Form 8-K - Current report

0000921299false00009212992024-11-122024-11-12

 

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): November 12, 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.)
350 Bay Street Suite 100 #6009
San Francisco, California				94133
(Address of Principal Executive Offices)				(Zip Code)

 

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

 

FibroGen, Inc.

409 Illinois Street

San Francisco, California 94158

(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 November 12, 2024, FibroGen, Inc. (“FibroGen”) issued a press release announcing financial results for the quarter ended September 30, 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 Third Quarter 2024 Financial Results,” dated November 12, 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 hereunto duly authorized.

			FIBROGEN, INC.
Date:	November 12, 2024	By:	/s/ Juan Graham
			Juan Graham Senior Vice President and Chief Financial Officer

 

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Exhibit 99.1

FibroGen Reports Third Quarter 2024 Financial Results

 

•

Topline results from Phase 2 portion of the investigator-sponsored study of FG-3246, a first-in-class antibody-drug conjugate (ADC) targeting CD46, in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) are expected in 1H 2025

•

Initiation of Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC anticipated in 1Q 2025

•

Third quarter net revenue growth of 15% year over year, driven by strong performance of roxadustat in China, with year over year volume growth of 34%

o

Reiterate full year net product revenue guidance of $135 million to $150 million, representing full year total roxadustat net sales in China1 between $330 million to $350 million

•

Meaningful progress on U.S. cost reduction plan

o

Expected to be substantially complete by year-end 2024

•

Cash, cash equivalents and accounts receivable balance of $160.0 million

 

SAN FRANCISCO, November 12, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for the third quarter 2024 and provided an update on the company’s recent developments.

“This past quarter we transformed into a lean and more focused organization, resulting in significant cost savings that will extend into the future. Moreover, roxadustat continued its impressive performance, generating $96.6 million in net sales in China during the quarter,” said Thane Wettig, Chief Executive Officer, FibroGen. “Having implemented our cost reduction plan, we are well positioned to advance FG-3246, with topline results from the Phase 2 portion of the investigator-sponsored study of FG-3246 in combination with enzalutamide at the University of California San Francisco (UCSF) on track for the first half of 2025, and the anticipated start of our Phase 2 monotherapy trial in the first quarter of 2025. We continue to be optimistic about our future prospects.”

 

Recent Developments and Key Events of Third Quarter 2024:

•

Meaningful progress on U.S. cost reduction plan.

o

Expected to be substantially complete by year-end 2024

•

Reported topline results from the pamrevlumab arm of PanCAN Precision Promise Phase 2/3 adaptive platform trial for the treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC), in which the trial did not meet the primary endpoint.

•

Reported topline results from the LAPIS Phase 3 study of pamrevlumab in patients with locally advanced, unresectable pancreatic cancer (LAPC), in which the trial did not meet the primary endpoint.

 

Upcoming Milestones:

Roxadustat

•

Expect approval decision for roxadustat in chemotherapy-induced anemia (CIA) in China in early 2025. If approved, FibroGen will receive a $10 million milestone payment from AstraZeneca.

FG-3246 and FG-3180 (PET Imaging Agent)

•

Topline results from the Phase 2 portion of the investigator-sponsored Phase 1b/2 study conducted by UCSF of FG-3246 in combination with enzalutamide in patients with mCRPC expected in 1H 2025.

•

Anticipate initiation of Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC in 1Q 2025. This trial will include a sub-study of FG-3180 to enable assessment of CD46 expression and response to FG-3246.

 

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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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China:

•

Third quarter FibroGen net product revenue under U.S. GAAP from the sale of roxadustat in China was $46.2 million compared to $29.4 million in the third quarter of 2023, an increase of 57% year over year.

•

Third quarter total roxadustat net sales in China1 by FibroGen and the distribution entity jointly owned by FibroGen and AstraZeneca (JDE) was $96.6 million, compared to $77.1 million in the third quarter of 2023, an increase of 25% year over year, driven by a 34% increase in volume.

•

Roxadustat continues to be the number one brand based on value share in the anemia of CKD market in China.

•

For 2024, FibroGen’s expected full year net product revenue under U.S. GAAP reiterated to a range between $135 million to $150 million, representing expected full year roxadustat net sales in China1 by FibroGen and the JDE of $330 million to $350 million.

 

Financial:

•

Total revenue for the third quarter of 2024 was $46.3 million, as compared to $40.1 million for the third quarter of 2023, an increase of 15% year over year.

•

Net loss for the third quarter of 2024 was $17.1 million, or $0.17 net loss per basic and diluted share, compared to a net loss of $63.6 million, or $0.65 net loss per basic and diluted share one year ago.

•

At September 30, 2024, FibroGen reported $160.0 million in cash, cash equivalents and accounts receivable.

•

Assuming additional repatriation of cash from our China operations, we expect our cash, cash equivalents and accounts receivable to be sufficient to fund our operating plans into 2026.

