Full Press Release Details
OPERATING AND FINANCIAL REVIEW AND PROSPECTS
Unless otherwise indicated or the context otherwise requires, references in this Operating and Financial Review and Prospects to "Nanobiotix," or the "Company" refer to Nanobiotix S.A. and its
consolidated subsidiaries. All references to "$," "dollars" and "USD" mean U.S. dollars and all references to all references to " " and "euros" mean euros.
You should read following discussion and analysis included in this Operating and Financial Review and Prospects in conjunction with the Company's interim consolidated financial
statements and the related notes thereto included in the Company's Half-Year Financial Report (the "Half-Year Report") filed with the Securities and Exchange Commission (the "SEC") on Form 6-K on September 8, 2021, and together with the Company's
audited consolidated financial statements and the related notes thereto including in the Company's Annual Report on Form 20-F (the "Annual Report") filed with the SEC on April 7, 2021, as amended. The consolidated financial statements
included in the Half-Year Report and the Annual Report have been prepared in accordance with IFRS, International Accounting Standards ("IAS"), as issued by the International Accounting Standards Board ("IASB"), as well as interpretations issued by
the IFRS Interpretations Committee ("IFRS-IC") and the Standard Interpretations Committee (the "SIC"), which application is mandatory as of January 1, 2021. The consolidated financial statements are also compliant with IFRS as adopted by the European
Special Note Regarding Forward-Looking Statements
In addition to historical information, the following discussion and analysis contains forward-looking statements within the meaning of applicable securities laws, including the Private Securities
Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as "at this time," "anticipate," "believe," "expect," "intend," "on track," "plan," "scheduled," and "will," or the negative of these and similar expressions.
These forward-looking statements, which are based on Nanobiotix's management's current expectations and assumptions and on information currently available to its management, include statements about the Company's future results of operations and
financial position, its business strategy, the sufficiency of its capital resources, the development and commercialization of NBTXR3, and the execution of the Company's development and commercialization strategy. Such forward-looking statements are
made in light of information currently available to the Company and based on assumptions that Nanobiotix considers to be reasonable. However, these forward-looking statements are subject to numerous risks and uncertainties, including with respect to
the risk that subsequent studies and ongoing or future clinical trials may not generate favorable data notwithstanding positive preclinical or early clinical result, the risk that the Company's product candidates may not receive regulatory approval
or be successfully commercialized, the risk that the Company's capital resources and sources of liquidity may be insufficient to support its future operating expenses, and the risks associated with the evolving nature of the duration and severity of
the COVID-19 pandemic and governmental and regulatory measures implemented in response to it. Furthermore, many other important factors, including those described in the Annual Report under "Item 3.D. Risk Factors," as supplemented by the risk factor
set forth under "Item 5. Main Risks and Uncertainties" in the Half-Year Report, and other known and unknown risks and uncertainties may adversely affect such forward-looking statements and cause the Company's actual results, performance or
achievements to be materially different from those expressed or implied by the forward-looking statements. Nanobiotix undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or
otherwise, except as required by law.
Nanobiotix is a late-stage clinical biotechnology company developing, manufacturing, and preparing to commercialize potentially first-in-class therapeutic candidates derived from its proprietary nanotechnology
platforms. Starting with cancer, its goal is to revolutionize treatment outcomes for millions of patients with major diseases around the world.
Its lead therapeutic candidate, a solid tumor- and therapeutic combination-agnostic radioenhancer that we call NBTXR3, is an aqueous suspension composed of functionalized, crystalline hafnium oxide nanoparticles that
is delivered via one-time intratumoral injection and activated by radiotherapy (RT). After activation, the physical mechanism of action (MoA) of NBTXR3 is designed to increase the dose of radiotherapy delivered within tumor cells, inducing
significant tumor cell death without increasing damage to surrounding healthy tissues. Subsequent to its local tumor-killing effect, the radioenhancer may potentially prime an immune response against the target tumor and distant tumors as well.
