AVEO PHARMACEUTICALS, INC. You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and the audited financial information and the notes thereto included in our Annual Report on Form 10-K for the year endedDecember 31, 2020 , or Annual Report. Overview We are a commercial stage, oncology-focused biopharmaceutical company committed to delivering medicines that provide a better life for patients with cancer. We currently market FOTIVDA® (tivozanib) inthe United States . FOTIVDA is our first commercial product and was approved by theU.S. Food and Drug Administration , or FDA, for marketing and sale inthe United States onMarch 10, 2021 for the treatment of adult patients with relapsed or refractory renal cell carcinoma, or RCC, following two or more prior systemic therapies. We continue to develop tivozanib in immuno-oncology combinations in RCC and other indications, and we have other investigational programs in clinical development. FOTIVDA is an oral, next-generation vascular endothelial growth factor receptor, or VEGFR, tyrosine kinase inhibitor, or TKI. The FDA approval of FOTIVDA is based on our pivotal phase 3 randomized, controlled, multi-center, open-label clinical trial comparing tivozanib to an approved therapy, Nexavar® (sorafenib), in RCC patients whose disease had relapsed or become refractory to two or three prior systemic therapies, which we refer to as the TIVO-3 trial. The approval is also supported by three additional trials in RCC and includes safety data from over 1,000 clinical trial subjects. FOTIVDA became commercially available inthe United States onMarch 22, 2021 and is available to patients through a network of specialty pharmacies and distributors. We are currently commercializing FOTIVDA inthe United States through the support of approximately 65 field-based employees, which includes approximately 50 oncology sales professionals calling on practicing oncologists. The field force is supported by the AVEO ACE Patient Support program, which is an extensive patient and healthcare provider support program designed to optimize patient access and help patients navigate their treatment journey. COVID-19 related restrictions have posed challenges for gaining in-person access to customers, prescribers, other healthcare professionals and to certain institutions that remain closed to industry representatives. In light of the restrictions necessitated by the COVID-19 pandemic, we designed our strategic commercial approach to be optimized for remote as well as in-person customer engagement capabilities and expanded our digital marketing strategies. However, changes to standard sales and marketing practices resulting from the COVID-19 pandemic, including the shift from in-person to telephonic and virtual interactions with healthcare professionals, have caused, and may continue to cause, challenges to our ability to successfully commercialize FOTIVDA. We believe there is significant commercial opportunity for FOTIVDA inthe United States . We estimate that the current U.S. market for relapsed or refractory RCC therapy is more than$1.0 billion , including$820 million in the second line and$350 million in the third and fourth lines. As the TIVO-3 trial is the first positive phase 3 study in RCC patients whose disease had relapsed or become refractory to two or three prior systemic therapies as well as the first phase 3 study in RCC to investigate a predefined subpopulation of patients who received prior immunotherapy, a predominant standard of care for earlier lines of therapy, we believe that FOTIVDA could become a standard of care inthe United States in this relapsed or refractory setting. Based on FOTIVDA's demonstrated anti-tumor activity, tolerability profile and reduction of regulatory T-cell production, we are seeking to advance tivozanib in additional cancer indications with significant unmet medical needs. We are studying tivozanib in combination with immune checkpoint inhibitors for the treatment of RCC and hepatocellular carcinoma, or HCC. We opened enrollment for a phase 3 clinical trial, which we refer to as the TiNivo-2 Trial, in the third quarter of 2021.The TiNivo-2 Trial is a randomized, open-label, controlled, parallel-arm, pivotal phase 3 clinical trial of tivozanib in combination with OPDIVO®(nivolumab), as compared to tivozanib as a monotherapy, in patients with advanced refractory RCC following one or two lines of prior therapy, one of which must include immunotherapy. We are the sponsor of the trial and Bristol-Myers Squibb Company, or BMS, is supplying nivolumab, BMS's antibody directed against programmed death-1, or PD-1, therapy for the trial. The TiNivo-2 Trial will seek to further understand the activity and tolerability of this combination following prior immunotherapy. 38 -------------------------------------------------------------------------------- Table of Contents We are conducting the DEDUCTIVE trial through a drug supply and cost sharing collaboration with AstraZeneca PLC, or AstraZeneca. The DEDUCTIVE trial is an open-label, multi-center, randomized phase 1b/2 clinical trial of tivozanib in combination with AstraZeneca's IMFINZI (durvalumab), a human monoclonal antibody directed against programmed death-ligand 1, or PD-L1. The DEDUCTIVE trial was amended to include patients with advanced, unresectable HCC who have progressed after first-line bevacizumab and atezolizumab treatment as well as first-line treatment of patients with advanced, unresectable HCC who have not received prior systemic therapy for metastatic disease. Enrollment for the first line cohort of the DEDUCTIVE trial is complete. Enrollment for the second line cohort is ongoing and is expected to be completed in the first half of 2022. We expect interim data for the first line cohort to be presented in the first half of 2022 at a scientific meeting. FOTIVDA, through our partnerEUSA Pharma (UK) Limited , or EUSA, is also approved in theEuropean Union , or the EU,New Zealand andSouth Africa and is reimbursed in theUnited Kingdom ,Germany ,Spain and certain other countries in EUSA's territory. FOTIVDA is approved in the EU for the first-line treatment of adult patients with advanced RCC and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC. FOTIVDA has been commercially available in the EU since 2017. EUSA is working to secure reimbursement approval in and commercially launch FOTIVDA in additional countries in the EUSA territory. However, there is significant competition in the first-line RCC setting in the EU due to the approval of several immunotherapy combinations which have become a standard of care and impacted the market opportunity for monotherapy treatments. EUSA has reported to us that, to date, it has not experienced a decrease in sales trends or interruptions in supply or distribution of FOTIVDA during the COVID-19 pandemic; however, the future impact of the COVID-19 pandemic on FOTIVDA sales is difficult to predict. We are also seeking to advance our pipeline of three wholly owned humanized immunoglobulin G1, or IgG1, monoclonal antibody product candidates, ficlatuzumab, AV-380 and AV-203, and one IgG1 antibody preclinical product candidate, AV-353. Ficlatuzumab is a potent humanized IgG1 monoclonal antibody that targets hepatocyte growth factor, or HGF. We have previously reported promising early clinical data on ficlatuzumab in squamous cell carcinoma of the head and neck, or HNSCC, pancreatic cancer and acute myeloid leukemia, or AML. InJune 2021 , we announced results from the randomized phase 2 confirmatory study of ficlatuzumab, or the Phase 2 HNSCC Trial, in combination with ERBITUX® (cetuximab), an epidermal growth factor receptor, or EGFR, targeted antibody, in patients with recurrent or metastatic HNSCC who relapsed or were refractory to prior immunotherapy, chemotherapy and cetuximab (pan-refractory). We continue to evaluate opportunities for the further clinical development of ficlatuzumab, including a potential registrational clinical trial of ficlatuzumab in the human papillomavirus negative, or HPV-, HNSCC patient population. In 2020, we contracted with a contract manufacturing organization, or CMO, to manufacture the