2020 Q3 Form 10-Q Financial Statement

#000156459020042354 Filed on September 02, 2020

View on sec.gov

Income Statement

Concept 2020 Q3 2020 Q2 2019 Q2
Revenue $0.00 $0.00
YoY Change
Cost Of Revenue
YoY Change
Gross Profit
YoY Change
Gross Profit Margin
Selling, General & Admin $6.720M $3.270M
YoY Change
% of Gross Profit
Research & Development $17.18M $8.885M $2.755M
YoY Change 203.84% 222.5%
% of Gross Profit
Depreciation & Amortization $20.00K $20.00K
YoY Change
% of Gross Profit
Operating Expenses $23.90M $12.15M $5.945M
YoY Change 181.91% 104.42%
Operating Profit -$23.90M -$12.15M
YoY Change 181.91%
Interest Expense $110.0K $170.0K
YoY Change
% of Operating Profit
Other Income/Expense, Net $174.0K $355.0K $140.0K
YoY Change -59.25% 153.57%
Pretax Income -$23.61M -$11.63M
YoY Change
Income Tax
% Of Pretax Income
Net Earnings -$23.60M -$11.63M -$5.302M
YoY Change 224.62% 119.39%
Net Earnings / Revenue
Basic Earnings Per Share
Diluted Earnings Per Share -$382.9K -$168.1K
COMMON SHARES
Basic Shares Outstanding 21.57M
Diluted Shares Outstanding

Balance Sheet

Concept 2020 Q3 2020 Q2 2019 Q2
SHORT-TERM ASSETS
Cash & Short-Term Investments $378.5M $104.5M
YoY Change
Cash & Equivalents $142.3M $78.27M $41.43M
Short-Term Investments $236.2M $26.18M
Other Short-Term Assets $4.900M $2.400M
YoY Change
Inventory
Prepaid Expenses
Receivables $200.0K $400.0K
Other Receivables $400.0K $0.00
Total Short-Term Assets $383.9M $107.3M
YoY Change
LONG-TERM ASSETS
Property, Plant & Equipment $9.800M $313.0K
YoY Change
Goodwill
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets
YoY Change
Total Long-Term Assets $9.800M $10.56M
YoY Change
TOTAL ASSETS
Total Short-Term Assets $383.9M $107.3M
Total Long-Term Assets $9.800M $10.56M
Total Assets $393.7M $117.8M
YoY Change
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $1.800M $680.0K
YoY Change
Accrued Expenses $11.00M $4.546M
YoY Change
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $13.50M $8.915M
YoY Change
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00
YoY Change
Other Long-Term Liabilities $6.300M $7.100M
YoY Change
Total Long-Term Liabilities $6.300M $7.100M
YoY Change
TOTAL LIABILITIES
Total Short-Term Liabilities $13.50M $8.915M
Total Long-Term Liabilities $6.300M $7.100M
Total Liabilities $19.80M $16.01M
YoY Change
SHAREHOLDERS EQUITY
Retained Earnings -$76.29M
YoY Change
Common Stock $7.000K
YoY Change
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $373.9M -$71.29M -$36.65M
YoY Change
Total Liabilities & Shareholders Equity $393.7M $117.8M
YoY Change

Cashflow Statement

Concept 2020 Q3 2020 Q2 2019 Q2
OPERATING ACTIVITIES
Net Income -$23.60M -$11.63M -$5.302M
YoY Change 224.62% 119.39%
Depreciation, Depletion And Amortization $20.00K $20.00K
YoY Change
Cash From Operating Activities -$18.06M -$11.12M
YoY Change
INVESTING ACTIVITIES
Capital Expenditures
YoY Change
Acquisitions
YoY Change
Other Investing Activities -$210.3M $25.00M
YoY Change
Cash From Investing Activities -$210.3M $25.00M
YoY Change
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 292.3M 0.000
YoY Change
NET CHANGE
Cash From Operating Activities -18.06M -11.12M
Cash From Investing Activities -210.3M 25.00M
Cash From Financing Activities 292.3M 0.000
Net Change In Cash 64.01M 13.88M
YoY Change
FREE CASH FLOW
Cash From Operating Activities -$18.06M -$11.12M
Capital Expenditures
Free Cash Flow
YoY Change

