Fulgent Genetics, Inc. quarterly report, Q3 FY2022

Fulgent Genetics, Inc. — Q3 2022 Form 10-Q

Reporting period: Three and nine months ended September 30, 2022. Unaudited results; dollar amounts below are in millions unless noted. Fulgent provides COVID-19 testing, molecular diagnostics, and genetic testing. Results include Inform Diagnostics from its acquisition date, April 26, 2022.

Key financial results

MetricQ3 2022Q3 2021Nine months 2022Nine months 2021
Revenue$105.7$227.9$551.3$740.9
Gross profit / margin$46.1 / 43.6%$184.4 / 80.9%$353.9 / 64.2%$587.5 / 79.3%
Operating income$0.4$159.3$215.1$525.1
Net income attributable to Fulgent$1.7$122.5$167.2$403.0
Diluted EPS$0.06$3.93$5.38$13.04
Cash from operating activitiesNot provided quarterlyNot provided quarterly$220.3$461.5

Balance sheet, liquidity, and cash flow

  • At September 30, 2022, cash and cash equivalents were $168.8 million and marketable securities were $749.2 million, for combined cash and securities of $918.0 million. Current assets were $696.6 million versus current liabilities of $102.5 million.
  • Total assets were $1.406 billion; total liabilities were $124.4 million and stockholders’ equity was $1.281 billion.
  • Debt included a $15.0 million margin borrowing secured by securities and approximately $8.8 million of notes payable. The margin loan rate was 3% at quarter-end and could change; the custodian may issue a margin call.
  • Nine-month investing cash outflow was $168.7 million, including $137.8 million for Inform Diagnostics, $15.0 million for a private-company preferred stock investment, and $14.1 million in fixed-asset purchases. Financing cash outflow was $47.5 million, primarily reflecting $45.3 million of share repurchases.
  • Management said existing cash, short-term securities, and expected operating cash flows should meet anticipated cash needs for at least 12 months, while noting that cash flows and needs could vary.

Changes and management commentary

  • Revenue fell 54% in Q3 and 26% year to date, primarily because COVID-19 testing volume declined. Billable tests fell 56% in Q3 and 27% year to date; the HRSA COVID-19 Uninsured Program stopped accepting claims on March 22, 2022.
  • Management stated that it expects COVID-19 testing demand to continue declining as the pandemic recedes, with future demand subject to uncertainty, including variants, vaccines, and customer preferences.
  • Q3 cost of revenue rose 37% despite the revenue decline, reflecting Inform Diagnostics, higher personnel and depreciation costs, and test mix. Cost per billable test increased to $63 from $20; gross margin dropped to 43.6% from 80.9%.
  • General and administrative expense more than doubled in Q3, including a $6.5 million provision for credit losses. The nine-month provision was $25.3 million; the receivables allowance was $35.4 million at September 30, compared with $11.2 million at year-end 2021.
  • Inform Diagnostics contributed $53.9 million of revenue and an $11.2 million operating loss from acquisition through September 30. The acquisition increased goodwill and intangible assets; related amortization and acquisition costs also weighed on results.
  • Fulgent repurchased 995,000 shares for $45.3 million during the first nine months under a $250 million authorization; $204.7 million remained available at September 30.

Risks, contingencies, and subsequent events

  • The company disclosed a Department of Justice Civil Investigative Demand concerning allegations of medically unnecessary testing, improper billing, and remuneration potentially implicating the Anti-Kickback Statute and Stark Law. Fulgent said it is cooperating and does not presently expect a material adverse impact, but cannot predict the outcome or potential impact.
  • A putative securities class action filed in September 2022 makes related allegations against the company and two executives. Fulgent denies the allegations; it could not estimate a possible loss or range at this stage.
  • Marketable securities had $33.7 million of gross unrealized losses at quarter-end; the filing reported no credit losses recognized on those securities. The nine-month comprehensive income attributable to Fulgent was $142.4 million, including substantial securities and foreign-currency losses in other comprehensive income.
  • On November 7, 2022, after quarter-end, Fulgent completed its acquisition of Fulgent Pharma Holdings for approximately $100 million, including cash and stock consideration, and assumed employee restricted stock units. The acquired therapeutic business is early-stage: FID-007 was its only candidate in clinical trials. The filing highlights clinical, regulatory, financing, and commercialization risks, including uncertainty around use of the FDA’s 505(b)(2) pathway.
  • Management reported effective disclosure controls as of September 30, 2022. No material changes to internal control over financial reporting were reported for the quarter.

Important facts for investors to verify

  • How quickly COVID-19 testing revenue declines, and whether genetic testing and Inform Diagnostics can offset that decline profitably.
  • Receivables collectability and the adequacy of the credit-loss allowance, given the higher provision and allowance balance.
  • Developments, potential financial exposure, and business or reputational effects from the DOJ investigation and related securities litigation.
  • Fulgent Pharma’s acquisition terms and ongoing costs, clinical progress, regulatory pathway, and ability to produce commercial value.
  • Market value and liquidity of the investment portfolio, including unrealized losses, and the collateral and margin-call terms on the $15.0 million borrowing.
  • Whether operating cash generation can support acquisitions, investment, and repurchases amid falling COVID-19 testing demand; the filing provides no numerical revenue or earnings guidance.