8-K
false000092129900009212992023-08-072023-08-07

 

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): August 07, 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 August 7, 2023, FibroGen, Inc. (“FibroGen”) issued a press release announcing financial results for the quarter ended June 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 Second Quarter 2023 Financial Results,” dated August 7, 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:

August 7, 2023

By:

/s/ Juan Graham

 

 

 

Juan Graham
Senior Vice President and Chief Financial Officer

 


EX-99.1

Exhibit 99.1

FibroGen Reports Second Quarter 2023 Financial Results

 

Topline data from three late-stage pamrevlumab trials expected through 1H 2024, including the Pancreatic Cancer Action Network (PanCAN) Precision PromiseSM Phase 2/3 study in metastatic pancreatic cancer
Robust roxadustat volume growth of over 40% in China
Entered into exclusive license for FOR46, a first-in-class CD46-targeting antibody-drug conjugate (ADC) for the treatment of metastatic castration-resistant prostate cancer
Implemented cost reduction plan extending cash runway into 2026
Thane Wettig appointed Interim CEO

 

SAN FRANCISCO, August 7, 2023 (GLOBE NEWSWIRE) - FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for the second quarter 2023 and provided an update on the Company’s recent developments.

“We saw another record quarter of roxadustat sales in China, and we recently submitted the sNDA to the China Health Authority for chemotherapy-induced anemia,” said Thane Wettig, Interim Chief Executive Officer, FibroGen. “As I assume the leadership role, I am very optimistic about our future. Within the next year, we have three pamrevlumab read-outs and key milestones for our early-stage pipeline, which combined with our deeply experienced team and strong cash position, set us up well for delivering value to patients and shareholders.”

 

Recent Developments and Key Events of Second Quarter 2023:

Appointed Thane Wettig as Interim Chief Executive Officer.
Entered into exclusive license for FOR46 (now FG-3246), a first-in-class CD46-targeting ADC for the treatment of metastatic castration-resistant prostate cancer (mCRPC).
Reported positive topline data from Company’s Phase 3 clinical study of roxadustat for treatment of anemia in patients receiving concurrent chemotherapy treatment for non-myeloid malignancies in China.
Filed Supplemental New Drug Application (sNDA) with China Health Authority for roxadustat in patients with chemotherapy-induced anemia.
Announced a non-dilutive term loan facility with investment funds managed by Morgan Stanley Tactical Value (MSTV), which resulted in proceeds to FibroGen of $75 million.
Reported negative topline results from MATTERHORN Phase 3 clinical study of roxadustat for treatment of anemia in patients with transfusion-dependent lower risk myelodysplastic syndromes (MDS).
Reported negative topline results from the LELANTOS-1 Phase 3 study of pamrevlumab for the treatment of non-ambulatory patients with Duchenne muscular dystrophy (DMD).
Reported negative topline results from the ZEPHYRUS-1 Phase 3 study of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF). Discontinued ZEPHYRUS-2 Phase 3 study of pamrevlumab in patients with IPF.
Implemented a cost reduction plan, resulting in an expected reduction of total annualized U.S. GAAP expenses of $100-120 million.

 


China Performance:

Achieved second quarter net product revenue under U.S. GAAP from the sale of roxadustat in China of $23.9 million compared to $23.3 million in the second quarter of 2022.
Achieved second quarter total roxadustat net sales in China1 by FibroGen and the distribution entity (JDE) jointly owned by FibroGen and AstraZeneca of $76.4 million, compared to $53.1 million in the second quarter of 2022, an increase of 44%, driven by over 40% 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.

 

Upcoming Milestones:

Pamrevlumab

Topline data from the LELANTOS-2 Phase 3 study of pamrevlumab in ambulatory DMD patients expected in 3Q 2023.
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.

Early-Stage Oncology Pipeline

Anticipate the initiation of a Phase 2 trial of FG-3246, a first-in-class ADC targeting a novel epitope on CD46 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 second quarter of 2023 was $44.3 million, as compared to $29.8 million for the second quarter of 2022, an increase of 49%.
Net loss for the second quarter of 2023 was $87.7 million, or $0.90 net loss per basic and diluted share, compared to a net loss of $72.6 million, or $0.78 net loss per basic and diluted share one year ago.
Research and development expenses for the second quarter of 2023 included a one-time, non-cash charge of acquired in-process research and development expenses of $24.6 million, or $0.25 impact to net loss per basic and diluted share, resulting from the recent exclusive license for FG-3246 from Fortis Therapeutics.
At June 30, 2023, cash – defined as cash, cash equivalents, investments, and accounts receivable – was$361.3 million, including proceeds received during the quarter from the Company’s use of its at-the-market equity facility and the closing of the recently announced term loan.
We expect our cash, cash equivalents, investments, and accounts receivable to be sufficient to fund our operating plans into 2026.

 

___________________________________

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, August 7, 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), 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 locally advanced unresectable pancreatic cancer (LAPC), ambulatory 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, and Fast Track designation to pamrevlumab for the treatment of patients with 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 DMD, 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) in China.

