On July 21, 2022 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported financial results for the second quarter ended June 30, 2022 (Press release, Quest Diagnostics, JUL 21, 2022, View Source [SID1234616839]).

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Quest Diagnostics Incorporated logo. (PRNewsFoto/Quest Diagnostics Incorporated)

"In the second quarter our base business revenues grew year over year while we increased our share of COVID-19 molecular testing thanks largely to our expanded retail relationships," said Jim Davis, CEO-elect. "Our base business performed well despite softer utilization trends which we believe impacted us and the rest of the health care industry. We also continued to ramp our investments to accelerate growth in the base business, particularly in the areas of advanced diagnostics and direct to consumer testing."

Steve Rusckowski, Chairman, CEO and President said: "We have raised our full year guidance based on our performance in the quarter and our expectations for the remainder of 2022.

"Finally, we appreciate the bipartisan efforts of the members of Congress who introduced the Saving Access to Laboratory Services Act (SALSA). If enacted, SALSA would fix PAMA and put the Medicare Clinical Laboratory Fee Schedule back on a sustainable path. The COVID-19 pandemic has demonstrated the clear need for patient access to timely, accurate and reliable clinical laboratory testing for the diagnosis, monitoring, and screening for all diseases. The excessive cuts under the flawed implementation of PAMA could make it far more challenging for the clinical laboratory community to invest in testing capacity and infrastructure to meet the health care needs of the country, especially in medically underserved communities and during a time when many patients are resuming routine care."

Excludes COVID-19 testing

For further details impacting the year-over-year comparisons related to operating income, operating income as a percentage of netg.
revenues, net income attributable to Quest Diagnostics, and diluted EPS, see note 2 of the financial tables attached below.

The sum of reported and adjusted diluted EPS for the first two quarters of 2021 did not equal the totals for the six months ended June 30, 2021 due to both quarterly fluctuations in the company’s earnings and in the weighted average common shares outstanding throughout the period as a result of the impact of accelerated share repurchase agreements ("ASRs") that the company entered into during April 2021.

Updated Guidance for Full Year 2022

Note on Non-GAAP Financial Measures

As used in this press release the term "reported" refers to measures under accounting principles generally accepted in the United States ("GAAP"). The term "adjusted" refers to non-GAAP operating performance measures that exclude special items such as restructuring and integration charges, certain financial impacts resulting from the COVID-19 pandemic, amortization expense, excess tax benefits ("ETB") associated with stock-based compensation, costs associated with donations, contributions, and other financial support through Quest for Health Equity (our initiative with the Quest Diagnostics Foundation to reduce health disparities in underserved communities), gains and losses associated with changes in the carrying value of our strategic investments, a gain on sale of an ownership interest in a joint venture, and other items.

Non-GAAP adjusted measures are presented because management believes those measures are useful adjuncts to GAAP results. Non-GAAP adjusted measures should not be considered as an alternative to the corresponding measures determined under GAAP. Management may use these non-GAAP measures to evaluate our performance period over period and relative to competitors, to analyze the underlying trends in our business, to establish operational budgets and forecasts and for incentive compensation purposes. We believe that these non-GAAP measures are useful to investors and analysts to evaluate our performance period over period and relative to competitors, as well as to analyze the underlying trends in our business and to assess our performance. The additional tables attached below include reconciliations of non-GAAP adjusted measures to GAAP measures.

Conference Call Information

Quest Diagnostics will hold its quarterly conference call to discuss financial results beginning at 8:30 a.m. Eastern Time today. The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, passcode: 7895081; or via live webcast on our website at www.QuestDiagnostics.com/investor. We suggest participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or, from approximately 10:30 a.m. Eastern Time on July 21, 2022 until midnight Eastern Time on August 4, 2022, by phone at 888-566-0439 for domestic callers or 203-369-3045 for international callers. Anyone listening to the call is encouraged to read our periodic reports, on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