clinical supply for this registrational clinical trial of ficlatuzumab. However, a shortage of required key raw materials and manufacturing supplies also used in COVID-19 vaccine manufacturing process has delayed the delivery of the clinical supply of ficlatuzumab. Based on our ongoing discussions with our CMO, we expect the key required raw materials and manufacturing supplies for ficlatuzumab to become available in the second quarter of 2022 and we have secured a manufacturing slot with our CMO to meet this timeline. InSeptember 2021 , the FDA granted Fast Track designation for the investigation of ficlatuzumab and cetuximab for the treatment of patients with relapsed or recurrent HNSCC. Assuming the timely manufacturing of ficlatuzumab, the availability of financial resources or strategic partner funding and the continued discussions with the FDA to finalize the trial design under the Fast Track designation, we expect to initiate a registrational clinical trial of ficlatuzumab and cetuximab in the HPV-, recurrent or metastatic, or R/R HNSCC, patient population in the first half of 2023. AV-380 is a potent humanized IgG1 monoclonal antibody that targets growth differentiation factor 15, or GDF15. InDecember 2020 , the FDA approved our investigational new drug application, or IND, for AV-380 for the potential treatment of cancer cachexia. In the first quarter of 2021, we initiated a phase 1 clinical trial in healthy volunteers and targeted enrollment for the trial was reached inOctober 2021 . We expect data from this phase 1 clinical trial to become available in the first half of 2022. We plan to initiate a phase 1b clinical trial in cancer patients in the middle of 2022. AV-203 is a potent humanized IgG1 monoclonal antibody that targets ErbB3 (also known as HER3) to which we regained worldwide rights inSeptember 2021 . We are exploring AV-203 as a potential oncology treatment. 39 -------------------------------------------------------------------------------- Table of Contents AV-353 is a preclinical selective and potent IgG1 antibody that targets the Notch 3 pathway. We are exploring AV-353 as a potential oncology treatment. Business Update Regarding COVID-19. The pandemic caused by an outbreak of a new strain of coronavirus, or the COVID-19 pandemic, that is affecting theU.S. and global economy and financial markets is also impacting our employees, patients, communities and business operations to varying degrees. In the paragraphs that follow, we have described impacts of the COVID-19 pandemic on our commercialization plans and clinical development programs, as applicable. The extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition will depend on future developments that are highly uncertain and cannot be accurately predicted at this time, such as the duration, scope and severity of the pandemic, the duration and extent of travel restrictions and social distancing inthe United States and other countries, business closures and business disruptions, its impact and the economic impact on local, regional, national and international markets, the effectiveness of actions taken inthe United States and other countries to contain and treat the disease, periodic and seasonal spikes in infection rates, new strains of the virus that cause outbreaks of COVID-19 and the broad availability of effective vaccines and antiviral treatments. Certain of our operations had been conducted remotely prior to the COVID-19 pandemic, and we have now transitioned essentially all of our business operations to be conducted remotely in response to COVID-19. If the COVID-19 pandemic continues or becomes more severe, it may further impact our ability to maintain that level of productivity, to grow the company as we have anticipated and to execute our commercialization and other long-term business strategies. Management is actively monitoring this situation and the possible effects on our financial condition, liquidity, operations, commercial launch, suppliers, manufacturers, industry and workforce. For additional information on risks posed by the COVID-19 pandemic, please see "Part II, Item 1A. Risk Factors - Risks Related to the COVID-19 Pandemic," included elsewhere in this Quarterly Report on Form 10-Q. Financial Overview We do not have a history of generating operating profits and, as ofSeptember 30, 2021 , we had an accumulated deficit of$667.3 million . We anticipate that we will continue to incur significant operating expenses for the foreseeable future as we seek to successfully commercialize FOTIVDA inthe United States and continue our planned development activities for our clinical stage assets. We may require substantial additional funding to continue to advance our pipeline of clinical stage assets, and the timing and nature of these activities will be conducted subject to the availability of sufficient financial resources, principally product sales of FOTIVDA inthe United States . Please see "Management's Discussion and Analysis of Financial Condition and Results of Operations - Liquidity and Capital Resources -Liquidity and Going Concern" for a further discussion of our funding requirements. Revenue Our revenues have historically been generated primarily through collaborative research, development and commercialization agreements. Payments to us under these arrangements typically include one or more of the following: non-refundable, upfront license fees; option exercise fees; funding of research and/or development efforts; milestone payments; and royalties on future product sales. InNovember 2017 , we began earning sales royalties upon EUSA's commencement of the first commercial launch of FOTIVDA . In the future, we may generate revenue from a combination of product sales, license fees, milestone payments and research and development payments in connection with strategic partnerships, and royalties resulting from the sales of products developed under licenses of our intellectual property. OnMarch 10, 2021 , the FDA approved FOTIVDA inthe United States for the treatment of adult patients with relapsed or refractory advanced RCC following two or more prior systemic therapies. We commenced commercial sales of our first product FOTIVDA inthe United States onMarch 22, 2021 . We expect that any revenue we generate will fluctuate from quarter to quarter and year to year as a result of the timing and amount of the payments that we receive upon the sales of FOTIVDA and any future products, to the extent any are successfully commercialized, and license fees, research and development reimbursements, milestones, royalties and other payments received under our strategic partnerships. If we or our strategic partners fail to complete the development of our product candidates in a timely manner or to obtain or maintain regulatory approval for them, our ability to generate future revenue, and our results of operations and financial position, would be materially adversely affected. 40 -------------------------------------------------------------------------------- Table of Contents Research and Development Expenses Research and development expenses have historically consisted of expenses incurred in connection with the discovery and development of our product candidates. We recognize research and development expenses as they are incurred. These expenses consist primarily of: •employee-related expenses, including salaries, bonuses, benefits, stock-based compensation and research-related overhead; •external development-related expenses, including clinical trials, preclinical studies, consultants and other outsourced services; •costs of acquiring and manufacturing drug development related materials and related distribution; •costs associated with our regulatory and quality assurance operations and medical affairs; •upfront license payments, milestones, sublicense fees and royalties related to in-licensed products and technology; and •allocated expenses for facilities and information technology.
Research and development expenses is net of amounts reimbursed under our agreement with AstraZeneca for their respective share of development costs incurred by us under our joint development plans.
