On May 11, 2022 Takeda (TOKYO:4502/NYSE:TAK) reported strong financial results for fiscal year 2021 (period ended March 31, 2022), driven by the performance of its growth products, new product launches and strength across its key business areas (Press release, Takeda, MAY 11, 2022, View Source [SID1234614239]).

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Takeda president and chief executive officer, Christophe Weber, commented: "We are pleased to report another year of strong performance, driven by our growth products. I am energized by the impact we are making for patients and by our continued momentum. We are seeing the potential of our innovative pipeline of approximately 40 clinical stage assets come to life, as demonstrated by the approval and launch of EXKIVITY and LIVTENCITY.

Looking ahead, our goal is to continue to grow Takeda into the most trusted, science-driven, digital biopharmaceutical company, and our strong performance against our strategy in FY2021 reinforces my confidence about the path we are on."

Takeda chief financial officer, Costa Saroukos, commented: "Takeda’s strong FY2021 performance against our management guidance provides a solid foundation for our FY2022 outlook for continued topline growth and robust cash flow generation. This will allow us to allocate capital to maximize value for patients and shareholders as we invest in our R&D engine, new product launches and other growth drivers while continuing to rapidly reduce debt and return cash to shareholders."

(a) Further information regarding certain of Takeda’s Non-IFRS measures is posted on Takeda’s investor relations website at View Source

(b) 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.

(c) Underlying growth compares two periods (quarters or years) of financial results under a common basis and is used by management to assess the business. These financial results are calculated on a constant currency basis and excluding the impact of divestitures and other amounts that are unusual, non-recurring items or unrelated to our ongoing operations.

(d) 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 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.

COMMERCIAL UPDATES ACROSS FIVE KEY BUSINESS AREAS

– Gastroenterology (GI), with 875.7 billion yen in reported revenue, grew +7% on an underlying basis driven by gut-selective ENTYVIO and anti-acid therapy TAKECAB. Following a review of assumptions regarding ENTYVIO biosimilars, Takeda is no longer expecting entry of biosimilars upon loss of data exclusivity.

– Rare Diseases, with 611.2 billion yen in reported revenue, declined -1% on an underlying basis, impacted by a decline in line with expectations in Rare Hematology due to intensified competition. Hereditary Angioedema (HAE) had underlying growth of +4% driven by the strong growth of global market leader TAKHZYRO, which continued its geographic expansion with approval in Japan in March 2022. Post-transplant antiviral infection treatment LIVTENCITY, which launched in the U.S. in December 2021, has been well received by U.S. transplant centers. Additionally, in a recent exploratory data analysis LIVTENCITY showed reductions in hospitalization rates and length of hospital stay.

– Plasma Derived Therapy (PDT) Immunology, with 507.0 billion yen in reported revenue, delivered exceptional growth of +14% on an underlying basis. This was driven by continued strong growing global demand for our Immunoglobulin portfolio and increasing demand for FLEXBUMIN in China and the U.S., both enabled by improved supply. FY2021 plasma donation volume grew 16% compared to COVID-19-impacted FY2020 and was up 3% over pre-pandemic levels.

– Oncology, with 468.7 billion yen in reported revenue, grew +8% on an underlying basis driven by increased market penetration and strong demand increases in Growth and Emerging Markets, particularly China. Non-small cell lung cancer (NSCLC) treatment EXKIVITY, which launched in the U.S. in September 2021, continued its global expansion with recent conditional approval in the U.K.

– Neuroscience, with 482.3 billion yen in reported revenue, grew +10% on an underlying basis driven by increased demand for VYVANSE following the impact of COVID-19 in FY2020.

PIPELINE UPDATE

Takeda strives to advance a steady stream of potential first-in-class or best-in-class therapies through a pipeline of approximately 40 molecules in clinical development – 90 percent of which did not exist six years ago. Leveraging its development strength, robust partnerships and innovative research engine, Takeda is focused on providing transformative treatments for targeted populations with high unmet needs across its core therapeutic areas.

