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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): November 07, 2022

 

 

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 November 7, 2022, FibroGen, Inc. (“FibroGen”) issued a press release announcing financial results for the quarter ended September 30, 2022. 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 2022 Financial Results,” dated November 7, 2022
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:	November 7, 2022	By:	/s/ Juan Graham
			Juan Graham Senior Vice President and Chief Financial Officer

 

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Exhibit 99.1

FibroGen Reports Third Quarter 2022 Financial Results

 

SAN FRANCISCO, November 7, 2022 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for the third quarter 2022 and provided an update on the company’s recent developments.

 

“I am very pleased with our progress across our clinical development programs with 3 pivotal trials expected to read out for pamrevlumab in 2023 and two more in 2024. Notably, our Phase 3 trials of roxadustat in the U.S. and Europe for anemia of myelodysplastic syndromes, and chemotherapy-induced anemia in China add two more pivotal readouts next year,” said Enrique Conterno, Chief Executive Officer, FibroGen. “The strategic financing transaction with NovaQuest provides additional non-dilutive capital which strengthens our balance sheet to support the development and commercialization of pamrevlumab while continuing to advance and expand our pipeline.”

 

Recent Developments:

 

China Performance:

 

 

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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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Upcoming Milestones:

Pamrevlumab

 

Roxadustat
 

 

Financial:

 

Conference Call and Webcast Details

FibroGen will host a conference call and webcast today, Monday, November 7, 2022, 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 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), a common factor in fibrotic and proliferative disorders characterized by persistent and excessive scarring that can lead to organ dysfunction and failure. Pamrevlumab is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), and Duchenne muscular dystrophy (DMD), and in Phase 2/3 for the treatment of metastatic pancreatic cancer. The U.S. Food and Drug Administration has granted Orphan Drug Designation (ODD), and Fast Track designation to pamrevlumab for the treatment of patients with IPF, DMD, and LAPC. The U.S. Food and Drug Administration has also granted Rare Pediatric Disease Designation to pamrevlumab for the treatment of patients with DMD. Pamrevlumab has demonstrated a safety and tolerability profile that has supported ongoing clinical investigation in IPF, DMD, and LAPC. Pamrevlumab is an investigational drug and not approved for marketing by any regulatory authority. For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.

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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 anemia of chronic kidney disease (CKD) and anemia associated with myelodysplastic syndromes (MDS), and for chemotherapy-induced anemia (CIA).

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. FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in the U.S., China, and other markets not licensed to Astellas.

 

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 connective tissue growth factor (CTGF) biology and hypoxia-inducible factor (HIF) to advance innovative medicines for the treatment of unmet needs. 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), metastatic pancreatic cancer, and Duchenne muscular dystrophy (DMD). Roxadustat (爱瑞卓®, EVRENZOTM) is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in CKD patients on dialysis and not on dialysis. Roxadustat is in Phase 3 clinical development in the U.S. and Europe for anemia associated with myelodysplastic syndromes (MDS), and in Phase 3 clinical development in China for the treatment of chemotherapy-induced anemia (CIA). FibroGen recently expanded its research and development portfolio to include product candidates in the immuno-oncology and autoimmune space. 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, and our clinical programs. 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, 2021 and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, 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 we undertake 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, 2022				December 31, 2021
	(Unaudited)				(1)
Assets
Current assets:
Cash and cash equivalents	$	155,960			$	171,223
Short-term investments		252,560				233,967
Accounts receivable, net		15,328				17,401
Inventory		39,950				31,015
Prepaid expenses and other current assets		10,426				20,453
Total current assets		474,224				474,059
Restricted time deposits		2,072				2,072
Long-term investments		17,780				167,796
Property and equipment, net		22,287				28,277
Equity method investment in unconsolidated variable interest entity		4,631				3,825
Operating lease right-of-use assets		82,903				91,112
Other assets		4,940				6,680
Total assets	$	608,837			$	773,821
Liabilities, stockholders’ equity and non-controlling interests
Current liabilities:
Accounts payable	$	19,323			$	26,097
Accrued and other liabilities		213,806				172,599
Deferred revenue		7,361				15,857
Operating lease liabilities, current		11,504				10,944
Total current liabilities		251,994				225,497
Product development obligations		15,422				17,613
Deferred revenue, net of current		199,758				186,801
Operating lease liabilities, non-current		81,091				88,776
Other long-term liabilities		14,299				26,021
Total liabilities		562,564				544,708
Total stockholders’ equity		26,306				209,146
Non-controlling interests		19,967				19,967
Total equity		46,273				229,113
Total liabilities, stockholders’ equity and non-controlling interests	$	608,837			$	773,821

 

 

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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,
	2022				2021				2022				2021
	(Unaudited)
Revenue:
License revenue	$	—			$	116,434			$	22,590			$	116,434
Development and other revenue		2,453				26,097				19,672				60,325
Product revenue, net		17,359				13,442				59,495				42,175
Drug product revenue		(4,077	)			—				4,610				(168	)
Total revenue		15,735				155,973				106,367				218,766
Operating costs and expenses:
Cost of goods sold		4,308				3,266				15,355				9,746
Research and development		75,182				75,880				235,163				273,123
Selling, general and administrative		29,902				25,853				90,722				89,186
Total operating costs and expenses		109,392				104,999				341,240				372,055
Income (loss) from operations		(93,657	)			50,974				(234,873	)			(153,289	)
Interest and other, net:
Interest expense		(84	)			(109	)			(321	)			(965	)
Interest income and other income (expenses), net		1,798				(1,303	)			6,672				(2,120	)
Total interest and other, net		1,714				(1,412	)			6,351				(3,085	)
Income (loss) before income taxes		(91,943	)			49,562				(228,522	)			(156,374	)
Provision for income taxes		114				106				250				235
Investment income in unconsolidated    variable interest entity		407				342				1,293				664
Net income (loss)	$	(91,650	)		$	49,798			$	(227,479	)		$	(155,945	)
Net income (loss) per share - basic and diluted	$	(0.98	)		$	0.54			$	(2.43	)		$	(1.69	)
Weighted average number of common shares used to calculate net income (loss) per share:
Basic		93,767				92,644				93,431				92,206
Diluted		93,767				92,808				93,431				92,206

 

 

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Contacts:

 

FibroGen, Inc.

Investors:

Michael Tung, M.D.

Corporate Strategy / Investor Relations

415.978.1434

mtung@fibrogen.com

 

Media:

Meichiel Keenan

Investor Relations and Corporate Communications

mkeenan@fibrogen.com

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