FGEN FibroGen Inc

 

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): May 06, 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:

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. ☐

 

---

Item 2.02 Results of Operations and Financial Condition.

On May 6, 2024, FibroGen, Inc. (“FibroGen”) issued a press release announcing financial results for the quarter ended March 31, 2024. 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 First Quarter 2024 Financial Results,” dated May 6, 2024
104			Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

---

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:	May 6, 2024	By:	/s/ Juan Graham
			Juan Graham Senior Vice President and Chief Financial Officer

 

---

Exhibit 99.1

FibroGen Reports First Quarter 2024 Financial Results

 

 

SAN FRANCISCO, May 6, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for the first quarter 2024 and provided an update on the company’s recent developments.

“We are off to a strong start in 2024 marked by the recent release of compelling Phase 1 data on FG-3246, our CD46 targeted antibody drug conjugate, in metastatic castration-resistant prostate cancer and continued robust growth of our roxadustat business in China,” said Thane Wettig, Chief Executive Officer, FibroGen. “Looking ahead, we expect to report topline data from our two late-stage clinical trials of pamrevlumab in pancreatic cancer in the coming months. In addition, we have a strong balance sheet and reaffirm our cash runway into 2026.”
 

Upcoming Milestones:

Pamrevlumab

Roxadustat

Oncology Pipeline

 

---

Recent Developments:

Oncology Pipeline

Corporate

 

China:

 

Financial:

 

_________________________________

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.

---

 

 

Conference Call and Webcast Details

FibroGen will host a conference call and webcast today, Monday, May 6, 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, a fully human anti-CTGF 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. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46 is in development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of an associated CD46-targeted PET biomarker. In addition, FibroGen has expanded its research and development portfolio to include two immuno-oncology product candidates for the treatment of solid tumors. For more information, please visit www.fibrogen.com. www.fibrogen.com.

 

---

Forward-Looking Statements

This release contains forward-looking statements regarding FibroGen’s strategy, future plans and prospects, including statements regarding its clinical programs and those of its collaboration partners Fortis, UCSF, and the Pancreatic Cancer Action Network. These forward-looking statements include, but are not limited to, statements regarding the efficacy, safety, and potential success of FibroGen product candidates, and 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)

	March 31, 2024				December 31, 2023
	(Unaudited)				(1)
Assets
Current assets:
Cash and cash equivalents	$	105,734			$	113,688
Short-term investments		71,865				121,898
Accounts receivable, net		37,083				12,553
Inventory		27,335				41,565
Prepaid expenses and other current assets		36,150				41,855
Total current assets		278,167				331,559
Restricted time deposits		1,658				1,658
Property and equipment, net		12,166				13,126
Equity method investment in unconsolidated variable interest entity		5,776				5,290
Operating lease right-of-use assets		64,751				68,093
Other assets		3,350				3,803
Total assets	$	365,868			$	423,529
Liabilities, stockholders’ equity and non-controlling interests
Current liabilities:
Accounts payable	$	4,353			$	17,960
Accrued and other liabilities		164,286				172,891
Deferred revenue		12,863				12,740
Operating lease liabilities, current		15,231				14,077
Total current liabilities		196,733				217,668
Product development obligations		17,446				17,763
Deferred revenue, net of current		147,118				157,555
Operating lease liabilities, non-current		62,511				66,537
Senior secured term loan facilities, non-current		72,213				71,934
Liability related to sale of future revenues, non-current		52,216				51,413
Other long-term liabilities		3,786				2,858
Total liabilities		552,023				585,728
Redeemable non-controlling interests		21,480				21,480
Total stockholders’ deficit attributable to FibroGen		(228,122	)			(204,166	)
Nonredeemable non-controlling interests		20,487				20,487
Total deficit		(207,635	)			(183,679	)
Total liabilities, redeemable non-controlling interests and deficit	$	365,868			$	423,529

 

 

---

Condensed Consolidated Statements of Operations

(In thousands, except per share data)

 

	Three Months Ended March 31,
	2024				2023
	(Unaudited)
Revenue:
License revenue	$	—			$	6,000
Development and other revenue		878				3,891
Product revenue, net		30,538				24,161
Drug product revenue, net		24,486				2,109
Total revenue		55,902				36,161
Operating costs and expenses:
Cost of goods sold		25,753				3,491
Research and development		38,392				74,486
Selling, general and administrative		22,820				34,275
Total operating costs and expenses		86,965				112,252
Loss from operations		(31,063	)			(76,091	)
Interest and other, net:
Interest expense		(4,996	)			(2,372	)
Interest income and other income (expenses), net		2,570				1,036
Total interest and other, net		(2,426	)			(1,336	)
Loss before income taxes		(33,489	)			(77,427	)
Provision for income taxes		33				74
Investment income in unconsolidated    variable interest entity		589				796
Net loss	$	(32,933	)		$	(76,705	)
Net loss per share - basic and diluted	$	(0.33	)		$	(0.81	)
Weighted average number of common shares used to     calculate net loss per share - basic and diluted		98,982				94,691

# # #

 

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

---

v3.24.1.u1

Document And Entity Information	May 06, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	May 06, 2024
Entity Registrant Name	FIBROGEN, INC.
Entity Central Index Key	0000921299
Entity Emerging Growth Company	false
Entity File Number	001-36740
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	77-0357827
Entity Address, Address Line One	409 Illinois Street
Entity Address, City or Town	San Francisco
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94158
City Area Code	415
Local Phone Number	978-1200
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.01 par value
Trading Symbol	FGEN
Security Exchange Name	NASDAQ

---