On July 21, 2022 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, and the Menarini Group ("Menarini"), a privately-held, leading international pharmaceutical company, reported that the European Commission (EC) has granted Marketing Authorisation for NEXPOVIO (selinexor), a first-in-class, oral exportin 1 (XPO1) inhibitor, in combination with once-weekly bortezomib (Velcade) and low-dose dexamethasone (SVd) for the treatment of adults with multiple myeloma who have received at least one prior therapy (Press release, Karyopharm, JUL 21, 2022, View Source [SID1234616838]). With this approval for the extension of NEXPOVIO’s indication in the European Union (EU), the conditional marketing authorisation is now converted to a full approval. The marketing authorisation, which marks the second indication for NEXPOVIO, is valid in all 27 member states of the EU as well as Iceland, Liechtenstein, Norway, and Northern Ireland. Stemline Therapeutics B.V., a wholly owned subsidiary of the Menarini Group, will be responsible for all commercialization activities in Europe.

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The approval follows a positive opinion granted in May 2022 by the CHMP based on results from the Phase 3 BOSTON study that demonstrated once-weekly SVd resulted in a statistically significant reduction in the risk of disease progression or death compared to standard twice-weekly bortezomib plus dexamethasone (Vd) regimen. The results from the BOSTON study were published in The Lancet (Grosicki, et al.) in November 2020.

"The European Commission’s approval of an expanded use of NEXPOVIO provides another option for patients with multiple myeloma who have relapsed, or become resistant to current treatment regimens," said Richard Paulson, President and Chief Executive Officer of Karyopharm. "Our decision to pursue approval for this patient population is indicative of our commitment to expand access to selinexor across the globe and we look forward to working closely with Menarini who will commercialize NEXPOVIO in Europe."

"The approval of NEXPOVIO marks an important step forward for patients in Europe where nearly 51,000 new cases of multiple myeloma are diagnosed each year and therapeutic options are limited," said Elcin Barker Ergun, Chief Executive Officer of Menarini. "We are committed to offering patients and physicians a valuable new treatment option and are working hard to make NEXPOVIO available in different European countries as quickly as possible."

About the BOSTON study

The Marketing Authorisation is based upon the Phase 3 BOSTON (Bortezomib, Selinexor and Dexamethasone) study, which was a multi-center, randomized study (NCT03110562) that evaluated 402 adult patients with relapsed or refractory multiple myeloma who had received one to three prior lines of therapy. The study was designed to compare the efficacy, safety and certain health-related quality of life parameters of once-weekly SVd versus twice-weekly Vd. The primary endpoint of the study was progression-free survival and key secondary endpoints included overall response rate, rate of peripheral neuropathy, and others. To learn more about this study, please refer to Karyopharm and Menarini’s press release on the positive CHMP opinion issued on May 20, 2022.

About Multiple Myeloma in Europe

Multiple myeloma is an incurable cancer with significant morbidity and the second most common hematologic malignancy. According to the World Health Organization, in 2020, there were approximately 51,000 new cases and 32,000 deaths from multiple myeloma in Europe1. While the treatment of multiple myeloma has improved over the last 20 years, and overall survival has increased considerably, the disease remains incurable, and nearly all patients will eventually relapse and develop disease that is refractory to all approved anti-myeloma therapies. Therefore, there continues to be a high unmet medical need for new therapies, particularly those with novel mechanisms of action.

About NEXPOVIO (selinexor)

NEXPOVIO, which is marketed as XPOVIO in the U.S., has been approved in the following oncology indications by the European Commission: (i) in combination with dexamethasone for the treatment of multiple myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy; and (ii) in combination with bortezomib and dexamethasone for the treatment of adults with multiple myeloma who have received at least one prior therapy.

The expanded NEXPOVIO indication now allows adult patients with multiple myeloma to be treated in earlier lines of therapy. The indication for NEXPOVIO is valid in the EU Member States as well as Iceland, Liechtenstein, Norway, and Northern Ireland. NEXPOVIO is also approved in the UK under a Conditional Marketing Authorisation. The extension of indication in combination with bortezomib and dexamethasone for the treatment of adults with multiple myeloma who have received at least one prior therapy is currently under review by Medicines and Healthcare Products Regulatory Agency.

