On July 28, 2022 Seagen Inc. (Nasdaq:SGEN) reported financial results today for the second quarter ended June 30, 2022 (Press release, Seagen, JUL 28, 2022, View Source [SID1234617088]). The Company also highlighted PADCEV (enfortumab vedotin-ejfv), TUKYSA (tucatinib), ADCETRIS (brentuximab vedotin) and TIVDAK (tisotumab vedotin-tftv) commercial and development accomplishments, as well as progress across its deep and diverse oncology pipeline.

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"Seagen once again delivered strong commercial performance with record quarterly net product sales, in addition to accomplishing a number of important clinical milestones across our pipeline," said Roger Dansey, M.D., interim CEO and Chief Medical Officer. "We are pleased to have recently reported positive clinical trial results that could potentially support additional labels for ADCETRIS, PADCEV and TUKYSA and we have obtained approval of PADCEV in the EU. At the same time, we are progressing our deep pipeline of targeted cancer therapies and we are well-positioned for the future."

APPROVED PRODUCTS HIGHLIGHTS

PADCEV

Announced Positive Topline Results for Combination of PADCEV and KEYTRUDA (pembrolizumab) as First-Line Treatment for Advanced Urothelial Cancer: In July 2022, Seagen and Astellas announced positive topline results from the phase 1b/2 EV-103 clinical trial (also known as KEYNOTE-869) Cohort K evaluating PADCEV in combination with Merck’s anti-PD-1 therapy KEYTRUDA as first-line treatment in patients with unresectable locally advanced or metastatic urothelial cancer (la/mUC) who are ineligible to receive cisplatin-based chemotherapy. In patients treated with enfortumab vedotin and pembrolizumab, results demonstrated a 64.5% confirmed objective response rate (95% CI: 52.7 to 75.1) per blinded independent central review (BICR), the primary endpoint of Cohort K. The median duration of response per BICR was not reached. The most frequently reported treatment-emergent adverse events Grade 3 or greater that occurred in more than 5% of patients were rash maculo-papular, anemia, lipase increased, urinary tract infection, hyperglycemia, fatigue, neutropenia, hematuria, diarrhea, acute kidney injury, hyponatremia, chronic kidney disease, weight decreased, syncope, hypophosphatemia, pneumonitis, sepsis, and alanine aminotransferase increased. Overall, the results are generally consistent with previously reported efficacy and safety results of the EV-103 dose-escalation cohort and expansion Cohort A. Data will be presented at a future medical conference and will be discussed with the U.S. Food and Drug Administration (FDA) with the intention of submitting a supplemental Biologics License Application later in 2022 under the FDA’s Accelerated Approval Program.
Received European Commission (EC) Approval for PADCEV in Previously Treated Metastatic Urothelial Cancer in Addition to Other Countries: In April 2022, Seagen and Astellas announced the EC approval of PADCEV as monotherapy for the treatment of adult patients la/mUC who have previously received a platinum-containing chemotherapy and a PD-1/L1 inhibitor. The approval is applicable in the European Union Member States, as well as Iceland, Norway and Liechtenstein. Additionally, in the second quarter of 2022, PADCEV was approved for la/mUC in Australia, Brazil, Great Britain and Singapore.
TUKYSA