In FY2021, Takeda further demonstrated its ability to bring new therapies to patients, receiving its highest total number of approvals in a fiscal year across Japan (4 NMEs), China (3 NMEs), the U.S. (2 NMEs), and Europe (1 NME) and leading the industry in drug approvals in Japan in calendar year 2021. Significant pipeline updates in Q4 FY2021 and since include:

Approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for NUVAXOVID Intramuscular Injection, a novel recombinant protein-based COVID-19 vaccine, for primary and booster immunization in individuals aged 18 and older. (Press Release)
VONVENDI received approval from the U.S. FDA for adult patients living with severe type 3 von Willebrand Disease (VWD), making it the first and only treatment approved for routine prophylaxis to reduce the frequency of bleeding episodes in adults living with severe type 3 VWD receiving on-demand therapy. (Press Release)
TAKHZYRO was approved by Japan’s MHLW for adult and pediatric patients 12 years of age and older for prophylaxis against acute attacks of hereditary angioedema (HAE) (Press Release). In February, the U.S. FDA approved a single-dose prefilled syringe injection for adult and pediatric patients 12 years and older (Press Release). Studies investigating TAKHZYRO for pediatric patients aged 2 to up to 12 years of age are ongoing and global regulatory filings for this patient population are planned to begin in FY2022. (Press Release)
ALOFISEL showed clinical remission rate at six-months in the real-world INSPIRE study interim analysis consistent with the pivotal clinical ADMIRE-CD Study. ALOFISEL offers a potential cell-mediated closure option for patients with complex Crohn’s perianal fistulas who have shown an inadequate response to at least one conventional or biologic therapy. (Press Release)
First Phase 2 study of TAK-755 was completed. TAK-755 is the first and only ADAMTS-13 replacement therapy in clinical development to address congenital thrombotic thrombocytopenic purpura (cTTP) and immune mediated thrombotic thrombocytopenic purpura (iTTP), life-threatening thrombotic disorders caused by ADAMTS-13 deficiency. Takeda expects Phase 3 data for TAK-755 in cTTP in FY2022 and potential filing for approval in FY2022.
After years of extensive regulatory discussions, Takeda has decided to discontinue development of TAK-609 as data are not sufficient for filing. Takeda remains committed to developing therapies for Hunter syndrome and other lysosomal storage disorders.
Regulatory filings in Europe and endemic countries are ongoing for TAK-003, Takeda’s dengue vaccine candidate, and U.S. regulatory filings are planned for later this year. (Press Release). Additional clinical data (the DEN-301 4.5 year analysis) will be presented at a scientific congress in June 2022.
Expanded collaboration with JCR Pharmaceuticals to develop gene therapies that apply JCR’s J-Brain Cargo blood-brain barrier (BBB) penetration technology for lysosomal storage disorders​.
Entered into a strategic collaboration and license agreement with Evozyne to develop proteins for gene therapies for genetic disorders within the inborn errors of metabolism and lysosomal storage disease areas of research.
FY2022 GUIDANCE

CER: Constant Exchange Rate

Company guidance reflects management’s expectations for continued business momentum across Takeda’s five key business areas, discipline in operating expenses, and FX favorability.

In FY2022, Takeda expects continued revenue growth driven by an acceleration of our Growth and Launch Products, alongside FX tailwinds, to fully offset the impact from loss of exclusivity of VELCADE in the U.S. and the non-recurrence of 133.0 billion JPY from the sale of a diabetes portfolio in Japan recorded in FY2021. Core operating profit is expected to reach 1.1 trillion JPY, mainly driven by business momentum.

Key Assumptions in FY2022 Forecast and Management Guidance

Based on currently available information, Takeda expects that its financial results for FY2022 will not be materially affected by COVID-19 or the crisis in Ukraine and Russia and, accordingly, Takeda’s FY2022 reported forecast and management guidance reflect this expectation.

The FY2022 reported forecast and management guidance include approximately 50.0 billion JPY revenue contribution from COVID-19 vaccines.

On May 11, 2022 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported financial results and a business update for the first quarter ended March 31, 2022 (Press release, VolitionRX, MAY 11, 2022, View Source [SID1234614261]). Volition management will host a conference call tomorrow, May 12 at 8:30 a.m. U.S. Eastern Time to discuss these results. Conference call details can be found below.

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"I am delighted with the progress we are making, and in particular could not be prouder of the team’s achievement in securing a global licensing and supply agreement for our Nu.Q Vet Cancer Screening Test with Heska Corporation, one of the industry’s leading companies," commented Cameron Reynolds, President and Chief Executive Officer of Volition. "In April, we expanded our geographic footprint with the launch of the Nu.Q Vet Cancer Test in Singapore through SAGE Healthcare. We have also made good progress in other key areas including our Nu.Q NETs and Nu.Q Capture programs as we shift gears towards our goal of becoming a commercial company with a wide range of world class products."