We anticipate that research and development expenses will remain consistent at current levels during the remainder of 2021 and increase in 2022, principally related to the enrollment of the TiNivo-2 Trial for the treatment of advanced refractory RCC, the manufacturing of ficlatuzumab clinical drug supply in 2022 for a potential registrational clinical trial in the HPV- HNSCC patient population that we plan to initiate in the first half of 2023, and a phase 1b clinical trial in AV-380 in cancer patients that we plan to initiate in the middle of 2022 and the related manufacturing of AV-380 clinical drug supply. These increases in 2022 will be partially offset by lower costs, principally related to the TIVO-3 Trial that was closed in the second half of 2021 following theFDA's approval of FOTIVDA onMarch 10, 2021 . We anticipate that research and development expenses will be approximately$30 million in 2021 in support of our existing pipeline plans. We expect costs for the TiNivo-2 trial to be approximately$40 million to$45 million over the next three or four years. The timing and nature of contemplated activities in 2022 will be conducted subject to the availability of sufficient financial resources. Currently, we track direct external development expenses and direct salary on a program-by-program basis and allocate general-related expenses, such as indirect compensation, benefits and consulting fees, to each program based on the personnel resources allocated to such program. Facilities, IT costs and stock-based compensation are not allocated amongst programs and are considered overhead. Uncertainties of Estimates Related to Research and Development Expenses The process of conducting preclinical studies and clinical trials necessary to obtain FDA approval for each of our product candidates is costly and time-consuming. The probability of success for each product candidate and clinical trial may be affected by a variety of factors, including, among others, the risk benefit profile of the product candidates' clinical activity, investment in the program, competition, manufacturing capabilities and commercial viability. At this time, we cannot reasonably estimate or know the nature, specific timing and estimated costs of the efforts that will be necessary to complete the development of our product candidates, or the period, if any, in which material net cash inflows may commence from sales of any approved products. This uncertainty is due to the numerous risks and uncertainties associated with developing drugs, including the uncertainty of: •our ability to establish and maintain strategic partnerships, the terms of those strategic partnerships and the success of those strategic partnerships, if any, including the timing and amount of payments that we might receive from strategic partners; •the scope, progress, results and costs of preclinical development, laboratory testing and clinical trials for any product candidate; •the progress and results of our clinical trials; •the costs, timing and outcome of regulatory review of our product candidates; 41 -------------------------------------------------------------------------------- Table of Contents •the emergence of competing technologies and products and other adverse market developments; •the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property-related claims; and •additional manufacturing requirements. As a result of the uncertainties associated with developing drugs, including those discussed above, we are unable to determine the exact duration and completion costs of current or future clinical stages of our product candidates, or when, or to what extent, we will generate revenues from the commercialization and sale of any of our product candidates for which we may obtain regulatory approval. Development timelines, probability of success and development costs vary widely. We anticipate that we will make determinations as to which additional programs to pursue and how much funding to direct to each program on an ongoing basis in response to the scientific and clinical success, if any, of each product candidate, as well as ongoing assessment of each product candidate's commercial potential. We will need to raise substantial additional capital in the future in order to fund the development of our preclinical and clinical product candidates. Selling, General and Administrative Expenses Selling, general and administrative expenses consist principally of compensation, benefits and travel for employees in executive, finance, legal, human resource and commercial functions. Other selling, general and administrative expenses include professional fees for audit, tax, general legal, patent legal, investor relations, commercial, consulting services and directors' fees, as well as facility and information technology-related costs not otherwise included in research and development expenses. We anticipate that selling, general and administrative expenses associated with the commercialization of FOTIVDA, principally related to our sales force, our marketing, market access and commercial capabilities, and general and administrative support will remain consistent at the current levels during the remainder of 2021 and increase in 2022, principally reflective of a full year of commercialization following the launch of FOTIVDA onMarch 22, 2021 . We anticipate that selling, general and administrative expenses will be approximately$60 million in 2021, including approximately$40 million in commercial expenses and approximately$20 million in general and administrative expenses. Interest Expense, Net Interest expense consists of interest, amortization of debt discount and amortization of deferred financing costs associated with our loans payable, and is shown net of interest income, which consists of interest earned on our cash, cash equivalents and marketable securities. The primary objective of our investment policy is capital preservation. Income Taxes We calculate our provision for income taxes on ordinary income based on our projected annual tax rate for the year. As ofSeptember 30, 2021 , we are forecasting an effective tax-rate of 0% for the year endingDecember 31, 2021 , and since we maintain a full valuation allowance on all of our deferred tax assets, we have recorded no income tax provision or benefit in the current quarter. Critical Accounting Policies and Significant Judgments and Estimates Our discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements and the notes thereto included elsewhere in this Quarterly Report on Form 10-Q, which have been prepared in accordance with accounting principles generally accepted inthe United States , or GAAP. The preparation of financial statements in conformity with GAAP requires us to make estimates and assumptions that affect certain reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements, the assessment of our ability to continue as a going concern, and the reported amounts of revenues and expenses during the reporting periods. Significant items subject to such estimates and assumptions include revenue recognition, clinical trial costs and contract research accruals, measurement of trade receivables net, measurement of stock-based compensation and estimates of our capital requirements over the next twelve months from the date of issuance of the consolidated financial statements. We base our estimates on historical experience and various other assumptions that we believe to be reasonable under the circumstances. Material changes in these estimates could occur in the future. Changes in estimates are recorded or reflected in our disclosures in the period in which they become known. Actual results may differ from our estimates if 42 -------------------------------------------------------------------------------- Table of Contents past experience or other assumptions do not turn out to be substantially accurate. Our significant accounting policies are described in the notes to our consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q. For a discussion of recent accounting pronouncements, refer to Note 3 - "Significant Accounting Policies - Recently Adopted Accounting Pronouncements", to our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q. Results of Operations Comparison of Three and Nine Months EndedSeptember 30, 2021 and 2020 Revenues (in thousands) Three Months Ended Nine Months Ended September 30, Change September 30, Change 2021 2020 $ % 2021 2020 $ % FOTIVDA U.S. product revenue, net$ 14,318 $ -$ 14,318 100 %$ 22,119 $ -$ 22,119 100 % Partnership revenue - KKC - 2,800 (2,800) (100) % - 2,800 (2,800) (100) % Partnership revenue - EUSA 855 800 55 7 % 2,530 2,333 197 8 % Total revenues$ 15,173 $ 3,600 $ 11,573 321 %$ 24,649 $ 5,133 $ 19,516 380 % Our total revenues increased by$11.6 million , or 321%, to$15.2 million in the three months endedSeptember 30, 2021 from$3.6 million in the same period in 2020 and by$19.5 million , or 380%, to$24.6 million in the nine months endedSeptember 30, 2021 from$5.1 million in the same period in 2020, principally due to the commencement of sales of our first commercial product FOTIVDA inthe United States onMarch 22, 2021 for the treatment of adult patients with relapsed or refractory advanced RCC following two or more prior systemic therapies. Partnership revenues from Kyowa Kirin Co., or KKC, decreased by$2.8 million , or 100%, in the three and nine months endedSeptember 30, 2021 , compared to the same periods in 2020. OnAugust 2, 2020 , we earned a$2.8 million development milestone payment from KKC for the acceptance of KKC's investigational new drug, or IND, for a non-oncology formulation of tivozanib by thePharmaceuticals and Medical Devices Agency ofJapan . In the third quarter of 2020, we recognized this$2.8 million development milestone as revenue in accordance with ASC 606. No milestones were earned in the three and nine months endedSeptember 30, 2021 . Partnership revenues from EUSA increased by$0.1 million , or 7%, and$0.2 million , or 8%, in the three and nine months endedSeptember 30, 2021 , respectively, from the same periods in 2020. FOTIVDA U. S. Product Revenue, Net (in thousands) Three Months Ended Nine Months Ended September 30, Change September 30, Change 2021 2020 $ % 2021 2020 $ % Gross product revenue$ 16,978 $ -$ 16,978 100 %$ 26,227 $ -$ 26,227 100 % Discounts and allowances (2,660) - (2,660) 100 % (4,108) - (4,108) 100 % Product revenue, net$ 14,318 $ -$ 14,318 100 %$ 22,119 $ -$ 22,119 100 %
We commenced sales of our first commercial product FOTIVDA in
43
--------------------------------------------------------------------------------
Table of Contents
Cost of Products Sold (in thousands)
Three Months Ended Nine Months Ended
September 30, Change September 30, Change
2021 2020 $ % 2021 2020 $ %
Cost of products sold $ 1,744 $ - $ 1,744 100 % $ 2,704 $ - $ 2,704 100 %
Gross margin % 88 % - 88 % 100 % 88 % - 88 % 100 %
We commenced sales of our first commercial product FOTIVDA in the United States
on March 22, 2021 for the treatment of adult patients with refractory advanced
RCC following two or more prior systemic therapies. Cost of products sold is
related to our product revenues for FOTIVDA and consists primarily of tiered
royalty payments we are required to pay to KKC on all net sales of tivozanib in
our North American territory, which range from the low to mid-teens as a
percentage of net sales. Cost of products sold also consists of shipping and
other third-party logistics and distribution costs for FOTIVDA. We consider
regulatory approval of our product candidates to be uncertain and product
manufactured prior to regulatory approval may not be sold unless regulatory
approval is obtained. As such, the manufacturing costs for FOTIVDA incurred
prior to regulatory approval were not capitalized as inventory but were expensed
as research and development costs, which favorably impacted our gross margin. We
anticipate that gross margins will be in the mid-to-high 80th percentile for the
remainder of 2021 and in 2022.
