On August 9, 2022 Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, reported its financial results for the second quarter ended June 30, 2022 and provided a corporate update (Press release, Intra-Cellular Therapies, AUG 9, 2022, View Source [SID1234617901]).

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"In this quarter, CAPLYTA experienced significant revenue growth, increasing nearly 60% over the first quarter of 2022, driven by strong uptake in bipolar depression. We expect to continue to deliver strong revenue growth throughout 2022 and also look forward to advancing our development programs," said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies.

SECOND QUARTER FINANCIAL HIGHLIGHTS

Total revenues were $55.6 million for the second quarter of 2022, compared to $20.0 million for the second quarter of 2021. Net product revenues of CAPLYTA were $55.1 million for the second quarter of 2022, compared to $19.0 million for the same period in 2021, representing a year-over-year increase of 190% and a 58% increase over the first quarter of 2022.
Cost of product sales were $4.7 million in the second quarter of 2022, compared to $2.0 million for the second quarter of 2021.
Selling, general and administrative (SG&A) expenses were $100.3 million for the second quarter of 2022, compared to $69.9 million for the second quarter of 2021. This increase is primarily due to an increase in marketing and advertising expenses and labor related costs.
Research and development (R&D) expenses for the second quarter of 2022 were $38.5 million, compared to $17.3 million for the second quarter of 2021. This increase is due to higher lumateperone clinical trial and non-clinical related costs and an increase in non-lumateperone project costs.
Net loss for the quarter ended June 30, 2022 was $86.6 million, compared to a net loss of $68.7 million for the quarter ended June 30, 2021.
Cash, cash equivalents, restricted cash and investment securities totaled $679.2 million at June 30, 2022, compared to $413.7 million at December 31, 2021. In January 2022, the Company completed a $460.0 million public offering resulting in net proceeds to the Company of approximately $433.7 million from the sale of 10,952,381 shares of its common stock, after deducting underwriting discounts and commissions and offering expenses.
COMMERCIAL HIGHLIGHTS

Q2 2022 marks the second full quarter of the launch of the CAPLYTA’s bipolar depression indication following U.S. Food and Drug Administration (FDA) approval in late December 2021. CAPLYTA is the first and only FDA-approved treatment for depressive episodes associated with bipolar I or II disorder (bipolar depression) in adults as monotherapy and as adjunctive therapy with lithium or valproate.
The significant launch inflection continued in both new and total prescriptions, reflecting sustained robust growth following approval in bipolar depression. Second quarter CAPLYTA new and total prescriptions increased by 55% and 51%, respectively, versus the first quarter of 2022. Second quarter CAPLYTA new and total prescriptions increased by 225% and 191%, respectively, versus the second quarter of 2021.
Following FDA approval during the second quarter of 2022, two new dosage strengths of CAPLYTA, 10.5 mg and 21 mg, are expected to be available in pharmacies this month. This will expand the patient population who has access to CAPLYTA, specifically for patients taking strong or moderate CYP3A4 inhibitors and patients with moderate or severe hepatic impairment.
CAPLYTA maintained broad coverage in the Medicare Part D and Medicaid channels, with greater than 98% of lives covered and, during the quarter, we further expanded coverage in the Commercial channel to approximately 85% of lives covered. Our LytaLink patient support program continues to be highly effective in supporting patient access.
CLINICAL HIGHLIGHTS

Lumateperone:

Mixed Features program: Patient enrollment is progressing well in Study 403, a global clinical trial evaluating lumateperone 42 mg in patients with major depressive disorder (MDD) and in patients with bipolar depression who exhibit mixed features. The primary endpoint is change from baseline versus placebo on the MADRS total score at week 6, and the CGI-S scale is the key secondary endpoint. We expect to complete clinical conduct in this study in late 2022.
Adjunctive MDD program: Patient enrollment in pivotal global studies 501 and 502 evaluating lumateperone 42 mg as adjunctive treatment to anti-depressants is ongoing. We expect to file a supplemental New Drug Application (sNDA) with the FDA for lumateperone as an adjunctive therapy to antidepressants for the treatment of MDD in 2024.
Presentations: In the second quarter of 2022, there were lumateperone research presentations at the American Psychiatric Association (APA) Meeting, the International Conference for Bipolar Disorders (ISBD) Annual Meeting, the American Society of Clinical Psychopharmacology (ASCP), and the Schizophrenia International Research Society (SIRS). The presentations included additional analyses from our lumateperone bipolar depression program including findings consistent with broad antidepressant effects, marked improvements in patients’ daily functioning, and further evidence of a favorable metabolic profile.

At SIRS, we presented safety analyses from our open-label safety switching study evaluating lumateperone 42 mg in patients with stable schizophrenia. Overall, data from this post-hoc analysis further support the favorable safety and tolerability profile of lumateperone 42 mg in patients with schizophrenia who switched from another antipsychotic, irrespective of the previous antipsychotic. In addition, patients switching from risperidone/paliperidone or olanzapine to lumateperone had significant improvements in cardiometabolic parameters and prolactin concentrations.
Lumateperone Long Acting Injectable (LAI) formulation: We have completed the preclinical development of an LAI formulation, and we have conducted a Phase 1 single ascending dose study with this formulation. This study evaluated the pharmacokinetics, safety and tolerability of lumateperone LAI in patients with stable symptoms of schizophrenia. We are exploring alternate sites of injection with this formulation as well as progressing other formulations. This will assist us in evaluating dosing strategies and formulation for our efficacy studies. The goal of our program is to develop LAI formulations that are effective, safe and well-tolerated with treatment durations of one month and longer.
Other Programs:

ITI-1284-ODT-SL program: ITI-1284 is a deuterated form of lumateperone, a new chemical entity formulated as an oral disintegrating tablet for sublingual administration. We are presently evaluating ITI-1284-ODT-SL in Phase 1 studies including drug-drug interaction studies. We expect to commence clinical conduct in Phase 2 clinical trials in agitation in patients with probable Alzheimer’s disease, in dementia-related psychosis and certain depressive disorders in the elderly in 2023.
Phosphodiesterase type I inhibitor (PDE1) program: We have initiated our Phase 2 clinical program with lenrispodun for Parkinson’s disease and expect to commence patient enrollment in the second half of 2022.

We continue to investigate the anti-cancer effects of PDE1 inhibitors. In April of this year, we presented preclinical data at the AACR (Free AACR Whitepaper) Annual meeting describing the antitumor effects of PDE1 inhibitors, when administered in conjunction with checkpoint inhibitor immunotherapy in an animal model of triple negative breast cancer. We have now shown that our PDE1 inhibitors can potentiate the action of checkpoint inhibitors in various models of colorectal, kidney, breast and glioblastoma cancers. We plan to present additional data from this program at future scientific meetings.
ITI-333 program in Opioid Use Disorder: We continue to advance the development of ITI-333. Following the recent completion of our single ascending dose study, we have commenced a neuroimaging study to investigate brain occupancy for receptors that play a role in substance use disorder and also have applicability for pain. The results of this study will support the dose selection for future studies.
Conference Call and Webcast Details

The Company will host a live conference call and webcast today at 8:30 AM Eastern Time to discuss the Company’s financial results and provide a corporate update. The live webcast and subsequent replay may be accessed by visiting the Company’s website at www.intracellulartherapies.com. Please connect to the Company’s website at least 5-10 minutes prior to the live webcast to ensure adequate time for any necessary software download. Alternatively, please call 1-(877) 407-8291 (U.S.) or 1-(201) 689-8345 (international) to listen to the live conference call. Please dial in approximately 10 minutes prior to the call.

CAPLYTA (lumateperone) is indicated in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate.

