What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-10-29 compared with 2024-07-30 · 139 added, 132 removed, 728 unchanged (27% of the section changed)

Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion of our financial condition and results of operations as of and for the three and six months ended June 30, 2024 should be read in conjunction with the unaudited condensed consolidated financial statements and notes to those statements included elsewhere in this Quarterly Report on Form 10-Q and our audited consolidated financial statements as of and for the year ended December 31, 2023 included in our Annual Report on Form 10-K for the year ended December 31, 2023 previously filed with the SEC.

The following discussion of our financial condition and results of operations as of and for the three and nine months ended September 30, 2024 should be read in conjunction with the unaudited condensed consolidated financial statements and notes to those statements included elsewhere in this Quarterly Report on Form 10-Q and our audited consolidated financial statements as of and for the year ended December 31, 2023 included in our Annual Report on Form 10-K for the year ended December 31, 2023 previously filed with the SEC.

Forward-Looking Statements

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These forward-looking statements include statements as to:

• the discovery, development, formulation, manufacturing and commercialization of our compounds, our drug candidates and JAKAFI ® /JAKAVI ® (ruxolitinib), PEMAZYRE ® (pemigatinib), ICLUSIG ® (ponatinib), MONJUVI ® (tafasitamab-cxix) / MINJUVI ® (tafasitamab), OPZELURA ® (ruxolitinib) cream and ZYNYZ ® (retifanlimab-dlwr);

• our plans to further develop our operations outside of the United States;

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• the need to raise additional capital;

• the costs associated with resolving matters in litigation and governmental proceedings;

• the costs and other financial impacts associated with resolving matters in litigation and governmental proceedings;

• our expectations regarding competition;

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• the impact of changing laws on our patent portfolio;

• developments in and expenses relating to litigation;

• developments in and expenses relating to litigation and governmental proceedings;

• our ability to in-license drug candidates or other technology;

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• risks relating to our ability to sustain profitability;

• risks related to public health pandemics such as the COVID-19 pandemic, natural disasters, or geopolitical events such as the Russian invasion of Ukraine;

• risks related to public health pandemics such as the COVID-19 pandemic, natural disasters, or geopolitical events such as the Russian invasion of Ukraine and conflicts in the Middle East;

• the risks set forth under “Risk Factors.”

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In this report all references to “Incyte,” “we,” “us,” “our” or the “Company” mean Incyte Corporation and our subsidiaries, except where it is made clear that the term means only the parent company.

Incyte, JAKAFI, MINJUVI, MONJUVI, OPZELURA, PEMAZYRE and ZYNYZ are our registered trademarks.

Incyte, JAKAFI, MINJUVI, MONJUVI, OPZELURA, PEMAZYRE and ZYNYZ are our registered trademarks and NIKTIMVO is our trademark.

We also refer to trademarks of other corporations and organizations in this Quarterly Report on Form 10-Q.

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Hematology and Oncology

Our hematology and oncology franchise comprises five approved products, which are JAKAFI (ruxolitinib), MONJUVI (tafasitamab-cxix)/MINJUVI (tafasitamab), PEMAZYRE (pemigatinib), ICLUSIG (ponatinib) and ZYNYZ (retifanlimab-dlwr), as well as numerous clinical development programs.

Our hematology and oncology franchise comprises six approved products, which are JAKAFI (ruxolitinib), MONJUVI (tafasitamab-cxix)/MINJUVI (tafasitamab), PEMAZYRE (pemigatinib), ICLUSIG (ponatinib), ZYNYZ (retifanlimab-dlwr), and NIKTIMVO (axatilimab-csfr), as well as numerous clinical development programs.

JAKAFI (ruxolitinib)

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Updated three-year data from L-MIND were presented at the American Society of Clinical Oncology (ASCO) 2021 and final five-year data were presented at the American Association for Cancer Research (AACR) 2023, which showed that the MONJUVI plus lenalidomide regimen followed by MONJUVI monotherapy provided prolonged, durable responses in adult patients with r/r DLBCL.

In August 2020, we and MorphoSys announced that MONJUVI in combination with lenalidomide had been included in the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for B-cell Lymphomas.

In August 2020, we and MorphoSys announced that MONJUVI in combination with lenalidomide had been included in the latest NCCN Clinical Practice Guidelines in Oncology for B-cell Lymphomas.

In August 2021, we and MorphoSys announced that the European Commission had granted conditional marketing authorization for MINJUVI (tafasitamab) in combination with lenalidomide, followed by MINJUVI monotherapy, for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for autologous stem cell transplant (ASCT).

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ZYNYZ (retifanlimab-dlwr)

In October 2017, we and MacroGenics, Inc., announced an exclusive global collaboration and license agreement for MacroGenics’ retifanlimab (formerly INCMGA0012), an investigational monoclonal antibody that inhibits PD-1.

In October 2017, we and MacroGenics, Inc., announced an exclusive global collaboration and license agreement for MacroGenics’ retifanlimab (formerly INCMGA0012), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1).

Under this collaboration, we obtained exclusive worldwide rights for the development and commercialization of retifanlimab in all indications.

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Two Phase 3 trials evaluating retifanlimab in squamous cell anal cancer (SCAC) and non-small cell lung cancer (NSCLC) are ongoing.

In March 2023, we announced that the FDA had approved ZYNYZ (retifanlimab-dlwr), a humanized monoclonal antibody targeting programmed death receptor-1 (PD-1), under accelerated approval, for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).

In March 2023, we announced that the FDA had approved ZYNYZ (retifanlimab-dlwr) under accelerated approval, for the treatment of adults with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).

This represents the first regulatory approval for our PD-1 inhibitor.

In April 2024, the European Commission approved ZYNYZ (retifanlimab) as monotherapy for the first-line treatment of adult patients with metastatic or recurrent locally advanced MCC not amenable to curative surgery or radiation therapy following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP).

Clinical Programs in Hematology and Oncology

We are evaluating combinations of ruxolitinib with other therapeutic modalities, as well as developing a once-a-day formulation of ruxolitinib for potential use as monotherapy and combination therapy.

Bioavailability and bioequivalence data were published for ruxolitinib’s once-daily (QD) extended release (XR) formulation at the European Hematology Association (EHA) Virtual Congress in June 2021.

