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
Date of Report (Date of earliest event reported):
(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation) |
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(Commission File Number) |
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(IRS Employer Identification No.) |
FibroGen, Inc.
(Address of principal executive offices, including zip code)
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(Registrant’s telephone number, including area code)
Not Applicable
(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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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:
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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).
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Emerging growth company |
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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.☐
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Item 2.02 |
Results of Operations and Financial Condition. |
On May 7, 2020, FibroGen, Inc. (“FibroGen”) issued a press release announcing financial results for the quarter ended March 31, 2020. 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.
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Item 9.01 |
Financial Statements and Exhibits. |
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(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 First Quarter 2020 Financial Results,” dated May 7, 2020 |
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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 hereunto duly authorized.
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FIBROGEN, INC. |
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Dated: May 7, 2020 |
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By: |
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/s/ Pat Cotroneo |
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Pat Cotroneo |
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Senior Vice President, Finance and Chief Financial Officer |
Exhibit 99.1
FibroGen Reports First Quarter 2020 Financial Results
- Roxadustat U.S. NDA review and E.U. MAA filing on track -
Conference Call Today at 5:00 p.m. Eastern Time/2:00 p.m. Pacific Time
SAN FRANCISCO, May 07, 2020 -- FibroGen, Inc. (NASDAQ: FGEN) today reported financial results for the first quarter of 2020 and provided an update on the company’s recent developments.
“During this difficult time, we continue to be inspired by our unique opportunity to leverage world-class science to benefit patients,” said Enrique Conterno, Chief Executive Officer, FibroGen. “The COVID-19 pandemic has presented a number of unprecedented challenges, including in the conduct and enrollment of our clinical trials. Nevertheless, I want to reassure patients, healthcare providers, and stakeholders of our continued commitment to bring to patients our potential first-in-class medicines for the treatment of chronic and life-threatening conditions. Our strong financial position gives us sufficient runway to navigate this storm.”
“We remain focused on ensuring the regulatory and commercial success of roxadustat, a potentially transformational oral medicine in anemia therapy, first demonstrated in patients with chronic kidney disease. With pamrevlumab, our monoclonal antibody targeting connective tissue growth factor (CTGF), we are implementing a comprehensive plan to accelerate development across the three indications of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer (LAPC), and Duchenne muscular dystrophy (DMD) once the situation with COVID-19 improves. Finally, we continue to advance the innovation of our hypoxia-inducible factor (HIF) and CTGF platforms.”
Key Events in Recent Months and Other Developments
Roxadustat
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U.S. NDA for roxadustat for the treatment of anemia of chronic kidney disease (CKD), in non-dialysis-dependent and dialysis-dependent patients, is under review with a Prescription Drug User Fee Act (PDUFA) date of December 20, 2020. |
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Japan sNDA for roxadustat for the treatment of anemia of chronic kidney disease (CKD) in non-dialysis-dependent patients is under review. |
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Presented new analyses from our Phase 3 roxadustat trials at the annual National Kidney Foundation Spring Clinical meeting which demonstrated: |
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Roxadustat corrected and maintained hemoglobin in non-dialysis dependent patients with anemia using similar doses regardless of iron status at baseline. |
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Roxadustat reduced the risk of red blood cell transfusions and IV iron rescue compared to placebo in non-dialysis CKD patients, regardless of iron status at baseline. |
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Roxadustat reduced the risk of red blood cell transfusion during anemia treatment in dialysis dependent CKD patients vs. epoetin alfa. |
Pamrevlumab
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To minimize the risk of exposure to COVID-19 in the vulnerable patient population with compromised lung function from idiopathic pulmonary fibrosis (IPF), paused near-term enrollment of ZEPHYRUS Phase 3 clinical trial of pamrevlumab in patients with IPF. |
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Continue to enroll the LAPIS Phase 3 clinical trial of pamrevlumab in patients with locally advanced unresectable pancreatic cancer (LAPC). |
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In Europe, the Marketing Authorization Application filing for roxadustat for the treatment of anemia in both dialysis- and non-dialysis-dependent patients with CKD is expected in the second quarter of 2020. |
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Plan to initiate ZEPHYRUS 2, a second IPF Phase 3 clinical trial similar in size and design to ZEPHYRUS, as COVID-19 conditions improve. |
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Plan to initiate LELANTOS, a Phase 3 global clinical trial of pamrevlumab in DMD in the second half 2020. This trial will enroll approximately 90 patients randomized 1:1 to placebo and have a treatment period of 52 weeks. |
Corporate and Financial
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Total revenue for the first quarter of 2020 was $24.4 million, as compared to $23.9 million for the first quarter of 2019. The current quarter revenue consisted of $19.4 million in development revenue, and $5.0 million in net roxadustat sales in China. |
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Net loss for the first quarter of 2020 was $78.3 million, or $0.89 net loss per basic and diluted share, compared to a net income of $45.4 million, or $0.53 net loss per basic and diluted share one year ago. |
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At March 31, FibroGen had $598.4 million in cash, cash equivalents, restricted time deposits, investments, and receivables. |
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Based on our latest forecast, we reiterate our year end 2020 estimate to be in the range of $720 million to $730 million in cash, cash equivalents, restricted time deposits, investments, and receivables. |
Conference Call and Webcast Details
FibroGen will host a conference call and webcast today, Thursday, May 7, 2020, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. A live audio webcast of the call may be accessed in the investor section of the company’s website, www.fibrogen.com. To participate in the conference call by telephone, please dial 1 (877) 658-9081 (U.S. and Canada) or 1 (602) 563-8732 (international), reference the FibroGen first quarter 2020 financial results conference call, and use passcode 9946439. A replay of the webcast will be available shortly after the call for a period of two weeks. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and use passcode 9946439.