Research and Development Expenses (in thousands)
Three Months Ended Nine Months Ended
September 30, Change September 30, Change
2021 2020 $ % 2021 2020 $ %
Tivozanib $ 5,514 $ 4,796 $ 718 15 % $ 13,997 $ 14,160 $ (163) (1) %
AV-380 Program in Cachexia 885 524 361 69 % 2,869 1,938 931 48 %
Ficlatuzumab 480 133 347 260 % 1,463 878 585 67 %
Overhead 623 407 216 53 % 1,848 1,129 719 64 %
Total research and development
expenses $ 7,502 $ 5,860 $ 1,642 28 % $ 20,177 $ 18,105 $ 2,072 11 %
Our total research and development expenses increased by $1.6 million , or 28%,
to $7.5 million in the three months ended September 30, 2021 from $5.9 million
in the same period in 2020.
Our total research and development expenses increased by $2.1 million , or 11%,
to $20.2 million in the nine months ended September 30, 2021 from $18.1 million
in the same period in 2020.
Tivozanib expenses increased by $0.7 million , or 15%, in the three months ended
September 30, 2021 as compared to the same period in 2020, principally related
to $2.7 million in total increases for costs incurred in the third quarter of
2021 that were not incurred in the same period in 2020, including $1.9 million
in connection with start-up activities for the TiNivo-2 Trial that was initiated
in the first quarter of 2021, $0.5 million in connection with the medical
affairs function in support of the commercial launch of FOTIVDA and $0.3 million
in certain consulting fees. These increases were partially offset by $2.2
million in total decreases for costs incurred in the third quarter of 2020 that
were not incurred in the same period in 2021, including $0.5 million in
connection with the tivozanib New Drug Application, or NDA, for relapsed or
refractory advanced RCC following two or more prior systemic therapies and $1.7
million in connection with drug substance manufacturing prior to marketing
approval of tivozanib.
Tivozanib expenses decreased by $0.2 million , or 1%, in the nine months ended
September 30, 2021 as compared to the same period in 2020, principally related
to $7.4 million in total decreases for costs incurred in the nine months ended
September 30, 2020 that were not incurred in the same period in 2021, including
$2.2 million in connection with the completion and review support for the
tivozanib NDA for relapsed or refractory advanced RCC following two or more
prior systemic therapies and the corresponding $2.9 million application user fee
pursuant to the Prescription Drug User Fee Act that was due upon the filing of
the tivozanib NDA on March 31, 2020 , $1.7 million in connection with drug
substance manufacturing prior to marketing approval of tivozanib and $0.6
million in connection with lower expenses for the TIVO-3 trial that was closed
in the second half of 2021 following FDA approval of FOTIVDA on March 10, 2021 .
These decreases
44
--------------------------------------------------------------------------------
Table of Contents
were partially offset by $7.1 million in total increases for costs incurred in
the nine months ended September 30, 2021 that were not incurred in the same
period in 2020, including $4.6 million in connection with start-up activities
for the TiNivo-2 Trial that was initiated in the first quarter of 2021, $2.1
million in connection with the medical affairs function in support of the
commercial launch of FOTIVDA and $0.4 million in certain consulting fees.
AV-380 expenses increased by $0.4 million , or 69%, in the three months ended
September 30, 2021 and by $0.9 million , or 48%, in the nine months ended
September 30, 2021 as compared to the same periods in 2020, respectively. These
increases were principally due to the conduct of the phase 1 clinical trial of
AV-380 in healthy volunteers that was initiated in the first quarter of 2021,
partially offset by a decrease in pre-clinical development costs incurred in the
nine months ended September 30, 2020 that were not incurred in the same period
in 2021.
Ficlatuzumab expenses increased by $0.3 million , or 260%, in the three months
ended September 30, 2021 and by $0.6 million , or 67%, in the nine months ended
September 30, 2021 as compared to the same periods in 2020, respectively. These
increases were principally related to the conduct of certain drug manufacturing
activities in 2021 for tech transfer, partially offset by costs incurred in the
first quarter of 2020 that were not incurred in 2021 in connection with the
discontinued phase 2 clinical trial evaluating ficlatuzumab in combination with
high-dose cytarabine versus high-dose cytarabine alone in patients with AML,
which we referred to as the CyFi-2 trial, net of cost sharing with Biodesix.
We anticipate that research and development expenses will remain consistent at
current levels during the remainder of 2021 and increase in 2022, principally
related to the enrollment of the TiNivo-2 Trial for the treatment of advanced
refractory RCC, the manufacturing of ficlatuzumab clinical drug supply in 2022
for a potential registrational clinical trial in the HPV- HNSCC patient
population that we plan to initiate in the first half of 2023, and a phase 1b
clinical trial in AV-380 in cancer patients that we plan to initiate in the
middle of 2022 and the related manufacturing of AV-380 clinical drug supply.
These increases in 2022 will be partially offset by lower costs, principally
related to the TIVO-3 Trial that was closed in the second half of 2021 following
the FDA's approval of FOTIVDA on March 10, 2021 . We anticipate that research and
development expenses will be approximately $30 million in 2021 in support of our
existing pipeline plans. We expect costs for the TiNivo-2 trial to be
approximately $40 million to $45 million over the next three or four years. The
timing and nature of contemplated activities in 2022 will be conducted subject
to the availability of sufficient financial resources.
Selling, General and Administrative Expenses (in thousands)
Three Months Ended Nine Months Ended
September 30, Change September 30, Change
2021 2020 $ % 2021 2020 $ %
Selling, general and administrative
expenses $ 15,142 $ 5,800 $ 9,342 161 % $ 45,162 $ 13,209 $ 31,953 242 %
Selling, general and administrative expenses increased by $9.3 million , or 161%,
to $15.1 million in the three months ended September 30, 2021 from $5.8 million
in the same period in 2020. The $9.3 million increase was principally related to
$9.0 million in total increases, including: (i) $7.6 million in commercial
launch initiatives incurred in the third quarter of 2021 that were not incurred
in the same period in 2020, including $4.5 million in connection with
compensation costs related to the growth in our commercial infrastructure,
including the hiring of the sales force, and $3.1 million in connection with
external commercial-launch activities in marketing, market access and commercial
operations, (ii) $0.7 million in other professional fees, and (iii) $0.7 million
in other compensation-related costs.