Important Safety Information

Boxed Warnings:

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. CAPLYTA is not approved for the treatment of patients with dementia-related psychosis.
Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adults in short-term studies. All antidepressant-treated patients should be closely monitored for clinical worsening, and for emergence of suicidal thoughts and behaviors. The safety and effectiveness of CAPLYTA have not been established in pediatric patients.
Contraindications: CAPLYTA is contraindicated in patients with known hypersensitivity to lumateperone or any components of CAPLYTA. Reactions have included pruritus, rash (e.g., allergic dermatitis, papular rash, and generalized rash), and urticaria.

Warnings & Precautions: Antipsychotic drugs have been reported to cause:

Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis, including stroke and transient ischemic attack. See Boxed Warning above.
Neuroleptic Malignant Syndrome (NMS), which is a potentially fatal reaction. Signs and symptoms include: high fever, stiff muscles, confusion, changes in breathing, heart rate, and blood pressure, elevated creatinine phosphokinase, myoglobinuria (and/or rhabdomyolysis), and acute renal failure. Patients who experience signs and symptoms of NMS should immediately contact their doctor or go to the emergency room.
Tardive Dyskinesia, a syndrome of uncontrolled body movements in the face, tongue, or other body parts, which may increase with duration of treatment and total cumulative dose. TD may not go away, even if CAPLYTA is discontinued. It can also occur after CAPLYTA is discontinued.
Metabolic Changes, including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma or death, has been reported in patients treated with antipsychotics. Measure weight and assess fasting plasma glucose and lipids when initiating CAPLYTA and monitor periodically during long-term treatment.
Leukopenia, Neutropenia, and Agranulocytosis (including fatal cases). Complete blood counts should be performed in patients with pre-existing low white blood cell count (WBC) or history of leukopenia or neutropenia. CAPLYTA should be discontinued if clinically significant decline in WBC occurs in absence of other causative factors.
Decreased Blood Pressure & Dizziness. Patients may feel lightheaded, dizzy or faint when they rise too quickly from a sitting or lying position (orthostatic hypotension). Heart rate and blood pressure should be monitored and patients should be warned with known cardiovascular or cerebrovascular disease. Orthostatic vital signs should be monitored in patients who are vulnerable to hypotension.
Falls. CAPLYTA may cause sleepiness or dizziness and can slow thinking and motor skills, which may lead to falls and, consequently, fractures and other injuries. Patients should be assessed for risk when using CAPLYTA.
Seizures. CAPLYTA should be used cautiously in patients with a history of seizures or with conditions that lower seizure threshold.
Potential for Cognitive and Motor Impairment. Patients should use caution when operating machinery or motor vehicles until they know how CAPLYTA affects them.
Body Temperature Dysregulation. CAPLYTA should be used with caution in patients who may experience conditions that may increase core body temperature such as strenuous exercise, extreme heat, dehydration, or concomitant anticholinergics.
Dysphagia. CAPLYTA should be used with caution in patients at risk for aspiration.

Drug Interactions: CAPLYTA should not be used with CYP3A4 inducers. Dose reduction is recommended for concomitant use with strong CYP3A4 inhibitors or moderate CYP3A4 inhibitors.

Special Populations: Newborn infants exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. Breastfeeding is not recommended. Dose reduction is recommended for patients with moderate or severe hepatic impairment.

Adverse Reactions: The most common adverse reactions in clinical trials with CAPLYTA vs. placebo were somnolence/sedation, dizziness, nausea, and dry mouth.

Please click here to see full Prescribing Information including Boxed Warning.

About CAPLYTA (lumateperone)

CAPLYTA 42 mg is an oral, once daily atypical antipsychotic approved in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. While the mechanism of action of CAPLYTA is unknown, the efficacy of CAPLYTA could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.

Lumateperone is being studied for the treatment of major depressive disorder, and other neuropsychiatric and neurological disorders. Lumateperone is not FDA-approved for these disorders.

On August 9, 2022 Neoleukin Therapeutics, Inc., "Neoleukin" (NASDAQ:NLTX), a biopharmaceutical company utilizing sophisticated computational methods to design de novo protein therapeutics, reported financial results for the second quarter ended June 30, 2022 and a midyear corporate update (Press release, Neoleukin Therapeutics, AUG 9, 2022, View Source [SID1234617917]).