Volition is hosting a Capital Markets Day at the New York Stock Exchange, in a hybrid format, on Friday, May 13, 2022, at 10 a.m. U.S. Eastern Time. Volition’s executive team will provide strategic updates and discuss the Company’s key short-term growth drivers. Details for this event can be found below.

An interview with Cameron Reynolds, President and Group Chief Executive Officer of Volition.

Company Highlights

Financial

Cash and cash equivalents as of March 31, 2022, totaled approximately $23.7 million compared with $20.6 million as of December 31, 2021.

On March 30th Volition received a $10 million milestone payment from Heska Corporation.

Net loss for the quarter was $7.7 million dollars compared to $6.1 million for the three-months ended March 31, 2021.

Personnel/ Operational

To support our commercial expansion of Nu.Q Vet we welcomed Daniel Sheres, Product Manager, Devin DeVoue, Marketing Manager and Kristy Valdivia, Global Accounts Manager to the Volition Veterinary Team.

Subsequent to quarter end we appointed Sharon Ballesteros as U.S. Head of Quality and Development Process.

Volition Veterinary

Executed a global licensing and supply agreement with one of the industry’s leading companies, Heska Corporation.

In exchange for granting Heska exclusive worldwide rights to sell the Nu.Q Vet Cancer Screening Test for companion animals at the Point of Care, Volition has received a $10 million upfront payment and is eligible to receive up to a further $18 million based upon the achievement of near/mid-term milestones.

In addition to these milestone payments Volition expects to receive ongoing revenue for the supply of key components for said exclusive point of care product(s).

Volition has also granted Heska non-exclusive rights to sell the Nu.Q Vet Cancer Screening Test in kit format for companion animals, through Heska’s network of central reference laboratories for which Volition will receive ongoing additional revenue for such kit sales.

This is a long-term deal with significant market and revenue potential for Volition through the sale of kits and key components.

Subsequent to the quarter end SAGE Healthcare launched our Nu.Q Vet Cancer Test in Singapore.

We are in advanced negotiations with other potential licensing partners in our efforts to make Nu.Q Vet products as accessible as possible worldwide and anticipate further announcements in 2022.

Nu.Q Capture

Nu.Q Capture, when used in combination with either sequencing, mass spectrometry and/or Volition’s Nu.Q assays could potentially aid diagnosis, treatment selection, and both treatment and disease monitoring in addition to aiding biomarker discovery.

The Nu.Q Capture program now has several strands of technology which:

essentially remove background noise, thereby amplifying the signal,

look to identify the signal in a novel way including through mass spectrometry, or

isolate various chromatin fragments, including nucleosomes and transcription factors.

Subsequent to the quarter end Volition sponsored a GenomeWeb webinar entitled "Novel Proteomics Approach to Epigenetic Profiling of Circulating Nucleosomes" featuring Professor Axel Imhof. To watch on demand, visit the GenomeWeb website.

Volition is developing a large 1000-plus patient Nu.Q Capture study in lung cancer and colorectal cancer with further announcements expected in 2022.

Upcoming Milestones

Drive near term revenue in the following key areas:

Licensing of its technology, with a particular but not exclusive focus on Nu.Q Vet.

Complete Heska Corporation agreement milestones in order to receive further milestone payments.

Sales of key components of Point of Care test with Heska.

Sales of kits from non-exclusive agreements for the use of Nu.Q Vet via central reference labs.

Ongoing and new Nu.Q Discover agreements.

Sales of its disease monitoring tests (e.g. COVID-19, sepsis).

Continue to progress the research program for the use of Nu.Q in NETosis, in monitoring disease progression of COVID-19, sepsis, and potentially other diseases and as a possible companion diagnostic for a treatment for sepsis.

Continue to advance its previously announced large-scale blood, lung, and colorectal cancer trials in Europe, Asia, and the U.S.

Publish several abstracts and peer-reviewed scientific papers with clinical results showing the robustness and utility of its Nu.Q platform.

Advance the development of Nu.Q Capture.

Continue to file patents to expand and extend its intellectual property portfolio.

