UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
or
| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number
(Exact Name of Registrant as Specified in its Charter)
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(State or Other Jurisdiction of Incorporation or Organization) |
| (I.R.S. Employer Identification No.) |
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(Address of Principal Executive Offices) |
| (Zip Code) |
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(Registrant’s Telephone Number, Including Area Code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ◻ |
| Accelerated filer | ◻ |
⌧ |
| Smaller reporting company | ||
Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ◻
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes
As of November 5, 2021 there were
ALTIMMUNE, INC.
TABLE OF CONTENTS
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
ALTIMMUNE, INC.
CONSOLIDATED BALANCE SHEETS
| September 30, | December 31, | ||||
2021 | 2020 | |||||
(unaudited) | ||||||
ASSETS |
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Current assets: |
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Cash and cash equivalents | $ | | $ | | ||
Restricted cash |
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Total cash, cash equivalents and restricted cash |
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Short-term investments |
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Accounts receivable |
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Income tax receivable |
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Prepaid expenses and other current assets |
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Total current assets |
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Property and equipment, net |
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Intangible assets, net |
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Other assets |
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Total assets | $ | | $ | | ||
LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current liabilities: |
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Accounts payable | $ | | $ | | ||
Accrued expenses and other current liabilities |
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Total current liabilities |
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Contingent consideration |
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Other long-term liabilities |
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Total liabilities |
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Commitments and contingencies (Note 16) |
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Stockholders’ equity: |
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Common stock, $ | | | ||||
Additional paid-in capital |
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Accumulated deficit |
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Accumulated other comprehensive loss, net |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity | $ | | $ | |
The accompanying notes are an integral part of the unaudited consolidated financial statements.
1
ALTIMMUNE, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(unaudited)
| For the Three Months Ended |
| For the Nine Months Ended | |||||||||
September 30, | September 30, | |||||||||||
2021 |
| 2020 | 2021 |
| 2020 | |||||||
Revenues | $ | | $ | | $ | | $ | | ||||
Operating expenses: |
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Research and development |
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General and administrative |
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Impairment loss on construction-in-progress |
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Total operating expenses |
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Loss from operations |
| ( |
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Other income (expense): |
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Interest expense |
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Interest income |
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Other (expense) income, net |
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Total other (expense) income, net |
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Net loss before income tax benefit |
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Income tax benefit |
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Net loss |
| ( |
| ( |
| ( |
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Other comprehensive (loss) income — unrealized (loss) gain on short-term investments |
| ( |
| ( |
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| ( | ||||
Comprehensive loss | $ | ( | $ | ( | $ | ( | $ | ( | ||||
Net loss per share, basic and diluted | ( | ( | ( | ( | ||||||||
Weighted-average common shares outstanding, basic and diluted |
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The accompanying notes are an integral part of the unaudited consolidated financial statements.
2
ALTIMMUNE, INC.
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(unaudited)
Accumulated | |||||||||||||||||
Additional | Other | Total | |||||||||||||||
| Common Stock |
| Paid-In |
| Accumulated |
| Comprehensive |
| Stockholders’ | ||||||||
Shares | Amount | Capital | Deficit | Loss | Equity | ||||||||||||
Balance at December 31, 2020 | | $ | | $ | | $ | ( | $ | ( | $ | | ||||||
Stock-based compensation |
| — |
| — |
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| — |
| — |
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Vesting of restricted stock awards including withholding, net |
| ( |
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| ( |
| — |
| — |
| ( | |||||
Issuance of common stock from Employee Stock Purchase Plan | | | | — | — | | |||||||||||
Retirement of common stock in exchange for common stock warrant |
| ( |
| ( |
| ( |
| ( |
| — |
| ( | |||||
Issuance of common stock warrant in exchange for retirement of common stock |
| — |
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| — |
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Issuance of common stock in at-the-market offerings, net | | | | — | — | | |||||||||||
Issuance of common stock upon cashless exercise of warrants |
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Unrealized gain on short-term investments |
| — |
| — |
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| — |
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Net loss |
| — |
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| — |
| ( |
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Balance at March 31, 2021 |
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| ( |
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Stock-based compensation |
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Exercise of stock options | |
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Vesting of restricted stock awards including withholding, net |
| ( |
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| ( |
| — |
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Issuance of common stock in at-the-market offerings, net | | | | — | — | | |||||||||||
Unrealized gain on short-term investments |
| — |
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Net loss |
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| — |
| ( |
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Balance at June 30, 2021 |
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Stock-based compensation |
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Exercise of stock options | |
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Vesting of restricted stock awards including withholding, net |
| ( |
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| ( |
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Issuance of common stock from Employee Stock Purchase Plan | | | | — | — | | |||||||||||
Unrealized loss on short-term investments |
| — |
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| ( |
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Net loss |
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| — |
| ( |
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Balance at September 30, 2021 |
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| $ | |
| $ | |
| $ | ( |
| $ | ( |
| $ | |
The accompanying notes are an integral part of the unaudited consolidated financial statements.