NEXPOVIO is a first-in-class, oral exportin 1 (XPO1) inhibitor. NEXPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). NEXPOVIO blocks the nuclear export of tumor suppressor, growth regulatory and anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion.

Please see NEXPOVIO Summary of Product Characteristics and European Public Assessment Report at View Source

UNITED STATES IMPORTANT SAFETY INFORMATION

Contraindications: Hypersensitivity to selinexor.

Special warnings and precautions for use:

Recommended concomitant treatments
Patients should be advised to maintain adequate fluid and caloric intake throughout treatment. Intravenous hydration should be considered for patients at risk of dehydration.
Prophylactic concomitant treatment with a 5-HT3 antagonist and/or other anti-nausea agents should be provided prior to and during treatment with NEXPOVIO.

Haematology:
Patients should have their complete blood counts (CBC) assessed at baseline, during treatment, and as clinically indicated. Monitor more frequently during the first two months of treatment.

Thrombocytopenia:
Thrombocytopenic events (thrombocytopenia and platelet count decreased) were frequently reported in adult patients receiving selinexor, which can be severe (Grade 3/4). Patients should be monitored for signs and symptoms of bleeding and evaluated promptly.

Neutropenia:
Severe neutropenia (Grade 3/4) has been reported with selinexor.
Patients with neutropenia should be monitored for signs of infection and evaluated promptly.

Gastrointestinal toxicity:
Nausea, vomiting, diarrhoea, which sometimes can be severe and may require the use of anti-emetic and anti-diarrhoeal medicinal products.

Weight loss and anorexia:
Patients should have their body weight, nutritional status and volume checked at baseline, during treatment, and as clinically indicated. Monitoring should be more frequent during the first two months of treatment.

Confusional state and dizziness:
Patients should be instructed to avoid situations where dizziness or confusional state may be a problem and to not take other medicinal products that may cause dizziness or confusional state without adequate medical advice. Patients should be advised not to drive or operate heavy machinery until symptoms resolve.

Hyponatraemia:
Patients should have their sodium levels checked at baseline, during treatment, and as clinically indicated. Monitoring should be more frequent during the first two months of treatment.

Cataract:
Selinexor can cause new onset or exacerbation of cataract. Ophthalmologic evaluation may be performed as clinically indicated. Cataract should be treated as per medical guidelines, including surgery if warranted.

Tumour lysis syndrome (TLS):
TLS has been reported in patients receiving therapy with selinexor. Patients at a high risk for TLS should be monitored closely. Treat TLS promptly in accordance with institutional guidelines.

Fertility, pregnancy and lactation
Women of childbearing potential/contraception in males and females:
Women of childbearing potential and male adult patients of reproductive potential should be advised to use effective contraceptive measures or abstain from sexual intercourse while being treated with selinexor and for at least 1 week following the last dose of selinexor.

Pregnancy:
There are no data from the use of selinexor in pregnant women. Selinexor is not recommended during pregnancy and in women of childbearing potential not using contraception.

Breast-feeding:
It is unknown whether selinexor or its metabolites are excreted in human milk. A risk to breast-fed children cannot be excluded. Breast-feeding should be discontinued during treatment with selinexor and for 1 week after the last dose.

Undesirable effects
Summary of the safety profile
The most frequent adverse reactions (≥30%) of selinexor in combination with dexamethasone were nausea, thrombocytopenia, fatigue, anaemia, decreased appetite, decreased weight, diarrhea, vomiting, hyponatraemia, neutropenia and leukopenia.

The most commonly reported serious adverse reactions (≥3%) were pneumonia, sepsis, thrombocytopenia, acute kidney injury, and anaemia.

Description of selected adverse reactions
Infections: Infection was the most common non-haematological toxicity. Upper respiratory tract infection and pneumonia were the most commonly reported infections with 25% of reported infections being serious and fatal infections occurring in 3% of treated adult patients.

