On August 1, 2023 Boehringer Ingelheim, a leading research-driven biopharmaceutical company, reported it continues to advance its pipeline in both Human Pharma and Animal Health expanding across its key therapy areas (Press release, Boehringer Ingelheim, AUG 1, 2023, View Source,first%20six%20months%20of%202023. [SID1234635014]).

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Currency-adjusted net sales rose by 9.7 percent to 12.2 billion EUR driven by high demand for medications during the first six months of 2023, driven by strong momentum in Jardiance for Human Pharma and NexGard for Animal Health.

"True innovation addressing high unmet patients’ needs has enabled us to reach ever more patients in the first half of this year," said Hubertus von Baumbach, Chairman of the Board of Managing Directors. "Persistent and above-average investments in our pipeline during the last years have resulted in many new treatment options for patients in the years to come, thus transforming lives for generations."

Boehringer Ingelheim continued expanding its pipeline portfolio through in-house as well as external innovation – 15 new innovation partnerships were formed in areas such as cancer immunology, fibrotic lung diseases and retinal diseases. Overall, the company has committed to invest 25 billion EUR in Research & Development and an additional 7 billion EUR for new production technologies over the next five years.

Net sales in Human Pharma were up 11.3 percent (currency-adjusted) at 9.6 billion EUR in the first half of the year, mainly driven by the Jardiance family at 3.5 billion EUR and the respiratory medicine OFEV at 1.7 billion EUR.

Jardiance experienced strong momentum in the first six months of 2023. It is expected to grow following additional regulatory action for treatment of chronic kidney disease. Worldwide 850 million people1 live with this disease. With the addition to existing indications in type 2 diabetes and heart failure, Jardiance will potentially be able to help manage cardio-renal-metabolic conditions. Over 1 billion people live with cardio-renal-metabolic conditions globally1.

In oncology, the company’s MDM2-p53 antagonist brigimadlin has advanced into the pivotal trial for the treatment of dedifferentiated liposarcoma, a rare cancer with limited treatment options so far. The clinical development of two additional investigational therapies (zongertinib, also known as BI 1810631, and BI 764532) from the oncology pipeline has been accelerated based upon positive early clinical data.

The PDE4B inhibitor BI 1015550 is now in two clinical Phase III trials for the treatment of Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis. Patient recruitment for trial investigating BI 1015550 in IPF is well ahead of plan.

"We have become very successful in bringing new products through our pipeline addressing patients’ needs faster," said Michael Schmelmer, Member of the Board of Managing Directors, responsible for Finance & Group Functions. "We expect to further increase our R&D spending as clinical trials progress into late-stage phases."

Animal Health recorded growth in Pets and Livestock, with sales increasing by 3.8 percent (currency-adjusted) to 2.5 billion EUR in the first six months of the year. Net sales of NexGard, a flea and tick prevention for dogs and cats, increased 9.2 percent (currency-adjusted) to 644 million EUR, while Ingelvac Circoflex, a vaccine used to protect pigs against porcine circovirus type 2, rose 8.7 percent to 127 million EUR.

In addition, the company complemented its market-leading NexGard portfolio through FDA approvals for NexGard PLUS, a new monthly combination product for dogs that protects against fleas, ticks, heartworm disease, roundworms and hookworms, and NexGard COMBO, the first-and-only feline broad-spectrum parasite protection that treats tapeworms.

The Animal Health business has made further progress in the pipeline development in infectious and non-infectious diseases for Pets and Livestock and is preparing for the launch of a highly innovative oral product for diabetes in cats.

For the remainder of the year Boehringer Ingelheim expects more progress in its innovation efforts, such as data readout for a Phase III trial with empagliflozin in patients after myocardial infarction and upcoming regulatory action for OFEV in children and adolescents between 6-17 years with interstitial lung disease.

Looking forward, the company aims to achieve more than 30 new medical approvals in Human Pharma by 2029 and expects around 20 product launches in Animal Health through 2025.

On August 1, 2023 Astellas reported the financial results for the first three months (April 1, 2023 – June 30, 2023) of the fiscal year 2023 ending March 31, 2024 (FY2023) (Press release, Astellas, AUG 1, 2023, View Source [SID1234634650]).

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On August 1, 2023 Recordati reported the interim financial statements as of June 30th, 2023, pursuant to Art. 154-ter of Italian Legislative Decree 58/1998 and subsequent amendments, prepared in accordance with said Decree and the CONSOB Issuers Regulation (Press release, Recordati, AUG 1, 2023, View Source [SID1234633836]). The statements were prepared in accordance with International Accounting Standard (IAS) 34 requirements for interim reporting, based on the assessment, measurement and recognition criteria set by the IFRSs. The interim financial statements on June 30th , 2023 – as well as the Independent Auditors’ report on such statements – will be available within the legal deadline at the company’s offices and on the company’s website (www.recordati.com) and can also be viewed on the authorized storage system 1Info (www.1Info.it).