Cameron Reynolds, President and Chief Executive Officer of Volition, will host the call along with Terig Hughes, Chief Financial Officer of Volition, Dr. Tom Butera, Chief Executive Officer of Volition Veterinary Diagnostics Development LLC, and Scott Powell, Executive Vice President, Investor Relations of Volition. The call will provide an update on important events which have taken place in the first quarter of 2022 and upcoming milestones.

A live audio webcast of the conference call will also be available on the investor relations page of Volition’s corporate website at View Source In addition, a telephone replay of the call will be available until May 25, 2022. The replay dial-in numbers are 1-844-512-2921 (toll-free) in the U.S. and Canada and 1-412-317-6671 (toll) internationally. Please use replay pin number 10167203.

The event will be webcast and the presentations will be posted to Volition’s website. A replay will be made available.

On May 11, 2022 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported results from its phase III SKYSCRAPER-01 study, evaluating the investigational anti-TIGIT immunotherapy tiragolumab plus Tecentriq (atezolizumab) versus Tecentriq alone as an initial (first-line) treatment for people with PD-L1-high locally advanced or metastatic non-small cell lung cancer (NSCLC) (Press release, Hoffmann-La Roche, MAY 11, 2022, View Source [SID1234614178]). The study did not meet its co-primary endpoint of progression-free survival. At this first analysis, the other co-primary endpoint of overall survival (OS) was immature, and the study will continue until the next planned analysis. A numerical improvement was observed in both co-primary endpoints. Data suggest that tiragolumab plus Tecentriq was well-tolerated and no new safety signals were identified when adding tiragolumab. Further analyses of these results are ongoing and data will be presented at an upcoming medical meeting.

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"While these results are not what we hoped for in our first analysis, we look forward to seeing mature overall survival for this study to determine next steps," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "We continue to believe that TIGIT may have a role in cancer treatment and we will share additional results from our tiragolumab programme as they emerge."

The tiragolumab programme continues to explore advances in multiple clinical trials to build on Tecentriq, expand into earlier stages of disease, and seeks to provide new treatment options in advanced and difficult-to-treat cancers with high unmet medical need.

About the SKYSCRAPER-01 study
SKYSCRAPER-01 is a global phase III, randomised double-blinded study evaluating tiragolumab plus Tecentriq (atezolizumab) versus Tecentriq alone in 534 patients with first-line PD-L1-high locally advanced, unresectable or metastatic non-small cell lung cancer. Patients were randomized 1:1 to receive either tiragolumab plus Tecentriq or placebo plus Tecentriq, until disease progression, loss of clinical benefit or unacceptable toxicity. Co-primary endpoints are overall survival and progression-free survival.

About tiragolumab
Tiragolumab is an investigational novel immune checkpoint inhibitor with an intact Fc region. Tiragolumab selectively binds to TIGIT, a novel inhibitory immune checkpoint which suppresses the immune response to cancer.1 Based on preclinical research, tiragolumab is thought to work as an immune amplifier with other cancer immunotherapies such as Tecentriq (atezolizumab).2 The TIGIT pathway is distinct but complementary to the PD-L1/PD-1 pathway. Dual blockade with tiragolumab and Tecentriq may help overcome immune suppression and restore the immune response.1

About Tecentriq (atezolizumab)
Tecentriq is a cancer immunotherapy approved for some of the most aggressive and difficult-to-treat forms of cancer. Tecentriq was the first cancer immunotherapy approved for the treatment of a certain type of early-stage (adjuvant) non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and hepatocellular carcinoma. Tecentriq is also approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies, for various forms of metastatic NSCLC, certain types of metastatic urothelial cancer, PD-L1-positive metastatic triple-negative breast cancer and BRAF V600 mutation-positive advanced melanoma.

Tecentriq is a monoclonal antibody designed to bind with a protein called programmed death ligand-1 (PD-L1), which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted therapies and various chemotherapies across a broad range of cancers. In addition to intravenous infusion, the formulation of Tecentriq is also being investigated as subcutaneous injection to hopefully provide a faster and more convenient option for cancer patients.

On May 11, 2022 Perrigo Company plc (NYSE: PRGO) ("Perrigo" or the "Company"), a leading provider of Consumer Self-Care Products, reported financial results for the first quarter ended April 2, 2022 (Press release, Perrigo Company, MAY 11, 2022, View Source,-RAISES-GUIDANCE [SID1234614222]). All comparisons are against the prior year fiscal first quarter, unless otherwise noted.