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<p style="text-align:justify;margin-bottom:0pt;margin-top:12pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">1. Nature of the Business </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:6pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">AlloVir, Inc., (&#8220;AlloVir&#8221; or &#8220;the Company&#8221;, formerly known as ViraCyte, Inc.) is a leading late, clinical-stage cell therapy company developing highly innovative allogeneic T&#160;cell therapies to treat and prevent devastating viral diseases. The Company&#8217;s innovative and proprietary virus-specific T cell, or VST, therapy platform allows AlloVir to generate off-the-shelf VSTs designed to restore immunity in patients with T&#160;cell deficiencies who are at risk from the life-threatening consequences of viral diseases. There is an urgent medical need for therapies to treat a large number of patients suffering from viral diseases who currently have limited or no treatment options. To date, the Company has generated five innovative, allogeneic, off-the-shelf VST therapy candidates targeting 12 different devastating viruses, the most advanced of which has successfully completed a proof-of-concept trial across five viruses and is entering initial pivotal trials for the treatment of virus-associated hemorrhagic cystitis in the fourth quarter of 2020. </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:12pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Company&#8217;s lead product candidate, Viralym-M, is a multi-VST cell therapy that targets five viruses: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus and human herpesvirus 6. To fully explore the clinical benefit of Viralym-M, the Company plans to initiate a total of three Phase&#160;3 pivotal and three Phase&#160;2 proof-of-concept trials in 2020 and 2021 for the treatment and prevention of life-threatening viral diseases in pediatric and/or adult patients, each representing a potential meaningful commercial opportunity. In addition, the Company anticipates filing an Investigational New Drug, or IND, application with the FDA in the second half of 2020 for its second cell therapy, ALVR106, an allogeneic, off-the-shelf, VST therapy designed to target severe respiratory diseases caused by four respiratory viruses: respiratory syncytial virus, influenza, parainfluenza virus and human metapneumovirus. The Company plans to initiate a Phase 1/2 clinical study in autologous and allogeneic hematopoietic stem cell transplant patients with respiratory viral diseases in the fourth quarter of 2020. We own worldwide development and commercialization rights to our cell therapies. Pursuant to the Company&#8217;s sponsored research agreement with Baylor College of Medicine (&#8220;BCM&#8221;), the Company anticipates BCM will initiate a proof-of-concept trial for ALVR109, an allogeneic, off-the-shelf VST therapy designed to target SARS-CoV-2, the virus that causes the severe and life-threatening viral disease, COVID-19. ALVR109 is being developed to arrest the progression of COVID-19 by eradicating SARS-CoV-2 virus-infected cells. </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:12pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Company was formed on August&#160;16, 2013 as a Delaware limited liability company (&#8220;LLC&#8221;) under the name AdCyte LLC and on July&#160;29, 2014 the Company changed its name to ViraCyte LLC. On September&#160;17, 2018, the Company converted from a Delaware LLC to a Delaware corporation (the &#8220;LLC Conversion&#8221;) and changed its name to ViraCyte, Inc. On May&#160;22, 2019, the Company changed its name to AlloVir, Inc. The Company has principal offices in Houston, Texas and Cambridge, Massachusetts. </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:12pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">On August&#160;8, 2019, AlloVir formed AlloVir International Designated Activity Company (&#8220;AlloVir International&#8221;), a wholly-owned subsidiary established in Ireland. </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:12pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">On October&#160;9, 2019, AlloVir Securities Corporation was incorporated as a Massachusetts Security Corporation, a wholly-owned subsidiary of AlloVir. </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:12pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">On November&#160;10, 2019, AlloVir International formed AlloVir Italia S.R.L. (&#8220;AlloVir Italia&#8221;), a wholly-owned subsidiary in Italy. </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:12pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">On August 3, 2020, the Company completed an initial public offering (&#8220;IPO&#8221;) in which the Company issued and sold 18,687,500 shares of its common stock, at a public offering price of $17.00 per share, resulting in gross proceeds of $317.7 million. The Company received approximately $292.4 million in net proceeds after deducting underwriting discounts and commissions and offering