Presented Positive Results of Pivotal Trial of TUKYSA in Combination with Trastuzumab in HER2-Positive Metastatic Colorectal Cancer: In July 2022, the Company presented positive results from the pivotal phase 2 MOUNTAINEER trial investigating TUKYSA in combination with trastuzumab in patients with previously treated HER2-positive metastatic colorectal cancer at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) World Congress Gastrointestinal Cancer. The combination of tucatinib and trastuzumab was generally well-tolerated with durable responses in patients assigned to receive the combination demonstrating a 38.1% confirmed response rate after a median duration of follow-up of 20.7 months. The most common (greater than or equal to 20%) treatment-emergent adverse events were diarrhea, fatigue, nausea and infusion-related reaction. In July 2022, a supplemental New Drug Application was submitted to the FDA under the Accelerated Approval Program.
TUKYSA Granted Breakthrough Therapy Designation (BTD) for HER2-positive Metastatic Colorectal Cancer: In July 2022, the FDA granted TUKYSA BTD for use in combination with trastuzumab for the treatment of adult patients with unresectable or metastatic HER2-positive colorectal cancer who have previously received fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy. The designation is based on results of the MOUNTAINEER trial.
Completed Global Enrollment in Pivotal HER2CLIMB-02 Trial: The Company completed enrollment in the phase 3 HER2CLIMB-02 clinical trial evaluating TUKYSA versus placebo, in combination with KADCYLA (ado-trastuzumab emtansine), for patients with locally advanced or metastatic HER2-positive breast cancer, including those with brain metastases.
ADCETRIS

ADCETRIS Combination Data Published in the New England Journal of Medicine (NEJM)Demonstrating Statistically Significant Improvement in Overall Survival (OS) for Patients with Advanced Hodgkin Lymphoma: In July 2022, longer-term follow-up data from the ECHELON-1 phase 3 clinical trial were published in NEJM demonstrating that ADCETRIS in combination with chemotherapy resulted in a 41% reduction in risk of death versus standard of care in patients with advanced Hodgkin lymphoma. The safety profile of ADCETRIS was consistent with previous studies, and no new safety signals were observed. The Company expects to submit the data to the FDA in a sBLA during 2022.
Children’s Oncology Group Presented ADCETRIS Plus Chemotherapy Demonstrating Superior Event-Free Survival (EFS) versus Standard of Care Alone in Children and Young Adults with Previously Untreated High-Risk Hodgkin Lymphoma: In June 2022, the Company announced results from a phase 3 Children’s Oncology Group trial evaluating ADCETRIS in children and young adults with high-risk, previously untreated classical Hodgkin lymphoma. In the trial, ADCETRIS in combination with chemotherapy showed a clinically meaningful and statistically significant 59% reduction in the risk of disease progression or relapse, second malignancy or death and achieved superior event-free survival compared to the current standard of care. Based on these data, Seagen submitted a sBLA to the FDA for review. The sBLA was granted Priority Review with a target action date of November 16, 2022.
TIVDAK

Reported Data from TIVDAK Clinical Development Program in Cervical Cancer at ASCO (Free ASCO Whitepaper): In June 2022, the Company announced interim data from the innovaTV 205 trial, which included data evaluating TIVDAK in combination with KEYTRUDA (Cohort E) in patients with recurrent or metastatic cervical cancer who have not received prior systemic therapy. These data showed encouraging and durable anti-tumor activity. TIVDAK and KEYTRUDA in combination with other anti-cancer agents continue to be evaluated in front-line recurrent or metastatic cervical cancer.
PIPELINE PROGRAMS

For additional information on Seagen’s pipeline, visit www.seagen.com/science/pipeline.

CORPORATE HIGHLIGHTS

Patent Infringement Suit Against Daiichi Sankyo. In July 2022, the U.S. Patent and Trademark Office denied Daiichi Sankyo’s Request for a Post Grant Review of the 10,808,039 Patent (the ‘039 Patent’). The U.S. District Court for the Eastern District of Texas also denied Daiichi Sankyo’s claim that the ‘039 Patent should be unenforceable under the equitable theory of prosecution laches, entered judgment in favor of Seagen based on the jury’s verdict that Daiichi Sankyo willfully infringed the ‘039 Patent consisting of pre-trial damages in the sum of $41.8 million, and awarded Seagen pre- and post-trial interest and costs. The company intends to request a royalty on Daiichi Sankyo’s future sales of ENHERTU in the United States through November 5, 2024.
Announced Roger Dansey, M.D., Chief Medical Officer, Appointment as Interim CEO: In May 2022, the Company announced Roger Dansey, M.D., Seagen’s Chief Medical Officer since 2018, was appointed interim CEO following the resignation of Clay Siegall, Ph.D. the Company’s former President and CEO.
Received Milestone Payment Triggered by AbbVie Initiating a Phase 3 Trial of Telisotuzumab Vedotin (ABBV- 399): Seagen received a $12 million milestone payment under its antibody drug conjugate (ADC) technology licensing agreement with AbbVie following the initiation of a phase 3 study of AbbVie’s telisotuzumab vedotin for the treatment of non-small cell lung cancer.
Announced Plans to Expand Biomanufacturing Capacity to Support Growing Portfolio of Cancer Medicines: In April 2022, the Company announced plans to build a new facility in Everett, WA, to expand the Company’s biomanufacturing capacity and enable the company greater control and flexibility over the production of its medicines to treat cancer. The new facility will be in addition to Seagen’s existing manufacturing site in Bothell, WA.
SECOND QUARTER AND SIX-MONTHS 2022 FINANCIAL RESULTS