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President and CEO, Murray S. Kessler commented, "We delivered another quarter of very strong organic net sales growth as consumer demand driven sales again strengthened sequentially. The categories in which we compete are growing and remain on-trend, and the products in our portfolio that were most disrupted by the pandemic, including cough/cold, have rebounded. The strong performance of our U.S. infant formula business, which benefited from innovation and availability while a competitor experienced quality issues, was also notable."

Kessler continued, "First quarter earnings were in-line with our expectations, despite significant and increasing cost headwinds and a significantly strengthening U.S. dollar. We now expect full year 2022 cost headwinds to increase by approximately $125 million versus prior year as compared to our original expectation of an increase of $80 million. While price increases and procurement actions are expected to offset inflation for the full year, adverse foreign exchange rate movements and to a lesser extent business disruption in Ukraine and Russia are likely to remain. With the addition of HRA Pharma and higher expectations for organic net sales growth, we expect to more than offset these headwinds and have raised our net sales and adjusted EPS guidance for the year."

Kessler concluded, "With our consumer self-care transformation complete, our focus going forward will be to ‘Optimize and Accelerate’ through gross margin enhancement via supply chain reinvention, pricing actions and portfolio consolidation, the successful integration of HRA and by continually improving our organization and culture. The path ahead is clear and we remain on track to deliver significant profitable growth over the next few years."

Refer to Tables I – IV at the end of this press release for a reconciliation of non-GAAP adjustments to the current year and prior year periods and additional non-GAAP information. The Company’s reported results are included in the attached Consolidated Statements of Operations, Balance Sheets and Statements of Cash Flows.

First Quarter 2022 Perrigo Results from Continuing Operations

Perrigo net sales for the first quarter were $1.1 billion, an increase of $65 million, or 6.4%. Organic net sales grew 9.7%.

Net sales were driven by 1) higher incidences of cough/cold and flu-like illnesses globally, leading to an increase of $49 million in cough/cold sales that benefited the Upper Respiratory and Pain and Sleep Aids categories, 2) strong growth in U.S. Nutrition stemming from store brand infant formula share gains and a competitor recall, 3) the addition of $33 million in contract manufacturing sales to the divested RX business, 4) higher net sales in the CSCI Skincare and Personal Hygiene category, and 5) increased pricing across both Consumer Self-Care segments. These drivers also benefited from new product sales and e-commerce growth. These increases were partially offset by 1) lower net sales in the global Healthy Lifestyle and CSCI VMS categories, 2) unfavorable currency exchange rate movements of $34 million, and lower sales in Ukraine and Russia.

First quarter reported operating income was $22 million in 2022, compared to $51 million in 2021. Adjusted operating income decreased $32 million, or 26.8%, to $87 million in 2022 driven by 1) $34 million in cost headwinds, including cost of goods sold inflation, carry over of unfavorable plant absorption in 2021 and increased freight expenses, 2) higher customer service claims related to unfulfilled customer orders due to unusual ordering patterns during the quarter in CSCA, 3) higher planned advertising and promotion investments to support brand growth, 4) lower profitability in contract manufacturing sales to the divested RX business compared to the prior year, and 5) the impact from lower sales in Ukraine and Russia. These factors were partially offset by higher gross profit flow-through resulting from higher volumes and pricing.

Reported net loss was $1.3 million, or $0.01 per diluted share, compared to reported net income of $2.8 million, or $0.02 per diluted share in the prior year period. Excluding certain charges as outlined in Table I, first quarter 2022 adjusted net income was $45 million, or $0.33 per diluted share, compared to $67 million, or $0.50 per diluted share, last year. Currency-neutral EPS for the quarter was $0.37, including a $0.02 per share negative impact from the war in Ukraine.

First Quarter 2022 Business Segment Results from Continuing Operations

Consumer Self-Care Americas Segment

CSCA first quarter net sales of $710 million increased $70 million, or 10.9%. Primary category drivers are provided below.

Upper Respiratory
Net sales of $153 million increased 28.8% due primarily to higher incidences of cough/cold and flu-like illnesses that led to strong demand for cough/cold products, particularly store brand liquid-based cough/cold offerings, and demand for oral allergy products.

Digestive Health
Net sales of $119 million increased 0.2% as growth in e-commerce was offset by temporary packaging constraints on a specific product, which is expected to alleviate during the second half of 2022, and lower category consumption of proton pump inhibitors compared to the prior year.