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"Our focus at Neoleukin is the advancement of de novo proteins to solve important therapeutic challenges and address unmet medical needs," said Jonathan Drachman, M.D., Chief Executive Officer of Neoleukin. "We are excited to be part of a revolutionary approach to creating therapeutic proteins that are not based on native sequences. Our first programs, including our lead product candidate, NL-201, were developed using sophisticated computational algorithms combined with directed evolution in the laboratory. We have now added machine learning and neural networks to our technological approach, enabling faster, more accurate development of increasingly complex proteins. Using these new processes, we have been able to add two new cytokine mimetics to our discovery pipeline this year."

"At Neoleukin, we are excited to be testing NL-201, which we believe is the first fully de novo protein in clinical trials," said Priti Patel, M.D., Chief Medical Officer. "We are pleased to have begun testing NL-201 in combination with pembrolizumab in mid-May of this year. We believe this is just one of many potential opportunities to harness the immune activating properties of NL-201 in novel combination regimens."

NL-201 Update

Neoleukin is conducting a clinical trial of intravenous NL-201 in patients with advanced solid tumors. The trial is evaluating two different schedules and multiple dose levels in order to determine a recommended Phase 2 dose and schedule. Intermediate dose levels have been added to both schedules, which has extended the timeline to reach the anticipated Phase 2 dose. Dose escalation continues in both schedules, and Neoleukin now anticipates disclosing interim data in 2023.

In April 2022, Neoleukin announced the presentation of preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, highlighting the potential for NL-201 to treat non-Hodgkin lymphoma as well as synergistic antitumor activity when NL-201 is combined with radiation therapy, including significant inhibition of tumor growth and increased survival in preclinical models.

In May 2022, Neoleukin announced treatment of the first patient in a combination arm evaluating the safety and efficacy of Neoleukin’s NL-201 in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab), as part of Neoleukin’s ongoing Phase 1 trial. Up to 132 patients will be enrolled in the combination arm of the study, which is being conducted through a clinical collaboration and supply agreement with Merck (known as MSD outside the United States and Canada). The trial is assessing safety, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity. KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Research Updates

Technology: Neoleukin’s research team is actively engaged in the discovery of additional de novo cytokine mimetics as well as technological advances in order to accelerate the process from concept to proof of preclinical activity. Among these advances, the use of machine learning and neural networks have made it possible to design de novo proteins even when high-resolution structures have not yet been solved, using less compute resources and with a higher percentage of functional sequences. In addition to NL-201, Neoleukin has previously reported preclinical data for two de novo proteins: NL-CVX1, a decoy protein that mimics the human ACE2 binding site of the SARs-CoV2 spike protein and Neo-5171, an inhibitor of both IL-2 and IL-15 signaling.

Pipeline: Neoleukin is exploring an activator of T-regulatory cells for the treatment of inflammation and autoimmune diseases, a next generation IL-2/IL-15 agonist, and two additional undisclosed de novo cytokine mimetics for the treatment of cancer.

Summary of Financial Results

Cash Position: Cash, cash equivalents, and short-term investments totaled $116.5 million as of June 30, 2022, compared to $142.5 million as of December 31, 2021.

Based upon current internal infrastructure and pipeline initiatives, Neoleukin believes it has sufficient cash to fund operations through 2023.

R&D Expenses: Research and development expenses for the second quarter of 2022 increased to $11.0 million from $9.8 million for the second quarter of 2021. The increase was primarily due to increased clinical trial expenses related to NL-201.

G&A Expenses: General and administrative expenses for the second quarter of 2022 decreased to $4.9 million from $5.3 million for the second quarter of 2021. The decrease was primarily attributable to decreases in personnel-related and facility-related costs.

Net Loss: Net loss for the second quarter of 2022 was $15.7 million compared to a net loss of $15.1 million in the second quarter of 2021.

