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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
(Mark One)
☑ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2021
OR
☐ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number: 001-36740
FIBROGEN, INC.
(Exact name of registrant as specified in its charter)
Delaware |
|
77-0357827 |
(State or Other Jurisdiction of
Incorporation or Organization) |
|
(I.R.S. Employer
Identification No.) |
409 Illinois Street |
|
|
San Francisco, CA |
|
94158 |
(Address of Principal Executive Offices) |
|
(Zip Code) |
(415) 978-1200
Registrant’s telephone number, including area code:
Securities registered pursuant to Section 12(b) of the Act:
|
|
|
Title of each class |
Trading Symbol |
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: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☑ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☑ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act:
Large accelerated filer |
☑ |
Accelerated filer |
☐ |
Non-accelerated filer |
☐ |
Smaller reporting company |
☐ |
|
|
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. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Exchange Act Rule 12b-2). Yes ☐ No ☑
The number of shares of common stock outstanding as of October 31, 2021 was 92,709,943.
FIBROGEN, INC.
TABLE OF CONTENTS
1
SUMMARY RISK FACTORS
The success of the Company will depend on a number of factors, many of which are beyond our control and involve risks, including but not limited to the following:
Risks Related to the Development and Commercialization of Our Product Candidates
• |
We are substantially dependent on the success of our lead product, roxadustat, and our second compound in development, pamrevlumab. |
• |
As a company, we have limited commercialization experience, and the time and resources to develop such experience are significant. If we fail to achieve and sustain commercial success for roxadustat with our collaboration partners, our business would be harmed. |
• |
Although regulatory approval has been obtained for roxadustat in the European Union, Great Britain, China, Japan, South Korea, and Chile, we may be unable to obtain regulatory approval for other countries, or such approval may be delayed or limited, due to a number of factors, many of which are beyond our control. |
• |
The CRL we received for roxadustat has decreased the likelihood of approval and successful commercialization of roxadustat in the U.S., will decrease and/or delay expected revenue, and may increase the possibility that our Collaboration Agreement with AstraZeneca could be amended or terminated. |
• |
Preclinical, Phase 1 and Phase 2 clinical trial results may not be indicative of the results that may be obtained in larger clinical trials. |
• |
We do not know whether our ongoing or planned clinical trials of roxadustat or pamrevlumab will need to be redesigned based on interim results or if we will be able to achieve sufficient patient enrollment or complete planned clinical trials on schedule. |
• |
Our product candidates may cause or have attributed to them undesirable side effects or have other properties that delay or prevent their regulatory approval or limit their commercial potential. |
• |
Clinical trials of our product candidates may not uncover all possible adverse effects that patients may experience. |
• |
If our manufacturers or we cannot properly manufacture the appropriate volume of product, we may experience delays in development, regulatory approval, launch or successful commercialization. |
• |
Regulatory authorities will do their own benefit risk analysis and may reach a different conclusion than we or our partners have, and these regulatory authorities may base their approval decision on different analyses, data, and statistical methods than ours. |
• |
Even if we are able to obtain regulatory approval of our product candidates, the label we obtain may limit the indicated uses for which our product candidates may be marketed. |
• |
We face substantial competition in the discovery, development and commercialization of product candidates. |
• |
Our product candidates may not achieve adequate market acceptance among physicians, patients, healthcare payors, and others in the medical community necessary for commercial success. |
• |
No or limited reimbursement or insurance coverage of our approved products, if any, by third-party payors may render our products less attractive to patients and healthcare providers. |
Risks Related to COVID-19
• |
Our business could continue to be adversely affected by the ongoing COVID-19 global pandemic. |
Risks Related to Our Reliance on Third Parties
• |
If our collaborations were terminated or if Astellas or AstraZeneca were to prioritize other initiatives over their collaborations with us, our ability to successfully develop and commercialize our product candidates would suffer. |
• |
If our preclinical and clinical trial contractors do not properly perform their agreed upon obligations, we may not be able to obtain or may be delayed in receiving regulatory approvals for our product candidates. |
• |
We currently rely, and expect to continue to rely, on third parties to conduct many aspects of our product manufacturing and distribution, and these third parties may terminate these agreements or not perform satisfactorily. |
• |
Certain components of our products are acquired from single-source suppliers or without long-term supply agreements. The loss of these suppliers, or their failure to supply, would materially and adversely affect our business. |
Risks Related to Our Intellectual Property
• |
If our efforts to protect our proprietary technologies are not adequate, we may not be able to compete effectively in our market. |
• |
Intellectual property disputes may be costly, time consuming, and may negatively affect our competitive position. |
