Mirum Pharmaceuticals Reports Third Quarter 2026 Financial Results and Provides Business Update
Mirum Pharmaceuticals, Inc. (MIRM) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Mirum Pharmaceuticals Reports Third Quarter 2026 Financial Results and Provides Business Update – Q3 2026 net product sales of $185.7 million; 2026 net product sales guidance increased to $715 million to $720 million – Received U.S. FDA approval of and launched ATEBR
How this was made
The 30-second read
Why it matters
The guidance raise and product launch could lift the stock, while upcoming trial readouts add upside potential.
Market read
First‑report disclosure of earnings and regulatory approval provides fresh material for traders.
What to watch
execution risk of upcoming regulatory submissions
Mirum Pharmaceuticals Reports Third Quarter 2026 Financial Results and Provides Business Update
Third-quarter product sales grew to $185.7 million, with LIVMARLI and Bile Acid Medicines both posting reported year-over-year growth, and Mirum raised 2026 net product sales guidance to $715 million to $720 million. However, GAAP net loss was $40.8 million, total operating expenses rose to $245.5 million, and nine-month results included $756.2 million of acquired in-process research and development expense.
Key metrics
shortened, hover for the filing’s print| Metric | Value | q/q | y/y |
|---|---|---|---|
| Product sales, net, three months ended September 30, 2026GAAP | $185.7M | – | – |
| Product sales, net, nine months ended September 30, 2026GAAP | $521.8M | – | – |
| Cost of sales, three months ended September 30, 2026GAAP | $35.17M | – | – |
| Research and development expense, three months ended September 30, 2026GAAP | $107.9M | – | – |
| Acquired in-process research and development expense, three months ended September 30, 2026GAAP | $13.5M | – | – |
| Selling, general and administrative expense, three months ended September 30, 2026GAAP | $88.86M | – | – |
| Total operating expenses, three months ended September 30, 2026GAAP | $245.5M | – | – |
| Loss from operations, three months ended September 30, 2026GAAP | −$59.75M | – | – |
| Interest income, three months ended September 30, 2026GAAP | $4.69M | – | – |
| Interest expense, three months ended September 30, 2026GAAP | −$1.61M | – | – |
| Other income, net, three months ended September 30, 2026GAAP | $16.44M | – | – |
| Net loss before provision for income taxes, three months ended September 30, 2026GAAP | −$40.23M | – | – |
| Provision for income taxes, three months ended September 30, 2026GAAP | $538K | – | – |
| Net loss, three months ended September 30, 2026GAAP | −$40.77M | – | – |
| Net loss per share, basic, three months ended September 30, 2026GAAP | $ (0.62) | – | – |
| Net loss per share, diluted, three months ended September 30, 2026GAAP | $ (0.87) | – | – |
| Weighted-average shares of common stock used to compute net loss per share, basic, three months ended September 30, 2026GAAP | 65,527,401 | – | – |
| Weighted-average shares of common stock used to compute net loss per share, diluted, three months ended September 30, 2026GAAP | 66,049,776 | – | – |
| Total operating expenses, nine months ended September 30, 2026GAAP | $1.41B | – | – |
| Loss from operations, nine months ended September 30, 2026GAAP | −$891.7M | – | – |
| Net loss, nine months ended September 30, 2026GAAP | −$898.1M | – | – |
| Net loss per share, basic, nine months ended September 30, 2026GAAP | $ (14.35) | – | – |
| Net loss per share, diluted, nine months ended September 30, 2026GAAP | $ (14.35) | – | – |
| Cost of sales excluding intangible amortization and stock-based compensation expense, three months ended September 30, 2026non-GAAP | $27.9M | – | – |
| Selling, general, and administrative expense excluding stock-based compensation expense, three months ended September 30, 2026non-GAAP | $70.4M | – | – |
| Research and development expense excluding stock-based compensation expense, three months ended September 30, 2026non-GAAP | $93.6M | – | – |
| Brelovitug development expense, three months ended September 30, 2026other | $42.1M | – | – |
| Stock-based compensation, intangible amortization, and other non-cash expenses, three months ended September 30, 2026other | $40M | – | – |
| Total stock-based compensation, three months ended September 30, 2026GAAP | $33.31M | – | – |
Segments
| Segment | Revenue | q/q | y/y |
|---|---|---|---|
| LIVMARLI net product salesThird quarter 2026 LIVMARLI net product sales. | $133.4M | – | 45% growth over third quarter 2025 net product sales |
| Bile Acid Medicines net product salesThird quarter 2026 Bile Acid Medicines net product sales. | $52.3M | – | 28% growth over third quarter 2025 net product sales |
Amounts quoted below without a unit are in thousands, as in the filing’s tables. Per-share figures are as printed.