Revenues: Total revenues for the second quarter and six months ended June 30, 2022 were $497.5 million and $924.0 million, respectively, compared to $388.5 million and $720.5 million for the same periods in 2021. Revenues in the 2022 periods reflected higher net product sales across the Company’s commercial portfolio.

Net Product Sales: The increases in net product sales for the second quarter and year-to-date of 2022 compared to the same periods in 2021 were driven by growth from the Company’s marketed products. PADCEV growth was driven by continued penetration in its approved indications and, to a lesser extent, sales of drug product for use in clinical trials being conducted by another company. TUKYSA growth was driven primarily by increased sales in European markets following its approval in February 2021 and continued use in its current indication in the U.S. TIVDAK commercialization began in the U.S. following FDA approval in September 2021.
Royalty Revenues: Royalty revenues were primarily driven by sales of ADCETRIS outside the U.S. and Canada by Takeda as well as royalties from sales of Polivy (polatuzumab vedotin) by Roche and Blenrep (belantamab mafodotin) by GlaxoSmithKline, which are ADCs that use Seagen technology.
Collaboration and License Agreement Revenues: The increases in collaboration and license agreement revenues in the second quarter and year-to-date in 2022 compared to the same period in 2021 were primarily the result of a $12 million milestone payment received from AbbVie in the second quarter of 2022 related to the initiation of a phase 3 trial of telisotuzumab vedotin, an upfront license payment relating to the Company’s ADC collaboration with Sanofi in the first quarter of 2022, royalty contribution from Astellas’ PADCEV sales in its territory, as well as higher amounts of drug product supplied to a collaborator.
Cost of Sales: Cost of sales for the second quarter and year-to-date of 2022 were $106.1 million and $193.7 million, respectively, compared to $78.1 million and $142.2 million for the same periods in 2021. The increases were primarily related to the gross profit share amounts owed to collaboration partners, which were $65.5 million and $118.3 million in the second quarter and year-to-date of 2022, respectively, compared to $38.6 million and $71.1 million for the same periods in 2021. Cost of sales also reflects amortization of TUKYSA acquired in-process technology costs, third-party royalties owed for PADCEV and TUKYSA net product sales, and cost of products sold.

Research and Development (R&D) Expenses: R&D expenses for the second quarter and year-to-date of 2022 were $304.3 million and $601.9 million, respectively, compared to $234.9 million and $465.3 million for the same periods in 2021. The increases in the periods ended June 30, 2022 primarily reflected continued investment in clinical development of the Company’s approved drugs and to advance its novel programs and technologies.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the second quarter and year-to-date of 2022 were $220.3 million and $394.5 million, respectively, compared to $165.1 million and $325.0 million for the same periods in 2021. The increases in 2022 were driven by commercialization efforts for our approved products including investments to support ongoing European TUKYSA launches, the U.S. commercial launch of TIVDAK, and other corporate activities.

Non-cash, share-based compensation expense for the six months ended June 30, 2022 was $98.0 million, compared to $76.0 million for the same period in 2021.