In March 2023, the FDA issued a complete response letter for ruxolitinib extended-release (XR) tablets for once-daily (QD) use in the treatment of certain types of MF, PV and GVHD.

In December 2023, we received FDA feedback and agreed on the requirements to address the complete response letter.

Phase 2 trials combining ruxolitinib with investigational agents from our portfolio such as INCB57643 (BET) and INCB00928 (Zilurgisertib) in patients with MF are ongoing with data presented demonstrating early signals of clinical activity of both agents in monotherapy and in combination with ruxolitinib.

Additional discovery and development initiatives are also ongoing with two Phase 1 studies in INCA33989 (mCALR) and INCB160058 (JAK2V617Fi), both of which hold the potential to be disease modifying therapeutics and address significant unmet need in MF, PV and ET.

NIKTIMVO (axatilimab-csfr)

In September 2021, we and Syndax Pharmaceuticals, Inc.

announced an exclusive worldwide collaboration and license agreement to develop and commercialize axatilimab, Syndax’s anti-CSF-1R monoclonal antibody.

Together, we plan to develop axatilimab as a therapy for patients with chronic GVHD where CSF-1R-dependent monocytes and macrophages are believed to contribute to organ fibrosis.

Together, we are developing axatilimab as a therapy for patients with chronic GVHD where CSF-1R-dependent monocytes and macrophages are believed to contribute to organ fibrosis.

In December 2021, updated positive data were presented at ASH from the Phase 1/2 trial evaluating axatilimab as a monotherapy in patients with recurrent or refractory chronic GVHD after two or more prior lines of therapy.

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Plans are underway to initiate two combination trials with axatilimab in cGVHD in 2024, including a randomized Phase 2 combination trial with ruxolitinib and a randomized Phase 3 combination trial with steroids, both directed at treating patients with cGVHD in earlier lines of therapy.

INCA33989 (mCALR)

In August 2024, we and Syndax announced the FDA approval of NIKTIMVO (axatilimab-csfr) for the treatment of chronic GVHD after failure of at least two prior lines of systemic therapy in adult and pediatric patients.

NIKTIMVO is the first approved anti-CSF-1R antibody targeting the drivers of inflammation and fibrosis seen in chronic GVHD.

In September, we and Syndax announced the New England Journal of Medicine publication of data from the pivotal AGAVE-201 trial of NIKTIMVO in chronic GVHD and the addition of NIKTIMVO to the NCCN Clinical Practice Guidelines in Oncology for the treatment of chronic GVHD.

To facilitate patient dosing and limit product waste, following the FDA’s approval of NIKTIMVO, we, along with Syndax, have submitted to the FDA for the approval of two smaller vial sizes.

Following the potential FDA approval of the new vial sizes, we currently anticipate launching NIKTIMVO in the United States in the first quarter of 2025.

Clinical Programs in Hematology and Oncology

In March 2023, the FDA issued a complete response letter for ruxolitinib extended-release (XR) tablets for once-daily (QD) use in the treatment of certain types of MF, PV and GVHD.

In December 2023, we received FDA feedback and agreed on the requirements to address the complete response letter.

In December 2022, new research detailing the development and mechanism of action of INCA033989, an Incyte-discovered, investigational novel anti-mutant calreticulin (CALR)-targeted monoclonal antibody, was featured in the Plenary Scientific Session at the 64th American Society of Hematology (ASH) Annual Meeting.

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firstMIND is a Phase 1b safety trial of tafasitamab as a first-line therapy for patients with DLBCL, and frontMIND, a placebo-controlled Phase 3 trial evaluating tafasitamab in combination with lenalidomide added to rituximab plus chemotherapy (R-CHOP) as a first-line therapy for patients with DLBCL, is ongoing.

A placebo-controlled Phase 3 trial (inMIND) of tafasitamab added to lenalidomide plus rituximab (R 2 ) in patients with relapsed or refractory follicular or marginal zone lymphomas is ongoing.

In January 2021, the FDA granted orphan drug designation to tafasitamab as a treatment for patients with follicular lymphoma.

Pemigatinib is a potent and selective inhibitor of the fibroblast growth factor receptor (FGFR) isoforms 1, 2 and 3 with demonstrated activity in preclinical studies.

The FGFR family of receptor tyrosine kinases can act as oncogenic drivers in a number of liquid and solid tumor types.

We initiated the FIGHT clinical program to evaluate pemigatinib across a spectrum of cancers that are driven by FGF/FGFR alterations.

The program initially included three Phase 2 trials – FIGHT-201 in patients with bladder cancer, FIGHT-202 in patients with cholangiocarcinoma, and FIGHT-203 in patients with myeloid/lymphoid neoplasms with FGFR1 rearrangement.

Based on data generated from these trials, we have initiated additional trials including FIGHT-302, a Phase 3 study in first-line cholangiocarcinoma.

FIGHT-207, a solid tumor-agnostic trial evaluating pemigatinib in patients with driver-alterations of FGF/FGFR, is now closed to recruitment.

Pemigatinib has Breakthrough Therapy designation as a treatment for patients with myeloid/lymphoid neoplasms (MLN) with FGFR1 rearrangement who have relapsed or are refractory to initial chemotherapy.

In July 2024, we announced positive topline results from both the two Phase 3 clinical studies evaluating retifanlimab, a humanized monoclonal antibody targeting programmed cell death receptor-1 (PD-1), in squamous cell anal carcinoma (SCAC) and non-small cell lung cancer (NSCLC).

In August 2024, we announced positive topline results from the Phase 3 clinical study evaluating tafasitamab in relapsed or refractory follicular lymphoma (FL).

The pivotal Phase 3 inMIND trial evaluating the efficacy and safety of tafasitamab or placebo in combination with lenalidomide and rituximab compared to lenalidomide and rituximab alone, met the primary endpoint of progression free survival (PFS) by investigator assessment in FL.

The trial also met key secondary endpoints of PFS in the overall population by investigator assessment as well as the positron-emission tomography-complete response rate in the FDG-avid FL population.

No new safety signals with tafasitamab were observed.

The full dataset is anticipated to be presented at an upcoming medical meeting in 2024 and we currently expect to file a supplemental Biologics License Application (sBLA) for tafasitamab in combination with lenalidomide and rituximab in FL by the end of 2024.