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Financial highlights
Consolidated net revenue in the first half of the year was € 1,044.3 million, +17.0% vs H1 2022 or +15.4% on a like-for-like(3) basis at CER, driven by strong momentum across all businesses and the successful integration of EUSA Pharma. These results have been achieved despite strong FX headwinds over recent months, with an adverse FX impact in H1 of € 29.7 million (-3.3%) mainly affecting Specialty & Primary Care, and the unwinding, in Q2, of part of the sales phasing benefits posted in the first quarter. Our Specialty & Primary Care portfolio contributed revenues of € 668.9 million in the first six months of 2023, growing 15.0% at CER (+8.8% Türkiye excluded), ahead of the reference markets, driven by all the main therapeutic areas, with particularly strong cough and cold sales in Q1. Revenue of the rare diseases segment in the first half of 2023 totaled € 344.4 million, up 32.2% (or 15.5% on a like-for-like(3) basis at CER) versus same period of prior year, reflecting the integration of the rare oncology products acquired with EUSA Pharma, which contributed revenues of € 95.6 million (growing by 13.1% on a pro-forma basis(3)), a continued growth in sales of Signifor and Isturisa (totalling € 110.6 million, up 38.2%), with resilient sales of our metabolic franchise, thanks to strong growth of Panhematin and limited erosion of generic products in US.

Adjusted operating income(4) of €338.2 increased by 22.8% compared to the first half in 2022, with a ratio to sales of 32.4%, reflecting the robust revenue performance , with continued strong cost discipline and efficiency initiatives offsetting the impact of inflation, investment behind new franchises and increased amortisation charges of € 9.8 million (mainly from the consolidation of EUSA Pharma in the second quarter of 2022). Operating income was € 313.4 million, up 34.9% over the same period of the previous year; this reflects gross margin-related charges arising from the fair value step up of acquired EUSA Pharma inventory of € 20.9 million (vs € 16.9 million in 2022), and non-recurring costs of € 3.9 million, significantly reduced vs 2022 levels, mainly arising from streamlining activities within the sales area of Specialty and Primary Care.

EBITDA(1) was € 406.2 million, up 21.3% compared to the first half of 2022, and with a margin on revenue of 38.9% (vs 37.5% in the first half of 2022), reflecting the operational leverage benefit and previously announced efficiency initiatives, together with a significant resilience of adjusted gross margin, which remained broadly in line with previous year.

Adjusted net income(2) was € 287.4 million, +27.9% over the same period in 2022, at 27.5% of revenue. In addition to the higher operating income this benefits from lower net financial charges of € 24.6 million in the first half, down € 13.6 million compared to the same period of the previous year, with positive effect of FX gains and losses (€ 4.7 million gains in 2023 vs € 18.7 million losses in 2022, mainly driven by the volatility of the Russian rouble), more than off-setting increased interest expenses. Net income was € 227.6 million, up 50.3% over the same period in 2022, at 21.8% of revenue, reflecting also significantly lower non-recurring expenses.

Free cash flow(5) was € 261.7 million for the period, significantly above the same period of last year (up by € 43.0 million), absorbing increase in working capital, driven by higher revenue, and higher cash interest expense.

The net financial position(6) as of June 30th 2023 recorded net debt of € 1,326.2 million, or 1.8x EBITDA, compared to net debt of € 1,419.9 million on December 31st 2022. During the period, USD 20 million of residual Isturisa milestones to Novartis and dividends for € 127.0 million were paid.

Shareholders’ equity was € 1,609.2 million.

Management Comments
"We delivered a strong financial performance in the first half of the year, with continued growth across the business and ongoing delivery of sector-leading margins. The Company is going into the second half of 2023 with very strong underlying momentum and continued ability to convert revenue growth into profits and cashflow. We are also particularly pleased with the agreement signed with GSK in July, which adds two well established brands to our core urology portfolio in Specialty & Primary Care, leveraging our competitive commercial platform to address different patient needs. This deal reflects the successful execution of our strategy to date and strengthens the position of our group for future growth," commented Chief Executive Officer Rob Koremans.

Corporate development news and other key events
On June 27th, the Chinese Medicines Agency (NMPA) approved the marketing of the drug Carbaglu. The launch is expected in early 2024.

As part of the development path aimed to obtain FDA approval of a Biologics License Application (BLA) for the registration of Qarziba in the United States, preparatory activities are ongoing for a Type C Meeting with the FDA, expected in second half of 2023. Planned phase II study for pasireotide in the treatment of Post-Bariatric Hypoglycemia is on track to start in the third quarter of 2023. Patient enrolment in the global phase II study in neurotrophic keratitis for REC 0559 is proceeding according to plan, with data read out expected in the second quarter of 2024. Finally, our focus and efforts in driving our ESG strategy have been further recognized in June 2023, with confirmation of our inclusion in the FTSE4GOOD Index series and of our "Platinum" rating by EcoVadis.

