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FGEN FibroGen

Exhibit 99.1

FibroGen Reports SECOND Quarter 2020 Financial Results

 

- Strong Second Quarter China Roxadustat Net Sales of $15.7 million -

- Conference Call Today at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time -

 

August 6, 2020 -- FibroGen, Inc. (NASDAQ: FGEN) reported financial results for the second quarter of 2020 and provided an update on the company’s recent developments.

 

“Despite this difficult time, we continue to be inspired by our unique opportunity to leverage world-class science to benefit patients,” said Enrique Conterno, Chief Executive Officer, FibroGen. “I am pleased with the progress we are making with roxadustat across a number of fronts; including our engagement with the FDA, the European submission, and our impressive sales in China. Additionally, we recently initiated three new trials with pamrevlumab: our Phase 3 study with DMD and two trials in patients hospitalized with COVID-19.”

 

Key Events in Recent Months and Other Developments

 

Roxadustat

 

U.S. NDA for roxadustat for the treatment of anemia of chronic kidney disease (CKD), in dialysis-dependent and non-dialysis-dependent patients, is under review with a Prescription Drug User Fee Act (PDUFA) date of December 20, 2020.

 

Marketing authorization application (MAA) for roxadustat for the treatment of anemia in adult patients with CKD, both on dialysis and not on dialysis, accepted by the European Medicines Agency (EMA) for regulatory review in May.

 

Japan sNDA for roxadustat for the treatment of anemia of CKD in non-dialysis-dependent patients is under review.

 

Presented results from the DOLOMITES Phase 3 study at the 57th ERA-EDTA Virtual Congress in which roxadustat demonstrated non-inferiority to darbepoetin alfa in achievement of hemoglobin correction in non-dialysis-dependent patients with CKD.

 

Continued enrollment of Phase 3 roxadustat clinical trial in anemia associated with myelodysplastic syndromes (MDS) and Phase 2 roxadustat clinical trial in chemotherapy-induced anemia (CIA).

 

Pamrevlumab

 

Initiated a randomized, double-blind, placebo-controlled Phase 2 study investigating the efficacy and safety of pamrevlumab in approximately 130 hospitalized patients with acute COVID-19 infection in the U.S.

 

Initiated BOREA, a Phase 2/3 investigator-initiated clinical trial investigating the efficacy and safety of pamrevlumab in approximately 68 patients hospitalized with COVID-19 in Italy.

 

Reopened enrollment of the ZEPHYRUS Phase 3 clinical trial of pamrevlumab in patients with IPF after pausing for two months to minimize the risk of exposure to COVID-19.

 

Continued enrollment of the LAPIS Phase 3 clinical trial of pamrevlumab in patients with locally advanced unresectable pancreatic cancer (LAPC).

 

Upcoming Events

 

Plan to initiate ZEPHYRUS 2, a second IPF Phase 3 clinical trial similar in size and design to ZEPHYRUS, as COVID-19 conditions improve.

 

Plan to initiate LELANTOS, a Phase 3, randomized, double-blind, placebo-controlled trial of pamrevlumab in approximately 90 patients with non-ambulatory Duchenne muscular dystrophy (DMD).

 



Corporate and Financial

 

Total revenue for the second quarter of 2020 was $42.9 million, as compared to $191.6 million for the second quarter of 2019. The current quarter revenue consisted of $15.7 million in net roxadustat sales in China, $19.0 million in development revenue, and $8.2 million in roxadustat API sales to Astellas in Japan.

 

Net loss for the second quarter of 2020 was $85.3 million, or $0.95 net loss per basic and diluted share, compared to a net income of $116.0 million, or $1.34 net income per basic share and $1.26 per diluted share one year ago.

 

At June 30, 2020, FibroGen had $716.0 million in cash, cash equivalents, restricted time deposits, investments, and receivables.

 

Based on our latest forecast, we reiterate our year-end 2020 estimate to be in the range of $720 to $730 million in cash, cash equivalents, restricted time deposits, investments, and receivables.

 

Amended China Agreement with AstraZeneca in July 2020 such that both parties are optimally aligned to maximize the economic value of the roxadustat franchise, with more predictable economics and profitability for FibroGen.

 

Appointed Thane Wettig to the newly-created position of Chief Commercial Officer.

 

Appointed Aoife Brennan, M.B., B.Ch., President and CEO of Synlogic Inc. (NASDAQ:SYBX) to board of directors effective August 5, 2020.

 

Appointed Ben Cravatt, Ph.D., Professor and the Norton B. Gilula Chair of Chemical Biology in the Department of Chemistry at The Scripps Research Institute to board of directors effective August 5, 2020.

 

Conference Call and Webcast Details  

FibroGen will host a conference call and webcast today, Thursday, August 6, 2020, 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 second quarter 2020 financial results conference call, and use passcode 8363719. A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and use passcode 8363719.

 

About Roxadustat

Roxadustat is a first-in-class, orally administered small molecule HIF-PH inhibitor that promotes erythropoiesis through increasing endogenous production of erythropoietin, and improved iron absorption, transport and mobilization. Roxadustat is approved in China for the treatment of anemia in adult patients with CKD, both on dialysis and not on dialysis. In Japan it is approved for the treatment of anemia in CKD patients on dialysis and a supplemental NDA for the treatment of anemia in CKD patients not on dialysis is under regulatory review. The roxadustat NDA for the treatment of anemia in CKD is under review by the U.S. Food and Drug Administration with a Prescription Drug User Fee Act date of December 20, 2020. The Marketing Authorization Application for roxadustat for the treatment of anemia in CKD was filed by our partner Astellas and accepted by the European Medicines Agency for review on May 21, 2020. Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA).