About Roxadustat
Roxadustat is a first-in-class, orally administered small molecule HIF-PH inhibitor that promotes erythropoiesis through increasing endogenous production of erythropoietin, and improved iron absorption, transport and mobilization. Roxadustat is approved in China for the treatment of anemia in CKD patients on dialysis and patients not on dialysis, and is approved in Japan for the treatment of anemia in CKD patients on dialysis, and a supplemental NDA for the treatment of anemia in CKD patients not on dialysis is under regulatory review. The roxadustat NDA for the treatment of anemia in CKD is under review by the U.S. FDA with a Prescription Drug User Fee Act date of December 20, 2020. Our partner Astellas expects the Marketing Authorization Application filing for roxadustat for the treatment of anemia in CKD in the second quarter of 2020. Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia.
Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in territories including Japan and Europe. AstraZeneca and FibroGen are collaborating on the development and commercialization of roxadustat for the treatment of anemia in the U.S., China, and other markets.
About Pamrevlumab
Pamrevlumab is a first-in-class antibody developed by FibroGen that inhibits the activity of connective tissue growth factor (CTGF), a common factor in fibrotic and proliferative disorders. Pamrevlumab is in Phase 3 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF) and locally advanced unresectable pancreatic cancer (LAPC), and in Phase 2 clinical development for the treatment of Duchenne muscular dystrophy (DMD). For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.
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 hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology to advance innovative medicines to treat unmet needs. The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD). Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia. Pamrevlumab, an anti-CTGF human monoclonal antibody, is in clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), locally advanced unresectable pancreatic cancer, and Duchenne muscular dystrophy (DMD). For more information, please visit www.fibrogen.com.
Forward-Looking Statements
This release contains forward-looking statements regarding our strategy, future plans and prospects, including statements regarding the development and commercialization of the company’s product candidates, our financial results, the potential safety and efficacy profile of our product candidates, our clinical programs and regulatory events, and those of our partners. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts 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. Our 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 our various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and our Quarterly Report on Form 10-Q for quarter ended March 31, 2020 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 we undertake 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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March 31, 2020 |
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December 31, 2019 |
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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 |
$ |
121,560 |
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$ |
126,266 |
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Short-term investments |
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413,869 |
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407,491 |
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Accounts receivable, net |
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58,540 |
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28,455 |
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Inventory |
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8,408 |
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6,887 |
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Prepaid expenses and other current assets |
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134,028 |
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133,391 |
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Total current assets |
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736,405 |
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702,490 |
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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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223 |
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61,118 |
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Property and equipment, net |
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40,058 |
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42,743 |
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Finance lease right-of-use assets |
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37,017 |
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39,602 |
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Other assets |
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8,602 |
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9,372 |
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Total assets |
$ |
824,377 |
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$ |
857,397 |
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Liabilities, stockholders’ equity and non-controlling interests |
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Current liabilities: |
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Accounts payable |
$ |
2,865 |
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$ |
6,088 |
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Accrued and other liabilities |
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42,309 |
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83,816 |
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Deferred revenue |
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8,531 |
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490 |
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Finance lease liabilities, current |
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12,396 |
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12,351 |
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Total current liabilities |
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66,101 |
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102,745 |
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Long-term portion of lease obligations |
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1,040 |
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1,141 |
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Product development obligations |
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16,536 |
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16,780 |
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Deferred revenue, net of current |
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139,404 |
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99,449 |
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Finance lease liabilities, non-current |
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34,545 |
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37,610 |
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Other long-term liabilities |
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89,122 |
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64,266 |
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Total liabilities |
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346,748 |
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321,991 |
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Total stockholders’ equity |
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458,358 |
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516,135 |
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Non-controlling interests |
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19,271 |
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19,271 |
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Total equity |
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477,629 |
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535,406 |
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Total liabilities, stockholders’ equity and non-controlling interests |
$ |
824,377 |
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$ |
857,397 |
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(1) |
The condensed consolidated balance sheet amounts at December 31, 2019 are derived from audited financial statements. |
Condensed Consolidated Statements of Operations
(In thousands, except per share data)
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Three Months Ended March 31, |
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2020 |
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2019 |
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(Unaudited) |
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Revenue: |
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License revenue |
$ |
— |
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$ |
— |
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Development and other revenue |
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19,446 |
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23,863 |
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Product revenue, net |
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4,955 |
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— |
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Total revenue |
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24,401 |
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23,863 |
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Operating costs and expenses: |
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Cost of goods sold |
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970 |
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— |
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Research and development |
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54,902 |
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50,496 |
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Selling, general and administrative |
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49,603 |
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22,210 |
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Total operating costs and expenses |
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105,475 |
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72,706 |
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Loss from operations |
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(81,074 |
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(48,843 |
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Interest and other, net: |
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Interest expense |
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(633 |
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(770 |
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Interest income and other, net |
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3,165 |
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4,177 |
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Total interest and other, net |
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2,532 |
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3,407 |
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Loss before income taxes |
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(78,542 |
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(45,436 |
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Benefit from income taxes |
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(194 |
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(25 |
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Net loss |
$ |
(78,348 |
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$ |
(45,411 |
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Net loss per share - basic and diluted |
$ |
(0.89 |
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$ |
(0.53 |
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Weighted average number of common shares used to calculate net loss per share - basic and diluted |
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88,219 |
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85,704 |
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(1) |
The condensed consolidated statement of operations amounts for the year ended December 31, 2019 are derived from audited financial statements. |
Contact: FibroGen, Inc.
Media Inquiries:
Sara Iacovino
1.703.474.4452
Investors:
Michael Tung, M.D.
Corporate Strategy / Investor Relations
1.415.978.1434