About NL-201

NL-201 is a de novo agonist of the IL-2 and IL-15 receptors, designed to expand cancer-fighting CD8 T cells and natural killer (NK) cells without any bias toward cells expressing the alpha receptor subunit (CD25). Previously presented preclinical data has demonstrated the ability of NL-201 to stimulate and expand CD8+ and NK cells at low doses with minimal impact on immunosuppressive regulatory T cells. Furthermore, NL-201 has demonstrated both monotherapy and combination activity across a wide range of preclinical syngeneic tumor models.

Conference Call Information

Neoleukin will host a conference call today to provide a second quarter corporate update and review financials. Details are as follows:

The archived audio webcast with slides will be available on the Investor Relations section of the Neoleukin website approximately two hours after the event and will be available for replay for at least 30 days after the event.

On August 9, 2022 Perrigo Company plc (NYSE: PRGO) ("Perrigo" or the "Company"), a leading provider of Consumer Self-Care Products, reported financial results for the second quarter ended July 2, 2022 (Press release, Perrigo Company, AUG 9, 2022, View Source [SID1234617933]). All comparisons are against the prior year fiscal second quarter, unless otherwise noted.

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President and CEO, Murray S. Kessler commented, "This was a truly remarkable quarter for the Perrigo team. During the quarter: we closed the HRA transaction, closed on $2.6 billion senior secured credit facilities, received FDA approval for and launched the Company’s first led Rx-to-OTC switch of Nasonex 24HR, filed with the FDA for the first ever Rx-to-OTC switch for a daily birth control pill, and worked around the clock at our infant formula facilities to help mitigate the shortage in the United States – all the while delivering a constant currency 20% increase in net sales and a 310 basis points sequential improvement in our consolidated adjusted gross margin. All of this was achieved despite a dynamic external environment, including severe inflationary headwinds. I couldn’t be prouder of the performance of my Perrigo colleagues as our self-care strategy is being executed with excellence."

Kessler continued, "While we remain certain that the self-care strategy is the correct approach and we are executing well against it, we recognize that the macro-economic environment has and will continue to present significant headwinds in the near-term. Based on the strong performance of the business, as evident in continued strong demand, increased organic net sales outlook and sequentially improving margins, we expect to cover incremental headwind costs with the exception of the massive negative impact from foreign currency exchange. We continue to be excited about our future and look forward to delivering double-digit top and bottom line growth over the next few years as we ‘Optimize and Accelerate’ the newly transformed Perrigo Consumer Self-Care Company."

Refer to Tables I – VI 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.

Global Reporting Category Updates
As a result of the completed acquisition of HRA, the Company has updated its global reporting categories beginning in the second quarter of 2022 as follows:

The creation of a new "Women’s Health" reporting category, comprised of the women’s health portfolio of HRA, including ellaOne and Hana, in addition to legacy Perrigo women’s health products, including feminine hygiene and pregnancy products.
The creation of a new "Skin Care" reporting category, comprised of Compeed, Mederma, and all of the products in the legacy Perrigo "Skincare and Personal Hygiene" category except for legacy Perrigo women’s health products.
The "Other" category now includes the HRA Rare Diseases business.
These product category updates have been adjusted retrospectively to reflect this change. These updates have no impact on the Company’s historical consolidated financial position, results of operations, or cash flows.

Second Quarter 2022 Perrigo Results from Continuing Operations
Perrigo net sales for the second quarter were $1.1 billion, an increase of $141 million or 14.3%, including a positive impact of 6.8 percentage points from acquisitions, and negative impacts of 5.9 percentage points and 3.8 percentage points from adverse currency translation and divested businesses, respectively. Organic net sales increased 17.2%.