Selling, general and administrative expenses increased by $32.0 million , or
242%, to $45.2 million in the nine months ended September 30, 2021 from $13.2
million in the same period in 2020. The $32.0 million increase was principally
related to $31.4 million in total increases, including: (i) $25.9 million in
commercial launch initiatives incurred in the nine months ended September 30,
2021 that were not incurred in the same period in 2020, including $14.3 million
in connection with compensation and recruiting costs related to the growth in
our commercial infrastructure, including the hiring of the sales force, and
$11.6 million in connection with external commercial-launch activities in
marketing, market access and commercial operations, (ii) $3.0 million in other
professional fees and (iii) $2.5 million in other compensation-related costs.
We anticipate that selling, general and administrative expenses associated with
the commercialization of FOTIVDA, principally related to our sales force, our
marketing, market access and commercial capabilities, and general and
administrative support will remain consistent at the current levels during the
remainder of 2021 and increase in 2022,
45
--------------------------------------------------------------------------------
Table of Contents
principally reflective of a full year of commercialization following the launch
of FOTIVDA on March 22, 2021 . We anticipate that selling, general and
administrative expenses will be approximately $60 million in 2021, including
approximately $40 million in commercial expenses and approximately $20 million
in general and administrative expenses.
Change in Fair Value of Expired PIPE Warrant Liability (in thousands)
Three Months Ended Nine Months Ended
September 30, Change September 30, Change
2021 2020 $ % 2021 2020 $ %
Change in fair value of expired
PIPE Warrant liability $ - $ 86 $ (86) (100 %) $ 199 $ 3,184 $ (2,985) (94) %
In May 2016 , we issued PIPE Warrants, or the PIPE Warrants, in connection with a
private placement financing and recorded the warrants as a liability. The PIPE
Warrants were exercisable for a period of five years from the date of issuance
until their scheduled expiration on May 16, 2021 . The PIPE Warrants were subject
to revaluation at each balance sheet date and any changes in fair value were
recorded as a non-cash gain or (loss) in our Statement of Operations as a
component of other income (expense). We recorded changes in the fair market
value of the expired PIPE Warrants of $0 and $0.1 million in the three months
ended September 30, 2021 and 2020, respectively, and $0.2 million and $3.2
million in the nine months ended September 30, 2021 and 2020, respectively.
In the three months ended September 30, 2020 , we recorded an approximate
non-cash gain of $0.1 million in our Statement of Operations attributable to the
decrease in the fair value of the PIPE Warrant liability that resulted from a
decrease in our stock volatility rate and the shorter remaining term as the PIPE
Warrants approach expiration in May 2021 , partially offset by a higher stock
price of $5.94 on September 30, 2020 compared to the stock price of $5.15 on
June 30, 2020 .
In the nine months ended September 30, 2021 , we recorded an approximate non-cash
gain of $0.2 million in our Statement of Operations attributable to the decrease
in the fair value of the PIPE Warrant liability that resulted from the
expiration of the PIPE Warrants on May 16, 2021 .
In the nine months ended September 30, 2020 , we recorded an approximate non-cash
gain of $3.2 million in our Statement of Operations attributable to the decrease
in the fair value of the PIPE Warrant liability that resulted from a lower stock
price of $5.94 on September 30, 2020 compared to the stock price of $6.20 on
December 31, 2019 , as well as a decrease in our stock volatility rate and the
shorter remaining term as the PIPE Warrants approached the scheduled expiration
in May 2021 .
Interest Expense, net (in thousands)
Three Months Ended Nine Months Ended
September 30, Change September 30, Change
2021 2020 $ % 2021 2020 $ %
Interest expense, net $ (1,153) $ (419) $ (734) 175 % $ (2,892) $ (1,083) $ (1,809) 167 %
Interest expense, net increased by $0.7 million , or 175%, in the three months
ended September 30, 2021 and by $1.8 million , or 167%, in the nine months ended
September 30, 2021 , as compared to the same periods in 2020.
These increases were principally due to higher loan balances on a
quarter-to-quarter basis under the 2020 Loan Amendment and 2021 Loan Amendment,
as defined below, that were entered into with Hercules Capital Inc. and certain
of its affiliates, or Hercules, on August 7, 2020 and February 1, 2021 .
respectively. See "Item 2. Management's Discussion and Analysis of Financial
Condition and Results of Operations - Liquidity and Capital Resources - Hercules
Loan Facility" below for a description of the 2020 Loan Amendment and 2021 Loan
Amendment.
We anticipate that interest expense, net will remain at the current level during
the remainder of 2021 and in 2022 due to the $35.0 million loan balance as of
September 30, 2021 and the extended interest-only period through September 30,
2022 pursuant to the 2020 Loan Amendment and 2021 Loan Amendment with Hercules.
46
--------------------------------------------------------------------------------
Table of Contents
Liquidity and Capital Resources
We have financed our operations to date primarily through private placements and
public offerings of our common stock, license fees, milestone payments and
research and development funding from strategic partners, loan proceeds and
commercial sales of our first commercial product FOTIVDA in the United States .
As of September 30, 2021 we had cash, cash equivalents and marketable securities
of approximately $94.0 million . See "Part II, Item 7. Management's Discussion
and Analysis of Financial Condition and Results of Operations - Liquidity and
Capital Resources -Liquidity and Going Concern" below and Note 1 to the
consolidated financial statements included elsewhere in this Quarterly Report on
Form 10-Q for a further discussion of our liquidity. Currently, our funds are
invested in a United States government money market fund.
