On April 27, 2023 AbbVie (NYSE:ABBV) reported financial results for the first quarter ended March 31, 2023 (Press release, AbbVie, APR 27, 2023, View Source [SID1234630585]).

"This year is off to an excellent start, with first-quarter revenues and EPS ahead of our expectations, driven by strong commercial execution across all areas of our diversified portfolio," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "These balanced results give us confidence to increase our full-year guidance and we see numerous opportunities for key assets to drive compelling long-term growth."

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Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year’s foreign exchange rates. 1

First-Quarter Results

•Worldwide net revenues were $12.225 billion, a decrease of 9.7 percent on a reported basis, or 8.3 percent on an operational basis.

•Global net revenues from the immunology portfolio were $5.587 billion, a decrease of 9.0 percent on a reported basis, or 7.8 percent on an operational basis.
◦Global Humira net revenues of $3.541 billion decreased 25.2 percent on a reported basis, or 24.3 percent on an operational basis. U.S. Humira net revenues were $2.948 billion, a decrease of 26.1 percent. Internationally, Humira net revenues were $593 million, a decrease of 20.3 percent on a reported basis, or 14.8 percent on an operational basis.
◦Global Skyrizi net revenues were $1.360 billion, an increase of 44.7 percent on a reported basis, or 46.3 percent on an operational basis.
◦Global Rinvoq net revenues were $686 million, an increase of 47.5 percent on a reported basis, or 51.2 percent on an operational basis.

•Global net revenues from the hematologic oncology portfolio were $1.416 billion, a decrease of 14.0 percent on a reported basis, or 12.9 percent on an operational basis.
◦Global Imbruvica net revenues were $878 million, a decrease of 25.2 percent, with U.S. net revenues of $638 million and international profit sharing of $240 million.
◦Global Venclexta net revenues were $538 million, an increase of 13.7 percent on a reported basis, or 17.5 percent on an operational basis.

•Global net revenues from the neuroscience portfolio were $1.695 billion, an increase of 13.9 percent on a reported basis, or 15.0 percent on an operational basis.
◦Global Botox Therapeutic net revenues were $719 million, an increase of 17.1 percent on a reported basis, or 18.7 percent on an operational basis.
◦Global Vraylar net revenues were $561 million, an increase of 31.3 percent.
◦Global Ubrelvy net revenues were $152 million, an increase of 10.0 percent.

•Global net revenues from the aesthetics portfolio were $1.300 billion, a decrease of 5.4 percent on a reported basis, or 2.0 percent on an operational basis.
◦Global Botox Cosmetic net revenues were $659 million, an increase of 2.9 percent on a reported basis, or 5.8 percent on an operational basis.
◦Global Juvederm net revenues were $355 million, a decrease of 13.4 percent on a reported basis, or 7.4 percent on an operational basis.

•On a GAAP basis, the gross margin ratio in the first quarter was 67.4 percent. The adjusted gross margin ratio was 84.2 percent.

•On a GAAP basis, selling, general and administrative (SG&A) expense was 24.9 percent of net revenues. The adjusted SG&A expense was 24.4 percent of net revenues.

•On a GAAP basis, research and development (R&D) expense was 18.8 percent of net revenues. The adjusted R&D expense was 13.6 percent of net revenues, reflecting funding actions supporting all stages of our pipeline.

•Acquired IPR&D and milestones expense was 1.2 percent of net revenues.

•On a GAAP basis, the operating margin in the first quarter was 22.6 percent. The adjusted operating margin was 45.0 percent.

•Net interest expense was $454 million.

•On a GAAP basis, the tax rate in the quarter was 49.3 percent. The adjusted tax rate was 13.7 percent.

•Diluted EPS in the first quarter was $0.13 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.46. These results include an unfavorable impact of $0.08 per share related to acquired IPR&D and milestones expense.
Note: "Operational" comparisons are presented at constant currency rates that reflect comparative local currency net revenues at the prior year’s foreign exchange rates.
2

Recent Events

•AbbVie announced the European Commission (EC) approved Rinvoq (upadacitinib, 45 mg induction dose, 15 mg and 30 mg maintenance doses) as the first oral Janus Kinase (JAK) inhibitor for the treatment of adult patients with moderately to severely active Crohn’s disease (CD) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. The approval is based on results from three studies in which Rinvoq achieved the co-primary endpoints of clinical remission and endoscopic response, compared to placebo, as both induction and maintenance therapy. This is the seventh approved indication for Rinvoq in the European Union (EU).

