Q4 2024 Earnings Summary
- Strong growth potential for Jakafi, particularly in the polycythemia vera (PV) indication, which is growing the fastest among the three indications and is expected to become the largest contributor over time, driven by earlier treatment adoption based on positive clinical data and changes in Medicare co-payments.
- Upcoming pivotal data readouts for povorcitinib in hidradenitis suppurativa (HS), with the company expressing confidence in its competitive profile against existing treatments, and potential to transform the current standard of care, which could significantly boost future revenues.
- Achievement of bioequivalence for ruxolitinib extended release (XR), with plans to submit for approval by the end of the year and expected commercialization by 2026, providing an opportunity to extend the Jakafi franchise before generic competition enters the market.
- Regulatory risks with ruxolitinib XR (Jakafi XR): The extended-release formulation cannot replicate the C<sub>max</sub> of the twice-daily formulation, and approval is pending completion of stability studies following a prior FDA Complete Response Letter (CRL). This may delay commercialization and impact market potential. ,
- Competitive threats in hidradenitis suppurativa (HS): Upcoming readouts from competitors like canakinumab and Rinvoq may impact the value proposition of povorcitinib in HS, potentially affecting Incyte's market share upon approval.
- Limited commercialization window before generics: With expected commercialization of ruxolitinib XR in 2026, and generics of the twice-daily formulation entering in 2029, Incyte has approximately 2.5 years to switch patients to the new formulation, potentially limiting its commercial opportunity.
| Metric | YoY Change | Reason |
|---|---|---|
Total Revenue | +16% | Primarily driven by stronger product demand for Jakafi (+11%), Opzelura (+48%), and Minjuvi (+260%), as well as stable royalty revenues. These gains reflect ongoing market adoption and expanded indications. |
Total Product Revenue | +18% | Increased patient uptake of Jakafi, Opzelura, and Minjuvi led to higher sales, supported by geographic expansion (especially for Opzelura) and favorable coverage decisions. |
Jakafi | +11% | Growth driven by rising demand across myelofibrosis, polycythemia vera, and GVHD, with early intervention data (e.g., MAGIC PV) contributing to broader physician adoption. Jakafi remains a standard-of-care despite competition. |
Opzelura | +48% | Fueled by new patient starts and refills in atopic dermatitis and vitiligo, along with European market uptake in Germany and France, and improved payer coverage in the U.S. |
Minjuvi | +260% | Reflects the acquisition of exclusive global rights to tafasitamab in early 2024, enabling broader commercialization and significantly boosting sales. |
Total Royalty Revenue | +6% | Supported by robust Jakavi and Olumiant royalties, although currency factors and prior-period one-time deductions influenced the net growth. |
Operating Income (EBIT) | +61% | Higher product revenues and disciplined expense management drove EBIT growth; however, milestone payments and increased R&D spending partially offset gains. |
Diluted EPS | +15% | Resulted from strong revenue expansion outpacing spending on R&D and SG&A, even as one-time costs (e.g., milestone fees) weighed on profits, leading to net EPS improvement. |
| Metric | Period | Previous Guidance | Current Guidance | Change |
|---|---|---|---|---|
Jakafi Net Revenue | FY 2024 | no prior guidance | $2.74B–$2.77B | no prior guidance |
Other Hematology/Oncology Products | FY 2024 | no prior guidance | $310M–$320M | no prior guidance |
R&D Expenses | FY 2024 | no prior guidance | $2.54B–$2.59B | no prior guidance |
Jakafi Net Revenue | FY 2025 | no prior guidance | $2.925B–$2.975B | no prior guidance |
Opzelura Net Revenue | FY 2025 | no prior guidance | $630M–$670M | no prior guidance |
Other Oncology Products | FY 2025 | no prior guidance | $415M–$455M | no prior guidance |
COGS | FY 2025 | no prior guidance | 8.5%–9% of net product revenue | no prior guidance |
R&D Expenses | FY 2025 | no prior guidance | $1.93B–$1.96B | no prior guidance |
SG&A Expenses | FY 2025 | no prior guidance | $1.28B–$1.31B | no prior guidance |
| Metric | Period | Guidance | Actual | Performance |
|---|---|---|---|---|
Jakafi Net Revenue | FY 2024 | $2.74B to $2.77B | $2.79B (sum of Q1: 571.8, Q2: 706.0, Q3: 741.2, Q4: 773.1) | Beat |
Other Hematology/Oncology Products | FY 2024 | $310M to $320M | $318.4M (sum of ICLUSIG: Q1 30.3, Q2 26.9, Q3 29.7, Q4 27.4; PEMAZYRE: Q1 17.7, Q2 20.3, Q3 20.7, Q4 23; MINJUVI: Q1 23.9, Q2 31.1, Q3 31.4, Q4 32.8; ZYNYZ: Q1 0.5, Q2 0.6, Q3 0.7, Q4 1.4) | Met |
GAAP R&D | FY 2024 | $2.54B to $2.59B | $2.61B (sum of Q1: 429.26, Q2: 1,138.38, Q3: 573.17, Q4: 466.034) | Missed |
| Topic | Previous Mentions | Current Period | Trend |
|---|---|---|---|
Jakafi (growth across PV, MF, GVHD, LOE) | Mentioned in Q1 2024 and Q2 2024 with revenue growth (Q1: $572M, Q2: $706M), strong PV uptake, LOE concerns, and plans for future revenue amid patent protection. | Q4 2024 call highlighted net product revenue of $2.8B, continued growth in PV, MF, and GVHD, and strategic planning for LOE via ruxolitinib XR. | Consistently discussed, reflecting confidence in ongoing growth. |
Pipeline expansion (CDK2 inhibitor, immunology/dermatology) | In Q1 2024 and Q2 2024, updates on the CDK2 inhibitor’s move toward ovarian cancer trials and the dermatology portfolio (ruxolitinib cream, povorcitinib). | Q4 2024 emphasized pivotal trials for CDK2 in 2025 and progress in immunology (povorcitinib, ruxolitinib cream). | Continued focus, underscoring long-term R&D strategy. |