The phase 3 study in SCAC met its primary endpoint of progression free survival while the Phase 3 study in NSCLC meet its primary endpoint of overall survival.

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POD1UM-304 is a Phase 3, global, multicenter, randomized, double-blind study evaluating platinum-based chemotherapy with retifanlimab or placebo in patients with first-line, metastatic squamous or nonsquamous NSCLC.

In September 2024, we presented late-breaking Phase 3 results for retifanlimab that were featured during the 2024 European Society for Medical Oncology (ESMO) Presidential Symposium.

The Phase 3 POD1UM-303/InterAACT2 trial for retifanlimab met the primary endpoint of PFS and demonstrated improvement across key secondary endpoints in patients with SCAC receiving retifanlimab in combination with platinum-based chemotherapy (carboplatin-paclitaxel).

Incyte plans to file an sBLA for retifanlimab in SCAC by the end of 2024.

A potential approval in 2025 could represent the first PD-(L)1 antibody for patients with SCAC.

MPN, GVHD and Oncology Programs Indication and Phase

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(JAK1/JAK2 + BETi) Myelofibrosis:

Axatilimab (anti-CSF-1R) 1

Chronic GVHD:

Pivotal Phase 2 (third-line plus therapy) (AGAVE-201);

BLA under review in the U.S.

Ruxolitinib + axatilimab 1

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Chronic GVHD:

Phase 2 in preparation

Steroids + axatilimab 1

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(mCALR) Myelofibrosis, essential thrombocythemia:

(JAK2V617Fi) Phase 1

Pemigatinib (PEMAZYRE)

Myeloid/lymphoid neoplasms (MLN):

approved in the U.S.

Cholangiocarcinoma (CCA):

Phase 3 (FIGHT-302)

(JAK2V617Fi) Myelofibrosis:

Tafasitamab (MONJUVI/MINJUVI)

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Phase 3 ( front MIND)

Relapsed or refractory follicular lymphoma (FL) and relapsed or refractory marginal zone lymphoma (MZL):

Relapsed or refractory follicular lymphoma (FL):

Phase 3 ( in MIND)

Retifanlimab (ZYNYZ) 2

Merkel cell carcinoma (MCC):

approved in the U.S.

Squamous cell anal cancer (SCAC):

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(CDK2i) Solid tumors with Amplification/ Overexpression of CCNE1:

(KRASG12D) Advanced metastatic solid tumors with a KRAS G12D mutation:

(KRASG12D) Advanced metastatic solid tumors with a KRASG12D mutation:

(TGFßR2×PD-1) 3

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In July 2024, we announced a strategic review of our pipeline with an increased focus on high potential impact programs.

We will discontinue further development of both oral, small molecule PD-L1 inhibitors, as well as LAG-3 monoclonal antibody, TIM-3 monoclonal antibody and LAG-3xPD-1 bispecific.

We will discontinue further development of both oral, small molecule PD-L1 inhibitors.

Additionally, we plan to forgo further development of our LAG-3 monoclonal antibody, TIM-3 monoclonal antibody and LAG-3xPD-1 bispecific program and in parallel, seek partners to advance further development of these programs.

INCB123667 (CDK2)

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Additional data from this trial is anticipated in 2024.

In September 2024, we presented initial data from the Phase 1 CDK2 inhibitor program at the 2024 ESMO Congress.

Phase 1 data of INCB123667 were presented demonstrating single-agent antitumor activity across a range of doses and regimens, notably in patients with ovarian cancer and endometrial cancer whose tumors overexpress Cyclin E1.

The Phase 1 trial is ongoing with INCB123667 in combination with other agents.

We currently anticipate initiating a pivotal trial in ovarian cancer in 2025.

INCB161734 (KRASG12D)

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OPZELURA subsequently was approved by the FDA and European Commission for vitiligo in July 2022 and April 2023, respectively.

Incyte’s IAI efforts also include numerous clinical development programs.

Our IAI efforts also include numerous clinical development programs.

OPZELURA (ruxolitinib) cream

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In the United States, we estimate that there are approximately 10 million diagnosed adolescent and adult patients with AD.

1 In collaboration with Merus.

The approval of OPZELURA was based on data from two randomized, double-blind, vehicle-controlled Phase 3 studies (TRuE-AD1 and TRuE-AD 2) evaluating the safety and efficacy of OPZELURA in adolescents and adults with mild to moderate AD.

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These results showed that patients who initially experienced limited or no facial or total body repigmentation at six months achieved improved repigmentation after continued treatment with OPZELURA for up to two years.

In January 2024, we received approval in France to promote and distribute OPZELURA for vitiligo under a process called “Accès Direct.” This process is intended to allow for early access to a therapy while a final price is negotiated.

We achieved full reimbursement for OPZELURA in Spain and Italy at the end of the second quarter 2024 and in France in July 2024.

In October 2024, OPZELURA cream 1.5% was granted a Notice of Compliance by Health Canada for the topical treatment of both mild to moderate atopic dermatitis and nonsegmental vitiligo in patients 12 years of age and older.

Clinical Programs in Dermatology

Ruxolitinib cream

Ruxolitinib cream is a potent, selective inhibitor of JAK1 and JAK2 that provides the opportunity to directly target diverse pathogenic pathways that underlie certain dermatologic conditions, including atopic dermatitis, vitiligo, lichen planus, lichen sclerosus, hidradenitis suppurativa and prurigo nodularis.

In October 2021, we announced the validation of the MAA for ruxolitinib cream as a potential treatment for adolescents and adults (age ≥12 years) with nonsegmental vitiligo with facial involvement.

Ruxolitinib cream is a potent, selective inhibitor of JAK1 and JAK2 that provides the opportunity to directly target diverse pathogenic pathways that underlie certain dermatologic conditions, including AD, vitiligo, lichen planus, lichen sclerosus, hidradenitis suppurativa (HS) and prurigo nodularis (PN).

In October 2021, we announced the validation of the European marketing authorization application (MAA) for ruxolitinib cream as a potential treatment for adolescents and adults (age ≥12 years) with nonsegmental vitiligo with facial involvement.

In November 2022, we initiated two Phase 2 trials evaluating ruxolitinib cream in lichen planus and lichen sclerosus.

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Again, significantly more patients treated with ruxolitinib cream (0.75% and 1.5%) achieved Investigator’s Global Assessment Treatment Success (IGA-TS) than patients treated with vehicle control (non-medicated cream).