Net Loss: Net loss for the second quarter of 2022 was $134.8 million, or $0.73 per diluted share, and net loss for the year-to-date in 2022 was $271.3 million, or $1.48 per diluted share.

The net loss for the second quarter of 2021 was $84.6 million, or $0.47 per diluted share, and net loss for the year-to-date in 2021 was $206.0 million, or $1.14 per diluted share.

Cash and Investments: As of June 30, 2022, Seagen had approximately $1.9 billion in cash and investments.

2022 FINANCIAL OUTLOOK

Seagen anticipates 2022 revenues, operating expenses and other costs to be in the ranges shown in the table below, which includes increased net sales expectations for ADCETRIS, as well as higher collaboration and license agreement revenues.

1. TIVDAK sales guidance not provided and excluded from product sales and total revenues guidance.

2. Non-cash costs include share-based compensation, depreciation, and amortization of intangible assets.

Conference Call Details

Seagen management will host a conference call and webcast with supporting slides to discuss its second quarter 2022 financial results and provide an update on business activities. The event will be held today at 1:30 p.m. Pacific Time (PT); 4:30 p.m. Eastern Time (ET). The live event will be simultaneously webcast and available for replay from the Seagen website at investor.seagen.com. Investors may also participate in the conference call by calling 844-763-8274 (domestic) or 412-717-9224 (international). The conference ID is 10167970. Supporting slides are available on the Seagen website at investor.seagen.com under the Investors section. A webcast replay will be archived on the Company’s website investor.seagen.com, under the Investors section.

On July 28, 2022 Takeda (TOKYO:4502/NYSE:TAK) reported that strong financial results for the first quarter of fiscal year 2022 (period ended June 30, 2022) and is on track to meet its full-year management guidance (Press release, Takeda, JUL 28, 2022, View Source [SID1234617104]).

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The gain on the sale of Takeda’s Japan diabetes portfolio in the first quarter of the previous fiscal year has impacted reported financial results on a year-over-year basis, as expected. The sale contributed a one-off 133 billion yen to revenue and 131.4 billion yen to operating profit in Q1 FY2021. This impact is excluded from core financial results; the Company delivered +8.3% core revenue growth and +17% core operating profit growth at CER this quarter, with a core operating profit margin of 32.8%.

Takeda chief financial officer, Costa Saroukos, commented: "Takeda has delivered strong first quarter performance with Growth and Launch Products continuing to drive robust core revenue growth. Our results reflect continued momentum and solid commercial execution across key business areas."

"First quarter results also reflect the impact of the last of our major non-core divestitures in the prior year. The sale of the Japan diabetes portfolio in FY2021 is the main factor behind the year-over-year decline in reported operating profit and is the only difference between reported and core revenue growth in our Q1 FY2022 results."

"Foreign exchange has been a tailwind for our performance in the first quarter, while our portfolio momentum and prudent cost management have allowed us to improve our core operating profit margin despite rising inflation and other emerging macro challenges. We also remain resilient amid the outlook for increasing interest rates as approx. 98% of our debt is now secured at fixed interest rates averaging approx. 2%."

(a) Further information regarding certain of Takeda’s Non-IFRS measures is posted on Takeda’s investor relations website at View Source
(b) We define Free Cash Flow as cash flows from operating activities, subtracting acquisition of property, plant and equipment ("PP&E"), intangible assets and investments as well as removing any other cash that is not available to Takeda’s immediate or general business use, and adding proceeds from sales of PP&E, as well as from sales of investments and businesses, net of cash and cash equivalents divested.
(c) Core results adjust our reported results calculated and presented pursuant to IFRS to exclude the effect of items unrelated to Takeda’s core operations, such as, to the extent applicable for each line item, amortization and impairment of intangible assets, other operating income and expenses, certain JV-related accounting adjustments, non-recurring items, purchase accounting effects and transaction related costs.
(d) CER (Constant Exchange Rate) change eliminates the effect of foreign exchange rates from year-over-year comparisons by translating Reported or Core results for the current period using corresponding exchange rates in the same period of the previous fiscal year.