Elderly population
Patients 75 years and older had a higher incidence of discontinuation due to an adverse reaction, higher incidence of serious adverse reactions, and higher incidence of fatal adverse reactions.

Reporting of suspected adverse reactions
Reporting of suspected adverse reactions after Authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

On July 21, 2022 Karo Pharma reported that Interim report half year 1, 2022 (Press release, Karo Pharma, JUL 21, 2022, View Source [SID1234616837])

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· Revenues amounted to SEK 1,965.3 (1,460.9) million. This corresponds to an increase of +35% for the period.

· The organic growth 1 in the period amounted to +6%. The currency effect was +3%, while the acquisitions of the Sylphar group and E45 from Reckitt contributed to growth of 26%.
· EBIT (Operating profit) amounted to SEK 3.8 (159.1) million, corresponding to a decrease of 98%.
· EBITDA 1 (Operating profit before depreciation) amounted to SEK 394.6 (440.4) million, corresponding to a decrease of 10%. Adjusted for non-recurring items in the form of transaction costs, directly related to business acquisitions, of SEK 92.0 million, EBITDA 1 amounted to SEK 486.6 million, corresponding to an increase of 10%.
· The gross margin, calculated as the gross profit in relation to net sales, amounted to 56.6% (58.6%) for the period. The margin was negatively affected by the mix effect from the acquisitions.
· Cash flow from operating activities amounted to SEK 146.2 (172.1) million. Adjusted for non-recurring items in the form of transaction costs, directly related to the business acquisitions, of SEK 92.0 million, the cash flow [] from operating activities amounted to SEK 238.2 million.
· Earnings per share were SEK -0.56 (0.14), before and after dilution.

1 Alternative Key Figures (APM), see notes for further information.

Comment from CEO Christoffer Lorenzen

Karo continues to develop as a company and organization, and is growing at a rapid pace. During the first half of the year, we ran the business in accordance with the goals for 2022 set out in our annual report for 2021. We have integrated acquired businesses, expanded our geographical footprint and increased investments in resources, (digital) skills and brand activations. We have also raised the organic growth rate from Karo’s existing operations.

In the first half of 2022, revenues increased by 35% compared with the previous year, driven by the acquired business Sylphar and the E45 brand. About 15% of sales now come from brand portfolios within so-called digital-first. Organic growth was 6% in a challenging consumer market.

During H1, Karo has continued to demonstrate strength and stability in a fast-moving and volatile business environment: Karo’s delivery capability (service level) is maintained at levels above 98% despite supply chain disruptions that have adversely affected many international companies. Karo’s gross margins, adjusted for the mix effect from the acquisitions, have increased compared to the previous year. This reflects that we have successfully absorbed and acted on cost increases from our suppliers as a result of increased raw material and energy costs. The reduction in reported gross margin is a result of the acquisitions, which have increased logistics costs, more specifically about SEK 100 million in costs related to Amazon’s logistics service, FBA (Fulfillment By Amazon).

H1 noterade även höga aktivitetsnivåer inom förvärvs-transaktioner, vilket resulterade i engångsposter som inte hör till den vanliga verksamheten på strax under 100 MSEK. Dessa kostnader försvårar jämförelsetalen i de rapporterade siffrorna för nyckeltal så som EBITDA och kassaflöde. Efter normalisering växte vår justerade EBITDA med 10%.

Some highlights from H1:
· The acquisition of Sylphar was completed on 13 January. The company has been integrated and a new organization has been established to leverage Sylphar’s entrepreneurial strengths in digital marketing and e-commerce to drive organic growth under an omni-channel strategy for the entire brand portfolio.
· The E45 transaction was completed on April 1st. The takeover of the brand from Reckitt is on schedule with the first commercial markets operating on 1 July (including Spain and South Africa).
· Fully subscribed rights issue of EUR 250 million completed the financing of Karo’s latest acquisition; change of listing location to Nasdaq First North was completed on March 23.
· ESG goals were established in connection with the annual report for 2021 and set a clear and ambitious agenda for Karo’s continued development and promotion of the important sustainability work.
· Karo organization for direct commercial operations established in Spain, which expands Karo’s footprint to yet another "major-5 market" within the EU.
· Continued development of Karo’s commercial organization with increased investments in marketing as well as in e-commerce and digital assets.
· Karo’s organization has continued strong engagement with eNPS figures increasing to 60 in June 2022 (compared to 52 in June 2021).
· As a result of the war in Ukraine, Karo donated painkillers (1.6 million doses of paracetamol and ibuprofen) and sanitary products (Decubal Hand Wash and DAX Alcogel) to meet the specific needs of Ukrainian hospitals and emergency departments. The donations have been made in collaboration with global aid organizations and the Swedish authorities and are proof that Karo’s brand portfolio is relevant for meeting important health care needs.