Net sales were driven by 1) $65 million in constant currency net sales from the April 29, 2022 closing of the acquisition of HRA, 2) higher global incidences of cough/cold and flu-like illnesses, including COVID-19, leading to an increase of $72 million in cough/cold-related sales that benefited the Upper Respiratory and Pain and Sleep Aids categories, 3) contract manufacturing sales to the divested RX business of $38 million, and 4) strong growth of $29 million in the Nutrition category stemming from store brand infant formula share gains amid a national brand recall. These drivers also benefited from increased pricing across both Consumer Self-Care segments, strong e-commerce growth and new product sales. These increases were partially offset by 1) the impact of adverse currency translation of $58 million, and 2) $30 million from divested businesses.

Second quarter reported operating loss was $7 million, compared to an operating loss of $126 million in the prior year period, due primarily to the absence of $159 million of prior year impairment charges related to the divested Latin American businesses. Adjusted operating income decreased $1 million, or 0.9%, to $116 million. Constant currency adjusted operating income increased 7.9% driven by 1) higher gross profit flow-through resulting from higher volumes and increased pricing, 2) the addition of HRA, and 3) cost savings from Project Momentum. These factors were partially offset by 1) $39 million in cost headwinds, including cost of goods sold inflation, increased freight expenses and lower plant productivity stemming from a tight labor market, and 2) higher operating expenses, driven primarily by the inclusion of HRA, in addition to higher employee and distribution costs compared to the prior year.

Reported net loss was $65 million, or $0.48 per diluted share, compared to reported net loss of $112 million, or $0.84 per diluted share, in the prior year period. Excluding certain charges as outlined in Table I, second quarter 2022 adjusted net income was $59 million, or $0.43 per diluted share, compared to $68 million, or $0.50 per diluted share, in the prior year. Constant currency EPS for the quarter was $0.49.

Cough/cold-related net sales includes the cough/cold sub-category within Upper Respiratory and the adult and children’s analgesics sub-categories within the Pain and Sleep Aids category.

Second Quarter 2022 Business Segment Results from Continuing Operations
Consumer Self-Care Americas Segment

CSCA second quarter net sales of $728 million increased $106 million, or 17.0%, including a positive impact of 1.6 percentage points from acquisitions, and a negative impact of 5.8 percentage points from divested businesses. Organic net sales growth was 21.2%. Primary category drivers are provided below.

Upper Respiratory
Net sales of $146 million increased 38.6% due primarily to higher incidences of cough/cold and flu-like illnesses, including COVID-19, that led to strong demand, online and in-store, for cough/cold-related products. Sales of allergy products were higher, despite lower levels of incidence compared to the year ago period, due primarily to increased promotions at a particular customer.

Digestive Health
Net sales of $125 million increased 8.8% due primarily to growth in store brand proton pump inhibitor products, including the store brand versions of Esomeprazole and Omeprazole, driven by share gains, in addition to growth in store brand versions of Famotidine.

Nutrition
Net sales of $125 million increased 30.6% due primarily to strong growth in infant formula stemming from store brand share gains, due in part to new product launches and a national brand recall, as well as third-party contract sales. Continued growth in the oral electrolytes business also contributed to the quarter.

Pain & Sleep-Aids
Net sales of $103 million increased 14.8% due primarily to strong demand, online and in-store, for analgesics products stemming from higher incidences of cough/cold and flu-like illnesses, including COVID-19.

Oral Care
Net sales of $77 million increased 1.2% due primarily to sales of store brand products, particularly non-power toothbrushes, mostly offset by a decline in branded offerings stemming from delayed receipt of products manufactured outside the U.S., leading to unfulfilled customer orders.

Healthy Lifestyle
Net sales of $67 million increased 4.0% due primarily to increased distribution of store brand smoking cessation products, partially offset by the discontinuation of diabetes products.

Skin Care
Net sales of $49 million increased 3.2% due primarily to the addition of HRA brands, including Mederma and Compeed, partially offset by the divested ScarAway brand asset and discontinued product in non-strategic category segments.

Women’s Health
Net sales of $12 million increased 48.1% due primarily to the addition of HRA brands, including ella.

Vitamins, Minerals, and Supplements ("VMS") and Other
Net sales of $25 million increased 17.0% due primarily to contract manufacturing sales to the divested RX business in the Other category.