• |
Our reliance on third parties and agreements with collaboration partners requires us to share our trade secrets, which increases the possibility that a competitor may discover them or that our trade secrets will be misappropriated or disclosed. |
• |
The cost of maintaining our patent protection is high and requires continuous review and diligence. We may not be able to effectively maintain our intellectual property position throughout the major markets of the world. |
• |
The laws of some foreign countries do not protect proprietary rights to the same extent as do the laws of the U.S., and we may encounter significant problems in securing and defending our intellectual property rights outside the U.S. |
2
• |
Intellectual property rights do not address all potential threats to any competitive advantage we may have. |
• |
The existence of counterfeit pharmaceutical products in pharmaceutical markets may compromise our brand and reputation and have a material adverse effect on our business, operations and prospects. |
Risks Related to Government Regulation
• |
The regulatory approval process is highly uncertain and we may not obtain regulatory approval for our product candidates. |
• |
Our product candidates could fail to receive regulatory approval from the FDA or other regulatory authorities for many reasons. |
• |
Our current and future relationships with customers, physicians, and third-party payors are subject to healthcare fraud and abuse laws, false claims laws, transparency laws, privacy and security laws, and other regulations. If we are unable to comply with such laws, we could face substantial penalties. |
• |
We are subject to laws and regulations governing corruption, which will require us to maintain costly compliance programs. |
• |
We have identified material weaknesses in our internal control over financial reporting. If we are unable to remediate these, or if we otherwise fail to maintain an effective system of internal control, it may result in material misstatements in our financial statements. |
• |
The impact of U.S. healthcare reform may adversely affect our business model. |
• |
Roxadustat is considered a Class 2 substance on the 2019 World Anti-Doping Agency Prohibited List that could limit sales and increase security and distribution costs for our partners and us. |
• |
Our employees may engage in misconduct or improper activities, which could result in significant liability or harm our reputation. |
• |
If we fail to comply with environmental, health or safety laws and regulations, we could incur fines, penalties or other costs. |
Risks Related to Our International Operations
• |
We have established operations in China and are seeking approval to commercialize our product candidates outside of the U.S., and a number of risks associated with international operations could materially and adversely affect our business. |
• |
The pharmaceutical industry in China is highly regulated and such regulations are subject to change. |
• |
We have limited experience distributing drugs in China. |
• |
We use our own manufacturing facilities in China to produce roxadustat API and drug product for the market in China. There are risks inherent to operating commercial manufacturing facilities, and with these being our single source suppliers, we may not be able to continually meet market demand. |
• |
As a company, we have limited experience in pharmacovigilance, medical affairs, and management of the third-party distribution logistics, and cannot assure you we will be able to meet regulatory requirements or operate in these capacities successfully. |
• |
Our collaboration partner in China, AstraZeneca, and we may experience difficulties in successfully growing and sustaining sales of roxadustat in China. |
• |
The retail prices of any product candidates that we develop may be subject to pricing control in China and elsewhere. |
• |
FibroGen Beijing would be subject to restrictions on paying dividends or making other payments to us, which may restrict our ability to satisfy our liquidity requirements. |
• |
Any capital contributions from us to FibroGen Beijing must be approved by the Ministry of Commerce in China, and failure to obtain such approval may materially and adversely affect the liquidity position of FibroGen Beijing. |
• |
We may be subject to currency exchange rate fluctuations and currency exchange restrictions with respect to our operations in China, which could adversely affect our financial performance. |
• |
Because FibroGen Beijing’s funds are held in banks that do not provide insurance, the failure of any bank in which FibroGen Beijing deposits its funds could adversely affect our business. |
• |
We may be subject to tax inefficiencies associated with our offshore corporate structure. |
• |
Our foreign operations, particularly those in China, are subject to significant risks involving the protection of intellectual property. |
• |
Uncertainties with respect to the China legal system and regulations could have a material adverse effect on us. |
• |
Changes in China’s economic, governmental, or social conditions could have a material adverse effect on our business. |
• |
Our operations in China subject us to various Chinese labor and social insurance laws, and our failure to comply with such laws may materially and adversely affect our business, financial condition and results of operations. |
Risks Related to the Operation of Our Business
• |
Please see Part II – Other Information, Item 1A. Risk Factors for additional risk factors related to the operation of our Business. |
There are also a variety of Risks Related to Our Common Stock
• |
Please see Part II – Other Information, Item 1A. Risk Factors for additional risk factors related to our Common Stock. |
3
Table of Contents
FIBROGEN, INC.