COMMERCIAL UPDATES ACROSS FIVE KEY BUSINESS AREAS

Growth in key business areas in Q1 FY2022 was driven mainly by Growth & Launch Products, which delivered revenue of 363.6 billion yen and +26% growth at CER.

Gastroenterology (GI), with 270.4 billion yen in reported revenue, grew +15% on a CER basis driven by gut-selective ENTYVIO and TAKECAB/VOCINTI. The strong launch in China of VOCINTI was a key contributor to growth. Global revenue for ENTYVIO is forecast to grow +20% on a CER basis in FY2022.
Rare Diseases, with 181.6 billion yen in reported revenue, grew +7% on a CER basis driven by continued strong performance of TAKHZYRO and promising LIVTENCITY sales following a U.S. launch in December 2021. Geographical expansion is expected to continue with additional TAKHZYRO launches and LIVTENCITY approvals planned for FY2022.
Plasma-Derived Therapies (PDT) Immunology, with 141.9 billion yen in reported revenue, delivered outstanding growth of +18% on a CER basis driven by continued strong global demand for Immunoglobulin and higher sales of Albumin. Our global plasma donation footprint grew to 212 centers as of June 30, 2022. With plans for >25 centers to be opened this fiscal year, the Company is targeting to increase plasma collection volume by 10-20% in FY2022 compared to FY2021.
Oncology, with 117.5 billion yen in reported revenue, declined -10% on a CER basis mainly due to the impact of generic competition to VELCADE. ALUNBRIG delivered growth of +34.7% on a CER basis. EXKIVITY market data showed early signs of commercial success with a U.S. launch in September 2021 and global expansion continues with approvals in UK, Switzerland, Australia and South Korea. Additional approval decisions are expected in FY2022, including in China. Following discussions with the EMA, Takeda has decided to withdraw the EU Marketing Authorization Application (MAA) for EXKIVITY in second-line treatment of EGFR Exon20 insertion+ non-small cell lung cancer (NSCLC).
Neuroscience, with 142.4 billion yen in reported revenue, grew +11% on a CER basis signaling a continued rebound from COVID-19. TRINTELLIX grew +5.2% at CER driven by continued market share gains, notably in Japan. We expect VYVANSE growth in FY2022 to be driven by the expanding adult market in the U.S.
PIPELINE UPDATE

In Q1 FY2022, Takeda further demonstrated pipeline momentum and its ability to bring new therapies to patients. Pipeline updates in Q1 FY2022 include:

TAK-003, Takeda’s dengue vaccine candidate, prevented 84% of hospitalized dengue cases and 61% of symptomatic dengue cases with no important safety risks identified in the overall population, including both seropositive and seronegative individuals through 54 months. These data from the Phase 3 TIDES trial were presented at the 8th Northern European Conference on Travel Medicine (NECTM8). TAK-003 is currently undergoing regulatory review in the European Union and select dengue-endemic countries, with decisions expected in FY2022.
Additional information related to this announcement is available here.
The New England Journal of Medicine published results from a Phase 2 clinical study of investigational fazirsiran (TAK-999/ARO-AAT) for the treatment of liver disease associated with alpha-1 antitrypsin deficiency (AATD). Co-developed with Arrowhead Pharmaceuticals, fazirsiran was granted Breakthrough Therapy Designation in July 2021 and Orphan Drug Designation in February 2018 by the U.S. FDA for the treatment of AATD.
Additional information related to this announcement is available here.
ADCETRIS Phase 3 data was presented at the 59th American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, demonstrating statistically significant improvement in overall survival in adult patients with previously untreated Stage III or IV classical Hodgkin Lymphoma.
Additional information related to this announcement is available here.
Takeda and Moderna announced plans to transfer marketing authorization for Spikevax COVID-19 vaccine in Japan to Moderna.
Additional information related to this announcement is available here.
TAKHZYRO demonstrated positive results in the prevention of hereditary angioedema (HAE) attacks in patients 2 to <12 years of age. These results, which were consistent with earlier studies in adult and adolescent patients, were presented at the European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress 2022. There are currently no long-term prophylactic treatments approved for HAE patients younger than 6 years and global regulatory filings are scheduled to begin in FY2022.
Additional information related to this announcement is available here.
HYQVIA met its primary endpoint in a pivotal Phase 3 clinical trial evaluating its efficacy and safety as a maintenance therapy for Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP). Preparations are now underway for regulatory filings in the U.S. and EU.
Additional information related to this announcement is available here.
In June 2022, Takeda signed a licensing agreement with Momenta Pharmaceuticals, Inc., which was acquired by Johnson & Johnson, for an investigational hypersialylated immunoglobulin (HsIG) candidate. HsIG has the potential to have similar efficacy as IGs but at a lower dose due to its increased potency. If proven safe and effective, it has the potential to help address patient needs for significantly lower administration volume with better tolerability and convenience, while simultaneously helping to address existing supply constraints.
FY2022 OUTLOOK
On track towards full-year FY2022 guidance (Unchanged from May 2022)