costs. </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:12pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">In connection with the IPO, <font style="Background-color:#FFFFFF;">the Company effected a 1-for-1.49020520953831 reverse stock split of the Company&#8217;s common stock and adjusted the ratio at which the Company&#8217;s preferred stock is convertible into common stock, as well as the number of shares under the 2018 Equity Incentive Plan (&#8220;2018 Plan&#8221;), as well as the share amounts of restricted stock grants under the 2018 Plan and the number of options and exercise prices of options under the 2018 Plan as a result of the 1-for-1.49020520953831 reverse stock split. Accordingly, all common shares, stock options, and per share information presented in the accompanying condensed consolidated financial statements and notes thereto have been adjusted, where applicable, to reflect the reverse stock split on a retroactive basis for all periods presented. The per share par value and authorized number of shares of the Company&#8217;s common stock were not adjusted as a result of the split.</font></p> <p style="text-align:justify;margin-bottom:0pt;margin-top:12pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Upon the closing of the IPO, all of the then-outstanding shares of convertible preferred stock automatically converted into 39,859,139 shares of common stock at the applicable conversion ratio then in effect. Subsequent to the closing of the IPO, there were no shares of convertible preferred stock outstanding. The condensed consolidated financial statements as of June 30, 2020, including share and per share amounts, do not give effect to the IPO, as it closed subsequent to June 30, 2020.</p> <p style="text-align:justify;margin-bottom:0pt;margin-top:18pt;text-indent:0%;font-weight:bold;font-style:italic;font-size:10pt;font-family:Times New Roman;text-transform:none;font-variant: normal;">ElevateBio, LLC </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:6pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">On September&#160;17, 2018, the Company executed a Series A2 Preferred Stock Purchase Agreement (&#8220;Series&#160;A2 Agreement&#8221;) with ElevateBio, LLC, a Delaware LLC (&#8220;ElevateBio&#8221;) concurrent with the LLC Conversion. ElevateBio was formed on November&#160;29, 2017 and is headquartered in Cambridge, Massachusetts with a focus on the development of a portfolio of novel cell therapy programs acquired through business development activities with biotechnology companies. ElevateBio is structured as a holding company, comprised of asset-specific subsidiaries focused on the development of pipeline assets, as well as a manufacturing subsidiary with the expertise to provide drug development and manufacturing services. As a result of the purchase of the Company&#8217;s Series A2 Preferred Stock, ElevateBio acquired an ownership interest in the Company. The Chief Executive Officer, Chief Financial Officer, and other executives of ElevateBio also serve in similar management roles with AlloVir. </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:18pt;text-indent:0%;font-weight:bold;font-style:italic;font-size:10pt;font-family:Times New Roman;text-transform:none;font-variant: normal;">Going Concern </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:6pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">In accordance with Accounting Standards Update (&#8220;ASU&#8221;) 2014-15,<font style="font-style:italic;">&#160;Disclosure of Uncertainties about an Entity&#8217;s Ability to Continue as a Going Concern (Subtopic 205-40)</font>, the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company&#8217;s ability to continue as a going concern within one year after the date the condensed consolidated financial statements are issued. </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:12pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, development by competitors of new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations and the ability to secure additional capital to fund operations. Product candidates currently under development will require significant additional research and development efforts, including preclinical and clinical testing and regulatory approval, prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel and infrastructure and extensive compliance and reporting capabilities. Even if the Company&#8217;s product development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales. </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:12pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Company believes that its $104.5&#160;million of cash, cash equivalents and short-term investments held at June 30, 2020 in addition to the proceeds from the IPO, are sufficient to fund planned operations for at least twelve months from the date that these condensed consolidated financial statements are available to be issued. </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:12pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The accompanying