The following table sets forth the primary sources and uses of cash for each of
the periods set forth below (in thousands):
For the Nine Months Ended September
30,
2021 2020
Net cash used in operating activities $ (45,073) $ (25,103)
Net cash used in investing activities (25,228) (11,152)
Net cash provided by financing activities 77,380 46,318
Net increase in cash and cash equivalents $
7,079
Our operating activities used cash of$45.1 million and$25.1 million in the nine months endedSeptember 30, 2021 and 2020, respectively. Cash used in operations was principally due to our net loss adjusted for non-cash items and changes in working capital. Our investing activities used cash of$25.2 million and$11.2 million in the nine months endedSeptember 30, 2021 and 2020, respectively, principally due to net changes in the purchases and maturities of marketable securities. Our financing activities provided cash of$77.4 million and$46.3 million in the nine months endedSeptember 30, 2021 and 2020, respectively. In the nine months endedSeptember 30, 2021 , we raised approximately$78.1 million in funding, including approximately$51.7 million in net proceeds from the sale of approximately 6.9 million shares of our common stock in an underwritten public offering inMarch 2021 , approximately$19.9 million in new loan funding pursuant to the 2020 Loan Amendment and 2021 Loan Amendment with Hercules, net of transaction costs, approximately$3.4 million in net proceeds from the sale of approximately 0.3 million shares of our common stock inMarch 2021 pursuant to our "at-the-market" sales agreement withSVB Leerink LLC , orSVB Leerink , which we refer to as the SVB Leerink Sales Agreement, and approximately$3.1 million in proceeds from the exercise of Offering Warrants. InJuly 2021 , we paid approximately$0.8 million in an end-of-term loan payment pursuant to theDecember 2017 Loan Amendment with Hercules. In the nine months endedSeptember 30, 2020 , we raised approximately$52.7 million , including approximately$47.7 million in net proceeds from the sale of approximately 9.7 million shares of our common stock in an underwritten public offering inJune 2020 and approximately$5.0 million in new loan funding pursuant to the 2020 Loan Amendment with Hercules, net of transaction costs, and paid approximately$6.5 million in principal payments pursuant to our thenDecember 2017 Loan Agreement with Hercules. Hercules Loan Facility ($45 Million Loan Facility -$10 Million Committed Funding Remaining) OnMay 28, 2010 , the Company entered into a loan and security agreement, or the First Loan Agreement with Hercules. The First Loan Agreement was subsequently amended inMarch 2012 ,September 2014 ,May 2016 and amended and restated inDecember 2017 , or the 2017 Loan Agreement. OnAugust 7, 2020 , we entered into a first amendment to the 2017 Loan Agreement or the 2020 Loan Amendment, to provide us, subject to certain terms and conditions, with additional term loans in an aggregate principal amount of up to$35.0 million , or the 2020 Loan Facility, to be used to repay in full the 2017 Loan Agreement and for general working capital purposes. The 2020 Loan Facility is available to us in four tranches, the first of which, in the amount of$15.0 million , was made available to us immediately upon the closing of the 2020 Loan Amendment. We used the$15.0 million in proceeds of the first tranche as follows: approximately$9.7 million was used to repay the outstanding 47 -------------------------------------------------------------------------------- Table of Contents balance of the 2017 Loan Agreement in full, and approximately$5.3 million was used for general working capital purposes. In connection with the 2020 Loan Amendment, we incurred approximately$0.3 million in loan issuance costs paid directly to Hercules, which are accounted for as a loan discount. The 2020 Loan Amendment was accounted for as a loan modification in accordance with ASC 470-50. The remaining$20.0 million of term loans is available to us under the 2020 Loan Facility subject to, among other terms and conditions, the achievement of the following milestones: (i) Tranche Two in the initial amount of$10.0 million was available throughJune 30, 2021 upon achieving Performance Milestone I for FDA approval of FOTIVDA, (ii) the third tranche, or Tranche Three, in the amount of$5.0 million , was initially available fromJuly 1, 2021 throughJanuary 31, 2022 if we were to achieve$20.0 million in net product revenues from sales of FOTIVDA, following FDA approval, by no later thanDecember 31, 2021 , or Performance Milestone II, and (iii) the fourth tranche, or Tranche Four, in the amount of$5.0 million , is available throughJune 30, 2022 if we achieve both Performance Milestone I and Performance Milestone II, and if Hercules consents to the advancement of Tranche Four. The 2020 Loan Amendment also amended the 2017 Loan Agreement by: (i) extending maturity of the loans fromJuly 1, 2021 untilSeptember 1, 2023 , which is extendable toSeptember 1, 2024 upon our option if the Tranche Three funding has occurred, (ii) providing for an interest-only period beginning on the closing date of 2020 Loan Amendment and endingSeptember 30, 2021 , which period may be extended throughSeptember 30, 2022 provided we achieved Performance Milestone I, and further extendable throughMarch 31, 2023 if the Tranche Three funding has occurred, and (iii) revising the interest rate to the greater of 9.65% and an amount equal to 9.65% plus the prime rate minus 3.25% (subject to a 15% cap). Principal payments were initially scheduled to commence onOctober 1, 2021 , at the earliest, as described above. The interest rate as ofSeptember 30, 2021 was 9.65%. Pursuant to the terms of the Loan Agreement, principal will be repaid in equal monthly installments following the conclusion of the interest-only period. We may prepay all of the outstanding principal and accrued interest under the Loan Agreement, subject to a prepayment charge up to 3.0% in the first year following the closing of the 2020 Loan Amendment, decreasing to 2.0% in year two and 1.0% in year three. We are obligated to make an end-of-term payment of (i) 6.95% of the aggregate amount of loan funding received under the Loan Agreement on the earlier of the maturity of the loans or the date on which we prepay the outstanding loan balance in full, and (ii) an approximate$0.8 million payment due on the earlier ofJuly 1, 2021 or the date on which we prepay the outstanding loan balance in full. This payment was made onJuly 1, 2021 . The Loan Agreement includes (i) a financial covenant that we maintain minimum unrestricted cash positions of$10.0 million through the date the Second Tranche funding is received,$15.0 million through the date the Third Tranche funding is received and$10.0 million thereafter through the maturity of the Loan Agreement, and (ii) an operating covenant that we achieve greater than or equal to 75% of our forecasted net product revenues from our sales of tivozanib over a six month trailing period, as defined and measured on a monthly basis, commencing upon the earlier to occur of (x) the Third Tranche funding and (y) the month ofApril 2022 . The Loan Agreement also includes various other affirmative and negative covenants, including covenants to deliver certain financial reports; to maintain insurance coverage; and to refrain from transferring assets, incurring additional indebtedness, engaging in mergers or acquisitions, paying dividends or making other distributions, making investments, creating liens, and suffering a change in control, in each case subject to certain exceptions. OnFebruary 1, 2021 , we entered into the 2021 Loan Amendment. The 2021 Loan Amendment increased the aggregate principal amount of loans available under the 2020 Loan Facility from up to$35.0 million to up to$45.0 million following FDA approval of FOTIVDA. The 2021 Loan Amendment also (i) increased Tranche Two funding upon achieving Performance Milestone I from$10.0 million to$20.0 million , (ii) increased the amount of net product revenues from sales of FOTIVDA required for us to achieve Performance Milestone II from$20.0 million to$35.0 million , and changed the deadline for achieving Performance Milestone II fromDecember 31, 2021 toApril 1, 2022 , and (iii) increased the amount of unrestricted cash required for us to satisfy the minimum financial covenant during the period between receiving Tranche Two funding and Tranche Three funding from$10.0 million to$15.0 million . In connection with the 2021 Loan Amendment, we incurred approximately$0.1 million in loan issuance costs paid directly to Hercules, which are accounted for as a loan discount. OnMarch 11, 2021 , we completed the$20.0 million drawdown of Tranche Two funding under the 2021 Loan Amendment that was made available in connection with the achievement of Performance Milestone I upon FDA approval of FOTIVDA onMarch 10, 2021 . The achievement of Performance Milestone I extended the interest-only period by twelve months fromSeptember 30, 2021 toSeptember 30, 2022 and increased the amount of unrestricted cash required for 48 -------------------------------------------------------------------------------- Table of Contents us to satisfy the minimum financial covenant during the period between receiving Tranche Two funding and Tranche Three funding from$10.0 million to$15.0 million . As ofSeptember 30, 2021 , the total principal balance was$35.0 million , principal payments are scheduled to commence onOctober 1, 2022 and the corresponding end-of-term payments under the 2020 Loan Facility, in the aggregate amount of approximately$2.4 