3
ALTIMMUNE, INC.
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
(unaudited)
Accumulated | |||||||||||||||||
Additional | Other | Total | |||||||||||||||
| Common Stock |
| Paid-In |
| Accumulated |
| Comprehensive |
| Stockholders’ | ||||||||
Shares | Amount | Capital | Deficit | Loss | Equity | ||||||||||||
Balance at December 31, 2019 | | $ | | $ | | $ | ( | $ | ( | $ | | ||||||
Stock-based compensation |
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Vesting of restricted stock awards including withholding, net |
| ( |
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| ( |
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Issuance of common stock from Employee Stock Purchase Plan |
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Issuance of common stock upon exercise of warrants |
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Unrealized loss on short-term investments |
| — |
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| ( |
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Net loss |
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| ( |
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Balance at March 31, 2020 |
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| ( |
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Stock-based compensation |
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Exercise of stock options | | | | — | — | | |||||||||||
Vesting of restricted stock awards including withholding, net |
| ( |
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Issuance of common stock in at-the-market offerings, net |
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Issuance of common stock upon exercise of warrants |
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Unrealized gain on short-term investments |
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Net loss |
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| ( |
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Balance at June 30, 2020 |
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Stock-based compensation |
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Issuance of common stock from exercise of stock options | | | | — | — | | |||||||||||
Vesting of restricted stock awards including withholding, net |
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Issuance of common stock from Employee Stock Purchase Plan |
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Issuance of common stock and pre-funded warrants in public offering, net |
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Issuance of common stock in at-the-market offerings, net | | | | — | — | | |||||||||||
Issuance of common stock upon exercise of warrants |
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Unrealized loss on short-term investments |
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Net loss |
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Balance at September 30, 2020 |
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| $ | |
| $ | |
| $ | ( |
| $ | ( |
| $ | |
The accompanying notes are an integral part of the unaudited consolidated financial statements.
4
ALTIMMUNE, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
| Nine Months Ended September 30, | |||||
2021 | 2020 | |||||
CASH FLOWS FROM OPERATING ACTIVITIES: |
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Net loss | $ | ( | $ | ( | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
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Change in fair value of contingent consideration liability |
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Impairment loss on construction-in-progress |
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Stock-based compensation expense |
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Depreciation and amortization |
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Unrealized losses (gains) on foreign currency exchange |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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Prepaid expenses and other current assets |
| ( |
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Accounts payable |
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Accrued expenses and other liabilities |
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Income tax receivable |
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Net cash used in operating activities |
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CASH FLOWS FROM INVESTING ACTIVITIES: |
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Proceeds from sales and maturities of short-term investments |
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Purchases of short-term investments |
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Purchases of property and equipment, net |
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Cash paid for internally developed patents |
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Net cash provided by (used in) investing activities |
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CASH FLOWS FROM FINANCING ACTIVITIES: |
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Payments of deferred offering costs | ( | ( | ||||
Proceeds from exercises of warrants |
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Proceeds from issuance of common stock in at-the-market offerings, net |
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Proceeds from issuance of common stock and pre-funded warrants in public offering, net |
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Proceeds from issuance of notes payable |
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Payments of notes payable |
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Proceeds from issuance of common stock from Employee Stock Purchase Plan |
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Proceeds from exercises of stock options |
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Net cash provided by financing activities |
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Net increase in cash and cash equivalents and restricted cash |
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Cash, cash equivalents and restricted cash at beginning of period |
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Cash, cash equivalents and restricted cash at end of period | $ | | $ | | ||
SUPPLEMENTAL CASH FLOW INFORMATION: |
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Cash paid for interest | $ | — | $ | | ||
SUPPLEMENTAL NON-CASH FINANCING ACTIVITIES: |
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Operating lease liability and right of use asset addition | $ | | $ | — |
The accompanying notes are an integral part of the unaudited consolidated financial statements.
5
ALTIMMUNE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
1. Nature of Business and Basis of Presentation
Nature of Business
Altimmune, Inc., headquartered in Gaithersburg, Maryland, United States, together with its subsidiaries (collectively, the “Company” or “Altimmune”) is a clinical stage biopharmaceutical company incorporated under the laws of the State of Delaware.
