KYNB 8-K
Kyntra Bio, Inc. (KYNB)
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 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 |
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Exhibit No. |
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Description |
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99.1 |
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Press Release titled “FibroGen Reports Second Quarter 2023 Financial Results,” dated August 7, 2023 |
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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 7, 2023 |
By: |
/s/ Juan Graham |
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Juan Graham |
Exhibit 99.1
FibroGen Reports Second Quarter 2023 Financial Results
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:
China Performance:
Upcoming Milestones:
Pamrevlumab
Early-Stage Oncology Pipeline
Financial:
___________________________________
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)
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June 30, 2023 |
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December 31, 2022 |
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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 |
$ |
152,585 |
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$ |
155,700 |
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Short-term investments |
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183,131 |
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266,308 |
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Accounts receivable, net |
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25,599 |
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16,299 |
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Inventory |
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41,179 |
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40,436 |
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Prepaid expenses and other current assets |
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8,863 |
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14,083 |
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Total current assets |
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411,357 |
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492,826 |
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Restricted time deposits |
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2,072 |
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2,072 |
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Long-term investments |
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— |
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4,348 |
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Property and equipment, net |
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16,829 |
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20,605 |
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Equity method investment in unconsolidated variable interest entity |
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6,112 |
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5,061 |
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Operating lease right-of-use assets |
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74,404 |
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79,893 |
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Other assets |
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4,353 |
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5,282 |
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Total assets |
$ |
515,127 |
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$ |
610,087 |
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Liabilities, stockholders’ equity and non-controlling interests |
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Current liabilities: |
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Accounts payable |
$ |
12,802 |
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$ |
30,758 |
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Accrued and other liabilities |
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162,769 |
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219,773 |
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Deferred revenue |
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7,490 |
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12,739 |
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Operating lease liabilities, current |
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11,011 |
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10,292 |
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Total current liabilities |
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194,072 |
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273,562 |
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Product development obligations |
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17,365 |
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16,917 |
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Deferred revenue, net of current |
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165,416 |
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185,722 |
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Operating lease liabilities, non-current |
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73,813 |
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79,593 |
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Senior secured term loan facilities, non-current |
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71,408 |
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— |
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Liability related to sale of future revenues, non-current |
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48,399 |
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49,333 |
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Other long-term liabilities |
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4,961 |
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6,440 |
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Total liabilities |
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575,434 |
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611,567 |
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Redeemable non-controlling interests |
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21,480 |
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— |
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Total stockholders’ deficit attributable to FibroGen |
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(102,274 |
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(21,447 |
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Nonredeemable non-controlling interests |
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20,487 |
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19,967 |
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Total deficit |
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(81,787 |
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(1,480 |
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Total liabilities, redeemable non-controlling interests and deficit |
$ |
515,127 |
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$ |
610,087 |
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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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2023 |
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2022 |
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2023 |
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2022 |
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(Unaudited) |
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Revenue: |
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License revenue |
$ |
1,000 |
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$ |
— |
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$ |
7,000 |
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$ |
22,590 |
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Development and other revenue |
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5,158 |
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5,457 |
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9,050 |
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17,219 |
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Product revenue, net |
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23,889 |
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23,256 |
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48,049 |
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42,137 |
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Drug product revenue, net |
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14,272 |
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1,093 |
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16,381 |
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8,687 |
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Total revenue |
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44,319 |
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29,806 |
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80,480 |
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90,633 |
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Operating costs and expenses: |
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Cost of goods sold |
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5,708 |
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6,809 |
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9,199 |
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11,048 |
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Research and development |
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95,478 |
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70,963 |
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169,964 |
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159,981 |
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Selling, general and administrative |
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31,181 |
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30,258 |
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65,455 |
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60,820 |
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Total operating costs and expenses |
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132,367 |
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108,030 |
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244,618 |
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231,849 |
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Loss from operations |
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(88,048 |
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(78,224 |
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(164,138 |
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(141,216 |
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Interest and other, net: |
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Interest expense |
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(3,069 |
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(141 |
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(5,441 |
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(238 |
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Interest income and other income (expenses), net |
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2,652 |
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5,199 |
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3,687 |
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4,876 |
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Total interest and other, net |
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(417 |
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5,058 |
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(1,754 |
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4,638 |
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Loss before income taxes |
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(88,465 |
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(73,166 |
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(165,892 |
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(136,578 |
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Provision for income taxes |
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(235 |
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23 |
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(161 |
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136 |
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Investment income in unconsolidated |
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550 |
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565 |
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1,346 |
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885 |
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Net loss |
$ |
(87,680 |
) |
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$ |
(72,624 |
) |
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$ |
(164,385 |
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$ |
(135,829 |
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Net loss per share - basic and diluted |
$ |
(0.90 |
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$ |
(0.78 |
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$ |
(1.71 |
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$ |
(1.46 |
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Weighted average number of common shares used to |
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97,729 |
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93,475 |
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96,218 |
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93,260 |
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# # #
Contacts:
FibroGen, Inc.
Investors:
David DeLucia, CFA
Head of Corporate FP&A / Investor Relations
Media:
Michael Szumera