 

Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in territories including Japan and Europe. AstraZeneca and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in the U.S., China, and other markets.

 

About Pamrevlumab

Pamrevlumab is a first-in-class antibody developed by FibroGen that inhibits the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders. Pamrevlumab is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and locally advanced unresectable pancreatic cancer (LAPC), and in Phase 2 clinical development for the treatment of Duchenne muscular dystrophy (DMD) and coronavirus (COVID-19). 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 to treat 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 idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and coronavirus (COVID-19). 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, our financial results, 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, 2019 and our Quarterly Report on Form 10-Q for quarter ended June 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)

 

June 30, 2020

 

 

December 31, 2019

 

 

(Unaudited)

 

 

(1)

 

Assets

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

$

429,269

 

 

$

126,266

 

Short-term investments

 

256,317

 

 

 

407,491

 

Accounts receivable, net

 

26,519

 

 

 

28,455

 

Inventory

 

8,582

 

 

 

6,887

 

Prepaid expenses and other current assets

 

6,481

 

 

 

133,391

 

Total current assets

 

727,168

 

 

 

702,490

 

 

 

 

 

 

 

 

 

Restricted time deposits

 

2,072

 

 

 

2,072

 

Long-term investments

 

229

 

 

 

61,118

 

Property and equipment, net

 

36,984

 

 

 

42,743

 

Finance lease right-of-use assets

 

34,368

 

 

 

39,602

 

Other assets

 

6,862

 

 

 

9,372

 

Total assets

$

807,683

 

 

$

857,397

 

 

 

 

 

 

 

 

 

Liabilities, stockholders’ equity and non-controlling interests

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable

$

5,015

 

 

$

6,088

 

Accrued and other liabilities

 

50,464

 

 

 

83,816

 

Deferred revenue

 

9,813

 

 

 

490

 

Finance lease liabilities, current

 

12,279

 

 

 

12,351

 

Total current liabilities

 

77,571

 

 

 

102,745

 

 

 

 

 

 

 

 

 

Long-term portion of lease obligations

 

940

 

 

 

1,141

 

Product development obligations

 

16,959

 

 

 

16,780

 

Deferred revenue, net of current

 

138,242

 

 

 

99,449

 

Finance lease liabilities, non-current

 

31,586

 

 

 

37,610

 

Other long-term liabilities

 

127,242

 

 

 

64,266

 

Total liabilities

 

392,540

 

 

 

321,991

 

 

 

 

 

 

 

 

 

Total stockholders’ equity

 

395,872

 

 

 

516,135

 

Non-controlling interests

 

19,271

 

 

 

19,271

 

Total equity

 

415,143

 

 

 

535,406

 

Total liabilities, stockholders’ equity and non-controlling interests

$

807,683

 

 

$

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 June 30,

 

 

Six Months Ended June 30,

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

 

(Unaudited)

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

License revenue

$

 

 

$

150,581

 

 

$

 

 

$

150,581

 

Development and other revenue

 

18,957

 

 

 

40,985

 

 

 

38,402

 

 

 

64,848

 

Product revenue, net

 

15,693

 

 

 

 

 

 

20,648

 

 

 

 

Drug product revenue

 

8,238

 

 

 

 

 

 

8,238

 

 

 

 

Total revenue

 

42,888

 

 

 

191,566

 

 

 

67,288

 

 

 

215,429

 

Operating costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of goods sold

 

3,076

 

 

 

 

 

 

4,047

 

 

 

 

Research and development

 

61,414

 

 

 

52,008

 

 

 

116,315

 

 

 

102,505

 

Selling, general and administrative

 

63,535

 

 

 

26,739

 

 

 

113,138

 

 

 

48,948

 

Total operating costs and expenses

 

128,025

 

 

 

78,747

 

 

 

233,500

 

 

 

151,453

 

Income (loss) from operations

 

(85,137

)

 

 

112,819

 

 

 

(166,212

)

 

 

63,976

 

Interest and other, net:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

(651

)

 

 

(736

)

 

 

(1,284

)

 

 

(1,507

)

Interest income and other, net

 

644

 

 

 

4,125

 

 

 

3,810

 

 

 

8,303

 

Total interest and other, net

 

(7

)

 

 

3,389

 

 

 

2,526

 

 

 

6,796

 

Income (loss) before income taxes

 

(85,144

)

 

 

116,208

 

 

 

(163,686

)

 

 

70,772

 

Provision for (benefit from) income taxes

 

169

 

 

 

205

 

 

 

(25

)

 

 

180

 

Net income (loss)

$

(85,313

)

 

$

116,003

 

 

$

(163,661

)

 

$

70,592

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) per share

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

$

(0.95

)

 

$

1.34

 

 

$

(1.84

)

 

$

0.82

 

Diluted

$

(0.95

)

 

$

1.26

 

 

$

(1.84

)

 

$

0.77

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average number of common shares used to calculate net income (loss) per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

89,451

 

 

 

86,445

 

 

 

88,835

 

 

 

86,077

 

Diluted

 

89,451

 

 

 

91,728

 

 

 

88,835

 

 

 

92,069

 

 

# # #

 

Contact: FibroGen, Inc.

 

Media Inquiries:

Sara Iacovino

1.703.474.4452

sara.iacovino@gcihealth.com

 

Investors:

Michael Tung, M.D.

Corporate Strategy / Investor Relations

1.415.978.1434

mtung@fibrogen.com