In January, 2024, we announced positive topline results from a randomized controlled Phase 2 study evaluating ruxolitinib cream in Hidradenitis Suppurativa (HS).

In January 2024, we announced positive topline results from a randomized controlled Phase 2 study evaluating ruxolitinib cream in HS.

Ruxolitinib 1.5% cream BID met the primary efficacy endpoint as measured by a change from baseline in abscess and nodule count at Week 16 versus placebo in patients with mild to moderate HS.

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A Phase 3 study is expected to initiate in 2025.

In October 2024, we disclosed results from the Phase 2 study of ruxolitinib cream in patients with cutaneous lichen planus.

At this time, we do not plan to advance ruxolitinib cream into a registrational study for lichen planus and plan to publish the results of this study in the future.

Additionally, the Phase 2 study evaluating ruxolitinib cream for lichen sclerosus did not meet our internal bar for success and at this time, we are not planning to advance this indication into a registrational study.

In October 2024, we announced the Phase 3 trial for ruxolitinib cream in mild to moderate HS is on track to initiate in the first half of 2025 following achieving alignment on the study design with the FDA.

Ruxolitinib cream has the potential to provide a new therapeutic option for mild to moderate HS patients.

We also are developing povorcitinib (formerly INCB54707), which is an oral small molecule selective JAK1 inhibitor.

Povorcitinib is undergoing evaluation in patients with hidradenitis suppurativa (HS), nonsegmental vitiligo, prurigo nodularis (PN), asthma and chronic spontaneous urticaria (CSU).

Povorcitinib is undergoing evaluation in patients with hidradenitis suppurativa, nonsegmental vitiligo, prurigo nodularis, asthma and chronic spontaneous urticaria (CSU).

Hidradenitis Suppurativa.

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In October 2023, we announced that the Phase 2, randomized, double-blind, placebo-controlled, dose ranging study evaluating the efficacy and safety of povorcitinib in participants with PN had met its primary endpoint.

A Phase 3 study in PN is expected to initiate in 2024.

In October 2024, following the positive Phase 2 results, two Phase 3 studies in patients with PN were initiated.

Asthma and Chronic Spontaneous Urticaria.

In July 2023, we initiated two Phase 2 trials evaluating povorcitinib in patients with moderate to severe uncontrolled asthma and in chronic spontaneous urticaria.

INCB000262 (EP262) (MRGPRX2) & INCB000547 (EP547) (MRGPRX4)

Data for CSU are anticipated in the first half of 2025 and data in asthma are anticipated in the second half of 2025.

INCB000262 (MRGPRX2) & INCB000547 (MRGPRX4)

As more fully described in Note 6 to the Condensed Consolidated Financial Statements, in May 2024, we acquired Escient Pharmaceuticals, Inc.

Escient is a clinical-stage drug discovery and development company advancing novel small molecule therapeutics for systemic immune and neuro-immune disorders.

Escient’s clinical development portfolio includes EP262, a first-in-class, potent, highly selective, once-daily small molecule antagonist of Mas-related G protein-coupled receptor (MRGPRX2) and EP547, a first-in-class oral MRGPRX4 antagonist.

MRGPRX2 is a specific, novel mechanism for blocking mast cell activation, independent from IgE, and has been a high priority target to add to our IAI pipeline.

EP262 is a first-in-class medicine that entered the clinic in January 2023 and is currently being evaluated in the clinic.

In the Phase 1 healthy volunteer study, EP262 was well-tolerated, had low inter-patient PK variability and achieved exposures well above predicted efficacious levels.

EP262 is currently in a phase 1b open label study in chronic inducible urticaria (CIndU) and in two randomized phase 2 studies in chronic spontaneous urticaria (CSU) and atopic dermatitis (AD) with data for all three studies expected by early 2025.

EP547 is a potent and highly-selective antagonist of MRGPRX4.

Escient’s clinical development portfolio includes INCB000262 , a first-in-class, potent, highly selective, once-daily small molecule antagonist of Mas-related G protein-coupled receptor (MRGPRX2) and INCB000547 , a first-in-class oral MRGPRX4 antagonist.

INCB000262 is a specific, novel mechanism for blocking mast cell activation, independent from IgE, and has been a high priority target to add to our IAI pipeline.

INCB000547 is a first-in-class medicine that entered the clinic in January 2023 and is currently being evaluated in the clinic.

In the Phase 1 healthy volunteer study, INCB000547 was well-tolerated, had low inter-patient PK variability and achieved exposures well above predicted efficacious levels.

INCB000547 is currently in a phase 1b open label study in chronic inducible urticaria (CIndU) and in two randomized phase 2 studies in CSU and AD with data for all three studies expected by early 2025.

INCB000547 is a potent and highly-selective antagonist of MRGPRX4.

MRGPRX4 is expressed on neurons in the dorsal root ganglia and specifically activated by bile acids that are increased in cholestatic patients.

Initial evaluation is being conducted in cholestatic pruritus with clinical proof-of-concept for cholestatic pruritus associated with primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC), anticipated by early 2025.

Indication expansion opportunities for both EP262 and EP547 are under evaluation.

Indication expansion opportunities for both INCB000262 and INCB000547 are under evaluation.

IAI and Dermatology Programs Indication and Phase

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Phase 3 pediatric study (TRuE-AD3)

Approved in the U.S.

Lichen planus:

Lichen sclerosus:

Hidradenitis suppurativa:

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Phase 3 (TRuE-PN1, TRuE-PN2)

Ruxolitinib cream + UVB

(JAK1/JAK2 + phototherapy) Vitiligo:

(JAK1) Hidradenitis suppurativa:

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Prurigo nodularis:

Phase 3 expected to initiate in 2024

Phase 3 (STOP-PN1, STOP-PN2)

Chronic spontaneous urticaria:

INCB000262 (EP262)

(MRGPRX2) Chronic spontaneous urticaria:

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Atopic dermatitis:

INCB000547 (EP547)

(MRGPRX4) Cholestatic pruritus:

(anti-IL-15Rβ) Vitiligo:

(anti-CD122) Vitiligo:

Novartis’ rights for ruxolitinib outside of the United States under our Collaboration and License Agreement with Novartis do not include topical administration.