Reported operating income was $86 million in the quarter compared to an operating loss of $72 million in the prior year period, due primarily to the absence of $159 million of prior year impairment charges related to the divested Latin American businesses. Adjusted operating income decreased $2 million to $105 million due primarily to 1) cost headwinds, including cost of goods sold inflation and increased freight expenses, 2) lower plant productivity, including reduced volumes due to a tight labor market, 3) the impact of divestitures, and 4) higher operating expenses to support net sales growth. These factors were mostly offset by higher gross profit flow-through resulting from higher net sales growth and the addition of HRA.

Consumer Self-Care International Segment

CSCI net sales of $394 million increased $35 million, or 9.7%, including a positive impact of 15.2 percentage points from acquisitions, partially offset by negative impacts of 16.1 percentage points and 0.9 percentage points from currency translation and lower sales in Ukraine and Russia, respectively. Organic net sales growth was 10.6%. Primary category drivers are provided below.

Skin Care
Net sales of $120 million increased 21.9%, or an increase of 43.0% excluding the impact from currency translation, driven primarily by the addition of HRA brands, including Compeed, strong performance in the Sebamed and ACO skincare lines, and increased net sales of anti-parasite offerings, due to the easing of COVID-19-related restrictions. These benefits were partially offset by lower sales in Ukraine and Russia.

Upper Respiratory
Net sales of $60 million increased 41.0%, or 59.0% excluding the impact of currency, as the higher incidences of cough/cold and flu-like illnesses, including COVID-19, led to strong demand for cough/cold products, including Bronchonolo, Bronchostop and Coldrex and U.K. store brands. In addition, a relatively stronger hayfever season drove net sales performance of allergy products, particularly the Beconase brand in the U.K.

VMS
Net sales of $48 million decreased 11.9%, or 0.4% excluding the impact of currency, due primarily to lower overall category consumption and lower sales of the probiotic brand Probify in certain geographies, partially offset by the restocking of the Abtei brand in Germany following the third quarter 2021 recall of certain batches.

Pain & Sleep-Aids
Net sales of $49 million increased 0.4%, or 12.8% excluding the impact of currency, due primarily to higher demand for Solpadeine, a paracetamol-based analgesics product, as well as an increase in U.K. store brand consumption within the category. These increases were driven primarily by strong demand for analgesics products stemming from higher incidences of cough/cold and flu-like illnesses, including COVID-19.

Healthy Lifestyle
Net sales of $39 million decreased 17.6%, or 7.7% excluding the impact of currency, due primarily to lower net sales in the XLS Medical weight management franchise stemming from lower category consumption, partially offset by stronger performance of NiQuitin smoking cessation products, due to customer restocking following supply constraints earlier in the year.

Women’s Health
Net sales of $24 million increased 69.4%, or an increase of 93.3% excluding the impact of currency, due primarily to the addition of HRA brands, including ellaOne and NorLevo.

Digestive Health, Oral Care and Other
Net sales of $54 million increased 0.6%, or an increase of 17.1% excluding the impact of currency, due primarily to the addition of the HRA Rare Diseases portfolio in the Other category.

Reported operating income was $2 million in the quarter compared to $1 million in the prior year quarter. Adjusted operating income increased $7 million, or 15.1%, to $54 million. Constant currency adjusted operating income grew 36.3%, driven by higher gross profit flow-through resulting from higher volumes, increased pricing and the addition of HRA. These factors were partially offset by 1) cost headwinds, including cost of goods sold inflation and increased freight expenses, and 2) higher operating expenses, driven primarily by the inclusion of HRA, in addition to higher employee and distribution costs compared to the prior year.

Fiscal 2022 Outlook
The Company is increasing its fiscal 2022 organic net sales growth range outlook to 9.0%-10.0%, from 8.0%-9.0%, versus the prior year, due to continued strong global consumer demand. The Company is reaffirming its fiscal 2022 total net sales growth range outlook of 8.5%-9.5%, as the organic net sales growth outlook increase is expected to be offset by the worsening impact of currency translation.

