8-K
false000092129900009212992023-11-062023-11-06

 

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 06, 2023

 

 

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.

 

 


Item 2.02 Results of Operations and Financial Condition.

On November 6, 2023, FibroGen, Inc. (“FibroGen”) issued a press release announcing financial results for the quarter ended September 30, 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 Third Quarter 2023 Financial Results,” dated November 6, 2023

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:

November 6, 2023

By:

/s/ Juan Graham

 

 

 

Juan Graham
Senior Vice President and Chief Financial Officer

 


EX-99.1

Exhibit 99.1

FibroGen Reports Third Quarter 2023 Financial Results

 

Topline data from two pivotal pamrevlumab pancreatic cancer trials on track to read out in 1H 2024, including the Pancreatic Cancer Action Network (PanCAN) Precision PromiseSM Phase 2/3 study in metastatic pancreatic cancer
Third quarter net revenue of $40.1 million, an increase of 155% year over year
Roxadustat sNDA accepted in China for chemotherapy-induced anemia
Robust roxadustat volume growth of 37% in China
Strong execution of cost reduction plan reaffirming cash runway into 2026

 

SAN FRANCISCO, November 6, 2023 (GLOBE NEWSWIRE) - FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for the third quarter 2023 and provided an update on the Company’s recent developments.

“Today, we reported another quarter of strong roxadustat volume growth in China, achieving the highest ever value share, at 42%, in the anemia of CKD category,” said Thane Wettig, Chief Executive Officer, FibroGen. “The continued strength of our China business, sooner than expected realization of our corporate cost reduction efforts and our strong balance sheet provide us a cash runway into 2026. Over the next 12 months, we will obtain data read-outs from our two late-stage pancreatic cancer trials, start a Phase 2 metastatic castrate-resistant prostate cancer trial, and file two immuno-oncology INDs. 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.”
 

Recent Developments and Key Events of Third Quarter 2023:

Appointed Thane Wettig as Chief Executive Officer.
Supplemental New Drug Application (sNDA) accepted by the China Health Authority for roxadustat for the treatment of patients with chemotherapy-induced anemia (CIA). Expect approval decision of CIA in China in mid-2024.
Successful implementation of cost reduction plan, now resulting in an expected reduction of total annualized expenses of $120 million.
Reported negative topline results from the LELANTOS-2 Phase 3 study of pamrevlumab for the treatment of ambulatory patients with Duchenne muscular dystrophy (DMD).
Presented Phase 3 data of roxadustat for CIA in patients with non-myeloid malignancies in an oral presentation at the European Society for Medical Oncology Congress 2023.
FibroGen and its partners presented five roxadustat abstracts, including four poster presentations and one late-breaker poster presentation, at the recent American Society of Nephrology (ASN) Kidney Week 2023 conference.
Presented preclinical data for the FG-3165 anti-Gal9 antibody program at the Society for Immunotherapy of Cancer Annual Meeting 2023.

 

China Performance:

Achieved third quarter net product revenue under U.S. GAAP from the sale of roxadustat in China of $29.4 million compared to $17.4 million in the third quarter of 2022, an increase of 69% year over year.
Achieved third quarter total roxadustat net sales in China1 by FibroGen and the distribution entity (JDE) jointly owned by FibroGen and AstraZeneca of $77.1 million, compared to $59.0 million in the third quarter of 2022, an increase of 31% year over year, driven by 37% growth in volume.
Roxadustat continues to be the number one brand based on value share in the anemia of chronic kidney disease market in China.

 

_________________________________

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.


 

Upcoming Milestones:

Pamrevlumab

Topline data from the LAPIS Phase 3 study of pamrevlumab in locally advanced unresectable pancreatic cancer (LAPC) expected in 1Q 2024.
Topline data from the PanCAN Precision PromiseSM Phase 2/3 study of pamrevlumab in metastatic pancreatic cancer expected in 1H 2024.

Oncology Pipeline

Expect topline clinical trial results from Phase 1 monotherapy trial of FG-3246, a first-in-class antibody-drug conjugate (ADC) targeting a novel epitope on CD46 for metastatic castration-resistant prostate cancer (mCRPC) by 1Q 2024.
Anticipate the initiation of a Phase 2 trial of FG-3246 for mCRPC in 2H 2024.
Anticipate the filing of two INDs: FG-3165 (anti-Gal9 antibody) in 1Q 2024 and FG-3175 (anti-CCR8 antibody) in 2H 2024.

 

Financial:

Total revenue for the third quarter of 2023 was $40.1 million, as compared to $15.7 million for the third quarter of 2022, an increase of 155% year over year.
Net loss for the third quarter of 2023 was $63.6 million, or $0.65 net loss per basic and diluted share, compared to a net loss of $91.7 million, or $0.98 net loss per basic and diluted share one year ago.
Restructuring charge for the third quarter of 2023 was $12.6 million, or $0.13 impact to net loss per basic and diluted share, resulting from the reduction in U.S. workforce announced in July 2023.
At September 30, 2023, cash – defined as cash, cash equivalents, investments, and accounts receivable – was $283.0 million.
We expect our cash, cash equivalents, investments, and accounts receivable to be sufficient to fund our operating plans into 2026.

 

Conference Call and Webcast Details

FibroGen will host a conference call and webcast today, Monday, November 6, 2023, 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 in to 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. 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 locally advanced unresectable pancreatic cancer (LAPC) and metastatic pancreatic cancer. 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 clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted by the China Health Authority. FibroGen recently expanded its research and development portfolio to include product candidates in oncology. 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 company’s financial performance, the development and commercialization of the company’s product candidates, the potential safety and efficacy profile of its product candidates, and its clinical programs. These forward-looking statements include, but are not limited to, statements under the caption “Upcoming Milestones”, statements regarding the expected cost reduction savings, the statement that FibroGen expects its cash, cash equivalents, investments, and accounts receivable to be sufficient to fund its operating plans into 2026, 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, 2022, and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, 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.

