Altimmune, Inc. quarterly report, Q2 FY2022

Altimmune, Inc. — Q2 2022 Form 10-Q

Reporting period: Three and six months ended June 30, 2022; filed August 11, 2022. Altimmune is a clinical-stage biopharmaceutical company developing treatments for obesity and liver diseases. Its lead candidate, pemvidutide, is being developed for obesity and non-alcoholic steatohepatitis (NASH); HepTcell is being developed for chronic hepatitis B. The company has not generated product-sales revenue.

Financial results and liquidity

Amounts below are in U.S. dollars; financial statement figures are converted from thousands to millions.

MetricQ2 2022Q2 2021Six months 2022Six months 2021
Revenue$0.008M$0.137M$0.040M$0.975M
Research and development expense$15.993M$13.272M$31.097M$25.150M
General and administrative expense$4.410M$3.659M$8.837M$7.480M
Operating loss$(20.395)M$(24.864)M$(39.894)M$(39.725)M
Net loss$(20.107)M$(24.827)M$(39.537)M$(39.691)M
Basic and diluted net loss per share$(0.42)$(0.60)$(0.90)$(0.99)
  • At June 30, 2022, cash, cash equivalents and restricted cash were $135.9M, with $48.9M of short-term investments: total liquidity of approximately $184.8M. Total current assets were $195.5M and current liabilities $13.8M.
  • Six-month operating cash use was $30.2M, investing cash use $49.0M, and financing cash provided $24.8M. Cash and restricted cash declined $54.4M during the period.
  • Total liabilities were $15.4M; the balance sheet reports no borrowing balance. Lease obligations were $1.3M, including current and long-term portions. Accumulated deficit was $332.7M.
  • Operating margins and gross margins are not meaningful indicators here: revenue was minimal and there were no product sales. No clear product-level margin is provided.

Changes versus the prior comparable periods

  • Q2 revenue fell 94% and first-half revenue fell 96%, mainly because T-COVID and NasoShield development programs were discontinued and related grant revenue wound down.
  • R&D expense rose 21% in Q2 and 24% in the first half, primarily reflecting pemvidutide development, including ongoing NAFLD trials and initiation of the MOMENTUM Phase 2 obesity trial, and HepTcell activity. These increases were partly offset by lower COVID-program spending.
  • Q2 net loss narrowed from $24.8M to $20.1M, principally because the prior-year quarter included an $8.1M noncash impairment charge for construction-in-progress related to the discontinued AdCOVID program. First-half net loss was essentially unchanged year over year.
  • Interest income increased with higher interest-bearing balances. The company invested $48.9M in short-term investments during the first half.

Outlook, risks and unusual items

  • Management said cash and investments, together with expected income-tax refunds and R&D incentive receipts, were sufficient to fund planned operations for at least 12 months from issuance of the financial statements. The filing provides no specific revenue, earnings, or clinical-development financial guidance. Management noted that longer-term needs may require additional financing, government funding, partnerships, or asset monetization.
  • The company sold 2.49 million shares through its at-the-market program in the first half, generating $24.3M net proceeds. At June 30, $32.9M remained under that program and approximately $157.9M remained available under the broader shelf registration. Further equity issuance may dilute shareholders.
  • On June 10, 2022, Altimmune settled the Spitfire acquisition’s Phase 2 milestone by issuing 847,444 shares valued at $7.2M, following first dosing in the MOMENTUM trial. No contingent consideration liability remained at quarter-end. Up to $80M of sales-based milestone payments may still be payable if specified future sales milestones are achieved.
  • Clinical, regulatory, financing, and execution risks remain significant for a clinical-stage company without product revenue. Management reported no material COVID-19 impact to date but noted possible trial, supply, and cost disruptions. It reported no direct Russia-Ukraine exposure and did not then expect a material operating impact, while identifying potential broader economic and operational effects if the conflict escalates.
  • A lawsuit brought by a former employee was refiled in Maryland; the company said it considers the allegations without merit and intends to defend itself. The filing identifies no other ordinary-course claims considered reasonably possible or probable to result in material loss. No material changes to the risk factors in the 2021 Form 10-K were reported.
  • Management concluded disclosure controls were effective as of June 30, 2022, with no material change in internal control over financial reporting during the quarter.

Important facts for investors to verify

  • Progress, enrollment, and timing for pemvidutide obesity and NAFLD trials, and development plans for HepTcell.
  • Cash burn and the assumptions supporting management’s stated minimum 12-month runway, including timing and collection of tax refunds and R&D incentives.
  • Potential dilution from the ATM program, remaining shelf capacity, stock compensation, and outstanding warrants and options.
  • Status and potential outcome of the Maryland litigation and any changes to the company’s assessment of the matter.
  • Potential future sales-milestone obligations tied to the Spitfire acquisition and any future contingent payments.