Given NBTXR3's localized delivery, physical MoA, and potential immune priming effect, Nanobiotix believes the radioenhancer could be broadly applicable across any solid tumor indication where RT is viable
(approximately 60% of all cases), both as a single agent or in combination with other anti-cancer therapies, including immune checkpoint inhibitors. Nanobiotix is prioritizing Company-led development of NBTXR3 for commercial registration as a single
agent in locally advanced head and neck squamous cell carcinoma (LA-HNSCC), and the advancement of its Company-led pathway evaluating the radioenhancer in combination with anti-PD-1 for the treatment of advanced cancers, including locoregional
recurrent HNSCC (LRR-HNSCC), recurrent/metastatic HNSCC (R/M-HNSCC), lung metastasis (lung mets) from any primary tumor and/or liver metastasis (liver mets) from any primary tumor. In parallel, to support the overall development footprint for NBTXR3
and advance and expand the development of NBTXR3 across tumor indications and therapeutic combinations that complement those prioritized by the Company, Nanobiotix is also engaged in strategic collaborations with The University of Texas MD Anderson
Cancer Center (MD Anderson) and LianBio Oncology Limited (LianBio).
As of June 30, 2021, the Company had cash and cash equivalents of 102.3 million.
Cash and cash equivalents as of June 30, 2021 includes (i) the upfront payment of $20.0 million received in June 2021 from LianBio Oncology Limited, or LianBio, as consideration for the Company's entry into the
strategic License, Development and Commercialization Agreement ("the "LianBio Agreement") with LianBio and (ii) the payment by Nanobiotix pursuant to the Company's termination and release agreement (the "PharmaEngine Termination Agreement") with
PharmaEngine, Inc., or PharmaEngine, of $2.5 million to PharmaEngine in connection with the Company's announcement of the LianBio Agreement as well as a payment by Nanobiotix of $4.0 million to PharmaEngine in conjunction with the completion of
various administrative steps in connection with the winding-up of the PharmaEngine collaboration.
For the six months ended June 30, 2021 and 2020, the Company had revenues of 9.7 thousand and 36.9 thousand, respectively, in each case primarily driven by cross charges related to its previous collaboration with
PharmaEngine. The Company has not generated revenues to date from product sales or royalties, and it does not expect to generate significant revenues from product sales or royalties unless and until its product candidates are approved for marketing
and are successfully commercialized. Historically, the Company has financed its operations and growth through issuances of new shares of the Company, refunds of research tax credits, conditional advances and grants awarded by governmental agencies,
as well as bank loans from time to time. From the Company's inception in 2003 through June 30, 2021, the Company has received more than 324.4 million in financing in the form of external fundraising, loans and repayable advances. See -Liquidity
and Capital Resources'' below for additional information.
Nanobiotix operates in a single operating segment for accounting purposes, which is the research and development of product candidates that use proprietary nanotechnology to transform cancer treatment.
Comparison of the six-month periods ended June 30, 2021 and 2020
The Company's results of operations for the six months ended as of June 30, 2021 and 2020 are summarized in the table below:
| For the six-month period ended June 30, | ||||||||
| (in thousands of euros) | 2021 | 2020 | ||||||
| Revenues and other income | ||||||||
| Revenues | 10 | 37 | ||||||
| Other income | 1,309 | 1,411 | ||||||
| Total revenues and other income | 1,319 | 1,448 | ||||||
| Research and development expenses | (15,506 | ) | (13,077 | ) | ||||
| Selling, general and administrative expenses | (10,176 | ) | (6,755 | ) | ||||
| Other operating income and expenses | (5,414 | ) | - | |||||
| Total operating expenses | (31,096 | ) | (19,832 | ) | ||||
| Operating income (loss) | (29,778 | ) | (18,384 | ) | ||||
| Financial income | 2,511 | 234 | ||||||
| Financial expenses | (3,152 | ) | (2,428 | ) | ||||
| Financial income (loss) | (640 | ) | (2,194 | ) | ||||
| Income tax | (2 | ) | (1 | ) | ||||
| Net loss for the period | (30,420 | ) | (20,579 | ) |
Revenues and Other Income
Revenues and other income for the six months ended June 30, 2021 was 1.3 million, compared to 1.4 million for the six months ended June 30, 2020. This decrease of 0.1 million was primarily driven by the 0.1 million
decrease in Other income, described below. The Company has not generated any revenue from product sales to date.