Pain & Sleep-Aids
Net sales of $103 million increased 8.2% due primarily to strong demand for children’s analgesics products stemming from higher incidences of cough/cold and flu-like illnesses, partially offset by higher demand for certain premium dosage forms where the Company today does not provide a store brand offering.

Nutrition
Net sales of $127 million increased 38.0% due primarily to strong growth in U.S. store brand infant formula stemming from share gains and a competitor recall, new product launches within infant formula and continued growth in the oral electrolytes business.

Oral Care
Net sales of $70 million decreased 6.1% due primarily to delayed receipt of products manufactured outside the U.S., leading to unfulfilled customer orders.

Healthy Lifestyle
Net sales of $68 million decreased 11.1% due primarily to the discontinuation of diabetes products and lower category consumption and share of certain smoking cessation products.

Skincare & Personal Hygiene
Net sales of $49 million decreased 12.3% due primarily to service challenges related to the now divested Scaraway(R) brand and discontinued product in non-strategic category segments.

Vitamins, Minerals, and Supplements ("VMS") and Other
Net sales of $21 million increased 132.6% due primarily to contract manufacturing sales to the divested RX business.

Reported operating income was $79 million in the quarter compared to $96 million in 2021. Adjusted operating income decreased $23 million to $87 million driven primarily by 1) cost headwinds, including cost of goods sold inflation, carry over of unfavorable plant absorption in 2021 and increased freight expenses, 2) higher customer service claims related to unfulfilled customer orders due to unusual ordering patterns during the quarter in CSCA, and 3) lower profitability in contract manufacturing sales to the divested RX business compared to the prior year. These factors were partially offset by higher gross profit flow-through resulting from net sales growth and lower operating expenses.

Consumer Self-Care International Segment

CSCI net sales of $365 million decreased $5 million, or 1.4%, including a negative impact of 9.1 percentage points from unfavorable currency exchange rate movements. Organic net sales growth was a strong 7.7%. Primary category drivers are provided below.

Skincare & Personal Hygiene
Net sales of $102 million decreased 4.8%, or an increase of 4.9% excluding the impact of currency, driven primarily by increased net sales of the anti-parasite brand Paranix, due to the easing of COVID-19-related restrictions, and strong performances and new product launches in the ACO and Sebamed skincare lines.

Upper Respiratory
Net sales of $61 million increased 43.1%, or 56.6% excluding the impact of currency, as the higher incidences of cough/cold and flu-like illnesses led to strong demand for cough/cold products, including Bronchonolo, Coldrex, Phytosun, Physiomer and U.K. store brands. New products also contributed to growth in the quarter.

VMS
Net sales of $48 million decreased 18.8%, or 10.5% excluding the impact of currency, due primarily to lower category consumption and the lingering impact from the third quarter 2021 recall of certain batches of Davitamon and Abtei.

Pain & Sleep-Aids
Net sales of $52 million increased 5.5%, or 13.5% excluding the impact of currency, due primarily to an increase in U.K. store brand consumption and higher demand for Solpadeine, a paracetamol-based analgesics product.

Healthy Lifestyle
Net sales of $43 million decreased 15.1%, or 7.6% excluding the impact of currency, due primarily to lower net sales in the XLS Medical weight management franchise stemming from lower category consumption and timing of NiQuitin smoking cessation product sales to customers.

Oral Care
Net sales of $24 million decreased 4.3% or an increase of 5.5% excluding the impact of currency, due primarily to customer restocking following supply constraints in the prior year.

Digestive Health and Other
Net sales of $35 million decreased 3.6%, or an increase of 3.1% excluding the impact of currency, due primarily to higher sales of distribution brands.

Reported operating income was $16 million in the quarter compared to $17 million in the prior year quarter. Adjusted operating income decreased $7 million, or 12.1%, to $53 million as higher gross profit flow-through resulting from net sales growth was more than offset by higher planned advertising & promotion investments to support brand growth and unfavorable currency exchange rate movements. Excluding the impact of currency, adjusted operating income was flat compared to the prior year quarter.

Updated Fiscal 2022 Outlook

Based on current foreign exchange rates, the Company is raising its fiscal 2022 growth range outlook from 3.5%-4.5% to 8.5%-9.5% versus the prior fiscal year, primarily due to the acquisition of HRA, which closed on April 29, 2022. The Company is also raising its fiscal 2022 organic growth range outlook from 7%-8% to 8%-9%.

