anemia (CIA) in 4Q 2020.
  • Enrollment continued in the MATTERHORN Phase 3 roxadustat clinical trial in anemia associated with myelodysplastic syndromes (MDS).
  • Enrollment was completed in the ASPEN and DENALI Phase 3b roxadustat clinical trials in dialysis patients with anemia of CKD.

• Publications / Presentations:
  • Roxadustat data was presented at the following scientific meetings in 2020:
    • The National Kidney Foundation Spring Clinical Meeting
    • The 57th European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Virtual Congress
    • The American Society of Nephrology (ASN) Kidney Week 2020 Reimagined
    • The 62nd American Society of Hematology (ASH) Annual Meeting and Exposition
  • Roxadustat Phase 3 manuscripts on the treatment of anemia of CKD were published in peer-reviewed medical journals:
    • Pooled Analysis of Roxadustat for Anemia in Patients with Kidney Failure Incident to Dialysis Kidney International Reports
    • Roxadustat for Chronic Kidney Disease-related Anemia in Non-dialysis Patients Kidney International Reports
    • Roxadustat for Treating Anemia in Patients with CKD Not on Dialysis: Results from a Randomized Phase 3 Study Journal of the American Society of Nephrology
    • Roxadustat for the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients Not on Dialysis: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study (ALPS) Nephrology Dialysis Transplantation
    • Roxadustat for anemia in patients with end-stage renal disease incident to dialysis Nephrology Dialysis Transplantation

Pamrevlumab

• Enrollment continued in the LAPIS Phase 3 clinical trial of pamrevlumab in patients with locally advanced unresectable pancreatic cancer (LAPC).
• Enrollment continued in the LELANTOS Phase 3 clinical trial of pamrevlumab in non-ambulatory patients with Duchenne muscular dystrophy (DMD). 
• Enrollment continued in the ZEPHYRUS Phase 3 clinical trial of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF).
• In December, we initiated a second Phase 3 clinical trial of pamrevlumab, ZEPHYRUS-2, in patients with idiopathic pulmonary fibrosis (IPF).

Upcoming Data Catalysts

• Data from the Phase 2 WHITNEY study of roxadustat in chemotherapy-induced anemia (CIA) expected 2H 2021.
• Data from the Phase 3 MATTERHORN study of roxadustat in anemia of myelodysplastic syndromes (MDS) expected 1H 2022.
• Resection data from the Phase 3 LAPIS study of pamrevlumab in locally advanced pancreatic cancer (LAPC) expected 2H 2022.
• Data from the Phase 3 LELANTOS study of pamrevlumab in Duchenne muscular dystrophy (DMD) expected 2H 2022.

2020 Key Executive Additions

• Percy Carter, Ph.D., was appointed to the newly created position of Chief Scientific Officer.
• Mark Eisner, M.D., M.P.H., was appointed as Chief Medical Officer.
• Thane Wettig was appointed to the newly created position of Chief Commercial Officer.
  

Financial

• Total revenue for the fourth quarter of 2020 was $65.0 million, as compared to $8.0 million for the fourth quarter of 2019. The current quarter revenue consists of net product revenues of $29.2 million for roxadustat sales in China, $21.5 million in development revenue, and $14.3 million in license revenue related to NDD approval in Japan. Total net roxadustat sales in China for 2020 were $72.5 million.
• Net loss for the fourth quarter of 2020 was $58.6 million, or $0.64 net loss per basic and diluted share, compared to a net loss of $98.1 million, or $1.12 net loss per basic and diluted share one year ago.
• Net loss for the year was $189.3 million, or $2.11 net loss per basic and diluted share, compared to a net loss of $77.0 million, or $0.89 net loss per basic and diluted share one year ago.
• At December 31, 2020, FibroGen had $732.1 million in cash, restricted time deposits, cash equivalents, investments, and receivables.
• Based on our latest forecast, we estimate our 2021 ending cash to be in the range of $660 to $670 million.
• The China Agreement with AstraZeneca was amended in July 2020 to maximize the economic value of the roxadustat franchise for both parties with more predictable economics and profitability for FibroGen.

Conference Call and Webcast Details
FibroGen will host a conference call and webcast today, Monday, March 1, 2021, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. A live audio webcast of the call may be accessed in the investor section of the company’s website, www.fibrogen.com. To participate in the conference call by telephone, please dial 1 (877) 658-9081 (U.S. and Canada) or 1 (602) 563-8732 (international), reference the FibroGen fourth quarter and full year 2020 financial results conference call, and use confirmation number 3055327. A replay of the webcast will be available shortly after the call for a period of four weeks. To access the replay, please dial 1 (855) 859-2056 (domestic) or 1 (404) 537-3406 (international), and use passcode 3055327.

About Roxadustat
Roxadustat, an oral medicine, is the first in a new class of medicines, 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 also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA).

Roxadustat is approved in China, Japan, and Chile for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). In Europe, the Marketing Authorization Application for roxadustat for the treatment of anemia in with chronic kidney disease (CKD) in NDD and DD patients was filed by Astellas Pharma Inc. (Astellas) and accepted by the European Medicines Agency for review in May 2020. Several other licensing applications for roxadustat have been submitted by Astellas and AstraZeneca to regulatory authorities across the globe, and are currently in 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. FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in the U.S., China, other markets in the Americas, in Australia/New Zealand, and Southeast Asia.