•AbbVie announced positive top-line results from INSPIRE, a Phase 3 induction study, showing Skyrizi (risankizumab, 1200 mg intravenous (IV), at weeks 0, 4 and 8) met the primary endpoint of clinical remission at week 12, as well as all secondary endpoints in adult patients with moderately to severely active ulcerative colitis (UC). Safety results in this study were consistent with the known safety profile of Skyrizi, with no new safety risks observed. Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

•AbbVie announced positive top-line results from a Phase 2 study of Rinvoq (30 mg, once daily), given alone or as combination therapy (ABBV-599) with a Bruton’s Tyrosine Kinase inhibitor (elsubrutinib, 60 mg), in patients with moderately to severely active systemic lupus erythematosus (SLE). The study met the primary endpoint of SLE Responder Index (SRI-4) with a steroid dose of less than or equal to 10 mg per day at week 24 in patients with moderately to severely active SLE. Based on these results, AbbVie intends to advance its clinical program of Rinvoq in SLE to Phase 3.

•At the Congress of European Crohn’s and Colitis Organisation (ECCO), AbbVie presented 24 abstracts, including four oral presentations, two digital oral presentations and 18 posters from a broad range of studies across its inflammatory bowel disease (IBD) portfolio. Highlights included data from the ADVANCE, MOTIVATE and FORTIFY studies highlighting efficacy outcomes and clinical response in patients receiving Skyrizi for treatment of moderately to severely active CD, sub-analyses from the U-EXCEL, U-EXCEED and U-ENDURE studies evaluating Rinvoq for the treatment of moderately to severely active CD and analyses evaluating Rinvoq for the treatment of UC.

•At the 2023 American Academy of Dermatology (AAD) Annual Meeting, AbbVie presented more than 20 abstracts showcasing the strength of its dermatology portfolio. Notable presentations included late-breaking data that demonstrated Skyrizi improved plaque psoriasis (PsO) signs and symptoms among moderate to severe PsO patients that previously had a suboptimal response to IL-17 inhibitor therapy; abstracts assessing long-term outcomes of Skyrizi in patients with active psoriatic arthritis (PsA); subgroup analyses of outcomes in adults and adolescents with atopic dermatitis (AD) from three Phase 3 trials assessing the efficacy and safety of Rinvoq across 52 weeks; and results from a Phase 2 study evaluating the efficacy and safety of Rinvoq in moderate-to-severe hidradenitis suppurativa (HS).

•AbbVie announced that it intends to voluntarily withdraw the U.S. accelerated Imbruvica (ibrutinib) approvals for patients with mantle cell lymphoma (MCL) who received at least one prior therapy and patients with marginal zone lymphoma (MZL) who require systemic therapy and received at least one prior anti-CD20-based therapy. This voluntary action was due to requirements related to the accelerated approval status granted by the U.S. Food and Drug Administration (FDA) for MCL and MZL. Other approved indications for Imbruvica in the U.S. were not affected by this withdrawal and Imbruvica’s established clinical profile in other approved indications is unchanged. Imbruvica is jointly developed and commercialized with Janssen Biotech, Inc.

•AbbVie announced that the FDA approved expanding the indication of Qulipta (atogepant) for the preventive treatment of migraine in adults. The approval makes Qulipta the only oral calcitonin gene-related peptide (CGRP) receptor antagonist approved to prevent episodic and chronic migraine. The expanded indication provides an additional treatment option for those with chronic migraine whose frequent disabling attacks negatively impact performance of daily activities. Approval is based on a clinical trial that demonstrated statistically significant reduction from baseline in mean monthly migraine days and improvements in function and reduction in activity impairment.

•AbbVie announced it received a Complete Response Letter (CRL) from the FDA for the New Drug Application (NDA) for ABBV-951 (foscarbidopa/foslevodopa) for the treatment of motor fluctuations in adults with advanced Parkinson’s disease (PD). In its letter, the FDA requested additional information about the device (pump) as part of the NDA review. The CRL did not request that AbbVie conduct additional efficacy and safety trials related to the drug. AbbVie plans to resubmit the NDA as soon as possible.