Earlier-Stage Development Programs in Dermatology

INCA034460 (anti-CD122)

In November 2022, we acquired Villaris Therapeutics, Inc., an asset-centric biopharmaceutical company focused on the development of novel antibody therapeutics for vitiligo.

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All four Phase 3 trials met their respective primary endpoints.

In January 2016, Lilly submitted a New Drug Application (NDA) to the FDA and an MAA to the EMA for baricitinib as treatment for rheumatoid arthritis.

In January 2016, Lilly submitted a New Drug Application (NDA) to the FDA and an MAA to the European Medicines Agency (EMA) for baricitinib as treatment for rheumatoid arthritis.

In February 2017, we and Lilly announced that the European Commission approved baricitinib as OLUMIANT for the treatment of moderate-to-severe rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying antirheumatic drugs (DMARDs).

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The collaboration encompasses up to ten independent programs.

In September 2021, we entered into a Collaboration and License Agreement with Syndax covering the worldwide development and commercialization of SNDX-6352 (axatilimab), Syndax’s anti-CSF-1R monoclonal antibody.

In September 2021, we entered into a Collaboration and License Agreement with Syndax covering the worldwide development and commercialization of NIKTIMVO (axatilimab-csfr), Syndax’s anti-CSF-1R monoclonal antibody.

Axatilimab was granted Orphan Drug Designation by the FDA in March 2021 for the treatment of chronic GVHD and again in April 2021 for the treatment of idiopathic pulmonary fibrosis.

In August 2024, Incyte and Syndax announced the FDA approval of NIKTIMVO (axatilimab-csfr) for the treatment of chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy in adult and pediatric patients.

Under the terms of this agreement, we received exclusive commercialization rights to axatilimab outside of the United States, and co-commercialization rights in the United States.

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Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our Annual Report on Form 10-K for the year ended December 31, 2023.

There have been no significant changes to our critical accounting policies or estimates during the six months ended June 30, 2024.

There have been no significant changes to our critical accounting policies or estimates during the nine months ended September 30, 2024.

Recent Accounting Pronouncements and Regulatory Updates

In November 2023, the Financial Accounting Standards Board (the “FASB”) issued ASU No.

In November 2023, the Financial Accounting Standards Board (“FASB”) issued ASU No.

2023-07, “ Segment Reporting (Topic 280):

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Results of Operations

We recorded net loss of $444.6 million and basic and diluted net loss per share of $2.04 for the three months ended June 30, 2024, as compared to net income of $203.5 million and basic net income per share of $0.91 and diluted net income per share of $0.90 in the corresponding period in 2023.

We recorded net loss of $275.1 million and basic and diluted net loss per share of $1.24 for the six months ended June 30, 2024, as compared to net income of $225.3 million and basic net income per share of $1.01 and diluted net income per share of $1.00 in the corresponding period in 2023.

We recorded net income of $106.5 million and basic net income per share of $0.55 and diluted net income per share of $0.54 for the three months ended September 30, 2024, as compared to net income of $171.3 million and basic and diluted net income per share of $0.76 in the corresponding period in 2023.

We recorded net loss of $168.6 million and basic and diluted net loss per share of $0.80 for the nine months ended September 30, 2024, as compared to net income of $396.5 million and basic net income per share of $1.77 and diluted net income per share of $1.76 in the corresponding period in 2023.

Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

2024 2023 2024 2023

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Total revenues $ 1,137.9 $ 919.0 $ 3,062.5 $ 2,682.3

The increase in JAKAFI product revenues for the three months ended June 30, 2024 as compared to the corresponding period in 2023 was comprised of a volume increase of $17.2 million and a price increase of $6.4 million.

The increase in JAKAFI net product revenues for the six months ended June 30, 2024 as compared to the corresponding period in 2023 reflected a price increase of $17.2 million, subject to a volume decrease of $1.8 million.

The increase for the three months ended June 30, 2024 as compared to the corresponding period in 2023 was primarily driven by an increase in paid demand across all indications.

For the six months ended June 30, 2024 as compared to the corresponding period in 2023, the increase in net product revenues due to the increase in paid demand was offset by higher channel inventory levels at the end of the second quarter of 2023 versus the second quarter of 2024.

The increase in OPZELURA net product revenues for the three months ended June 30, 2024 as compared to the corresponding period in 2023 was comprised of a volume increase of $36.4 million and a price increase of $5.1 million.

The increase in OPZELURA net product revenues for the six months ended June 30, 2024 as compared to the corresponding period in 2023 was comprised of a volume increase of $63.2 million and a price increase of $7.4 million.

The increase in OPZELURA net product revenues for the three and six months ended June 30, 2024 was driven by continued growth in new patient starts and refills and approximately $11.0 million of net product revenues in the second quarter of 2024 were from Europe.

The increase in MINJUVI/MONJUVI net product revenues for the three and six months ended June 30, 2024 was driven by the acquisition completed in February 2024, under which we gained exclusive global rights to tafasitamab marketed in the United States as MONJUVI (tafasitamab-cxix).

The increase in JAKAFI product revenues for the three months ended September 30, 2024 as compared to the corresponding period in 2023 was comprised of a volume increase of $78.2 million and a price increase of $26.7 million.

The increase in JAKAFI net product revenues for the nine months ended September 30, 2024 as compared to the corresponding period in 2023 reflected a volume increase of $74.8 million and a price increase of $45.6 million.

The increase for the three and nine months ended September 30, 2024 as compared to the corresponding periods in 2023 was primarily driven by an increase in paid demand across all indications.

The increase in OPZELURA net product revenues for the three months ended September 30, 2024 as compared to the corresponding period in 2023 was comprised of a volume increase of $45.8 million and a price increase of $1.7 million.

The increase in OPZELURA net product revenues for the nine months ended September 30, 2024 as compared to the corresponding period in 2023 was comprised of a volume increase of $109.2 million and a price increase of $8.9 million.

The increase in OPZELURA net product revenues for the three and nine months ended September 30, 2024 was driven by continued growth in new patient starts and refills and approximately $20.4 million of net product revenues in the third quarter of 2024 were from Europe.

The increase in MINJUVI/MONJUVI net product revenues for the three and nine months ended September 30, 2024 was driven by the acquisition completed in February 2024, under which we gained exclusive global rights to tafasitamab marketed in the United States as MONJUVI (tafasitamab-cxix).