PART I—FINANCIAL INFORMATION
ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except per share amounts)
(Unaudited)
|
|
September 30, 2021 |
|
|
December 31, 2020 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
274,527 |
|
|
$ |
678,393 |
|
Short-term investments |
|
|
211,875 |
|
|
|
8,144 |
|
Accounts receivable, net ($23,126 and $4,127 from related parties) |
|
|
35,994 |
|
|
|
41,883 |
|
Inventories |
|
|
29,315 |
|
|
|
16,530 |
|
Prepaid expenses and other current assets ($0 and $889 from related parties) |
|
|
21,688 |
|
|
|
10,160 |
|
Total current assets |
|
|
573,399 |
|
|
|
755,110 |
|
Restricted time deposits |
|
|
2,072 |
|
|
|
2,072 |
|
Long-term investments |
|
|
142,636 |
|
|
|
244 |
|
Property and equipment, net |
|
|
29,052 |
|
|
|
33,647 |
|
Finance lease right-of-use assets |
|
|
771 |
|
|
|
29,606 |
|
Equity method investment in unconsolidated variable interest entity |
|
|
3,421 |
|
|
|
2,728 |
|
Operating lease right-of-use assets |
|
|
94,055 |
|
|
|
2,043 |
|
Other assets |
|
|
5,107 |
|
|
|
1,390 |
|
Total assets |
|
$ |
850,513 |
|
|
$ |
826,840 |
|
|
|
|
|
|
|
|
|
|
Liabilities, stockholders’ equity and non-controlling interests |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable ($0 and $1,118 to a related party) |
|
$ |
23,868 |
|
|
$ |
24,789 |
|
Accrued and other current liabilities ($18 and $24 to a related party) |
|
|
151,346 |
|
|
|
118,333 |
|
Deferred revenue ($9,113 and $2,907 to a related party) |
|
|
23,256 |
|
|
|
6,547 |
|
Finance lease liabilities, current |
|
|
15 |
|
|
|
12,330 |
|
Operating lease liabilities, current |
|
|
10,831 |
|
|
|
1,188 |
|
Total current liabilities |
|
|
209,316 |
|
|
|
163,187 |
|
Product development obligations |
|
|
17,914 |
|
|
|
18,697 |
|
Deferred revenue, net of current ($10,604 and $4,636 to a related party) |
|
|
162,415 |
|
|
|
138,474 |
|
Finance lease liabilities, non-current |
|
|
5 |
|
|
|
25,391 |
|
Operating lease liabilities, non-current |
|
|
91,478 |
|
|
|
853 |
|
Other long-term liabilities |
|
|
24,322 |
|
|
|
38,789 |
|
Total liabilities |
|
|
505,450 |
|
|
|
385,391 |
|
|
|
|
|
|
|
|
|
|
Commitments and Contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
|
|
|
Preferred stock, $0.01 par value; 125,000 shares authorized; no shares issued
and outstanding at September 30, 2021, and December 31, 2020 |
|
|
— |
|
|
|
— |
|
Common stock, $0.01 par value; 225,000 shares authorized at September 30, 2021, and December 31, 2020; 92,708 and 91,441 shares issued and outstanding at
September 30, 2021, and December 31, 2020 |
|
|
927 |
|
|
|
914 |
|
Additional paid-in capital |
|
|
1,458,979 |
|
|
|
1,399,774 |
|
Accumulated other comprehensive loss |
|
|
(4,158 |
) |
|
|
(4,499 |
) |
Accumulated deficit |
|
|
(1,129,956 |
) |
|
|
(974,011 |
) |
Total stockholders’ equity |
|
|
325,792 |
|
|
|
422,178 |
|
Non-controlling interests |
|
|
19,271 |
|
|
|
19,271 |
|
Total equity |
|
|
345,063 |
|
|
|
441,449 |
|
Total liabilities, stockholders’ equity and non-controlling interests |
|
$ |
850,513 |
|
|
$ |
826,840 |
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements
4
Table of Contents
FIBROGEN, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Revenue: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
License revenue(includes $108,434, $0, $108,434
and $0 from a related party) |
|
$ |
116,434 |
|
|
$ |
— |
|
|
$ |
116,434 |
|
|
$ |
— |
|
Development and other revenue (includes $14,127, $4,736,
$20,383 and $14,239 from a related party) |
|
|
26,097 |
|
|
|
20,663 |
|
|
|
60,325 |
|
|
|
59,065 |
|
Product revenue, net (includes $10,328, $0, $32,495 and
$0 from a related party) |
|
|
13,442 |
|
|
|
22,683 |
|
|
|
42,175 |
|
|
|
43,331 |
|
Drug product revenue (includes $0, $(3,957), $2,056
and $4,281 from a related party) |
|
|
— |
|
|
|
686 |
|
|
|
(168 |
) |
|
|
8,924 |
|
Total revenue |
|
|
155,973 |
|
|
|
44,032 |
|
|
|
218,766 |
|
|
|
111,320 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
|
3,266 |
|
|
