UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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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:
Securities registered pursuant to Section 12(b) of the Act:
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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 6, 2024, FibroGen, Inc. (“FibroGen”) issued a press release announcing financial results for the quarter ended June 30, 2024 and providing business update. 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.
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Exhibits |
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Exhibit No. |
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Description |
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99.1 |
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104 |
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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.
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FIBROGEN, INC. |
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Date: |
August 6, 2024 |
By: |
/s/ Juan Graham |
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Juan Graham |
Exhibit 99.1
FibroGen Reports Second Quarter 2024 Financial Results and Provides Business Update
SAN FRANCISCO, August 6, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for the second quarter 2024 and provided an update on the company’s recent developments.
“While we are disappointed with the results from the pamrevlumab pancreatic cancer trials, we continue to be very excited about the prospects of FG-3246 and PET46, our CD46 targeted antibody-drug conjugate and companion PET imaging agent. We have released compelling Phase 1 data on FG-3246 as a monotherapy and in combination with enzalutamide in metastatic castration-resistant prostate cancer. In addition, roxadustat continues its strong momentum in China, exceeding $92 million in net sales in the second quarter,” said Thane Wettig, Chief Executive Officer, FibroGen. “Looking ahead, we expect topline data from the Phase 2 portion of the FG-3246 + enzalutamide combination study in mCRPC in the first half of 2025 and plan on initiating our Phase 2 monotherapy study in mCRPC in the first quarter of 2025 with a more focused and streamlined organization. I would like to express my deepest gratitude to our FibroGen colleagues who have dedicated so much of their time and energy for the prospect of bringing much needed therapies to some of the most challenging and deadly diseases affecting humanity.”
Recent Developments and Key Events of Second Quarter 2024:
_________________________________
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:
Roxadustat
Oncology Pipeline
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.
Financial:
Conference Call and Webcast Details
FibroGen management will host a conference call and webcast today, Tuesday, August 6, 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). 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. 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.
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 expectation that cash, cash equivalents and accounts receivable will be sufficient 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 June 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.
# # #
Condensed Consolidated Balance Sheets
(In thousands)
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June 30, 2024 |
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December 31, 2023 |
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(Unaudited) |
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(1) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
$ |
140,714 |
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$ |
113,688 |
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Short-term investments |
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- |
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121,898 |
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Accounts receivable, net |
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6,412 |
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12,553 |
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Inventory |
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25,397 |
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41,565 |
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Prepaid expenses and other current assets |
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36,936 |
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41,855 |
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Total current assets |
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209,459 |
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331,559 |
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Restricted time deposits |
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1,658 |
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1,658 |
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Property and equipment, net |
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10,917 |
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13,126 |
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Equity method investment in unconsolidated variable interest entity |
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6,912 |
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5,290 |
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Operating lease right-of-use assets |
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61,212 |
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68,093 |
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Other assets |
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3,045 |
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3,803 |
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Total assets |
$ |
293,203 |
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$ |
423,529 |
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Liabilities, stockholders’ equity and non-controlling interests |
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Current liabilities: |
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Accounts payable |
$ |
9,938 |
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$ |
17,960 |
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Accrued and other liabilities |
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113,574 |
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172,891 |
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Deferred revenue |
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9,546 |
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12,740 |
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Operating lease liabilities, current |
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15,531 |
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14,077 |
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Total current liabilities |
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148,589 |
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217,668 |
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Product development obligations |
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17,397 |
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17,763 |
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Deferred revenue, net of current |
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131,192 |
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157,555 |
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Operating lease liabilities, non-current |
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58,376 |
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66,537 |
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Senior secured term loan facilities, non-current |
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72,478 |
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71,934 |
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Liability related to sale of future revenues, non-current |
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54,532 |
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51,413 |
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Other long-term liabilities |
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1,012 |
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2,858 |
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Total liabilities |
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483,576 |
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585,728 |
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Redeemable non-controlling interests |
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21,480 |
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21,480 |
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Total stockholders’ deficit attributable to FibroGen |
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(232,340 |
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(204,166 |
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Nonredeemable non-controlling interests |
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20,487 |
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20,487 |
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Total deficit |
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(211,853 |
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(183,679 |
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Total liabilities, redeemable non-controlling interests and deficit |
$ |
293,203 |
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$ |
423,529 |
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Condensed Consolidated Statements of Operations
(In thousands, except per share data)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2024 |
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2023 |
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2024 |
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2023 |
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(Unaudited) |
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Revenue: |
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License revenue |
$ |
— |
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$ |
1,000 |
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$ |
— |
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$ |
7,000 |
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Development and other revenue |
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269 |
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5,158 |
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1,147 |
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9,050 |
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Product revenue, net |
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49,643 |
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23,889 |
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80,181 |
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48,049 |
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Drug product revenue, net |
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729 |
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14,272 |
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25,216 |
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16,381 |
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Total revenue |
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50,641 |
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44,319 |
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106,544 |
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80,480 |
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Operating costs and expenses: |
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Cost of goods sold |
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5,178 |
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5,708 |
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30,931 |
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9,199 |
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Research and development |
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34,106 |
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95,478 |
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72,498 |
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169,964 |
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Selling, general and administrative |
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22,276 |
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31,181 |
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45,097 |
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65,455 |
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Total operating costs and expenses |
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61,560 |
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132,367 |
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148,526 |
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244,618 |
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Loss from operations |
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(10,919 |
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(88,048 |
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(41,982 |
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(164,138 |
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Interest and other, net: |
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Interest expense |
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(4,783 |
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(3,069 |
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(9,779 |
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(5,441 |
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Interest income and other income (expenses), net |
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(1,281 |
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2,652 |
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1,289 |
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3,687 |
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Total interest and other, net |
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(6,064 |
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(417 |
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(8,490 |
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(1,754 |
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Loss before income taxes |
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(16,983 |
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(88,465 |
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(50,472 |
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(165,892 |
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Benefit from income taxes |
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(262 |
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(235 |
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(229 |
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(161 |
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Investment income in unconsolidated |
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1,177 |
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550 |
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1,766 |
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1,346 |
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Net loss |
$ |
(15,544 |
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$ |
(87,680 |
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$ |
(48,477 |
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$ |
(164,385 |
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Net loss per share - basic and diluted |
$ |
(0.16 |
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$ |
(0.90 |
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$ |
(0.49 |
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$ |
(1.71 |
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Weighted average number of common shares used to |
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99,835 |
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97,729 |
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99,408 |
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96,218 |
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# # #
For Investor Inquiries:
David DeLucia, CFA
Vice President of Corporate FP&A / Investor Relations
ir@fibrogen.com
For Media Inquiries:
Simon Miller
Vice President, Marketing and Corporate Communications
media@fibrogen.com