•AbbVie and Capsida Biotherapeutics Inc. (Capsida) announced an expanded strategic collaboration to develop genetic medicines for eye diseases with high unmet need. The collaboration builds on the partnership announced in 2021. Under the expanded collaboration, AbbVie’s extensive capabilities will be paired with Capsida’s novel adeno-associated virus (AAV) engineering platform and manufacturing capability to identify and advance three programs.

Full-Year 2023 Outlook
AbbVie is raising its adjusted diluted EPS guidance for the full year 2023 from $10.62 – $11.02 to $10.72 – $11.12, which includes an unfavorable impact of $0.08 per share related to acquired IPR&D and milestones expense incurred during the first quarter 2023. The company’s 2023 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the first quarter of 2023, as both cannot be reliably forecasted.

On April 27, 2023 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its financial results for the first quarter of fiscal year 2023 (Press release, Chugai, APR 27, 2023, View Source;category= [SID1234630572]).

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"In the first quarter we saw an increase in both revenue and profits on a Core-basis due to steady growth of new and mainstay products. Sales increased both in Japan and overseas. Domestic sales were driven by new products Polivy and Vabysmo, mainstay products Hemlibra and Tecentriq, and the supply of Ronapreve to the government under the fiscal 2022 contract. Overseas sales increased from the growth of mainstay products. In R&D, Chugai’s crovalimab achieved the primary endpoint in its phase III clinical study and is scheduled to be filed for approval in Japan, the U.S., and Europe during the first half of this year. In addition, the foundation of future growth is steadily progressing, as evidenced by Chugai’s early-stage project SAIL66 entering the development pipeline, and the start of the full-scale operation of ‘Chugai Life Science Park Yokohama’ in April, which will serve as a center for innovation. Although contributions of COVID-19-related drugs will cease in the second quarter and beyond, sales of our global products and new/mainstay domestic products are strong, and projects that will contribute to mid-to long-term growth are progressing steadily. We will continue to strive to become a top innovator in the healthcare industry and deliver innovative new drugs to patients," said Dr. Osamu Okuda, Chugai’s President and CEO.

< First quarter results for 2023>

Chugai reported increased revenue and operating profit for the first quarter (Core-basis).

Revenue increased by 16.3% over the same period last year. Sales increased by approximately 20%, while other revenue decreased by approximately 20%. Domestic sales increased by approximately 20%. In the oncology field, the new product Polivy showed significant growth, and the mainstay product Tecentriq also contributed to the year-on-year increase despite the impact of biosimilars and NHI drug price revisions on mature products such as Avastin and Herceptin. In the specialty field, sales increased by approximately 30%, driven by the penetration of new products Vabysmo and Evrysdi, the supply of Ronapreve to the government, and the contribution of mainstay products Hemlibra and Enspryng. Overseas sales increased by approximately 20%. Sales of Alecensa increased significantly, more than tripling, and sales of Actemra remained strong. Other revenue decreased by approximately 20%, mainly due to the termination of royalty income from initial shipments of Hemlibra, despite the increase in royalties and profit-sharing income related to the intellectual property rights of Hemlibra. Revenue on IFRS basis, including Non-Core items, decreased due to the one-time impact of the lump-sum income from the settlement agreement with Alexion Pharmaceuticals, Inc in the previous year.

Cost to sales ratio rose by 4.8% points year-on-year to 51.8%, mainly due to a change in the product mix and the impact of foreign exchange. Research and development expenses increased mainly due to investments into drug discovery and early development, including the operation of Chugai Life Science Park Yokohama, and increases associated with the progress of development projects. Selling, general and administration expenses decreased mainly due to declines in various expenses. Other operating income (expense) was an income of ¥1.3 billion, mainly due to the recognition of gain on the sale of property, plant and equipment. As a result, Core operating profit totaled ¥105.4 billion (+6.6%).

The company also made good progress in research and development. Among our in-house projects that will contribute to mid to long-term profit growth, anti-C5 recycling anti-complement C5 recycling antibody crovalimab met the co-primary endpoints in the global Phase III clinical study in patients with paroxysmal nocturnal hemoglobinuria (PNH). Filing of applications for PNH is planned in Japan, the U.S., and Europe during the first half of this year. In addition, another phase I clinical study for crovalimab in lupus nephritis has newly started overseas. Furthermore, for GYM329, which is currently under development for several indications, a phase II study has started in facioscapulohumeral muscular dystrophy (FSHD), showing that simultaneous development of Chugai-originated projects is steadily progressing. Additionally, SAIL66, a novel antibody project which adopts Chugai’s proprietary antibody engineering technologies, entered the clinical development phase for solid tumors. For anti-IL-31 receptor A antibody nemolizumab, Galderma, the overseas licensee of the drug, announced that it achieved the primary endpoints in two phase III clinical studies for moderate to severe atopic dermatitis. Regarding projects in-licensed from Roche, late-stage clinical studies have started for the ophthalmic product Vabysmo and anti-CD20 antibody Gazyva for angioid streaks and pediatric nephrotic syndrome, respectively.