condensed consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities and commitments in the ordinary course of business. Through June 30, 2020, the Company has funded its operations primarily with proceeds received from capital contributions, research grants and from the sale of preferred stock. The Company has incurred recurring losses since its inception, including net losses attributable to AlloVir common stockholders of $11.6 million and $5.3 million for the three months ended June 30, 2020 and 2019, respectively and $21.0 million and $7.8&#160;million for the six months ended June 30, 2020 and 2019, respectively. In addition, at June 30, 2020, the Company had an accumulated deficit of $76.3&#160;million. The Company expects to continue to generate operating losses for the foreseeable future. </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:12pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The accompanying condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. Accordingly, the condensed consolidated financial statements have been prepared on a basis that assumes the Company will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the ordinary course of business. </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:18pt;text-indent:0%;font-weight:bold;font-style:italic;font-size:10pt;font-family:Times New Roman;text-transform:none;font-variant: normal;">COVID-19 Considerations </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:6pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The development of product candidates could be disrupted and materially adversely affected in the future by a pandemic, epidemic or outbreak of an infectious disease, such as the recent COVID-19 pandemic. The spread of COVID-19 has impacted the global economy and has impacted the Company&#8217;s operations, including the interruption of preclinical and clinical trial activities and potential interruption to the Company&#8217;s supply chain. For example, the COVID-19 pandemic has delayed clinical trials. If the disruption due to the COVID-19 pandemic continues, planned pivotal clinical trials also could be delayed due to government orders and site policies on account of the pandemic, and some patients may be unwilling or unable to travel to study sites, enroll in trials or be unable to comply with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services, which would delay the Company&#8217;s ability to conduct preclinical studies and clinical trials or release clinical trial results and could delay the Company&#8217;s ability to obtain regulatory approval and commercialize product candidates. Furthermore, COVID-19 could affect the Company&#8217;s employees or the employees of research sites and service providers on whom the Company relies on as well as those of companies with which the Company does business, including suppliers and contract manufacturing organizations or CMOs, thereby disrupting business operations. Quarantines and travel restrictions imposed by governments in the jurisdictions in which the Company and the companies with which it does business operate could materially impact the ability of employees to access preclinical and clinical sites, laboratories, manufacturing sites and offices. The Company has implemented work-at-home policies and only employees essential to the development and research of product candidates remain on-site at the Company&#8217;s research and manufacturing facilities; accordingly, the Company may experience limitations in employee resources. The outbreak and any other preventative or protective actions that the Company, its suppliers or other third parties with which it has business relationships, or governments may take in respect of the COVID-19 pandemic, could disrupt, delay or otherwise adversely impact the business. </p> <p style="text-align:justify;margin-bottom:0pt;margin-top:12pt;text-indent:4.54%;font-size:10pt;font-family:Times New Roman;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Company is still assessing business plans and the impact the COVID-19 pandemic may have on its ability to advance the testing, development and manufacturing of drug candidates, including as a result of adverse impacts on the research sites, service providers, vendors, or suppliers on whom the Company relies on, or to raise financing to support the development of our drug candidates. No assurances can be given that this analysis will enable the Company to avoid part or all of any impact from the spread of COVID-19 or its consequences, including downturns in business sentiment generally or this sector in particular. The Company cannot presently predict the scope and severity of any potential business shutdowns or disruptions, but if the Company or any of the third parties on whom it relies on or with whom it conducts business, were to experience shutdowns or other business disruptions, the Company&#8217;s ability to conduct business in the manner and on the timelines presently planned could be materially and adversely impacted. </p>
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