million , are due upon the current loan maturity date ofSeptember 1, 2023 . As ofSeptember 30, 2021 ,$10.0 million remains available to us in committed funding under the 2020 Loan Facility, including$5.0 million for Tranche Three funding upon the achievement of Performance Milestone II for$35.0 million in net product revenues from sales of FOTIVDA and$5.0 million in Tranche Four funding contingent upon the achievement of both Performance Milestone I and Performance Milestone II, and subject to the consent of Hercules. The unamortized discount to be recognized over the remainder of the loan period was approximately$2.0 million and$1.2 million as ofSeptember 30, 2021 andDecember 31, 2020 , respectively. Per the 2017 Loan Agreement, the end-of-term payment of approximately$0.8 million was due and paid onJuly 1, 2021 . Obligations under the Loan Agreement are secured by substantially all of our assets, excluding intellectual property. The Loan Agreement provides that certain events shall constitute a default by us, including failure by us to pay amounts under the Loan Agreement when due; breach or default in the performance of any covenant under the Loan Agreement by us, subject to certain cure periods; our insolvency and certain other bankruptcy proceedings involving us; our default of obligations involving indebtedness in excess of$0.5 million ; and the occurrence of an event or circumstance that would have a material adverse effect upon our business. We have determined that the risk of subjective acceleration under the material adverse events clause included in the Loan Agreement is remote and, therefore, have classified the outstanding principal amount in long-term liabilities based on the timing of scheduled principal payments. As ofSeptember 30, 2021 , we are in compliance with all of the loan covenants and, through the date of this filing, the lenders have not asserted any events of default under the Loan Agreement. We do not believe that there has been a material adverse change as defined in the Loan Agreement. Public Offering -March 2021 OnMarch 26, 2021 , we completed an underwritten public offering of 6,900,000 shares of our common stock, including the full exercise by the underwriters of their option to purchase an additional 900,000 shares, at the public offering price of$8.00 per share for gross proceeds of approximately$55.2 million . The net offering proceeds to us were approximately$51.7 million after deducting underwriting discounts and commissions and estimated offering expenses payable by us. Public Offering -June 2020 OnJune 19, 2020 , we completed an underwritten public offering of 9,725,000 shares of our common stock, including the partial exercise by the underwriters of their option to purchase an additional 1,225,000 shares, at the public offering price of$5.25 per share for gross proceeds of approximately$51.1 million . Three stockholders each beneficially holding more than 5% of our voting securities, including an entity affiliated withNew Enterprise Associates and two other stockholders purchased an aggregate of 4,503,571 shares in this offering at the same public offering price per share as the other investors. At such time, entities affiliated withNew Enterprise Associates (collectively) beneficially held more than 5% of our voting securities. The net offering proceeds to us were approximately$47.7 million after deducting underwriting discounts and commissions and estimated offering expenses payable by us. Sales Agreement withSVB Leerink ($22 Million Availability Future Stock Sales) InFebruary 2018 , we entered into the SVB Leerink Sales Agreement withSVB Leerink pursuant to which we may issue and sell shares of our common stock from time to time up to an aggregate amount of$50.0 million , at our option, throughSVB Leerink as our sales agent, with any sales of common stock throughSVB Leerink being made by any method that is deemed an "at-the-market offering" as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, or in other transactions. Any such shares of common stock will be sold pursuant to a prospectus supplement filed under the 2020 Shelf, as defined below. We agreed to paySVB Leerink a commission of up to 3% of the gross proceeds of any sales of common stock pursuant to the SVB Leerink Sales Agreement. We sold 470,777 shares, 1,251,555 shares, 1,070,175 shares and 330,688 shares pursuant to the SVB Leerink Sales Agreement, resulting in approximate proceeds net of commissions of$10.3 million ,$7.5 million ,$5.9 million and$3.4 million in the fourth quarter of 2018,February 2019 , 49 -------------------------------------------------------------------------------- Table of ContentsNovember 2020 andMarch 2021 , respectively. As ofSeptember 30, 2021 , approximately$22.2 million was available for issuance in connection with future stock sales pursuant to the SVB Leerink Sales Agreement. Universal Shelf Registration Statement OnNovember 9, 2020 , we filed a shelf registration statement on Form S-3 with theSEC , which covers the offering, issuance and sale of up to$300.0 million of our common stock, preferred stock, debt securities, warrants and/or units or the 2020 Shelf. The 2020 Shelf (File No. 333-249982) was declared effective by theSEC onNovember 18, 2020 and was filed to replace our then existing shelf registration statement, which was terminated. As ofSeptember 30, 2021 , there was approximately$213.0 million available for future issuance of our common stock, preferred stock, debt securities, warrants and/or units. Expired Offering Warrants fromApril 2019 Public Offering - Expiration Date ofApril 8, 2021 InApril 2019 , we completed an underwritten public offering of 2,173,913 shares of our common stock and warrants to purchase an aggregate of 2,500,000 shares of our common stock, which we refer to herein as the Offering Warrants, including warrants to purchase an aggregate of 326,086 shares of our common stock sold pursuant to the underwriter's partial exercise of its overallotment option, at the public offering price of$11.40 per share and$0.10 per warrant for gross proceeds of approximately$25.0 million . The Offering Warrants were immediately exercisable upon issuance at an exercise price of$12.50 per share, subject to adjustment in certain circumstances, and expired two years from the date of issuance onApril 8, 2021 . Any Offering Warrants that had not been exercised for cash prior to their expiration were to be automatically exercised via cashless exercise on the expiration date. The shares and warrants were issued separately and were separately transferable. An entity affiliated withNew Enterprise Associates purchased 434,782 shares and warrants to purchase an aggregate of 434,782 shares in this offering at the same public offering price per share as the other investors. At such time, entities affiliated withNew Enterprise Associates (collectively) beneficially held more than 5% of our voting securities. The net offering proceeds to us were approximately$22.8 million after deducting underwriting discounts and commissions and estimated offering expenses payable by us. InMarch 2021 , Offering Warrants exercisable for 247,391 shares of common stock had been exercised, for approximately$3.2 million in cash proceeds. OnApril 8, 2021 , all of the remaining 2,252,609 Offering Warrants expired and no shares of our common stock were issued via automatic cashless exercises of unexercised warrants on the date of expiration as the$12.50 exercise price was greater than our closing stock price of$7.01 onApril 8, 2021 . Expired Offering Warrants fromMay 2016 Private Placement - Expiration Date ofMay 16, 2021 InMay 2016 , we entered into a securities purchase agreement with a select group of qualified institutional buyers, institutional accredited investors and accredited investors pursuant to which we sold 1,764,242 units, at a price of$9.65 per unit, for gross proceeds of approximately$17.0 million . Each unit consisted of one share of our common stock and a PIPE Warrant to purchase one share of our common stock. The PIPE Warrants had an exercise price of$10.00 per share and expired five years from the date of issuance onMay 16, 2021 . Certain of our directors and executive officers purchased an aggregate of 54,402 units in this offering at the same price as the other investors. The net offering proceeds to us were approximately$15.4 million after deducting placement agent fees and other offering expenses payable by us. PIPE Warrants exercisable for 80,309 shares of common stock had been exercised for approximately$0.8 million in cash proceeds and all of the remaining 1,683,933 PIPE Warrants expired onMay 16, 2021 . Liquidity and Going Concern We have devoted substantially all of our resources to our drug development efforts, comprised of research and development, manufacturing, conducting clinical trials for our product candidates, protecting our intellectual property and general and administrative functions relating to these operations. Our future success is dependent on our ability to commercialize FOTIVDA inthe United States and develop our clinical stage assets and, ultimately, upon our ability to create shareholder value. OnMarch 10, 2021 , the FDA approved FOTIVDA inthe United States for the treatment of adult patients with relapsed or refractory advanced RCC following two or more prior systemic therapies. We anticipate that we will continue to incur significant operating expenses for the foreseeable future as we commercialize FOTIVDA inthe United States and continue our planned development activities for our clinical stage assets. Our future product revenues will depend upon