Company outlook for FY2022 reflects management’s expectations for continued business momentum across Takeda’s five key business areas, discipline in operating expenses, and FX favorability.
For more details on Takeda’s Q1 FY2022 results and other financial information including key assumptions in FY2022 forecast and management guidance, please visit: View Source

On July 28, 2022 Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, reported that the company has scheduled the release of its second quarter 2022 financial results after the market closes on Thursday, August 4, 2022 (Press release, Sangamo Therapeutics, JUL 28, 2022, View Source [SID1234617142]).

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The press release will be followed by a conference call at 4:30 p.m. ET, which will be open to the public. During the conference call, the company will review its financial results and provide business updates.

Participants should register for, and access, the call using this link. While not required, it is recommended to join 10 minutes prior to the event start. Once registered, participants will be given the option to either dial into the call with the number and unique passcode provided, or to use the dial-out option to connect their phone instantly. The link to access the live webcast can also be found on the Sangamo Therapeutics website in the Investors and Media section under Events and Presentations.

A replay will be available following the conference call, accessible under Events and Presentations.

On July 28, 2022 Ipsen (Euronext: IPN; ADR: IPSEY), a global specialty-driven biopharmaceutical company, reported its financial results for the first half of 2022 (Press release, Ipsen, JUL 28, 2022, View Source [SID1234617056]):

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H1 2022 financial results

Strong sales growth of 10.5% at CER1 (15.2% as reported)
Core operating margin of 39.6%; IFRS operating margin of 35.7%
Core consolidated net profit of €420m, growing by 19.9%. IFRS net profit up by 30.0% to €394m
Solid cash-flow generation and strong balance sheet (€2m closing net debt)
Strategic roadmap

Agreement to acquire Epizyme, expanding Ipsen’s portfolio in oncology
Completion of the divestment of Ipsen’s Consumer HealthCare business (CHC) to Mayoly Spindler
Submission acceptance by U.S. FDA for New Drug Application (NDA) for palovarotene
Upgraded 2022 financial guidance

Total-sales growth greater than 7.0% at CER1 (prior guidance: >2.0%)
Core operating margin greater than 36.0% (prior guidance: >35.0%)

David Loew, Chief Executive Officer, commented:

"In the first half of the year, the continuing execution of our strategy yielded strong results. Our innovative brands delivered double-digit growth, while sales of Somatuline remained stable. By divesting our consumer healthcare business, we are focusing Ipsen on Specialty Care. The transaction with Epizyme will further enrich our portfolio and pipeline in oncology. I am pleased with the recent positive regulatory developments for palovarotene.

The ongoing positive momentum at Ipsen is reflected in today’s upgraded sales and margin guidance. While we recognize an increasingly competitive environment for Somatuline in Europe and the U.S., our innovative brands will continue to deliver strong growth. With patients at the core of our purpose, we are well on track to execute on our four-pillar strategy, including the maximization of our brands and the replenishment of our pipeline."