The Company expects to achieve a fiscal 2022 constant currency adjusted EPS range outlook of $2.40-$2.50 per diluted share and is updating its fiscal 2022 adjusted EPS range outlook to $2.25-$2.35 from $2.30-$2.40, due entirely to the worsening impact of currency translation.

The Company continues to expect an adjusted effective tax rate of approximately 23% and cash flow from operations as a percentage of adjusted net income above its long-term range outlook of 95%-105%.

The Company cannot reconcile its organic net sales growth to reported net sales or its expected adjusted diluted EPS or constant currency adjusted EPS to diluted EPS 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. These items include taxes, interest costs that would occur if the Company issued debt, and costs to acquire and or sell a business if the Company executed such transactions, which could significantly affect our financial results. These items depend on highly variable factors and any such reconciliations would imply a degree of precision that would be confusing or misleading to investors.

On August 9, 2022 SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, reported it will host a conference call and live webcast at 8:30 a.m. EDT on Monday, August 15, 2022 to provide a corporate update and discuss the Company’s financial results for the second quarter ended June 30, 2022 (Press release, Scynexis, AUG 9, 2022, View Source [SID1234617949]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A live audio webcast can be accessed by visiting the Investor Relations section of the Company’s website, www.scynexis.com. A replay of the webcast will be archived on the SCYNEXIS website for 90 days following the event.

On August 9, 2022 HCA Healthcare, Inc. (NYSE: HCA), one of the nation’s leading healthcare providers, reported that it will collaborate with Johnson & Johnson to address key healthcare industry issues (Press release, Johnson & Johnson, AUG 9, 2022, View Source [SID1234617964]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The two leading healthcare companies initially will focus on improving health equity, enhancing nursing support, and improving patient outcomes:

HCA Healthcare and Johnson & Johnson will collaborate on a scalable program to improve health outcomes through early-stage lung cancer detection for the Black community. Lung cancer is the number one cause of cancer death among Black patients1, and the two companies will begin to work together on a pilot program in the coming months to increase early identification.
HCA Healthcare, which has more than 93,000 nurses in its system, and Johnson & Johnson have a long-standing commitment to advocating for and supporting nurses. The two healthcare leaders will work together to incorporate Johnson & Johnson’s nursing resources within HCA Healthcare and its affiliate Galen College of Nursing. The companies will work together on health equity issues focused on educational programming, training and other programs that elevate and support nurses with a goal of enriching the nursing experience and skillsets and improving patient outcomes.
HCA Healthcare, through its HCA Healthcare Research Institute, and Johnson & Johnson will collaborate on cardiovascular health initiatives including a retrospective analysis of patients who suffer from heart arrhythmia, as well as research to understand the role digital health technology plays in impacting clinical outcomes for patients with Coronary Artery Disease (CAD) and Peripheral Artery Disease (PAD) diseases.
"HCA Healthcare and Johnson & Johnson have had a long and productive relationship, and both companies have worked very hard to address many of our country’s healthcare challenges," said Sam Hazen, chief executive officer of HCA Healthcare. "We believe strongly in the power of strategic partnerships, and we are excited to collaborate to advance health equity, enhance patient care and provide even greater support to our nurses."

"No one company can solve society’s most pressing health challenges alone — it takes collaboration," said Joaquin Duato, chief executive officer of Johnson & Johnson. "That’s why we’re working with HCA Healthcare to improve patient access and outcomes, address the nursing crisis, and advance health equity. We are united in our focus to improve patient care."

HCA Healthcare uses data from more than 35 million annual patient encounters to continually improve care. In addition, with more than 93,000 Registered Nurses (RN), HCA Healthcare is one of the country’s top employers of RNs and invests significantly in nurses and nursing through education and professional development, equipment and technology, resources to promote their physical and emotional wellbeing, and representation at every level of the organization from the bedside to senior leadership.