In April, Chugai Life Science Park Yokohama, a new research center combining the previous Fuji Gotemba Research Center and Kamakura Research Center, went into full operation, which will further advance drug discovery research to create innovation.

[2023 first quarter results]

Billion JPY 2023
Jan – Mar 2022
Jan – Mar % change
Core results
　Revenue 312.2 268.4 +16.3%
　　Sales 291.5 242.7 +20.1%
　　Other revenue* 20.7 25.7 -19.5%
　Operating profit 105.4 98.9 +6.6%
　Net income 78.4 70.6 +11.0%
IFRS results**
　Revenue 312.2 360.3 -13.3%
　Operating profit 98.3 187.0 -47.4%
　Net income 73.5 131.8 -44.2%
*Changed the title from "Royalties and other operating income" to "Other revenue".

**IFRS results in 2022 include non-Core items, such as the income and other related items, which totaled ¥90.7 billion associated with the settlement agreement between Chugai and Alexion Pharmaceuticals, Inc., which are excluded from the Core results Chugai adopts to manage recurring business activities.

[Sales breakdown]

Billion JPY 2023
Jan – Mar 2022
Jan – Mar % change
Sales 291.5 242.7 +20.1%
　Domestic sales 192.7 161.7 +19.2%
　　Oncology 60.0 58.4 +2.7%
　　Specialty 132.7 103.2 +28.6%
　Overseas sales 98.8 81.0 +22.0%

About Core results

Chugai discloses its results on a Core basis from 2013 in conjunction with its decision to apply IFRS. Core results are the results after adjusting non-Core items to IFRS results. Chugai’s recognition of non-recurring items may differ from that of Roche due to the difference in the scale of operations, the scope of business and other factors. Core results are used by Chugai as an internal performance indicator, for explaining the underlying business performance both internally and externally, and as the basis for payment-by-results such as a return to shareholders.

Trademarks used or mentioned in this release are protected by law.

On April 27, 2023 Alligator Bioscience AB ("Alligator") (Nasdaq Stockholm: ATORX) and Amphera B.V. ("Amphera") reported the successful dosing of the last patient in the REACTIVE-2 Phase 1 trial evaluating mitazalimab in combination with MesoPher in patients with metastatic pancreatic cancer (Press release, Alligator Bioscience, APR 27, 2023, View Source [SID1234630539]).

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The open-label, single-center Phase 1 dose finding study is assessing the safety and efficacy of Alligator’s lead asset mitazalimab (agonistic CD40 mAb), in combination with Amphera’s cancer vaccine MesoPher, in patients with metastatic pancreatic cancer after standard of care treatment with mFOLFIRINOX (NCT05650918). REACTIVE-2 is an investigator-sponsored trial being performed at Erasmus Medical Center in Rotterdam. Preliminary results are expected in Q4 2023.

"We are very pleased to have successfully reached this important milestone in the REACTIVE-2 trial." said Rob Meijer, CEO of Amphera. "MesoPher is able to invigorate the immune system without toxicity to the patient. This makes MesoPher ideally suited in combination treatments for difficult to treat cancer indications."

"Our CD40 agonist and Amphera’s cancer vaccine have both shown great promise in their own separate clinical studies emphasizing the crucial role of dendritic cells and other myeloid cells in immune response to pancreatic cancer," said Søren Bregenholt, CEO of Alligator Bioscience. "We have high hopes that a combination of mitazalimab and MesoPher can drive clinically meaningful anti-tumor immunity and potentially offer a new therapeutic option in this hard to treat patient population."

Mitazalimab is being evaluated in combination with mFOLFIRINOX in OPTIMIZE-1, a Phase 2 trial in previously untreated patients with metastatic pancreatic cancer. In January 2023, Alligator announced strong interim results from OPTIMIZE-1, which demonstrated an objective response rate (ORR) of 52% in 23 evaluable patients (versus a reference ORR of around 32% in a similar patient population treated with standard of care FOLFIRINOX[1]).