The components of the revenues and other income of the Company are set forth in the table below:
| For the six months ended June 30, | ||||||||
| (in thousands of euros) | 2021 | 2020 | ||||||
| Services | 5 | 37 | ||||||
| Other sales | 5 | - | ||||||
| Total revenues | 10 | 37 | ||||||
| Research tax credit | 1,227 | 888 | ||||||
| Subsidies | 62 | 494 | ||||||
| Other | 20 | 28 | ||||||
| Total other income | 1,309 | 1,411 | ||||||
| Total revenues and other income | 1,319 | 1,448 |
Total revenue for the six-month period ended June 30, 2021 was 10 thousand, compared to revenue of 37 thousand for the six-month period ended June 30, 2020. Revenues for each of the six-months ended June 30, 2021 and
2020 were primarily derived from the charging-back of external contract research organization costs in connection with development support provided to PharmaEngine as part of the license and collaboration agreement, which was terminated in March
2021. In light of the termination of this agreement, the Company did not generate any revenue during the second quarter of 2021.
Other income for the six months ended June 30, 2021 was 1.3 million, compared to 1.4 million for the six months ended June 30, 2020. The decrease was primarily due to the 0.4 million decrease in subsidies,
reflecting amounts provided by the French State in 2020 as part of the French State's "partial unemployment measure," a National plan allowing companies facing economic challenges during the COVID-19 pandemic to receive from the French State a
percentage of specific employees' net salaries. This decrease is partially offset by the 0.3 million increase in research tax credit to be received.
Research and Development Expenses
Research and development expenses for the six months ended June 30, 2021 and 2020 are summarized below:
| For the six months ended June 30, | ||||||||
| (in thousands of euros) | 2021 | 2020 | ||||||
| Purchases, sub-contracting and other expenses | (9,386 | ) | (7,096 | ) | ||||
| Payroll costs (including share-based payments) | (5,105 | ) | (5,397 | ) | ||||
| Depreciation, amortization and provision expenses | (1,015 | ) | (583 | ) | ||||
| Total research and development expenses | (15,506 | ) | (13,077 | ) |
The total amount of expenses incurred with respect to research and development activities increased by 2.4 million, or 18.6%, from 13.1 million for the six months ended June 30, 2020 to 15.5 million for the six
months ended June 30, 2021. This was primarily due to 2.3 million increase in Purchases, sub-contracting and other expenses, reflecting the resumption of activities related to purchases and subcontracting in 2021, compared to the scale-back of
operations in the 2020 period as a result of the COVID-19 pandemic, and the Company's increased expenses related to its clinical trial development priorities, specifically the global Phase III registrational trial (NANORAY-312).
Selling, General and Administrative ("SG&A") Expenses
SG&A expenses for the six months ended June 30, 2021 and 2020 are summarized below:
| For the six months ended June 30, | ||||||||
| (in thousands of euros) | 2021 | 2020 | ||||||
| Purchases, fees and other expenses | (5,152 | ) | (2,955 | ) | ||||
| Payroll costs (including share-based payments) | (4,848 | ) | (3,641 | ) | ||||
| Depreciation, amortization and provision expenses | (176 | ) | (159 | ) | ||||
| Total SG&A expenses | (10,176 | ) | (6,755 | ) |
The Company's SG&A expenses increased by 3.4 million, or 56%, from 6.8 million for the six months ended June 30, 2020 to 10.2 million for the six months ended June 30, 2021. This was primarily due to (i) a 2.2
million increase in Purchases, fees and other expenses primarily resulting from additional consulting and legal fees related to U.S. public company compliance costs following its initial public offering, commercial contract negotiation and management
recruitment efforts and (ii) a 1.2 million increase in Payroll costs mainly due to a payment obligation in connection with the departure of the Company's former CFO and lower prior year payroll costs as a result of the French government's 2020
partial unemployment measure.