The Company is focused on developing treatments for obesity and liver diseases. The Company’s pipeline includes proprietary intranasal vaccines and next generation peptide therapeutics for obesity, NASH (pemvidutide, proposed INN, formerly known as ALT-801) and chronic hepatitis B (HepTcell). Since its inception, the Company has devoted substantially all of its efforts to business planning, research and development, recruiting management and technical staff, and raising capital, and has financed its operations through the issuance of common and preferred stock, long-term debt, and proceeds from research grants and government contracts. The Company has not generated any revenues from the sale of any products to date, and there is no assurance of any future revenues from product sales.
Basis of Presentation
The accompanying unaudited consolidated financial statements are prepared pursuant to the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) regarding interim financial reporting. Accordingly, they do not include all of the information and disclosures required by accounting principles generally accepted in the United States (“U.S. GAAP”) for complete consolidated financial statements and should be read in conjunction with the audited consolidated financial statements for the year ended December 31, 2020 included in the Annual Report on Form 10-K which was filed with the SEC on February 25, 2021. In the opinion of management, the Company has prepared the accompanying unaudited consolidated financial statements on the same basis as the audited consolidated financial statements, and these consolidated financial statements include all adjustments, consisting only of normal recurring adjustments, necessary for a fair presentation of the results of the interim periods presented. The operating results for the interim periods presented are not necessarily indicative of the results expected for the full year 2021 or any future years or periods.
The accompanying unaudited consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation.
The accompanying unaudited consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets, and the satisfaction of liabilities in the ordinary course of business. The financial statements do not include any adjustments relating to the recoverability and classification of recorded assets and liabilities that might be necessary should we be unable to continue as a going concern.
2. Summary of Significant Accounting Policies
During the nine months ended September 30, 2021, there have been no significant changes to the Company’s summary of significant accounting policies contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020 as filed with the SEC, except for the recently adopted accounting standard for income taxes.
Use of Estimates
The preparation of these financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. The extent to which the COVID-19 pandemic, including any resurgences or the emergence of new variants, may directly or indirectly impact the Company’s business, financial condition, and results of operations is highly uncertain and subject to change.
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The Company considered the potential impact of the COVID-19 pandemic on the Company’s estimates and assumptions and determined that there was not a material impact to the Company’s unaudited consolidated financial statements as of and for the three and nine months ended September 30, 2021. However, actual results could differ from those estimates and there may be changes to the Company’s estimates in future periods.
Recently Issued Accounting Pronouncements - Adopted
In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2019-12, Income Taxes (Topic 740), Simplifying the Accounting for Income Taxes (“ASU No. 2019-12”). ASU 2019-12 amends the approaches and methodologies in accounting for income taxes during interim periods and makes changes to certain income tax classifications. The new standard eliminates the legacy exceptions to the general guidance for intra-period tax allocation, when there is a loss from continuing operations and income or a gain from other items, and to the general methodology for calculating income taxes in an interim period, when a year-to-date loss exceeds the anticipated loss for the year. The standard also requires franchise or similar taxes partially based on income to be reported as income tax and the effects of enacted changes in tax laws or rates to be included in the annual effective tax rate computation from the date of enactment. Lastly, in any future acquisition, the Company would be required to evaluate when the step-up in the tax basis of goodwill is part of the business combination and when it should be considered a separate transaction. The Company adopted the standard as of January 1, 2021 and has evaluated the effects of this standard and determined that the adoption did not have a material impact on the Company’s consolidated financial statements.
3. Fair Value Measurements
The Company’s assets and liabilities measured at fair value on a recurring basis at September 30, 2021 consisted of the following:
Fair Value Measurement at September 30, 2021 | ||||||||||||
| Total |
| Level 1 |
| Level 2 |
| Level 3 | |||||
Assets: | ||||||||||||
Cash equivalents - money market funds | $ | | $ | | $ | — | $ | — | ||||
Short-term investments |
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| — |
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| — | ||||
Total | | | | — | ||||||||
Liabilities: | ||||||||||||
Contingent consideration liability (see Note 8) |
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| — |
| — |
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Total | $ | | $ | — | $ | — | $ | |
The Company’s assets and liabilities measured at fair value on a recurring basis at December 31, 2020 consisted of the following:
Fair Value Measurement at December 31, 2020 | ||||||||||||
| Total |
| Level 1 |
| Level 2 |
| Level 3 | |||||
Assets: | ||||||||||||
Cash equivalents - money market funds | $ | |
| $ | |
| $ | — |
| $ | — | |
Short-term investments |
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| — |
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| — | ||||
Total | | | | — | ||||||||
Liabilities: | ||||||||||||
Contingent consideration liability (see Note 8) |
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| — |
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Warrant liability |
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| — |
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Total | $ | | $ | — | $ | — | $ | |
The warrant liability is included in Other long-term liabilities in the consolidated balance sheet at December 31, 2020. The warrant liability was valued using the Monte Carlo simulation valuation model with Level 3 inputs.