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), metastatic pancreatic cancer, and ambulatory 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 clinical development for chemotherapy-induced anemia (CIA) in China. FibroGen recently expanded its research and development portfolio to include product candidates in the immuno-oncology space along with an exclusive license for FG-3246. 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 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 June 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)

 

June 30, 2023

 

 

December 31, 2022

 

 

(Unaudited)

 

 

(1)

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

$

152,585

 

 

$

155,700

 

Short-term investments

 

183,131

 

 

 

266,308

 

Accounts receivable, net

 

25,599

 

 

 

16,299

 

Inventory

 

41,179

 

 

 

40,436

 

Prepaid expenses and other current assets

 

8,863

 

 

 

14,083

 

Total current assets

 

411,357

 

 

 

492,826

 

 

 

 

 

 

 

Restricted time deposits

 

2,072

 

 

 

2,072

 

Long-term investments

 

 

 

 

4,348

 

Property and equipment, net

 

16,829

 

 

 

20,605

 

Equity method investment in unconsolidated variable interest entity

 

6,112

 

 

 

5,061

 

Operating lease right-of-use assets

 

74,404

 

 

 

79,893

 

Other assets

 

4,353

 

 

 

5,282

 

Total assets

$

515,127

 

 

$

610,087

 

 

 

 

 

 

 

Liabilities, stockholders’ equity and non-controlling interests

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

$

12,802

 

 

$

30,758

 

Accrued and other liabilities

 

162,769

 

 

 

219,773

 

Deferred revenue

 

7,490

 

 

 

12,739

 

Operating lease liabilities, current

 

11,011

 

 

 

10,292

 

Total current liabilities

 

194,072

 

 

 

273,562

 

 

 

 

 

 

 

Product development obligations

 

17,365

 

 

 

16,917

 

Deferred revenue, net of current

 

165,416

 

 

 

185,722

 

Operating lease liabilities, non-current

 

73,813

 

 

 

79,593

 

Senior secured term loan facilities, non-current

 

71,408

 

 

 

 

Liability related to sale of future revenues, non-current

 

48,399

 

 

 

49,333

 

Other long-term liabilities

 

4,961

 

 

 

6,440

 

Total liabilities

 

575,434

 

 

 

611,567

 

 

 

 

 

 

 

Redeemable non-controlling interests

 

21,480

 

 

 

 

Total stockholders’ deficit attributable to FibroGen

 

(102,274

)

 

 

(21,447

)

Nonredeemable non-controlling interests

 

20,487

 

 

 

19,967

 

Total deficit

 

(81,787

)

 

 

(1,480

)

Total liabilities, redeemable non-controlling interests and deficit

$

515,127

 

 

$

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 June 30,

 

 

Six Months Ended June 30,

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

 

(Unaudited)

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

License revenue

$

1,000

 

 

$

 

 

$

7,000

 

 

$

22,590

 

Development and other revenue

 

5,158

 

 

 

5,457

 

 

 

9,050

 

 

 

17,219

 

Product revenue, net

 

23,889

 

 

 

23,256

 

 

 

48,049

 

 

 

42,137

 

Drug product revenue, net

 

14,272

 

 

 

1,093

 

 

 

16,381

 

 

 

8,687

 

Total revenue

 

44,319

 

 

 

29,806

 

 

 

80,480

 

 

 

90,633

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

Cost of goods sold

 

5,708

 

 

 

6,809

 

 

 

9,199

 

 

 

11,048

 

Research and development

 

95,478

 

 

 

70,963

 

 

 

169,964

 

 

 

159,981

 

Selling, general and administrative

 

31,181

 

 

 

30,258

 

 

 

65,455

 

 

 

60,820

 

Total operating costs and expenses

 

132,367

 

 

 

108,030

 

 

 

244,618

 

 

 

231,849

 

Loss from operations

 

(88,048

)

 

 

(78,224

)

 

 

(164,138

)

 

 

(141,216

)

 

 

 

 

 

 

 

 

 

 

 

 

Interest and other, net:

 

 

 

 

 

 

 

 

 

 

 

Interest expense

 

(3,069

)

 

 

(141

)

 

 

(5,441

)

 

 

(238

)

Interest income and other income (expenses), net

 

2,652

 

 

 

5,199

 

 

 

3,687

 

 

 

4,876

 

Total interest and other, net

 

(417

)

 

 

5,058

 

 

 

(1,754

)

 

 

4,638

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss before income taxes

 

(88,465

)

 

 

(73,166

)

 

 

(165,892

)

 

 

(136,578

)

Provision for income taxes

 

(235

)

 

 

23

 

 

 

(161

)

 

 

136

 

Investment income in unconsolidated
   variable interest entity

 

550

 

 

 

565

 

 

 

1,346

 

 

 

885

 

Net loss

$

(87,680

)

 

$

(72,624

)

 

$

(164,385

)

 

$

(135,829

)

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share - basic and diluted

$

(0.90

)

 

$

(0.78

)

 

$

(1.71

)

 

$

(1.46

)

 

 

 

 

 

 

 

 

 

 

 

 

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

 

97,729

 

 

 

93,475

 

 

 

96,218

 

 

 

93,260

 

 

# # #

 


Contacts:

FibroGen, Inc.

 

Investors:

David DeLucia, CFA

Head of Corporate FP&A / Investor Relations

ddelucia@fibrogen.com

 

Media:

Michael Szumera

mszumera@fibrogen.com