About Pamrevlumab
Pamrevlumab is a first-in-class antibody developed by FibroGen that inhibits the activity of connective tissue growth factor (CTGF), an important biological mediator in fibrotic and proliferative disorders. Pamrevlumab is in Phase 3 clinical development for the treatment of locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and idiopathic pulmonary fibrosis (IPF). For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.

About FibroGen

FibroGen, Inc. is a biopharmaceutical company committed to discovering, developing, and commercializing a pipeline of first-in-class therapeutics. The Company applies its pioneering expertise in hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines for the treatment of unmet needs. The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD). Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA). Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and idiopathic pulmonary fibrosis (IPF). For more information, please visit www.fibrogen.com.

Forward-Looking Statements

This release contains forward-looking statements regarding our strategy, future plans and prospects, including statements regarding the development and commercialization of the company’s product candidates, the potential safety and efficacy profile of our product candidates, our clinical programs and regulatory events, and those of our partners. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts 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. Our 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 our various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and our Quarterly Report on Form 10-Q for quarter ended September 30, 2020 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 we undertake 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, 2020				December 31, 2019
	(Unaudited)				(1)
Assets
Current assets:
Cash and cash equivalents	$	678,393			$	126,266
Short-term investments		8,144				407,491
Accounts receivable, net		41,883				28,455
Inventory		16,530				6,887
Prepaid expenses and other current assets		10,160				133,391
Total current assets		755,110				702,490
Restricted time deposits		2,072				2,072
Long-term investments		244				61,118
Property and equipment, net		33,647				42,743
Finance lease right-of-use assets		29,606				39,602
Equity method investment in unconsolidated variable interest entity		2,728				—
Other assets		3,433				9,372
Total assets	$	826,840			$	857,397
Liabilities, stockholders’ equity and non-controlling interests
Current liabilities:
Accounts payable	$	24,789			$	6,088
Accrued and other liabilities		119,521				83,816
Deferred revenue		6,547				490
Finance lease liabilities, current		12,330				12,351
Total current liabilities		163,187				102,745
Product development obligations		18,697				16,780
Deferred revenue, net of current		138,474				99,449
Finance lease liabilities, non-current		25,391				37,610
Other long-term liabilities		39,642				65,407
Total liabilities		385,391				321,991
Total stockholders’ equity		422,178				516,135
Non-controlling interests		19,271				19,271
Total equity		441,449				535,406
Total liabilities, stockholders’ equity and non-controlling interests	$	826,840			$	857,397

(1)   The condensed consolidated balance sheet amounts at December 31, 2019 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,
	2020				2019				2020				2019
	(Unaudited)								(Unaudited)				(1)
Revenue:
License revenue	$	14,323			$	14,569			$	14,323			$	177,086
Development and other revenue		21,527				28,607				80,592				114,115
Product revenue, net		29,165				1,122				72,498				1,700
Drug product revenue		(17	)			(36,324	)			8,906				(36,324	)
Total revenue		64,998				7,974				176,319				256,577
Operating costs and expenses:
Cost of goods sold		2,615				905				8,869				1,147
Research and development		78,133				56,797				252,924				209,265
Selling, general and administrative		42,249				50,708				106,406				135,479
Total operating costs and expenses		122,997				108,410				368,199				345,891
Loss from operations		(57,999	)			(100,436	)			(191,880	)			(89,314	)
Interest and other, net:
Interest expense		(538	)			(668	)			(2,402	)			(2,876	)
Investment loss in unconsolidated variable interest entity		(190	)			—				(202	)			—
Interest income and other, net		264				3,053				5,553				15,548
Total interest and other, net		(464	)			2,385				2,949				12,672
Loss before income taxes		(58,463	)			(98,051	)			(188,931	)			(76,642	)
Provision for income taxes		171				72				360				328
Net loss	$	(58,634	)		$	(98,123	)		$	(189,291	)		$	(76,970	)
Net loss per share - basic and diluted	$	(0.64	)		$	(1.12	)		$	(2.11	)		$	(0.89	)
Weighted average number of common shares used to calculate net loss per share - basic and diluted		91,166				87,352				89,854				86,633

(1)   The condensed consolidated statement of operations amounts for the year ended December 31, 2019 are derived from audited financial statements.

Contacts:
FibroGen, Inc.

Investors:
Michael Tung, M.D.
Corporate Strategy / Investor Relations
415.978.1434
mtung@fibrogen.com 

Media:
Jennifer Harrington
610.574.9196
Jennifer.Harrington@gcihealth.com 

FAQ

What were the total revenues for FibroGen in Q4 2020?

FibroGen reported total revenues of $65.0 million in the fourth quarter of 2020.

What is the net loss reported by FibroGen for the full year 2020?

For the full year 2020, FibroGen reported a net loss of $189.3 million.

When is the FDA advisory committee meeting for roxadustat scheduled?

The FDA has not yet confirmed a date for the advisory committee meeting regarding the roxadustat NDA.

How much cash does FibroGen have as of December 31, 2020?

As of December 31, 2020, FibroGen had $732.1 million in cash and equivalents.

What are the upcoming data catalysts for FibroGen?

Upcoming data catalysts include results from the Phase 2 WHITNEY study and various Phase 3 trials expected in 2021 and 2022.