Escient Pharmaceuticals acquisition | Discussed in Q1 2024 ($750M deal), then detailed in Q2 2024 regarding pipeline integration (MRGPRX2, MRGPRX4 antagonists). | Not mentioned in Q4 2024. | No longer mentioned. |
Discontinued LAG-3, TIM-3, PD-1 programs | Only cited in Q2 2024 as part of a strategic pipeline restructuring. | No mention in Q4 2024. | No longer mentioned. |
Ruxolitinib XR formulation | Q1 2024 and Q2 2024 highlighted bioequivalence/stability studies expected to support launch before generic entry. | Q4 2024 call confirmed bioequivalence and a 2026 commercialization target, pending stability data completion. | Emerging details on regulatory path and timing. |
Povorcitinib in HS (competitive threats) | Q1 2024 and Q2 2024 showed positive Phase II data, Phase III initiation, and potential to address unmet needs in HS. | Q4 2024 underscored competitive efficacy and safety for STOP-HS trials, with data expected first half of 2025. | Sustained attention with updates on Phase III and market positioning. |
Capital allocation | Q1 2024 indicated uncertainty about buybacks; Q2 2024 highlighted a $2B share repurchase due to undervaluation and strong balance sheet. | No mention in Q4 2024. | No longer mentioned in the current call. |
Goal of 10+ prospective launches by 2030 | Q1 2024 and Q2 2024: reaffirmed target for multiple pipeline assets. | Q4 2024 reiterated 10+ high-impact launches by 2030, emphasizing pipeline depth. | Consistently reinforced as a key strategic objective. |
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Opzelura Guidance
Q: How did you arrive at the Opzelura guidance for this year?
A: The guidance range for Opzelura is $630 million to $670 million for the year, representing 24% to 32% year-over-year growth. This is driven by continued demand growth in atopic dermatitis (AD) and vitiligo, the potential launch in pediatric AD in the second half, and increased contribution from Europe. The range reflects variations in patient mix, patient activation rates, adherence in vitiligo, and European contribution. -
Povorcitinib in HS
Q: What results are needed for povorcitinib in HS to be competitive?
A: For povorcitinib in hidradenitis suppurativa (HS), the key is to achieve statistical significance for the primary endpoint, which is HiSCR50 at week 12 in the two HS studies. If we can replicate the Phase II results—showing strong effects on HiSCR50, 75, 90, and 100, as well as pain improvement—we believe we have a very competitive profile. The Phase II safety profile was also very clean, with no thrombotic events and no discontinuations due to adverse events in the high-dose arm. -
Impact of IRA on Sales
Q: When will the IRA out-of-pocket cap benefit show up in sales?
A: The out-of-pocket cap is reduced to $2,000 this year. Patients can spread this cost over the year in equal payments, but the process may take time to navigate. We might not see the immediate benefit right away, but we expect continued benefit from the lower out-of-pocket costs as we saw in 2024. -
Labeling for Povorcitinib in HS
Q: Will povorcitinib's label include biologic-naive patients?
A: Prior exposure to biologics is a stratification criterion in the Phase III trials. We plan to analyze data based on prior biologic exposure. While we're not commenting on the full powering, the studies are designed based on assumptions around the primary endpoint and key secondary endpoints. -
Variability in Povorcitinib Phase II Data
Q: Concerns about drop in efficacy from week 12 to 16 in Phase II?
A: In the Phase II study, the placebo-subtracted HiSCR50 was 28% at week 12 and 17% at week 16. This variability is likely due to clinical trial noise, particularly in diseases like HS with placebo effects. We're not concerned about the drop; the Phase III studies are well-powered to demonstrate statistically significant differences. -
Mutant-CALR and JAK2V617F Programs
Q: What can we expect from the upcoming data on mutant-CALR and JAK2V617F?
A: For mutant-CALR, we expect substantive proof-of-concept data this year, including different dose levels and follow-up to assess important measures of success. We aim to see impact not only on traditional endpoints but also early evidence of allele reduction. The JAK2V617F program started dosing patients with MF in Q3 2024, and we'll provide an update this year. -
Ruxolitinib XR Plans
Q: What are your plans to commercialize ruxolitinib XR?
A: We're waiting for the end of stability studies to submit to the FDA by the end of this year. We expect to commercialize in 2026, providing about 2.5 years before the first generic of the twice-a-day formulation. Our goal is to have as many patients as possible on the once-daily formulation during that period. -
CDK2 Program Updates
Q: Any updates on the CDK2 program for ovarian cancer?
A: We plan to initiate pivotal trials this year in platinum-resistant ovarian cancer. We're taking a dual approach with a single-arm study aiming for accelerated approval in the U.S., as well as a randomized trial. The program is advancing rapidly, and we'll provide an update later this year. -
BET Inhibitor Development
Q: What's the latest on the BET inhibitor in MF?
A: In second-line MF, we're accelerating the BET inhibitor program to provide better treatment options after Jakafi. For frontline development, we need more data on safety and impact when combined with Jakafi in previously untreated patients. We'll make decisions based on additional data and discussions with the FDA. -
KRAS G12D Program
Q: Can you share more about the KRAS G12D program?
A: We're focusing on pancreatic and colorectal cancer, aiming to accelerate enrollment due to the competitive space. Preclinical data suggest we have a highly selective and potent G12D inhibitor. We believe there's still room for a well-tolerated inhibitor, especially in combination with chemotherapy. We'll discuss data later this year.