Consumer HealthCare: completion of divestment

Ipsen today announces the closing of its agreement to divest its CHC business to Mayoly Spindler, with which it had entered into exclusive negotiations in February 2022. The consideration represents an enterprise value of €350m, including an earnout contingent payment of €50m.

The combination of Ipsen’s and Mayoly Spindler’s respective CHC businesses will create a global consumer-healthcare platform with a critical size and the capacity to support its growth. This was a major step forward in the Company’s execution of its strategic roadmap, presented in December 2020, towards building a more-focused Ipsen, centring on Specialty Care.

Review of results

In accordance with IFRS 5, the H1 2022 consolidated net profit and free cash flow resulting from the CHC business have been reclassified in separate line items: ‘Net profit/(loss) from discontinued operations’ in the profit and loss account and ‘Change in net cash/(debt) from discontinued operations’ in the cash-flow statement. The comparative figures for last year have been restated accordingly.

The performance of the CHC business is recorded within discontinued operations and, as such, all commentary on performance excludes the impact of CHC, unless stated otherwise.

Extract of half-year 2022 and 2021 condensed consolidated financial statements2:

– Total-sales growth in H1 2022 of 10.5% at CER3, or 15.2% as reported, to €1,433.7m, driven by double-digit growth of key medicines Cabometyx (cabozantinib), Dysport (botulinum toxin type A), Decapeptyl (triptorelin) and Onivyde (irinotecan), and stable sales of Somatuline (lanreotide)

– Core operating income of €568.0m, an increase of 21.8%, reflecting the strong growth in total sales and other revenue and a moderate increase in operating costs; core operating margin of 39.6%, an increase of 2.1 percentage points

– Core consolidated net profit of €420.5m, growing by 19.9% in line with the increase in core operating income; core EPS4 (fully diluted) up by 20.4% to reach €5.06

– IFRS operating income of €511.2m, increasing by 27.9% after higher amortization of intangible assets and lower other operating expenses

– IFRS consolidated net profit of €394.3m, an increase of 30.0% driven by a lower effective tax rate. IFRS EPS4 (fully diluted) up by 8% to €4.74

– Free cash flow of €339.0m, an increase of 17.3%, reflecting higher operating cash flow, partly offset by an increase in income tax

– Reduction in net debt to €2.3m, driven by the strong free cash flow of the period, the dividend distribution and milestones paid related to business development

The Board of Directors approved the condensed consolidated financial statements on 27 July 2022. The Company’s auditors performed a limited review of the H1 2022 condensed consolidated financial statements. The interim financial report, with regards to the regulated information, is available on ipsen.com, under the Regulated Information tab in the Investor Relations section.

Full-year 2022 guidance

Ipsen has upgraded its financial guidance for FY 2022. Guidance assumes a closing of the Epizyme acquisition in Q3 2022 and excludes any contribution from the CHC business:

– Total-sales growth greater than 7.0%, at constant currency. Based on the average level of exchange rates in June 2022, an anticipated additional favorable impact on total sales of 5% from currencies

– Core operating margin greater than 36.0% of total sales, excluding any potential impact of incremental investments from future external-innovation transactions

This guidance incorporates expectations of an increasing adverse impact from competitive activity on Somatuline in Europe and the U.S.

Business development

In June 2022, Ipsen and Epizyme announced that they had entered into a definitive merger agreement under which Ipsen will acquire Epizyme, a fully integrated, commercial-stage biopharmaceutical company developing and delivering transformative therapies against novel epigenetic targets for cancer patients. The terms of the agreement include an offer to acquire all outstanding shares of Epizyme for $1.45 per share in cash at closing for an initial estimated consideration of around $247m, and a contingent-value right (CVR) of up to $1.00 per share, based on the success of Tazverik (tazemetostat). The transaction is anticipated to close in the third quarter of 2022, subject to the satisfaction of all closing conditions.