Subsequent events
On July 20th, Recordati announced an agreement with GSK to commercialize Avodart (dutasteride) and Combodart/Duodart (dutasteride/tamsulosin) across 21 countries, mainly in Europe, excluding only those where GSK already has a distribution agreement in place. Avodart and Combodart/Duodart are marketed products, presented as oral form (capsules), indicated for the treatment of moderate to severe symptoms of benign prostatic hyperplasia (BPH) and for the reduction in the risk of acute urinary retention (AUR) and surgery in patients with moderate to severe symptoms of BPH. Avodart and Combodart/Duodart are leading and well-established brands, post loss of exclusivity, that enlarge and complete Recordati’s proven presence in the urology space, significantly reinforcing the competitiveness of its offer. Both brands are synergistic with Recordati’s urology portfolio, complementing Urorec and Eligard. The two products have been commercialized by GSK in the territories licensed to Recordati, with annual sales in 2022 in the region of approximately € 115 million. Recordati made an upfront payment of € 245 million and will start recognizing revenue and margins on a country-by-country basis progressively upon completion of the relevant transition activities, with first transitions expected in Q3 2023 and most to be finalized by end of Q4 2023. As announced, the deal is expected to be fully accretive by 2024 and will deliver €10-20 million of revenue in 2023 with positive EBITDA.

Business outlook
Given the continued strong performance of the Group, despite the significant increase in FX headwinds (FY estimate now -4% vs prior -2%), we confirm the improved guidance for FY 2023 as provided on May 11, with overall revenue of between € 2,050 million and € 2,090 million, EBITDA(1) of between € 750 and € 770 million and adjusted net income(2) of between € 490 and € 500 million.

On August 1, 2023 Merck & Co reported its Second-Quarter 2023 Financial Results (Press release, Merck & Co, AUG 1, 2023, View Source [SID1234633832]).

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On August 1, 2023 Recently, a researcher at Children’s Hospital Los Angeles developed a new way to diagnose retinoblastoma by sampling the fluid at the front of the eye (Press release, Children’s Hospital Los Angeles, AUG 1, 2023, View Source [SID1234633615]). These liquid biopsies also offer genetic and chromosomal information, which gives a more complete picture of each child’s disease. Now CHLA will lead an international liquid biopsy retinoblastoma study, the first of its kind.

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Jesse Berry, MD, is the Director of Ocular Oncology and the Retinoblastoma Program at CHLA. Once strictly a clinician, Dr. Berry transitioned to research with the goal of finding a better way to diagnose retinoblastoma. This cancer—which affects the light-sensing layer at the back of the eye—is extremely aggressive and can result in loss of one or both eyes if not treated quickly. But timely treatment depends on a timely and accurate diagnosis.

Most cancers are diagnosed with a biopsy: An oncologist samples tumor cells and performs various tests to confirm the type of cancer. Unfortunately, this cannot be done with retinoblastoma. "It isn’t a solid mass, like some cancers," says Dr. Berry. "It’s like a thick liquid, and it’s difficult to physically get to." Attempts to directly biopsy the tumor, she explains, can do more harm than good, potentially causing cancer cells to spread. Not only does this make diagnosing the cancer difficult, but it also prevents researchers from studying the cancer cells, a necessary process in understanding the disease and advancing treatments. Dr. Berry had the idea to examine the aqueous humor, the fluid inside the eye itself.

"The last five years have been really exciting in retinoblastoma research," says Dr. Berry. "We use a tiny amount of fluid—100 microliters, about half the size of a green pea—and from that we get a trove of information, things that were impossible to see before. We can see genetic mutations, chromosomal aberrations. We can diagnose retinoblastoma at a molecular level." This provides oncologists with a very specific map of each child’s disease.

"There are a few specific factors that come up in these biopsies," she says, "markers that we suspect are bad players, leading to a more severe disease." Indeed, this is what Dr. Berry has confirmed in studies involving CHLA patient samples. "But we need to really ramp up this research so we can help kids everywhere," says Dr. Berry. "We need to look at a much larger data set." This summer, Dr. Berry’s team will do just that, leading an international research study.

The National Cancer Institute of the National Institutes of Health (NIH) has awarded Dr. Berry $2.8 million to lead the first prospective international retinoblastoma liquid biopsy study to date. The study will include samples from 18 centers, including the largest retinoblastoma center in Canada. All material will be processed and studied at Children’s Hospital Los Angeles, under the direction of Dr. Berry, who is the sole principal investigator named on the grant.

Children will be followed for a minimum of two years, so researchers can examine samples for possible cancer recurrence. Because tumors return in approximately 50% of retinoblastoma patients, this information can be lifesaving.

"We know that detecting a cancer as early as possible gives a child the best chance," says Dr. Berry. "In continuing to take biopsies from these children, we can treat any recurrences early on, even before they’re visible to a clinician upon examination."

The results of Dr. Berry’s forthcoming study will help shape the next phase of her research. "Right now, we’re in this position where we see very strong data," she says, "and we need to ensure that what we’re seeing is also represented in the international population." Then, says Dr. Berry, the team has plans to develop a clinical trial to evolve the standard of care for diagnosing and treating retinoblastoma—and link specific treatments to the information identified in the liquid biopsy.