Short-term investments have been initially valued at the transaction price and subsequently valued, at the end of each reporting period, utilizing third party pricing services or other market observable data (Level 2). The pricing services
7
utilize industry standard valuation models, including both income and market-based approaches and observable market inputs to determine value.
Short-term investments had quoted prices at September 30, 2021 as shown below:
September 30, 2021 | |||||||||
Unrealized Gain | |||||||||
Amortized Cost | (Loss) | Market Value | |||||||
Certificate of deposit | $ | | $ | — | $ | | |||
Total | $ | | $ | — | $ | |
Short-term investments had quoted prices at December 31, 2020 as shown below:
December 31, 2020 | |||||||||
Unrealized Gain | |||||||||
Amortized Cost | (Loss) | Market Value | |||||||
United States treasury securities |
| $ | |
| $ | |
| $ | |
Commercial paper and corporate debt securities | | ( | | ||||||
Asset backed securities |
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| ( |
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Certificate of deposit | | — | | ||||||
Total | $ | | $ | ( | $ | |
The fair value of contingent payments classified as a liability is based on the regulatory milestones described in Note 8 and estimated using the Monte Carlo simulation valuation model with Level 3 inputs.
The assumptions used to estimate the fair value of contingent payments that are classified as a liability at September 30, 2021 include the following significant unobservable inputs:
Unobservable input | Value or Range |
| Weighted Average | |
Expected volatility |
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Risk-free interest rate |
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Cost of capital |
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Discount for lack of marketability |
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Probability of payment |
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Projected year of payment |
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If applicable, the Company will recognize transfers into and out of Level 3 within the fair value hierarchy at the end of the reporting period in which the actual event or change in circumstance occurs. There were
Separate disclosure is required for assets and liabilities measured at fair value on a recurring basis from those measured at fair value on a non-recurring basis. Assets recorded at fair value on a non-recurring basis, such as property and equipment and intangible assets are recognized at fair value when they are impaired. During the nine months ended September 30, 2021, the Company recorded a non-cash impairment charge to property and equipment, net on a non-recurring basis (see below). As of December 31, 2020, the Company had
Property and Equipment, Net
During the nine months ended September 30, 2021, the Company recorded a non-cash impairment charge of $
8
on the assets, the probability of satisfying the contractual restrictions, physical deterioration, functional obsolescence, and economic obsolescence. The fair value measurement is considered a Level 3 measurement within the valuation hierarchy.
4. Property and Equipment, Net
Property and equipment, net consists of the following:
September 30, 2021 | December 31, 2020 | |||||
Furniture, fixtures and equipment |
| $ | |
| $ | |
Laboratory equipment |
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Computers and telecommunications |
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Software |
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Leasehold improvements |
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Construction-in-progress | | — | ||||
Property and equipment, at cost |
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Less: accumulated depreciation and amortization |
| ( |
| ( | ||
Property and equipment, net | $ | | $ | |
As of September 30, 2021, construction-in-progress primarily includes costs related to the procurement of long-lead equipment associated with the Company’s manufacturing collaboration with Lonza Houston, Inc. (“Lonza”) for the manufacture of AdCOVID or other adenovirus-based vaccines. Under the agreement, the Company has committed approximately $
In June 2021, the Company announced the discontinuation of further development of AdCOVID following the Company’s review of findings from the Phase 1 clinical trial. Construction continues at Lonza, and the Company is currently assessing its strategic options with respect to the suite. The Company’s current expectation is that, more likely than not, the suite will be disposed of significantly before the end of its previously estimated useful life. As of September 30, 2021, the Company recorded $
Depreciation expense related to property and equipment was approximately $
9
5. Intangible Assets
The Company’s intangible assets consist of the following:
September 30, 2021 | |||||||||||
Gross | |||||||||||
Estimated | Carrying | Accumulated | Net Book | ||||||||
Useful Lives | Value | Amortization | Value | ||||||||
Internally developed patents |
|
| $ | |
| $ | ( |
| $ | | |
Acquired licenses |
|
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| ( |
| — | ||||
Total intangible assets subject to amortization |
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| ( |
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IPR&D assets |
| Indefinite |
| |
| — |
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Total |
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| $ | |