Pipeline update

In June 2022, Ipsen announced that the U.S. FDA had accepted for Priority Review its resubmitted NDA for investigational palovarotene for the treatment of patients with fibrodysplasia ossificans progressiva, an ultra-rare genetic disorder. The FDA has assigned 29 December 2022 as the Prescription Drug User Fee Act goal date.

Company Social Responsibility: Generation Ipsen

Ipsen has recently refocused its company social-responsibility strategy. The new Generation Ipsen identity centers on the four key pillars of Environment, Society represented by Patients and People, and Governance. Good progress was made in the first half of the year, including the examples below:

– Environment: a 20% year-on-year reduction in carbon emissions, reflecting the switch of European-based manufacturing and R&D to green electricity in April 2021, plus less gas being consumed at manufacturing sites, despite significant sales-volume growth

– Patients: a donation of €1.5m to The Red Cross and Tulipe (a pharmaceutical distributor managing donations from health companies to meet the emergency needs of populations in distress) and a donation of medicines to support patients in Ukraine

– People: 45% of the Global Leadership Team now represented by women

– Governance: renewal of ISO 37001 anti-bribery certification

Conference call

A conference call and webcast for investors and analysts will begin today at 1.30pm Paris time. Participants can join the call by dialling +1 785 424 1102 or, for U.S. participants, 800-791-4813 toll-free; the passcode is 33569. A recording will be available on ipsen.com, while the webcast can be accessed here.

Calendar

Ipsen intends to publish its year-to-date and third-quarter sales update on 27 October 2022.

Notes

All financial figures are in € millions (€m). The performance shown in this announcement covers the six-month period to 30 June 2022 (the first half or H1 2022) and the three-month period to 30 June 2022 (the second quarter or Q2 2022), compared to six-month period to 30 June 2021 (H1 2021) and the three-month period to 30 June 2021 (Q2 2021) respectively, unless stated otherwise. Commentary is based on the performance in H1 2022, unless stated otherwise.

On July 28, 2022 GSK plc (LSE/NYSE: GSK) reported it had signed a framework contract with the European Commission’s (EC) Health Emergency Preparedness and Response Authority (HERA) for the reservation of future production and supply of 85 million doses of its pandemic influenza vaccine Adjupanrix [pandemic influenza vaccine (split virion, inactivated, adjuvanted)] (Press release, GlaxoSmithKline, JUL 28, 2022, View Source [SID1234617073]).

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This is one of the first contracts signed by HERA since it was established in September 2021. Its core mission is to prevent, detect, and rapidly respond to health emergencies through working closely with other EC and national health agencies, industry and international partners to improve Europe’s readiness for health emergencies.

An influenza pandemic is a global epidemic caused by a new influenza strain to which there is little or no pre-existing immunity in the human population. Influenza pandemics are impossible to predict, and they may be mild or cause severe disease or death1.

Welcoming this contract, Roger Connor, President Vaccines and Global Health, GSK, said: "I’m delighted that HERA has chosen GSK as a key partner in pandemic flu preparedness. This contract follows three other agreements GSK has made, in the US, Canada and with the WHO. These agreements leverage GSK’s world class global vaccine manufacturing network to continue our long-standing partnerships on pandemic preparedness and response. We have all seen the devastating human, economic and social consequences of a pandemic and the important part that vaccines are playing in helping us return to normal life. Through this agreement for 85m doses, we can help the EU and European countries, as well as other countries and regions, be better prepared for future pandemics."

This agreement with HERA concludes a series of contracts secured by GSK this year, under which it could provide at least 200 million doses of pandemic influenza vaccine to governments around the world. In February 2022 GSK extended its pandemic influenza vaccine stockpile contract with the United States Government2. This was followed by a renewed agreement, in June, for supply of pandemic influenza vaccines to the World Health Organization (WHO), and in July a contract with the Government of Canada for both seasonal and pandemic influenza vaccines.