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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On April 26, 2023 Boston Scientific Corporation reported it generated net sales of $3.389 billion during the first quarter of 2023, growing 12.0 percent on a reported basis, 14.9 percent on an operational1 basis and 14.0 percent on an organic2 basis, all compared to the prior year period (Press release, Boston Scientific, APR 26, 2023, View Source [SID1234633023]). The company reported GAAP net income attributable to Boston Scientific common stockholders of $300 million or $0.21 per share (EPS), compared to $97 million or $0.07 per share a year ago, and achieved adjusted3 EPS of $0.47 for the period, compared to $0.39 a year ago.

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"I’m pleased with our excellent results this quarter, which highlight our team’s strong performance across each business and region," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "With a robust pipeline in 2023 and beyond, I’m optimistic about our ability to continue to deliver differentiated financial performance and the opportunity to reach more patients with life-changing therapies."

First quarter financial results and recent developments:

Reported net sales of $3.389 billion, representing an increase of 12.0 percent on a reported basis, compared to the company’s guidance range of 3 to 5 percent; 14.9 percent on an operational basis; and 14.0 percent on an organic basis, compared to the company’s guidance range of 6 to 8 percent, all compared to the prior year period.
Reported GAAP net income attributable to Boston Scientific common stockholders of $0.21 per share, compared to the company’s guidance range of $0.23 to $0.26 per share, and achieved adjusted EPS of $0.47 per share, compared to the guidance range of $0.42 to $0.44 per share.
Achieved the following net sales growth in each reportable segment, compared to the prior year period:
MedSurg: 11.0 percent reported, 13.4 percent operational and organic
Cardiovascular: 12.7 percent reported, 15.9 percent operational and 14.4 percent organic
Achieved the following net sales growth in each region, compared to the prior year period:
U.S.: 12.7 percent reported and operational
EMEA (Europe, Middle East and Africa): 14.2 percent reported and 20.0 percent operational
APAC (Asia-Pacific): 5.9 percent reported and 15.4 percent operational
LACA (Latin America and Canada): 17.4 percent reported and 20.0 percent operational
Emerging Markets4: 20.2 percent reported and 26.3 percent operational
Received U.S. Food and Drug Administration (FDA) clearance and launched in the U.S. and Japan the LithoVue Elite Single-Use Digital Flexible Ureteroscope System, the first ureteroscope system with a built-in sensor that enables urologists to monitor intrarenal pressure in real time during ureteroscopy procedures.
Received Japanese Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada and CE Mark approval for the POLARx FIT Cryoablation Balloon Catheter, an expandable balloon catheter capable of enabling 28 and 31mm sizes, which promotes procedural efficiency and adaptability to varying patient anatomies during the treatment of atrial fibrillation.
Announced real-world outcomes from the SURPASS one-year analysis of more than 66,000 patients with the WATCHMAN FLX Left Atrial Appendage Closure Device during a late-breaking session at the Cardiovascular Research Technologies (CRT) 2023 meeting, with data demonstrating a low 1.2% rate of ischemic stroke and 0.11% rate of systemic embolism at one year. Also exceeded 300,000 patients worldwide who have been treated with the WATCHMAN technology.
Completed enrollment in the ACURATE IDE trial, a prospective, multicenter, randomized study in the U.S. and Canada evaluating the safety and effectiveness of the ACURATE neo2 Aortic Valve System for the treatment of patients with severe, symptomatic aortic stenosis across all surgical risk levels who are indicated for transcatheter aortic valve replacement.
Commenced enrollment of the global ADVANTAGE AF clinical trial, which will evaluate the safety and effectiveness of the FARAPULSE Pulsed Field Ablation (PFA) System for the treatment of drug-resistant, symptomatic, persistent atrial fibrillation (AF). Also, presented as late-breaking science at the European Heart Rhythm Association (EHRA) annual meeting were real-world outcomes from the independent MANIFEST-PF registry, which demonstrated the real-world safety, efficacy and efficiency of the FARAPULSE PFA System. Despite a variety of workflows, procedure times remained at approximately one hour, and there was only one case of phrenic palsy and no reports of esophageal complications or pulmonary vein stenosis. One-year freedom from recurrence was 82% in patients with paroxysmal, or intermittent, AF and 72% in patients with persistent AF.
Closed the acquisition of Apollo Endosurgery, Inc., expanding the Boston Scientific endoluminal surgery portfolio and enabling entry into the endobariatric market.
Completed the acquisition of a majority stake investment in Acotec, a Chinese medical technology company that offers innovative solutions designed for several types of interventional procedures. This investment is expected to create strategic value for both companies through a variety of opportunities, including collaboration in research and development, manufacturing and commercial strategies.
Released the 2022 Performance Report, measuring progress on the ways in which the company is transforming care, investing in employees, protecting the environment and creating value responsibly.