|
2,207 |
|
|
|
9,746 |
|
|
|
6,253 |
|
Research and development |
|
|
75,880 |
|
|
|
58,476 |
|
|
|
273,123 |
|
|
|
174,792 |
|
Selling, general and administrative |
|
|
25,853 |
|
|
|
(48,981 |
) |
|
|
89,186 |
|
|
|
64,157 |
|
Total operating costs and expenses |
|
|
104,999 |
|
|
|
11,702 |
|
|
|
372,055 |
|
|
|
245,202 |
|
Income (loss) from operations |
|
|
50,974 |
|
|
|
32,330 |
|
|
|
(153,289 |
) |
|
|
(133,882 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other, net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(109 |
) |
|
|
(580 |
) |
|
|
(965 |
) |
|
|
(1,864 |
) |
Interest income and other income (expenses), net |
|
|
(1,303 |
) |
|
|
1,482 |
|
|
|
(2,120 |
) |
|
|
5,292 |
|
Total interest and other, net |
|
|
(1,412 |
) |
|
|
902 |
|
|
|
(3,085 |
) |
|
|
3,428 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes |
|
|
49,562 |
|
|
|
33,232 |
|
|
|
(156,374 |
) |
|
|
(130,454 |
) |
Provision for income taxes |
|
|
106 |
|
|
|
215 |
|
|
|
235 |
|
|
|
190 |
|
Investment income (loss) in unconsolidated variable
interest entity |
|
|
342 |
|
|
|
(13 |
) |
|
|
664 |
|
|
|
(13 |
) |
Net income (loss) |
|
$ |
49,798 |
|
|
$ |
33,004 |
|
|
$ |
(155,945 |
) |
|
$ |
(130,657 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.54 |
|
|
$ |
0.36 |
|
|
$ |
(1.69 |
) |
|
$ |
(1.46 |
) |
Diluted |
|
$ |
0.54 |
|
|
$ |
0.35 |
|
|
$ |
(1.69 |
) |
|
$ |
(1.46 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares used to
calculate net income (loss) per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
92,644 |
|
|
|
90,558 |
|
|
|
92,206 |
|
|
|
89,414 |
|
Diluted |
|
|
92,808 |
|
|
|
93,678 |
|
|
|
92,206 |
|
|
|
89,414 |
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements
5
Table of Contents
FIBROGEN, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(In thousands)
(Unaudited)
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Net income (loss) |
|
$ |
49,798 |
|
|
$ |
33,004 |
|
|
$ |
(155,945 |
) |
|
$ |
(130,657 |
) |
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustments |
|
|
396 |
|
|
|
(2,038 |
) |
|
|
366 |
|
|
|
(3,372 |
) |
Available-for-sale investments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on investments, net of tax effect |
|
|
13 |
|
|
|
(657 |
) |
|
|
(25 |
) |
|
|
(137 |
) |
Other comprehensive income (loss), net of taxes |
|
|
409 |
|
|
|
(2,695 |
) |
|
|
341 |
|
|
|
(3,509 |
) |
Comprehensive income (loss) |
|
$ |
50,207 |
|
|
$ |
30,309 |
|
|
$ |
(155,604 |
) |
|
$ |
(134,166 |
) |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements
6
Table of Contents
FIBROGEN, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(In thousands, except share data)
(Unaudited)
|
|
For The Three Month Period |
|
|
|
Common Stock |
|
|
Additional
Paid-in |
|
|
Accumulated
Other
Comprehensive |
|
|
Accumulated |
|
|
Non
Controlling |
|
|
|
|
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Income (Loss) |
|
|
Deficit |
|
|
Interests |
|
|
Total |
|
Balance at June 30,
2021 |
|
|
92,608,929 |
|
|
$ |
926 |
|
|
$ |
1,443,975 |
|
|
$ |
(4,567 |
) |
|
$ |
(1,179,754 |
) |
|
$ |
19,271 |
|
|
$ |
279,851 |
|
Net income |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
49,798 |
|
|
|
— |
|
|
|
49,798 |
|
Change in unrealized gain or
loss on investments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
13 |
|
|
|
— |
|
|
|
— |
|
|
|
13 |
|
Foreign currency translation
adjustments |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
396 |
|
|
|
— |
|
|
|
— |
|
|
|
396 |
|
Shares issued from stock
plans, net of payroll taxes
paid |
|
|
99,023 |
|
|
|
1 |
|
|
|
(700 |
) |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(699 |
) |
Stock-based compensation |
|
|
— |
|
|
|
— |
|
|
|
15,704 |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
15,704 |
|
Balance at September 30,
2021 |
|
|
92,707,952 |
|
|
$ |
927 |
|
|
$ |
1,458,979 |
|
|
$ |
(4,158 |
) |
|
$ |
(1,129,956 |
) |
|
$ |
19,271 |
|
|
$ |
345,063 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|