Depreciation, amortization and provision expenses increased by 17 thousand, from 159 thousand for the six months ended June 30, 2020 to 176 thousand for the six months ended June 30, 2021, primarily due to an
increase in provisions for routine employment disputes.
Other operating income and expenses
The Company's other operating income and expenses amounted to a net expense of 5.4 million for the six months ended June 30, 2021, resulting from the contractual payments made to PharmaEngine pursuant to the
PharmaEngine Termination Agreement. The Company did not record any other operating income and expenses in the prior year period.
Operating Income (Loss)
The Company's operating loss increased by 11.4 million, or 62%, from 18.4 million for the six months ended June 30, 2020 to 29.8 million for the six months ended June 30, 2021. This was primarily due to the 11.3
million increase in operating expenses driven by (i) 5.4 million of payments made to PharmaEngine pursuant to the PharmaEngine Termination Agreement, (ii) a 4.5 million increase in Purchase, subcontracting and other expenses reflecting the clinical
trial development priorities and increased compliance costs associated with operating as a public company in the United States, (iii) a 0.9 million increase in Payroll costs mainly resulting from the payment made in connection with the departure of
the Company's former CFO and lower prior year payroll costs as a result of the French government's 2020 partial unemployment measure, and (iv) a 0.4 million increase in provision for disputes.
At June 30, 2021, the Company's workforce totaled 98 which is stable in comparison with the same date in 2020.
Net Financial Income (Loss)
Net financial loss decreased by 1.6 million, from a loss of 2.2 million for the six months ended June 30, 2020 to a loss of 0.6 million for the six months ended June 30, 2021. This was primarily due to the 2.3
million increase in foreign exchange gains resulting from the fluctuation of the U.S. dollar over the period, partially offset by the 0.7 million increase in interest costs in connection with the Company's loan from the European Investment Bank, or
EIB (the "EIB loan").
Liquidity and Capital Resources
During the six-month period ended June 30, 2021, the Company's operations have focused on its organizing and staffing, business and financing planning, maintaining its intellectual property portfolio and conducting
preclinical studies and clinical trials.
Since its inception, the Company has incurred significant operating losses. Historically, Nanobiotix has financed its operations and growth primarily through:
For more information about these financing agreements, see "Item 5.B-Operating and Financial Review and Prospects-Liquidity and Capital Resources-Terms of our Primary Financing Agreements" in the Annual Report. As the
conditions required by the EIB finance contract for the Company to draw the 20.0 million third tranche of the EIB loan were not met as of the July 31, 2021 deadline, the Company will not request to draw this tranche.
Historical Changes in Cash Flows
The table below summarizes the cash inflows and outflows of the Company for the six months ended June 30, 2021 and 2020:
| For the six months ended June 30, | ||||||||
| (in thousands of euros) | 2021 | 2020 | ||||||
| Net cash flows used in operating activities | (15,071 | ) | (12,879 | ) | ||||
| Net cash flows used in investing activities | (50 | ) | (83 | ) | ||||
| Net cash flows from (used in) financing activities | (1,703 | ) | 4,404 | |||||
| Effect of exchange rates changes on cash | 8 | 54 | ||||||
| Net decrease in cash and cash equivalents | (16,814 | ) | (8,505 | ) |
Cash Flows used in operating activities
The Company's net cash flows used in operating activities were 15.1 million and 12.9 million for the six months ended June 30, 2021 and 2020, respectively.
The net cash used in each of these periods primarily reflects the net loss for those periods, which increased from 20.6 million for the six months ended June 30, 2020 to 30.4 million for the six months ended June 30,
2021, primarily due to the increase in operating expenses mainly resulting from the contractual payments made to PharmaEngine pursuant to the PharmaEngine Termination Agreement, the additional expenses reflecting the clinical trial development
priorities in 2021 and the increased compliance costs associated with operating as a public company in the United States
Cash Flows used in investing activities
The Company's net cash flows used in investing activities were 0.1 million for each of the six months ended June 30, 2021 and 2020, primarily due to purchases of property, plant and equipment.