Thanks to the above efforts, we are now one step closer to fulfilling our promise to create a highly efficient, leading European platform in everyday health!

Christopher Lorenzen
CEO

Significant events after the end of the reporting period
Nothing to report.

Upcoming reports
Year-end report 2022 February 22, 2023

Annual Report 2021 was published on April 12, 2022 and the Annual General Meeting was held on May 31, 2022

On July 21, 2022 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its financial results for the first half of fiscal year 2022 (Press release, Chugai, JUL 21, 2022, View Source [SID1234616836]).

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"Chugai achieved record-high revenues and profits in the first half of 2022 as our strong first-quarter performance was followed by steady increases in both revenues and profits during the second quarter. Results were driven by growing market penetration of new products Enspryng, Polivy, Evrysdi, and the new ophthalmic drug, Vabysmo, launched in May 2022. On the R&D side, nemolizumab, an investigational antibody originated by Chugai, achieved the primary endpoints in the first phase III clinical trial for prurigo nodularis, as announced by our overseas partner Galderma. The results demonstrated that the drug candidate may potentially provide new value to patients with a disease for which no approved drugs are available. Hemlibra and Tecentriq each obtained regulatory approval for an additional indication, offering a new treatment option for the patients. Hemlibra was approved for acquired hemophilia A, and Tecentriq became the first cancer immunotherapy in Japan to receive approval for adjuvant therapy in non-small cell lung cancer. We will continue to focus all our efforts on innovation to contribute to patients waiting for new treatments," said Dr. Osamu Okuda, Chugai’s President and CEO.

Half Year Financial Results (Core results, January to June 2022)

Chugai reported record-high financial results for the half year 2022 as revenues increased by approximately 30% and operating profit increased by approximately 20% over the same period last year.

An increase in domestic and overseas sales outweighed a decrease in royalties and other operating income, resulting in a 30% increase in total revenues. Sales increased by approximately 50%, of which domestic sales increased by approximately 30%, and overseas sales increased by approximately 80%. In domestic sales, the Oncology field reported flat growth while the Specialty field increased by approximately 90%. In the Oncology field, contributions of the new product Polivy and an increase in Kadcyla sales offset declines in mature products, including Avastin and Herceptin, due to NHI drug price revisions and biosimilars. In the Specialty field, renamed from the Primary field following the organizational change in July, there were contributions from the supply of Ronapreve to the government in the first quarter, as well as an approximately 20% increase in sales of the mainstay product Hemlibra, and steady market penetration of new products, Enspryng, Evrysdi, and Vabysmo, which was launched in May of this year. The increase in overseas sales was driven by a 2.7-times increase of Hemlibra owing to the full-scale export to Roche at regular shipping price and a 70% increase in Actemra, which obtained emergency use authorization and regulatory approval for severe COVID-19 in the U.S. and Europe, respectively, since last June. On the other hand, royalties and other operating income decreased by approximately 40%, mainly due to a significant decrease in royalty income related to the initial shipments of Hemlibra.

Cost to sales ratio rose by 2.7 percentage points year-on-year to 42.8%, mainly due to a change in the product mix. Operating expenses grew by 6.5% as both marketing and distribution, and research and development expenses increased, while general and administration expenses decreased. Marketing and distribution expenses increased mainly due to foreign exchange effects. Research and development expenses increased due to the progress of projects under development and foreign exchange effects. General and administrative expenses decreased primarily due to gain on sales of property, plant and equipment, despite increases in the enterprise tax and various expenses. As a result, Core operating profit totaled ¥201.4 billion (+21.5%).