Refer to Note 6 of Notes to the Condensed Consolidated Financial Statements for further information related to the acquisition.

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The following table provides a summary of activity with respect to our sales allowances and accruals (in thousands):

Six Months Ended June 30, 2024 Discounts and

Nine Months Ended September 30, 2024 Discounts and

Fees Government

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Credits/payments for prior period sales (16,226) (99,678) (4,237) (8,864) (129,005)

Balance at June 30, 2024 $ 21,226 $ 309,074 $ 10,600 $ 15,645 $ 356,545

Balance at September 30, 2024 $ 20,033 $ 339,496 $ 10,773 $ 17,714 $ 388,016

Government rebates and chargebacks are the most significant component of our sales allowances.

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We believe that such a reading would violate CMS’s statutory authority and be arbitrary and capricious given that OPZELURA, among other differentiators, is indicated to treat entirely different medical conditions and entirely different patient populations than JAKAFI.

As of June 30, 2024, we have accrued approximately $91.1 million within accrued and other current liabilities on the condensed consolidated balance sheet, relating to the incremental rebates that would be owed were OPZELURA considered a line extension of JAKAFI.

The impact on OPZELURA gross to net deductions for the quarter ending June 30, 2024 is approximately 6.8%.

As of September 30, 2024, we have accrued approximately $106.9 million within accrued and other current liabilities on the condensed consolidated balance sheet, relating to the incremental rebates that would be owed were OPZELURA considered a line extension of JAKAFI.

The impact on OPZELURA gross to net deductions for the quarter ending September 30, 2024 is approximately 6.7%.

If OPZELURA is not treated as a line extension of JAKAFI, this would result in a reversal of our accrual and a lower future gross to net deduction for OPZELURA.

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Product royalty revenues on commercial sales of PEMAZYRE by Innovent are based on net sales of licensed products in licensed territories as provided by Innovent.

Our milestone and contract revenues for the six months ended June 30, 2024, was derived from a $25.0 million upfront payment received during the first quarter of 2024 upon our transfer of functional intellectual property to CMSHL.

Our milestone and contract revenues for the nine months ended September 30, 2024, was derived from a $25.0 million upfront payment received during the first quarter of 2024 upon our transfer of functional intellectual property to CMSHL, and we recognized $18.0 million of upfront and milestone payments from two of our collaboration partners during the three months ended September 30, 2024.

Cost of Product Revenues

Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

2024 2023 2024 2023

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Cost of product revenues includes all product related costs, reserves for obsolescence, employee personnel costs, including stock compensation, for those employees dedicated to the production of our commercial products, royalties under our collaborative agreements and amortization of our licensed intellectual property rights for ICLUSIG and the amortization of capitalized milestone payments.

The increase in cost of product revenues for the three and six months ended June 30, 2024 as compared to the same periods in 2023 was primarily due to growth in net product revenues.

The increase in cost of product revenues for the three and nine months ended September 30, 2024 as compared to the same periods in 2023 was primarily due to growth in net product revenues, increased royalty expense and increased manufacturing related costs.

Operating Expenses

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Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

2024 2023 2024 2023

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We account for research and development costs by natural expense line and not costs by project.

The increase in salary and benefits related expense for the three and six months ended June 30, 2024 as compared to the corresponding period in 2023 was due primarily to increased development headcount to sustain our development pipeline.

The increase in salary and benefits related expense for the three and nine months ended September 30, 2024 as compared to the corresponding period in 2023 was due primarily to increased development headcount to sustain our development pipeline.

Stock compensation expense may fluctuate from period to period based on the number of awards granted, stock price volatility and expected award lives, as well as expected award forfeiture rates which are used to value equity-based compensation.

Additionally, as described in Note 6 to the Condensed Consolidated Financial Statements, as part of the Escient acquisition, during the three months ended June 30, 2024, we recognized compensation expense in research and development of $11.3 million associated with the accelerated vesting for certain Escient stock awards in connection with the acquisition on our condensed consolidated statements of operations.

Research and development expenses for the three and six months ended June 30, 2024 also include the $679.4 million of expense related to the acquired in-process research and development assets as part of the Escient acquisition, as described in Note 6 to the Condensed Consolidated Financial Statements.

The increase in clinical research and outside services expense for the three months ended June 30, 2024 as compared to the corresponding period in 2023, was primarily due to continued investment in our late stage development assets and timing of certain expenses.

Research and development expenses include upfront and milestone expenses related to our collaborative agreements of $0.4 million and $1.4 million, respectively, for the three and six months ended June 30, 2024.

Research and development expenses include upfront and milestone expenses related to our collaborative agreements of $7.0 million and $9.7 million, respectively, for the three and six months ended June 30, 2023.

Research and development expenses for the three and six months ended June 30, 2024 and 2023 were net of $4.2 million, $21.3 million, $25.1 million and $25.7 million, respectively, of costs reimbursed by our collaborative partners.

Additionally, as described in Note 6 to the Condensed Consolidated Financial Statements, as part of the Escient acquisition, during the second quarter of 2024, we recognized compensation expense in research and development of approximately $11.3 million associated with the accelerated vesting for certain Escient stock awards in connection with the acquisition on our condensed consolidated statements of operations.

Research and development expenses for the nine months ended September 30, 2024 also include the $679.4 million of expense related to the acquired in-process research and development assets as part of the Escient acquisition, as described in Note 6 to the Condensed Consolidated Financial Statements.

The increase in clinical research and outside services expense for the three months ended September 30, 2024 as compared to the corresponding period in 2023, was primarily due to continued investment in our late stage development assets, additional research and development expenses resulting from the Escient acquisition and timing of certain expenses.

Research and development expenses include upfront and milestone expenses related to our collaborative agreements of $100.0 million and $101.4 million, respectively, for the three and nine months ended September 30, 2024.

Research and development expenses include upfront and milestone expenses related to our collaborative agreements of $3.0 million and $12.7 million, respectively, for the three and nine months ended September 30, 2023.

Research and development expenses for the three and nine months ended September 30, 2024 and 2023 were net of approximately $3.8 million, $25.1 million, $11.3 million and $37.0 million, respectively, of costs reimbursed by our collaborative partners.

