NASDAQ$MIRM
Mirum Pharmaceuticals Inc · Q1 2021 earnings
Q1 2021 earnings · · Investor relations
Briefing
Mirum Pharmaceuticals reported financial results for Q1 2021 and provided a business update.
Mirum Pharmaceuticals reported a net loss of $50.5 million for the quarter ended March 31, 2021. The company is preparing for the potential launch of maralixibat for Alagille syndrome with a PDUFA date of September 29, 2021.
- NDA for maralixibat in Alagille syndrome (ALGS) granted priority review by U.S. FDA with a PDUFA date of September 29, 2021.
- Received additional $65.0 million in funding from Oberland Capital based on NDA acceptance.
- Commercial team hired in anticipation of U.S. launch of maralixibat in ALGS.
- Entered into two licensing agreements with Vivet Therapeutics and CANbridge Pharmaceuticals.
Headline financials
Revenue & EPS history
Mirum Pharmaceuticals · Revenue · Quarterly
$160M
Revenue by segment
Mirum Pharmaceuticals · $29.1M total across 1 segment · Q1 2023
- Net Product Sales$29.1M—100.0%
Forward guidance
Mirum is preparing for the potential launch of maralixibat and advancing its pipeline.
Tailwinds
- FDA has issued a PDUFA date of September 29, 2021 for maralixibat in ALGS.
- Mirum plans to launch maralixibat for the treatment of cholestatic pruritus in patients with ALGS one year of age and older in the United States, if approved.
- Mirum is planning to launch maralixibat for the treatment of PFIC2 in Europe in early 2022, if approved by the European Medicines Agency.
- Mirum plans to file for ALGS as an additional indication in Europe following the PFIC2 approval, if received, based on results from the ICONIC study and six-year event-free survival analyses.
- Phase 2b study in primary biliary cholangitis (PBC) planned for the second half of 2021.
Headwinds
- Topline data from the Phase 3 MARCH PFIC study expected in early 2022.
- Continuing enrollment in EMBARK Phase 2b study of maralixibat in biliary atresia.
- Continuing enrollment in Phase 2b OHANA study for intrahepatic cholestasis of pregnancy (ICP).
- Continuing enrollment in Phase 2b VISTAS study for primary sclerosing cholangitis (PSC).
- Interim analyses for OHANA and VISTAS studies expected in 2022.
Historical earnings impact
How earnings announcements have historically affected this stock's price.
Avg. return before/after earnings
Based on 20 quarterly earnings reports · overlaid with Q1 2021
+1.7%
Avg return
Earnings day
+0.3%
Avg return
5 days after
+2.9%
Avg return
30 days after
59%
16 / 27 earnings
Positive
+26.4%
Q2 2022
Best reaction
-16.2%
Q3 2022
Worst reaction
| Quarter | Report date | Reaction (Day 0) | +5 days | +30 days |
|---|---|---|---|---|
| Q1 2026 | +4.0% | +0.2% | -11.7% | |
| Q4 2025 | -15.1% | -19.2% | -18.6% | |
| Q3 2025 | -1.4% | -1.8% | -3.5% | |
| Q1 2025 | +9.9% | +9.8% | +12.5% | |
| Q4 2024 | -7.0% | -10.5% | -9.0% | |
| Q3 2024 | +5.6% | +6.9% | +1.6% | |
| Q2 2024 | +1.8% | +14.3% | +5.0% | |
| Q1 2024 | -0.3% | -4.4% | -3.2% | |
| Q4 2023 | -3.0% | -3.1% | -15.2% | |
| Q3 2023 | +5.6% | +5.6% | +12.6% | |
| Q2 2023 | +6.1% | +2.1% | +6.1% | |
| Q1 2023 | -8.3% | -7.9% | -7.9% | |
| Q4 2022 | -1.1% | -4.7% | +5.1% | |
| Q3 2022 | -16.2% | -19.7% | -24.1% | |
| Q2 2022 | +26.4% | +18.0% | +7.4% | |
| Q1 2022 | +7.1% | -4.4% | +7.0% | |
| Q4 2021 | +3.3% | +1.5% | +29.5% | |
| Q3 2021 | +0.1% | -1.2% | -7.9% | |
| Q2 2021 | +0.5% | -4.0% | +23.0% | |
| Q1 2021 | -1.4% | -6.3% | -10.8% | |
| Q4 2020 | +6.0% | +14.3% | +10.2% | |
| Q3 2020 | +11.6% | +16.9% | +48.0% | |
| Q2 2020 | +13.0% | +15.3% | -4.3% | |
| Q1 2020 | +0.1% | +6.2% | +10.8% | |
| Q4 2019 | +8.1% | -10.5% | +25.7% | |
| Q3 2019 | -0.1% | +4.0% | +22.6% | |
| Q2 2019 | -9.0% | -10.3% | -31.5% | |
| Q1 2019 | — | — | — | |
| Q4 2018 | — | — | — | |
| Q3 2018 | — | — | — |
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