The Company is raising its adjusted diluted EPS range from $2.10-$2.30 to $2.30-$2.40, reflecting approximately $0.35 from the HRA acquisition, partially offset by approximately $0.10 from additional unfavorable exchange rate movements, $0.05 from stopping distribution of product to Russia, and approximately $0.05 in higher interest expense from refinancing.

The Company continues to expect first half margin compression and second half margin expansion and an adjusted effective tax rate of approximately 23%. Cash flow from operations as a percentage of adjusted net income is now expected to be above the Company’s original range of 95%-105%.

The Company cannot reconcile its expected adjusted diluted earnings per share to diluted earnings per share under "Fiscal 2022 Outlook" without unreasonable effort because certain items that impact net income and other reconciling metrics are out of the Company’s control and/or cannot be reasonably predicted at this time.

On May 11, 2022 Neutron Therapeutics, a targeted radiation therapy company developing a comprehensive solution for Boron Neutron Capture Therapy (BNCT), and Cosylab, the world’s leading provider of control systems for the planet’s most complex machines, reported that Neutron Therapeutics’ nuBeam BNCT System, using Cosylab’s OncologyOne software, has reached a significant milestone in its clinical commissioning at Helsinki University Hospital – first simulated patient treatment (Press release, Neutron Therapeutics, MAY 11, 2022, View Source [SID1234614240]).

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BNCT is a targeted radiation cancer therapy in which neutron beams destroy only boron compound-bearing tumors without destroying neighboring normal tissue. BNCT has the potential to deliver highly effective and cell-localized radiation therapy to treat tumors with minimal impact on the patient’s quality of life compared to other radiation, chemotherapy or biological treatment modalities currently in use.

Neutron Therapeutics Inc. and the Helsinki University Hospital are collaborating to launch the first European hospital-based BNCT facility. Cosylab is a proven partner with over two decades of experience solving complex software challenges in radiation therapy.

Johanna Mattson, Senior Medical Director at the Helsinki University Hospital Comprehensive Cancer Center, commented: "Providing BNCT with the most sophisticated accelerator-based device will enable Finnish clinicians to treat patients with some of the most obstinate cancers and remain globally at the forefront of oncology. We are working hand in hand with our industry partners, Neutron Therapeutics and Cosylab, to bring the full clinical potential of BNCT to patients in Helsinki as soon as 2023."

Neutron Therapeutics’ nuBeam is a high-throughput, compact accelerator-based neutron source suitable for clinical settings. nuBeam replaces legacy nuclear reactors. It has the highest neutron flux of all currently available BNCT systems and is the only device producing an IAEA-compliant BNCT beam for the safe and effective clinical use of neutrons. During the commissioning process, the Helsinki nuBeam device has demonstrated both robustness and reliable operation, validating the Neutron Therapeutics technology as the best choice for a high-throughput BNCT clinic with stringent safety requirements.

"We are extremely excited that our collaboration with Helsinki University Hospital has demonstrated nuBeam’s excellent reliability in the clinical environment. We are committed to achieving the initiation of clinical trials in the first half of 2023 at our first European nuBeam installation. Our close partnership with Cosylab has enabled rapid progress towards this goal and positions Neutron Therapeutics to maximize the potential of BNCT and its beneficial impact on patients," said Dr. Elizabeth Reczek, CEO of Neutron Therapeutics.

The first simulated patient treatment at the Helsinki nuBeam installation was achieved using Cosylab’s OncologyOne software, the only solution on the market that covers all the needs of a radiation therapy device. It has already proven itself in other forefront radiation therapy modalities such as proton therapy and brings to the nuBeam system a software solution for radiation therapy that is much more readily upgradable and integrable than custom-built software while guaranteeing the shortest time-to-clinical-use.

"We are thrilled by the first-beam success and proud we could help Neutron Therapeutics stay on schedule with the commissioning of their nuBeam in Helsinki. Our OncologyOne suite of software products is designed from the ground up to empower our customers to bring their radiation therapy innovations into clinical practice in the shortest possible time and full working order, stated Dr. Mark Pleško, CEO of Cosylab.

Finland has been a European hotspot of BNCT trials since 1992. With the ongoing clinical verification and validation testing of the nuBeam system at the Helsinki University Hospital, patients who have inoperable, locally recurrent head, neck, and other cancers incurable with conventional radiation therapy are now much closer to reaping benefits from boron neutron capture therapy.