2026 outlook
- Revenue$715 million to $720 million
- NoteBrelovitug AZURE-4 Phase 3 in HDV topline data expected in Q4 2026.
- NoteVolixibat VANTAGE Phase 2b study in primary biliary cholangitis (PBC) topline data expected in Q1 2027.
- NoteVolixibat New Drug Application (NDA) submission for primary sclerosing cholangitis (PSC) planned for H1 2027.
- NoteLIVMARLI (maralixibat) EXPAND supplemental NDA (sNDA) submission planned for H1 2027.
- NoteATEBRIOZ (zilurgisertib) sNDA submission to expand the indication to pediatric patients aged 6 to <12 years planned for H1 2027.
- NoteBrelovitug Biologics License Application (BLA) submission planned for H1 2027, subject to supportive AZURE-4 results.
- NoteMRM-3379 BLOOM Phase 2 in fragile X syndrome (FXS) topline data expected in 2027.
Capital returns
- Repurchased $20.0 million aggregate principal amount of Mirum’s 4.00% convertible senior subordinated notes due 2029, which represented approximately 25% of the outstanding notes.
What drove it
- LIVMARLI net product sales were $133.4 million, representing 45% growth over third quarter 2025 net product sales.
- Bile Acid Medicines net product sales were $52.3 million, representing 28% growth over third quarter 2025 net product sales.
- Mirum received U.S. FDA approval of and launched ATEBRIOZ for adult and pediatric patients aged 12 years and older with FOP.
- The LIVMARLI EXPAND Phase 3 study met the primary endpoint and achieved statistical significance across all prespecified secondary endpoints.
- The brelovitug AZURE-1 Phase 3 study in chronic HDV met the primary endpoint.
Concerns
- Total operating expenses were $245.5 million for the quarter ended September 30, 2026 compared to $130.4 million for the quarter ended September 30, 2025.
- GAAP net loss was $ (40,766) (in thousands) for the three months ended September 30, 2026, compared to GAAP net income of $ 2,905 (in thousands) for the three months ended September 30, 2025.
- Acquired in-process research and development expense was $ 756,237 (in thousands) for the nine months ended September 30, 2026.
- Convertible notes payable, net, noncurrent were $ 731,250 (in thousands) as of September 30, 2026.
- The planned brelovitug BLA submission in H1 2027 is subject to supportive AZURE-4 results.
What to watch
- Brelovitug AZURE-4 Phase 3 in HDV topline data expected in Q4 2026.
- Full AZURE-1 results to be presented at The Liver Meeting on November 8 at 1:00 p.m. MT.
- Volixibat VANTAGE Phase 2b topline data in PBC expected in Q1 2027.
- Planned H1 2027 volixibat NDA, LIVMARLI sNDA, ATEBRIOZ sNDA, and brelovitug BLA submissions.
- Execution against increased 2026 net product sales guidance of $715 million to $720 million.
Balance sheet and cash flow
- As of September 30, 2026, Mirum had unrestricted cash, cash equivalents, and investments of $500.5 million compared to $391.4 million as of December 31, 2025.
- Cash and cash equivalents as of September 30, 2026: $ 243,188 (in thousands), compared to $ 296,683 (in thousands) as of December 31, 2025.
- Short-term investments as of September 30, 2026: $ 130,499 (in thousands), compared to $ 86,644 (in thousands) as of December 31, 2025.
- Long-term investments as of September 30, 2026: $ 126,768 (in thousands), compared to $ 8,105 (in thousands) as of December 31, 2025.
- Convertible notes payable, net, noncurrent as of September 30, 2026: $ 731,250 (in thousands), compared to $ 309,797 (in thousands) as of December 31, 2025.
- Total assets as of September 30, 2026: $ 1,026,613 (in thousands), compared to $ 842,813 (in thousands) as of December 31, 2025.
- Total liabilities as of September 30, 2026: $ 1,080,799 (in thousands), compared to $ 528,123 (in thousands) as of December 31, 2025.
- Total stockholders’ (deficit) equity as of September 30, 2026: $ (54,186) (in thousands), compared to $ 314,690 (in thousands) as of December 31, 2025.