MesoPher, which is comprised of autologous dendritic cells loaded with allogeneic tumor lysate (PheraLys), is being evaluated in the Phase 2 REACTIVE trial in patients with resected pancreatic cancer. In December 2022, Amphera announced topline results from this trial, in which MesoPher exceeded expectations, demonstrating a statistically significant 2-year Recurrence Free Survival of 60% and an excellent safety profile.

REACTIVE-2 is supported by strong preclinical data published in the high-ranking peer-reviewed Journal for ImmunoTherapy of Cancer[2], which demonstrated that CD40 agonists in combination with dendritic cells loaded with allogenic tumor lysate mediate powerful and significant anti-tumor effects in pancreatic cancer models.

On April 26, 2023 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical company, reported its sales performance for the first quarter of 2023 (Press release, Ipsen, APR 27, 2023, View Source [SID1234630534]).

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Q1 2023 Q1 2022 % change
€m €m Actual CER1
Oncology 570.8 556.4 2.6% 1.1%
Neuroscience 156.4 120.2 30.2% 24.4%
Rare Disease 14.7 11.3 29.8% 29.0%
Total Sales2 741.9 687.9 7.8% 5.7%

Highlights

Total-sales growth of 5.7% at CER1, or 7.8% as reported, driven by the performance of the growth platforms3, up by 14.7%1, with Dysport (abobotulinumtoxinA) up by 25.2%1 and Cabometyx (cabozantinib) up by 31.0%1, respectively. The performance included contributions from newly acquired Tazverik (tazemetostat) and Bylvay (odevixibat)
Completion of the definitive merger agreement for the acquisition of Albireo, expanding Ipsen’s scope in Rare Disease
Regulatory-decision dates in the U.S. confirmed for Bylvay in Alagille syndrome and palovarotene in fibrodysplasia ossificans progressiva (FOP), respectively
Full-year 2023 guidance confirmed, with total-sales growth greater than 4.0% at CER1 and a core operating margin of around 30% of total sales

David Loew, Chief Executive Officer, commented:

"Ipsen continues to make excellent progress in its transformation. We delivered further robust sales growth in the quarter, led by the standout performances of Dysport and Cabometyx. Based on the continued sales momentum, we are confirming our guidance for the full year. I was also delighted by the further enhancement of our pipeline, portfolio and organization as a result of the recent acquisition of Albireo; through our global presence, we will continue to meet the unmet medical needs of an increasing number of patients. As we replenish the pipeline and execute on recent transactions, we look forward to several milestones for our business, including the Phase III data readout for elafibranor and anticipated regulatory developments for Onivyde, palovarotene and Bylvay."

Full-year 2023 guidance

Ipsen has confirmed its financial guidance for FY 20234:

Total-sales growth greater than 4.0%, at constant exchange rates. Based on the average level of exchange rates in Q1 2023, an adverse impact on total sales of around 2% from currencies is expected
Core operating margin around 30% of total sales, excluding any potential impact of incremental investments from future external-innovation transactions

Business development

In March 2023, Ipsen announced that it had completed the acquisition of Albireo Pharma, Inc., a leading innovator in bile-acid modulators to treat rare liver conditions. Ipsen acquired all issued and outstanding shares at a price of $42.00 per share in cash, plus one non-transferable contingent value right of $10.00 per share.

Pipeline development

In February 2023, it was announced that the U.S. Food and Drug Administration had accepted the supplemental New Drug Application for a second Bylvay indication, for patients with Alagille syndrome. The administration also issued a Prescription Drug User Fee Act (PDUFA) action date of 15 June 2023.

In March 2023, it was announced that the PDUFA action date in the U.S., for the resubmitted New Drug Application for palovarotene as a potential treatment for FOP, will be 16 August 2023. The Company also recently requested a re-examination of the negative opinion from the CHMP5 for palovarotene, received in January 2023.

Conference call

A conference call and webcast for investors and analysts will begin today at 2pm, Paris time. Participants can access the call and its details by registering here; webcast details can be found here. A recording will be available on ipsen.com.

On April 26, 2023 Hanmi reported its first quarter 2023 earnings (Presentation, Hanmi, APR 26, 2023, View Source [SID1234633044]).

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