In addition to one-time expenses resulting from upfront fees in connection with the entry into any new or amended collaboration agreements and payment of milestones under those agreements, research and development expenses may fluctuate from period to period depending upon the stage of certain projects and the level of preclinical and clinical trial related activities.

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Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

2024 2023 2024 2023

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Total selling, general and administrative expenses $ 309.2 $ 267.9 $ 915.4 $ 867.4

The increase in salary and benefits related expense for the three and six months ended June 30, 2024 as compared to the corresponding period in 2023 was due primarily to increased headcount.

The increase in salary and benefits related expense for the three and nine months ended September 30, 2024 as compared to the corresponding period in 2023 was due primarily to increased headcount.

This increased headcount was due primarily to the establishment of our dermatology commercial organization.

Additionally, as described in Note 6 to the Condensed Consolidated Financial Statements, as part of the Escient acquisition, during the three months ended June 30, 2024, we recognized compensation expense in selling, general and administrative expenses of $20.2 million associated with the accelerated vesting for certain Escient stock awards in connection with the acquisition on our condensed consolidated statements of operations.

The decrease in other contract services and outside costs for the three months ended June 30, 2024, as compared to the corresponding period in 2023, was primarily due to the timing of consumer marketing activities and of certain other expenses.

Loss on change in fair value of acquisition-related contingent consideration

Additionally, as described in Note 6 to the Condensed Consolidated Financial Statements, as part of the Escient acquisition, during the second quarter of 2024, we recognized compensation expense in selling, general and administrative expenses of approximately $20.2 million associated with the accelerated vesting for certain Escient stock awards in connection with the acquisition on our condensed consolidated statements of operations.

The increase in other contract services and outside costs for the three months ended September 30, 2024, as compared to the corresponding period in 2023, was primarily due to the timing of consumer marketing activities and of certain other expenses.

Loss (gain) on change in fair value of acquisition-related contingent consideration

Acquisition-related contingent consideration, which consists of our future royalty obligations to ARIAD/Takeda, was recorded on the acquisition date, June 1, 2016, at the estimated fair value of the obligation, in accordance with the acquisition method of accounting.

The change in fair value of the acquisition-related contingent consideration for the three and six months ended June 30, 2024 was a loss of $0.9 million and $0.4 million, respectively, which is recorded in loss on change in fair value of acquisition-related contingent consideration on the condensed consolidated statements of operations.

The loss on change in fair value of the acquisition-related contingent consideration for the three and six months ended June 30, 2023 was $8.4 million and $14.6 million, respectively, which is recorded in loss on change in fair value of acquisition-related contingent consideration on the condensed consolidated statements of operations.

The change in fair value of the contingent consideration during the three and six months ended June 30, 2024 was due primarily to fluctuations in foreign currency exchange rates impacting future revenue projections of ICLUSIG and the passage of time.

The change in fair value of the contingent consideration during the three and six months ended June 30, 2023 was due primarily to the passage of time.

(Profit) and loss sharing under collaboration agreements

The change in fair value of the acquisition-related contingent consideration for the three and nine months ended September 30, 2024 was a loss of $23.4 million and $23.8 million, respectively, which is recorded in loss (gain) on change in fair value of acquisition-related contingent consideration on the condensed consolidated statements of operations.

The change in fair value of the acquisition-related contingent consideration for the three and nine months ended September 30, 2023 was a gain of $0.4 million and a loss of $14.1 million, respectively, which is recorded in loss (gain) on change in fair value of acquisition-related contingent consideration on the condensed consolidated statements of operations.

The change in fair value of the contingent consideration during the three and nine months ended September 30, 2024 was due primarily to fluctuations in foreign currency exchange rates impacting future revenue projections of ICLUSIG and the passage of time.

The change in fair value of the contingent consideration during the three and nine months ended September 30, 2023 was due primarily to fluctuations in foreign currency exchange rates impacting future revenue projections of ICLUSIG and the passage of time.

Loss and (profit) sharing under collaboration agreements

Under the former collaboration and license agreement with MorphoSys, which was executed in March 2020 and continued through February 5, 2024 as described further in Note 6 of Notes to the Condensed Consolidated Financial Statements, we and MorphoSys were both responsible for the commercialization efforts of tafasitamab in the United States and shared equally the profits and losses from the co-commercialization efforts.

For the period from January 1, 2024 through February 5, 2024, our 50% share of the profits for tafasitamab was $1.0 million, as recorded in (profit) and loss sharing under collaboration agreements on the condensed consolidated statement of operations.

For the three and six months ended June 30, 2023, our 50% share of the profits for tafasitamab was $0.5 million and $1.9 million, respectively, as recorded in (profit) and loss sharing under collaboration agreements on the condensed consolidated statement of operations.

For the period from January 1, 2024 through February 5, 2024, our 50% share of the profits for tafasitamab was $1.0 million, as recorded in loss and (profit) sharing under collaboration agreements on the condensed consolidated statement of operations.

For the three and nine months ended September 30, 2023, our 50% share of the losses and profits for tafasitamab was a loss of $1.1 million and a profit of $0.9 million, respectively, as recorded in loss and (profit) sharing under collaboration agreements on the condensed consolidated statement of operations.

Non-operating Income and Expenses

Interest income and other, net

Interest income and other, net for the three and six months ended June 30, 2024 was $49.8 million and $94.5 million, respectively.

Interest income and other, net for the three and six months ended June 30, 2023 was $42.7 million and $75.5 million, respectively.

The increase in Interest income and other, net for the three and six months ended June 30, 2024 primarily relates to an increase in interest earned on our cash equivalents and marketable securities generally due to higher interest rates.

Realized and unrealized gain on equity investments

Realized and unrealized gains and losses on equity investments will fluctuate from period to period, based on sales of securities and the change in fair value of the securities we hold in our publicly held collaboration partners.

The following table provides a summary of those realized and unrealized gains (losses):

Interest income and other, net for the three and nine months ended September 30, 2024 was $24.2 million and $118.7 million, respectively.

Interest income and other, net for the three and nine months ended September 30, 2023 was $46.4 million and $121.9 million, respectively.

The decrease in Interest income and other, net for the three and nine months ended September 30, 2024 primarily relates to a decrease in interest earned on our cash equivalents and marketable securities generally due to lower cash equivalent and marketable securities balance in third quarter of 2024 as compared to the corresponding period in 2023.

