Form 8-K FIBROGEN INC For: Mar 01

March 1, 2021 4:07 PM EST

Get instant alerts when news breaks on your stocks. Claim your 1-week free trial to StreetInsider Premium here.

Exhibit 99.1

FibroGen Reports Fourth Quarter and Full Year 2020 Financial Results

 

 

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 1, 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:

 

o

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 US. U.S. The companies have not received a confirmed AdCom meeting date from the FDA.

 

o

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.

 

o

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:

 

o

Enrollment was completed in the WHITNEY US Phase 2 roxadustat clinical trial in chemotherapy-induced anemia (CIA) in 4Q 2020.

 

o

Enrollment continued in the MATTERHORN Phase 3 roxadustat clinical trial in anemia associated with myelodysplastic syndromes (MDS).

 

o

Enrollment was completed in the ASPEN and DENALI Phase 3b roxadustat clinical trials in dialysis patients with anemia of CKD.

 

 

Publications / Presentations:

 

o

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


 

 

o

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



Serious News for Serious Traders! Try StreetInsider.com Premium Free!

You May Also Be Interested In





Related Categories

SEC Filings