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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 26, 2024

 

 

FIBROGEN, INC.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware			001-36740	77-0357827
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
409 Illinois Street
San Francisco, California				94158
(Address of Principal Executive Offices)				(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 415 978-1200

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.01 par value		FGEN		The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

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Item 2.02 Results of Operations and Financial Condition.

On February 26, 2024, FibroGen, Inc. (“FibroGen”) issued a press release announcing financial results for the quarter and the year ended December 31, 2023. A copy of such press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference.

The information in this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 2.02, in Exhibit 99.1 shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by FibroGen, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

Item 9.01 Financial Statements and Exhibits.

(d)	Exhibits
Exhibit No.			Description
99.1			Press Release titled “FibroGen Reports Fourth Quarter and Full Year 2023 Financial Results,” dated February 26, 2024
104			Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

			FIBROGEN, INC.
Date:	February 26, 2024	By:	/s/ Juan Graham
			Juan Graham Senior Vice President and Chief Financial Officer

 

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Exhibit 99.1

FibroGen Reports Fourth Quarter and Full Year 2023 Financial Results

 

SAN FRANCISCO, February 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

Roxadustat

Oncology Pipeline

 

Recent Developments and Key Highlights of 2023:

Pamrevlumab

Roxadustat

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Corporate

 

China:

 

Financial:

 

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).

 

 

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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.

 

 

 

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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®, EVRENZOTM) 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.

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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

 

 

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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

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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

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