 

Conference Call and Webcast Details

FibroGen management will host a conference call and webcast today, Tuesday, November 12, 2024, at 5:00 PM Eastern Time to discuss financial results and provide a business update. Interested parties may access the conference call by dialing 1-877-300-8521 (in the U.S.) or 1-412-317-6026 (outside the U.S.). The call will be available via webcast by clicking here or on the “Events and Presentation” page on the FibroGen website.

 

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). 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. 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 imaging agent, FG-3180. In addition, FibroGen’s research and development portfolio includes two immuno-oncology product candidates for the treatment of solid tumors. For more information, please visit www.fibrogen.com.

 

 

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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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Forward-Looking Statements

This release contains forward-looking statements regarding FibroGen’s strategy, future plans and prospects, including statements regarding its commercial products and clinical programs and those of its collaboration partners Fortis and UCSF. These forward-looking statements include, but are not limited to, statements regarding the efficacy, safety, and potential clinical or commercial success of FibroGen products and product candidates, statements under the caption “Upcoming Milestones”, statements regarding the potential for cash, cash equivalents and accounts receivable to fund FibroGen’s operating plans into 2026, and statements about FibroGen’s plans and objectives. These forward-looking statements are typically 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, and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, each 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)

 

	September 30, 2024				December 31, 2023
	(Unaudited)				(1)
Assets
Current assets:
Cash and cash equivalents	$	131,003			$	113,688
Short-term investments		—				121,898
Accounts receivable, net		29,030				12,553
Inventory		23,937				41,565
Prepaid expenses and other current assets		60,559				41,855
Total current assets		244,529				331,559
Restricted time deposits		1,658				1,658
Property and equipment, net		7,603				13,126
Equity method investment in unconsolidated variable interest entity		5,806				5,290
Operating lease right-of-use assets		2,093				68,093
Other assets		2,732				3,803
Total assets	$	264,421			$	423,529
Liabilities, stockholders’ equity and non-controlling interests
Current liabilities:
Accounts payable	$	9,238			$	17,960
Accrued and other liabilities		151,141				172,891
Deferred revenue		28,858				12,740
Operating lease liabilities, current		1,293				14,077
Total current liabilities		190,530				217,668
Product development obligations		18,199				17,763
Deferred revenue, net of current		126,219				157,555
Operating lease liabilities, non-current		707				66,537
Senior secured term loan facilities, non-current		72,779				71,934
Liability related to sale of future revenues, non-current		56,850				51,413
Other long-term liabilities		837				2,858
Total liabilities		466,121				585,728
Redeemable non-controlling interests		21,480				21,480
Total stockholders’ deficit attributable to FibroGen		(243,667	)			(204,166	)
Nonredeemable non-controlling interests		20,487				20,487
Total deficit		(223,180	)			(183,679	)
Total liabilities, redeemable non-controlling interests and deficit	$	264,421			$	423,529

(1)

The condensed consolidated balance sheet amounts at December 31, 2023 are derived from audited financial statements.

 

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Condensed Consolidated Statements of Operations

(In thousands, except per share data)

 

	Three Months Ended September 30,								Nine Months Ended September 30,
	2024				2023				2024				2023
	(Unaudited)
Revenue:
License revenue	$	—			$	2,649			$	—			$	9,649
Development and other revenue		385				6,775				1,532				15,825
Product revenue, net		46,210				29,390				126,391				77,439
Drug product revenue, net		(262	)			1,320				24,954				17,701
Total revenue		46,333				40,134				152,877				120,614
Operating costs and expenses:
Cost of goods sold		5,295				4,243				36,227				13,441
Research and development		21,708				61,194				94,206				231,158
Selling, general and administrative		17,554				25,573				62,650				91,029
Restructuring charge		18,554				12,606				18,554				12,606
Total operating costs and expenses		63,111				103,616				211,637				348,234
Loss from operations		(16,778	)			(63,482	)			(58,760	)			(227,620	)
Interest and other, net:
Interest expense		(4,994	)			(5,022	)			(14,774	)			(10,464	)
Interest income and other income (expenses), net		3,802				4,296				5,092				7,984
Total interest and other, net		(1,192	)			(726	)			(9,682	)			(2,480	)
Loss before income taxes		(17,970	)			(64,208	)			(68,442	)			(230,100	)
Benefit from income taxes		12				84				(217	)			(77	)
Investment income in unconsolidated    variable interest entity		898				677				2,664				2,023
Net loss	$	(17,084	)		$	(63,615	)		$	(65,561	)		$	(228,000	)
Net loss per share - basic and diluted	$	(0.17	)		$	(0.65	)		$	(0.66	)		$	(2.35	)
Weighted average number of common shares used to     calculate net loss per share - basic and diluted		100,515				98,245				99,780				96,901

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For Investor Inquiries:

David DeLucia, CFA

Vice President of Corporate FP&A / Investor Relations

[e-mail]

 

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Document And Entity Information	Nov. 12, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 12, 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	350 Bay Street
Entity Address, Address Line Two	Suite 100 #6009
Entity Address, City or Town	San Francisco
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	94133
City Area Code	415
Local Phone Number	978-1200
Entity Information, Former Legal or Registered Name	FibroGen, Inc.
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

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