 

 


Condensed Consolidated Balance Sheets

(In thousands)

 

September 30, 2023

 

 

December 31, 2022

 

 

(Unaudited)

 

 

(1)

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

$

120,914

 

 

$

155,700

 

Short-term investments

 

130,426

 

 

 

266,308

 

Accounts receivable, net

 

31,694

 

 

 

16,299

 

Inventory

 

40,696

 

 

 

40,436

 

Prepaid expenses and other current assets

 

40,378

 

 

 

14,083

 

Total current assets

 

364,108

 

 

 

492,826

 

 

 

 

 

 

 

Restricted time deposits

 

2,072

 

 

 

2,072

 

Long-term investments

 

 

 

 

4,348

 

Property and equipment, net

 

14,512

 

 

 

20,605

 

Equity method investment in unconsolidated variable interest entity

 

4,534

 

 

 

5,061

 

Operating lease right-of-use assets

 

71,248

 

 

 

79,893

 

Other assets

 

3,952

 

 

 

5,282

 

Total assets

$

460,426

 

 

$

610,087

 

 

 

 

 

 

 

Liabilities, stockholders’ equity and non-controlling interests

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

$

19,220

 

 

$

30,758

 

Accrued and other liabilities

 

170,986

 

 

 

219,773

 

Deferred revenue

 

7,325

 

 

 

12,739

 

Operating lease liabilities, current

 

11,884

 

 

 

10,292

 

Total current liabilities

 

209,415

 

 

 

273,562

 

 

 

 

 

 

 

Product development obligations

 

16,942

 

 

 

16,917

 

Deferred revenue, net of current

 

154,206

 

 

 

185,722

 

Operating lease liabilities, non-current

 

70,035

 

 

 

79,593

 

Senior secured term loan facilities, non-current

 

71,666

 

 

 

 

Liability related to sale of future revenues, non-current

 

49,109

 

 

 

49,333

 

Other long-term liabilities

 

4,255

 

 

 

6,440

 

Total liabilities

 

575,628

 

 

 

611,567

 

 

 

 

 

 

 

Redeemable non-controlling interests

 

21,480

 

 

 

 

Total stockholders’ deficit attributable to FibroGen

 

(157,169

)

 

 

(21,447

)

Nonredeemable non-controlling interests

 

20,487

 

 

 

19,967

 

Total deficit

 

(136,682

)

 

 

(1,480

)

Total liabilities, redeemable non-controlling interests and deficit

$

460,426

 

 

$

610,087

 

(1)
The condensed consolidated balance sheet amounts at December 31, 2022 are derived from audited financial statements.

 

 


Condensed Consolidated Statements of Operations

(In thousands, except per share data)

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

 

(Unaudited)

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

License revenue

$

2,649

 

 

$

 

 

$

9,649

 

 

$

22,590

 

Development and other revenue

 

6,775

 

 

 

2,453

 

 

 

15,825

 

 

 

19,672

 

Product revenue, net

 

29,390

 

 

 

17,359

 

 

 

77,439

 

 

 

59,495

 

Drug product revenue, net

 

1,320

 

 

 

(4,077

)

 

 

17,701

 

 

 

4,610

 

Total revenue

 

40,134

 

 

 

15,735

 

 

 

120,614

 

 

 

106,367

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

Cost of goods sold

 

4,243

 

 

 

4,308

 

 

 

13,441

 

 

 

15,355

 

Research and development

 

61,194

 

 

 

75,182

 

 

 

231,158

 

 

 

235,163

 

Selling, general and administrative

 

25,573

 

 

 

29,902

 

 

 

91,029

 

 

 

90,722

 

Restructuring charge

 

12,606

 

 

 

 

 

 

12,606

 

 

 

 

Total operating costs and expenses

 

103,616

 

 

 

109,392

 

 

 

348,234

 

 

 

341,240

 

Loss from operations

 

(63,482

)

 

 

(93,657

)

 

 

(227,620

)

 

 

(234,873

)

 

 

 

 

 

 

 

 

 

 

 

 

Interest and other, net:

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

(5,022

)

 

 

(84

)

 

 

(10,464

)

 

 

(321

)

Interest income and other income (expenses), net

 

4,296

 

 

 

1,798

 

 

 

7,984

 

 

 

6,672

 

Total interest and other, net

 

(726

)

 

 

1,714

 

 

 

(2,480

)

 

 

6,351

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss before income taxes

 

(64,208

)

 

 

(91,943

)

 

 

(230,100

)

 

 

(228,522

)

Provision for (benefit from) income taxes

 

84

 

 

 

114

 

 

 

(77

)

 

 

250

 

Investment income in unconsolidated
   variable interest entity

 

677

 

 

 

407

 

 

 

2,023

 

 

 

1,293

 

Net loss

$

(63,615

)

 

$

(91,650

)

 

$

(228,000

)

 

$

(227,479

)

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share - basic and diluted

$

(0.65

)

 

$

(0.98

)

 

$

(2.35

)

 

$

(2.43

)

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average number of common shares used to
    calculate net loss per share - basic and diluted

 

98,245

 

 

 

93,767

 

 

 

96,901

 

 

 

93,431

 

 

# # #

 

Contacts:

FibroGen, Inc.

 

Investors:

David DeLucia, CFA

Vice President of Corporate FP&A / Investor Relations

ddelucia@fibrogen.com

 

Media:

Meichiel Keenan

Director, Investor Relations and Corporate Communications

mkeenan@fibrogen.com