Analysis
Mirum reported third-quarter 2026 net product sales of $185.7 million, compared with $133.0 million in the third quarter of 2025. The commercial mix included $133.4 million of LIVMARLI net product sales, up 45% over third-quarter 2025, and $52.3 million of Bile Acid Medicines net product sales, up 28%. Management increased 2026 net product sales guidance to $715 million to $720 million, placing commercial execution at the center of the release.
Profitability moved sharply lower as expenses expanded. Total operating expenses were $245.5 million in the quarter versus $130.4 million a year earlier, including $107.9 million of GAAP research and development expense, $88.9 million of GAAP selling, general and administrative expense, and $13.5 million of acquired in-process research and development expense. The company reported a GAAP loss from operations of $59.7 million and a GAAP net loss of $40.8 million, compared with operating income of $2.6 million and net income of $2.9 million in the prior-year quarter.
The nine-month results highlight the effect of acquisition-related development spending. Acquired in-process research and development expense was $756.2 million for the nine months ended September 30, 2026, contributing to total operating expenses of $1.4 billion and a GAAP net loss of $898.1 million. Third-quarter research and development expense excluding stock-based compensation was $93.6 million, including $42.1 million for brelovitug development, underscoring the spend behind the late-stage pipeline.
The balance sheet showed $500.5 million of unrestricted cash, cash equivalents, and investments as of September 30, 2026, compared with $391.4 million as of December 31, 2025. Mirum also repurchased $20.0 million aggregate principal amount of its 4.00% convertible senior subordinated notes due 2029. Convertible notes payable, net, noncurrent were $731.3 million, while total stockholders’ equity was a deficit of $54.2 million at period end.
Operationally, the quarter included FDA approval and launch of ATEBRIOZ, positive LIVMARLI EXPAND Phase 3 results, and an AZURE-1 Phase 3 primary-endpoint result for brelovitug in chronic HDV. The next disclosed catalysts are AZURE-4 topline data in Q4 2026, VANTAGE Phase 2b topline data in Q1 2027, and a series of planned H1 2027 regulatory submissions. The brelovitug BLA timing is expressly subject to supportive AZURE-4 results.
Management, verbatim
The third quarter was an important period of execution for Mirum, with the approval and launch of ATEBRIOZ and positive Phase 3 results across our late-stage rare liver portfolio,
Chris Peetz, Chief Executive Officer of Mirum
Positive results from AZURE-1 and additional data we’ll be sharing at AASLD reinforce the potential of brelovitug to become an important new treatment for chronic HDV, while EXPAND results support the potential to bring LIVMARLI to more patients living with rare cholestatic liver diseases, including biliary atresia. Together with continued momentum across our commercial business, these milestones position Mirum for another meaningful inflection with five potential upcoming approvals and label expansions.
Chris Peetz, Chief Executive Officer of Mirum
Not in the filing
stated, not guessed- Gross profit and gross margin
- Operating cash flow
- Free cash flow
- Capital expenditures
- Dividend information
- Non-GAAP net income or loss
- Non-GAAP earnings per share
- Prior-quarter comparisons for reported operating metrics
- Prior 2026 net product sales guidance needed to compare current guidance with prior guidance
- Guidance for gross margin, operating expenses, tax rate, earnings, cash flow, or capital expenditures
Written by an AI language model from the company’s SEC earnings filing (Form 8-K Item 2.02, or Form 6-K for a foreign private issuer). Every figure was checked against the filing text, and a metric whose value, prior period and change do not add up is dropped from the metrics. The model can still misread a table, in the metrics or in the text, so check a number in the filing before you rely on it. Consensus estimates, price targets and share-price reactions are not shown because they are not in the filing. AI-generated research, not investment advice.
Background
Mirum Pharmaceuticals filed a Form 8‑K reporting Q3 2026 results, raised guidance, and announced FDA approval of ATEBRIOZ.
Ticker impact
raised guidance to $715-$720 million and FDA approval of ATEBRIOZ
likely upward pressure as market prices in higher sales outlook
the company increased full-year net product sales guidance to $715-$720M and launched ATEBRIOZ, indicating significant revenue growth potential
Market effects
boosts rare disease biotech sector sentiment
positive for US biotech investors
limited to biotech niche
Counterpoint
valuation may already price in guidance raise, limited upside
Key entities
- companyMirum Pharmaceuticals
US‑listed rare disease biotech (Nasdaq: MIRM)