the size of markets in which FOTIVDA, and any future products, have received approval, and our ability to achieve sufficient 50 -------------------------------------------------------------------------------- Table of Contents market acceptance, reimbursement from third-party payers and adequate market share for FOTIVDA and any future products in those markets. The likelihood of our long-term success must be considered in light of the expenses, difficulties and potential delays that may be encountered in the development and commercialization of new pharmaceutical products, competitive factors in the marketplace and the complex regulatory environment in which we operate. Absent the realization of sufficient revenues from product sales to support our cost structure, we may never attain or sustain profitability. We may require substantial additional funding to continue to advance our pipeline of clinical stage assets, and the timing and nature of these activities will be conducted subject to the availability of sufficient financial resources, principally product sales of FOTIVDA inthe United States . During the nine months endedSeptember 30, 2021 , we received an aggregate of approximately$94.7 million in funding, including approximately$58.2 million in equity funding, approximately$19.1 million in net loan funding from Hercules, approximately$15.6 million in cash receipts from the product sales of FOTIVDA inthe United States and approximately$1.8 million in partnership cost sharing payments. The approximate$58.2 million in equity funding included the$51.7 million in net proceeds from the sale of approximately 6.9 million shares of our common stock in an underwritten public offering inMarch 2021 , approximately$3.4 million in net proceeds from the sale of approximately 0.3 million shares of our common stock inMarch 2021 pursuant to our SVB Leerink Sales Agreement, and approximately$3.1 million in proceeds from the exercise of Offering Warrants. The approximate$19.1 million in net loan funding from Hercules included$20.0 million in new loan funding pursuant to the 2020 Loan Amendment and 2021 Loan Amendment upon FDA approval of FOTIVDA, net of payments of approximately$0.1 million in transaction costs related to the 2021 Loan Amendment and the approximate$0.8 million end-of-term payment pursuant to theDecember 2017 Loan Amendment. We believe that our$94.0 million in cash, cash equivalents and marketable securities as ofSeptember 30, 2021 , along with net product revenues from the commercial launch of FOTIVDA inthe United States , would enable us to maintain our current operations for a period of at least 12 months following the filing of this Quarterly Report on Form 10-Q. In 2021, we anticipate that research and development expenses will be approximately$30 million and selling, general and administrative expenses will be approximately$60 million , including approximately$40 million in commercial expenses and approximately$20 million in general and administrative expenses. However, there are numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical products, including, without limitation, risks related to our ability to generate product revenue from sales of FOTIVDA inthe United States , which became commercially available inthe United States onMarch 22, 2021 . Accordingly, our future funding requirements may vary from our current expectations and will depend on many factors, including, but not limited to: •the cost of commercialization activities of FOTIVDA inthe United States and any of our product candidates that may be approved for sale, including marketing, sales and distribution costs; •the cost of manufacturing FOTIVDA inthe United States , our product candidates and any additional products we may successfully commercialize; •the impact of COVID-19 on our operations, business and prospects; •our ability to establish and maintain strategic partnerships, licensing or other arrangements and the financial terms of such agreements; •the number and characteristics of the product candidates we pursue; •the scope, progress, results and costs of researching and developing our product candidates, and of conducting preclinical and clinical trials; •the timing of, and the costs involved in, completing our clinical trials and obtaining regulatory approvals for our product candidates; •the costs involved in preparing, filing, prosecuting, maintaining, defending and enforcing patent claims, including litigation costs and the outcome of such litigation; 51 -------------------------------------------------------------------------------- Table of Contents •the absence of any breach, acceleration event or event of default under our Loan Agreement, or under any other agreements with third parties; •the cost and outcome of any legal actions against us; •the timing, receipt and amount of sales of, or royalties on, tivozanib and our future products, if any; and •general economic, industry and market conditions. We may require substantial additional funding to continue to advance our pipeline of clinical stage assets. We may seek to sell additional equity or debt securities or obtain additional credit facilities. The sale of additional equity or convertible debt securities may result in additional dilution to our stockholders. If we raise additional funds through the issuance of debt securities or preferred stock or through additional credit facilities, these securities and/or the loans under credit facilities could provide for rights senior to those of our common stock and could contain covenants that would restrict our operations. Additional funds may not be available when we need them, on terms that are acceptable to us, or at all. For example, we may never achieve the milestones specified in the Loan Agreement that would allow us to access the remaining$10.0 million in available credit. We also expect to seek additional funds through arrangements with collaborators, licensees or other third parties. These arrangements would generally require us to relinquish or encumber rights to some of our technologies or product candidates, and we may not be able to enter into such arrangements on acceptable terms, if at all. If we are unable to raise substantial additional funding to advance our pipeline of clinical stage assets, whether on terms that are acceptable to us, or at all or if we were to default under the Loan Agreement, and Hercules accelerated the then remaining principal payments and fees due under the loan, then we may be required to: •delay, limit, reduce or terminate our clinical trials or other development activities for one or more of our product candidates; and/or •delay, limit, reduce or terminate our establishment of sales and marketing capabilities or other activities that may be necessary to commercialize our product candidates, if approved. Contractual Obligations and Commitments There have been no additional material changes to our contractual obligations and commitments outside the ordinary course of business from those disclosed in our Annual Report on Form 10-K for the year endedDecember 31, 2020 filed with theSEC onMarch 16, 2021 , except as discussed below. OnMarch 11, 2021 , we completed the$20.0 million drawdown of Tranche Two funding under the 2021 Loan Amendment with Hercules that was made available in connection with the achievement of Performance Milestone I upon FDA approval of FOTIVDA onMarch 10, 2021 . The achievement of Performance Milestone I extended the interest-only period by twelve months fromSeptember 30, 2021 toSeptember 30, 2022 . For more information, see "Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations - Liquidity and Capital Resources -Hercules Loan Facility", as well as Note 6, "-Hercules Loan Facility" of the Notes to our consolidated financial statements, each included elsewhere in this Quarterly Report on Form 10-Q. Off-Balance Sheet Arrangements We did not have, during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined under applicableSEC rules. Item 4. Controls and Procedures. Our management, with the participation of our President and Chief Executive Officer (our principal executive officer) and our Chief Financial Officer (our principal financial officer), evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Securities Exchange Act of 1934, as amended, or the Exchange Act) as ofSeptember 30, 2021 . The term "disclosure controls and procedures" means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in theSEC's rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company's management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, management recognized that any controls 52 -------------------------------------------------------------------------------- Table of Contents and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and our management necessarily applied its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on this evaluation, our President and Chief Executive Officer and Chief Financial Officer concluded that as ofSeptember 30, 2021 , our disclosure controls and procedures were effective at the reasonable assurance level. During the nine months endedSeptember 30, 2021 , we implemented certain internal controls in connection with our product sales of FOTIVDA upon the commercial launch inthe United States onMarch 22, 2021 . There were no other changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the three and nine months endedSeptember 30, 2021 , which have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. 53
--------------------------------------------------------------------------------
Table of Contents
© Edgar Online, source