Realized and unrealized (loss) gain on equity investments

Realized and unrealized losses and gains on equity investments will fluctuate from period to period, based on sales of securities and the change in fair value of the securities we hold in our publicly held collaboration partners.

The following table provides a summary of those realized and unrealized (losses) gains:

Three Months Ended

June 30, Six Months Ended

September 30, Nine Months Ended

September 30,

2024 2023 2024 2023

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Other (0.2) (0.1) (0.5) (0.2)

Total realized and unrealized gain on equity investments $ 39.2 $ 41.8 $ 139.2 $ 36.5

Total realized and unrealized (loss) gain on equity investments $ (13.0) $ (26.7) $ 126.2 $ 9.8

Provision for income taxes

The provision for income taxes for the three and six months ended June 30, 2024 was $54.8 million and $121.4 million, respectively.

The provision for income taxes for the three and six months ended June 30, 2023 was $74.1 million and $104.2 million, respectively.

Our effective tax rate for the three and six months ended June 30, 2024 was higher than the U.S.

statutory rate primarily due to the non-deductible charges of $710.9 million associated with the Escient acquisition.

Our effective tax rate for the three and six months ended June 30, 2023 was higher than the U.S.

The provision for income taxes for the three and nine months ended September 30, 2024 was $50.1 million and $171.5 million, respectively.

The provision for income taxes for the three and nine months ended September 30, 2023 was $62.5 million and $166.7 million, respectively.

Our effective tax rate for the three months ended September 30, 2024 was higher than the U.S.

statutory rate primarily due to foreign losses with no associated tax benefit (i.e., full valuation allowance) and an increase in our valuation allowance against certain U.S.

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This was partially offset by tax rate benefits associated with research and development and orphan drug tax credit generations and the foreign derived intangible income deduction.

Our effective tax rate for the nine months ended September 30, 2024 was higher than the U.S.

statutory rate primarily due to non-deductible charges of $710.9 million associated with the Escient acquisition.

Our effective tax rate for the three and nine months ended September 30, 2023 was higher than the U.S.

statutory rate primarily due to foreign losses with no associated tax benefit and an increase in our valuation allowance against certain U.S.

federal and state deferred tax assets.

This was partially offset by tax rate benefits associated with research and development and orphan drug tax credit generations and the foreign derived intangible income deduction.

Liquidity and Capital Resources

At June 30, 2024, we had available cash, cash equivalents and marketable securities of $1.4 billion.

At September 30, 2024, we had available cash, cash equivalents and marketable securities of $1.8 billion.

Our cash and marketable securities balances are primarily held in a variety of interest-bearing instruments, including money market accounts and U.S.

government debt securities.

Additionally, we had short term equity investments of $69.9 million as of June 30, 2024.

Additionally, we had short term equity investments of $3.3 million as of September 30, 2024.

Available cash is invested in accordance with our investment policy’s primary objectives of liquidity, safety of principal and diversity of investments.

Net cash used in operating activities for the six months ended June 30, 2024 was $356.8 million and net cash provided by operating activities for the six months ended June 30, 2023 was $200.9 million.

Net cash used in operating activities for the nine months ended September 30, 2024 was $45.9 million and net cash provided by operating activities for the nine months ended September 30, 2023 was $348.8 million.

The decrease in cash provided by operating activities was due primarily to the Escient acquisition and changes in working capital.

Our investing activities, other than purchases, sales and maturities of marketable securities, have consisted predominantly of capital expenditures and sales of equity investments.

Net cash provided by investing activities was $140.7 million for the six months ended June 30, 2024, which primarily represented sales of equity investments of $227.3 million and sale and maturities of marketable securities of $182.6 million, offset in part by purchases of marketable securities of $204.1 million, and capital expenditures of $63.7 million.

Net cash used in investing activities was $36.0 million for the six months ended June 30, 2023, which represented purchases of marketable securities of $152.3 million, payments for intangible assets of $15.0 million, and capital expenditures of $19.2 million, offset in part by the sales and maturities of marketable securities of $150.5 million.

Net cash provided by investing activities was $179.0 million for the nine months ended September 30, 2024, which primarily represented sales of equity investments of $282.9 million and sale and maturities of marketable securities of $207.9 million, offset in part by purchases of marketable securities of $229.0 million, capital expenditures of $68.9 million and payments for intangible assets of $13.9 million.

Net cash used in investing activities was $53.2 million for the nine months ended September 30, 2023, which represented purchases of marketable securities of $222.2 million, payments for intangible assets of $15.0 million, purchases of equity investments of $10.0 million and capital expenditures of $30.2 million, offset in part by the sales and maturities of marketable securities of $224.2 million.

In the future, net cash used by investing activities may fluctuate significantly from period to period due to the timing of strategic equity investments, acquisitions, and capital expenditures and maturities/sales and purchases of marketable securities.

Net cash used in financing activities was $2.01 billion for the six months ended June 30, 2024 and was primarily driven by expenditures associated with the share repurchase of $2.00 billion.

Net cash provided by financing activities was $16.9 million for the six months ended June 30, 2023, primarily representing proceeds from the issuance of common stock under our stock plans, offset in part by cash paid to ARIAD/Takeda for contingent consideration.

Net cash used in financing activities was $2.0 billion for the nine months ended September 30, 2024 and was primarily driven by expenditures associated with the share repurchase of $2.0 billion.

Net cash used in financing activities was $20.4 million for the nine months ended September 30, 2023, primarily representing cash paid to ARIAD/Takeda for contingent consideration.

In August 2021, we entered into a $500.0 million, revolving credit and guaranty facility, which was subsequently amended in May 2023 and June 2024 (as amended, the "Credit Agreement").

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We may increase the maximum revolving commitments or add one or more incremental term loan facilities, subject to obtaining commitments from any participating lenders and certain other conditions, in an amount not to exceed $250.0 million plus a contingent additional amount that is dependent on our pro forma consolidated leverage ratio.

As of June 30, 2024, we had no outstanding borrowings and were in compliance with all covenants under this facility.

As of September 30, 2024, we had no outstanding borrowings and were in compliance with all covenants under this facility.

Due to the full utilization of our research and development and orphan drug tax credit carryforwards generated in prior years, our U.S.

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-Q

Item 2. Management’s Discussion and Analysis