8-K
0000921299false00009212992024-05-062024-05-06

 

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): 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:

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 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

 


EX-99.1

Exhibit 99.1

FibroGen Reports First Quarter 2024 Financial Results

 

Topline data from the Pancreatic Cancer Action Network (PanCAN) Precision PromiseSM Phase 2/3 study in metastatic pancreatic cancer anticipated in mid-2024
Topline data from LAPIS Phase 3 study in locally advanced unresectable pancreatic cancer anticipated in 3Q 2024
Reported compelling data from Phase 1 monotherapy study of FG-3246, a CD46 targeted antibody drug conjugate, in metastatic castration-resistant prostate cancer
First quarter net revenue growth of 55% year over year, driven by roxadustat China performance and one-time drug product revenue recognized from US/RoW AstraZeneca agreement termination
Robust year over year roxadustat volume growth of 39% in China
Cash, cash equivalents, investments, and accounts receivable balance of $214.7 million; cash runway projected into 2026

 

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

Topline data from the PanCAN Precision PromiseSM Phase 2/3 study of pamrevlumab in metastatic pancreatic cancer expected in mid-2024, reflecting PanCAN’s updated timing to complete database lock and subsequent analysis of the topline results by the independent Statistical Monitoring Committee.
Topline data from the LAPIS Phase 3 study of pamrevlumab in locally advanced unresectable pancreatic cancer (LAPC) expected in 3Q 2024, due to the current trend in reported blinded overall survival events needed to complete the study.

Roxadustat

Expect approval decision for roxadustat in chemotherapy-induced anemia (CIA) in China in the second half of 2024. If approved, FibroGen will receive a $10 million milestone payment from AstraZeneca.

Oncology Pipeline

Initial data from Phase 1 investigator-initiated combination study of FG-3246 with enzalutamide in metastatic castration-resistant prostate cancer (mCRPC) to be presented at ASCO 2024.
Anticipate initiation of Phase 2 monotherapy dose optimization study of FG-3246 in mCRPC in 2H 2024.
Anticipate filing of an IND for FG-3175 (anti-CCR8 mAb) in 2025.

 


Recent Developments:

Oncology Pipeline

Additional data from a total of 56 biomarker unselected and heavily pre-treated patients in a Phase 1 monotherapy study of FG-3246 in mCRPC reported.
o
Efficacy analysis (includes adenocarcinoma patients receiving doses ≥ 1.2 mg/kg):
The median radiographic progression free survival (rPFS) in this patient population was 8.7 months.
For RECIST evaluable patients, 20% met the criteria of a partial response, or measurable tumor reduction in size of ≥ 30%, with a median duration of response of 7.5 months.
PSA reductions of ≥ 50% were observed in 36% of PSA evaluable patients
o
Safety analysis:
The most frequent adverse events were consistent with other MMAE-based antibody drug conjugates and included infusion-related reactions, fatigue, weight loss, neutropenia, and peripheral neuropathy.
IND submitted for FG-3165 (Galectin-9 targeting mAb) for solid tumors in April 2024.

Corporate

Appointed Deyaa Adib, MD as Chief Medical Officer.

 

China:

First quarter FibroGen net product revenue under U.S. GAAP from the sale of roxadustat in China was $30.5 million compared to $24.2 million in the first quarter of 2023, an increase of 26% year over year.
First quarter total roxadustat net sales in China1 by FibroGen and the distribution entity jointly owned by FibroGen and AstraZeneca (JDE) was $79.4 million, compared to $64.1 million in the first quarter of 2023, an increase of 24% year over year, driven by a 39% 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, we reiterate FibroGen’s full year net product revenue under U.S. GAAP to range between $120 million to $135 million, representing full year roxadustat net sales in China1 by FibroGen and the JDE to range between $300 million to $340 million.

 

Financial:

Total revenue for the first quarter of 2024 was $55.9 million, as compared to $36.2 million for the first quarter of 2023, an increase of 55% year over year. Total revenue increase was driven by net product revenue in China and one-time drug product revenue of $25.7 million recognized due to the termination of US/RoW AstraZeneca agreement.
Net loss for the first quarter of 2024 was $32.9 million, or $0.33 net loss per basic and diluted share, compared to a net loss of $76.7 million, or $0.81 net loss per basic and diluted share one year ago.
At March 31, 2024, FibroGen reported $214.7 million in cash - defined as cash, cash equivalents, investments, and accounts receivable.
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, 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

 

(1)
The condensed consolidated balance sheet amounts at December 31, 2023 are derived from audited financial statements.

 

 


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