Interim report half year 1, 2022

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

Chugai Announces 2022 Half Year Results

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.

Partial Revision of the Basic Alliance Agreement with Roche

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.

F. Hoffmann-La Roche Announces Half Year Results 2022

On July 21, 2022 F. Hoffmann-La Roche Ltd. (hereafter "Roche") [Head Office: Basel, Switzerland. CEO: Severin Schwan] reported its half year results 2022 (January 1 – June 30, 2022) (Press release, Chugai, JUL 21, 2022, View Source [SID1234616834]).

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Roche owns 59.89% of Chugai’s outstanding shares (61.14% of voting rights) as of the end of June 2022.

Its investor update and presentation materials can be found on its website (View Source).
Chugai’s performance for the period of January 1 to June 30, 2022 is included in the announced Roche Group’s results.

Cerus Corporation to Release Second Quarter 2022 Financial Results on August 4, 2022

On July 21, 2022 Cerus Corporation (Nasdaq: CERS) reported that its second quarter 2022 financial results will be released on Thursday, August 4, 2022, after the close of the stock market (Press release, Cerus, JUL 21, 2022, View Source [SID1234616833]). The Company will host a conference call and webcast at 4:30 P.M. ET that afternoon, during which management will discuss the Company’s financial results and provide a general business overview and outlook.

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To listen to the live webcast and view the presentation slides, please visit the Investor Relations page of the Cerus website at View Source Participants may register for the call here. While not required, interested participants are encouraged to join 10 minutes prior to the start of the event.

A replay will be available on Cerus’ website and will be available approximately three hours after the call through August 18, 2022.