Quarterly Financial Results (Core results, April to June 2022)

Revenues for the second quarter (Apr-Jun) increased by 6.4% year-on-year, as an increase in sales driven by overseas sales exceeded the significant decline in royalties and other operating income. Sales increased by approximately 20%, of which domestic sales increased by approximately 3%, and overseas sales increased by approximately 50%. The increase in domestic sales was driven by a double-digit growth in the Specialty field, which exceeded a decline in the Oncology field. The supply of Ronapreve to the government, which was the main reason for the 70% year-on-year increase in domestic sales in the first quarter, was not reported in the second quarter. Overseas sales of Hemlibra and Actemra increased both by more than 80%. The cost to sales ratio was almost at the same level as the same period of last year, while it improved compared to the first quarter of this year by approximately 9 percentage points due to a higher proportion of in-house products in total sales. Despite reporting double-digit growth in the first quarter, operating expenses in the second quarter were comparable to the same period of last year, mainly due to the reporting of gain on sales of property, plant and equipment in general and administrative expenses. As a result, Core operating profit for the second quarter increased by approximately 2%.

R&D activities

The Company also made good progress in research and development. Among in-house products, nemolizumab, an investigational antibody with a novel mode of action, achieved the primary endpoints in one of the two ongoing phase III clinical trials for prurigo nodularis, as announced by our overseas partner Galderma in June. Hemlibra, an anti-coagulation factor IXa/X humanized bispecific monoclonal antibody, was approved for the additional indication for acquired hemophilia A based on a domestic phase III AGEHA study in June as well. Furthermore, a clinical trial investigating GYM329 in combination with Evrysdi was initiated for spinal muscular atrophy. As for in-licensed products from Roche, Tecentriq, a cancer immune checkpoint inhibitor, was approved in May as the first cancer immunotherapy in Japan for adjuvant treatment of non-small cell lung cancer.

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 July 21, 2022 Chugai Pharmaceutical Co., Ltd. (hereafter "Chugai") reported that it resolved at the Board of Directors Meeting held today to partially revise the basic agreement for the strategic alliance (hereafter "Basic Alliance Agreement") between Chugai [Head Office: Tokyo, Japan. CEO: Osamu Okuda] and Roche Holding Ltd (hereafter "Roche") [Head Office: Basel, Switzerland. CEO: Severin Schwan], and that it has been concluded and put into effect as of today (Press release, Chugai, JUL 21, 2022, View Source [SID1234616835]).

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Although Chugai is majority-owned and subject to the consolidated results of Roche, as an independent, publicly listed company, Chugai makes all decisions based on the principles of self-governance. With regard to the trading of Chugai shares, the two companies had agreed to maintain Chugai shares to be listed on the first section of the Tokyo Stock Exchange even after ten years (from October 1, 2012) following the merger.

Following the revision of the market classification on the Tokyo Stock Exchange, new listing criteria were established for the Prime Market, which commenced operations on April 4, 2022. Accordingly, Chugai and Roche have made relevant revisions in light of the current situation while inheriting the basic spirit of the agreement.

The main revisions to the Basic Alliance Agreement are as follows:

Roche will cooperate in maintaining Chugai’s listing on the Prime Market1 of the Tokyo Stock Exchange.
In the event that Chugai issues shares, etc., Roche has the pre-emptive right to acquire the shares at the same price and under the same conditions as a third party, in order to maintain its current and future shareholding ratio in Chugai2.
1: Revised from "first section"
2: Revised from "50.1%"
Under the WIN-WIN strategic alliance with Roche, Chugai is promoting the growth strategy "TOP I 2030" with the aim of becoming a top innovator in the global healthcare industry as a listed company on the Prime Market of the Tokyo Stock Exchange. This matter has no impact on Chugai’s consolidated financial results for the fiscal year ending December 2022.