Perrigo Reports Third Quarter Fiscal Year 2022 Financial Results From Continuing Operations

On November 8, 2022 Perrigo Company plc (NYSE: PRGO) ("Perrigo" or the "Company"), a leading provider of Consumer Self-Care Products, reported financial results for the third quarter ended October 1, 2022 (Press release, Perrigo Company, NOV 8, 2022, View Source [SID1234623342]). All comparisons are against the prior year fiscal third quarter, unless otherwise noted.

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President and CEO, Murray S. Kessler commented, "Perrigo third quarter results were strong. Net sales, adjusted gross margin, adjusted operating income and adjusted diluted EPS grew substantially compared to prior year in the face of continued macro-economic headwinds. We gained market share globally, including increases across every segment as store brands continued to gain share from national brands. Although revenue growth in the quarter was robust, it was below our estimates due to unfavorable currency translation, labor shortages effecting supply and slower category growth rates."

Kessler continued, "Importantly, business fundamentals are strong, the labor issue has improved and we just announced the first major step in our Supply Chain Reinvention Program through the infant formula investment. These, along with other margin enhancement programs being implemented, including further strategic pricing initiatives, will enable Perrigo to deliver outsized growth in 2023."

Kessler concluded, "Going forward, our focus is on execution. Successful integration of HRA, achievement of HRA synergies, integration of the Gateway plant, implementation of supply chain initiatives and reducing leverage as planned will position Perrigo to achieve strong top and bottom line growth for years to come."

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.

Third Quarter 2022 Perrigo Results from Continuing Operations

Third Quarter 2022 Net Sales Change Compared to Prior Year

Reported

Net Sales

Net Acquisitions
& Divestitures
Adjustment

Foreign

Exchange
Adjustment

Organic

Net Sales

CSCA

4.0 %

3.3 %

— %

7.3 %

CSCI

8.4 %

(20.3) %

20.2 %

8.3 %

Total Perrigo

5.5 %

(4.5) %

6.7 %

7.7 %

Reported net sales increased 5.5%, constant currency net sales increased 12.3% and organic net sales increased 7.7%. Reported net sales were driven by 1) $81 million in constant currency net sales from the acquisition of HRA, 2) $55 million in strategic pricing actions across both Consumer Self-Care segments, 3) U.S. store brand share gains versus national brands and store brand competitors, and growing share in the E.U. marketplace, and 4) an increase of $25 million in cough/cold-related product sales3 that primarily benefited the Upper Respiratory category. These drivers also benefited from e-commerce growth and new product sales. This growth was partially offset by 1) the impact of unfavorable currency translation of $70 million, 2) $31 million from the divested Latin American businesses and ScarAway brand, and 3) lower net sales in certain categories, particularly in the CSCI Healthy Lifestyles category.

Third quarter reported operating income was $33 million, compared to operating income of $438 million in the prior year period. This decrease was due primarily to $418 million related to the Omega arbitration award received in the prior year. Adjusted operating income grew $21 million, or 19.2%, to $133 million. Constant currency adjusted operating income increased 32.2% driven by 1) higher gross profit flow-through resulting from strategic price increases, higher sales volumes and the addition of HRA, and 2) the absence of two product recalls that occurred in the prior year. These increases were partially offset by 1) a $36 million impact from inflation, including higher freight & distribution expenses, 2) higher operating expenses, driven primarily by the addition of HRA, and 3) divested businesses.

Reported net loss was $52 million, or ($0.39) per diluted share, compared to reported net loss of $54 million, or ($0.40) per diluted share, in the prior year period. Excluding certain charges as outlined in Table I, third quarter 2022 adjusted net income was $76 million, or $0.56 per diluted share, compared to $61 million, or $0.45 per diluted share, in the prior year. Constant currency EPS for the quarter was $0.65.

(3)

Cough/cold-related net sales includes the cough/cold sub-category within Upper Respiratory and the Pain and Sleep Aids category.

Third Quarter 2022 Business Segment Results from Continuing Operations

Consumer Self-Care Americas Segment

Third Quarter 2022 Net Sales Change Compared to Prior Year

Reported

Net Sales

Net Acquisitions
& Divestitures
Adjustment

Foreign

Exchange
Adjustment

Organic

Net Sales

CSCA

4.0 %

3.3 %

— %

7.3 %

CSCA reported net sales of $722 million increased 4.0%, and organic net sales increased 7.3%. Net sales growth was driven by strategic price increases, U.S. store brand share gains versus national brands and store brand competitors, and new product launches. Primary category drivers are provided below.

Upper Respiratory
Net sales of $132 million increased 8.4% due primarily to share gains from national brands and store brand competitors in cough/cold and allergy, and the new launch of Nasonex24HR. This growth was partially offset by an unfavorable 4.8 percentage points from the divested Latin American businesses.

Nutrition
Net sales of $124 million increased 18.1% due primarily to store brand share gains in infant formula, due in part to a national brand recall, as well as third-party contract sales. Oral electrolytes also contributed positively to sales in the quarter.

Digestive Health
Net sales of $120 million increased 8.1% due primarily to increased manufacturing capacity and demand for Polyethylene Glycol 3350, and new products, including Omeprazole Cool Mint. Growth in the category was partially offset by an unfavorable 2.2 percentage points from the divested Latin American businesses.

Pain & Sleep-Aids
Net sales of $104 million decreased 4.1% due primarily to the unfavorable impact of 7.7 percentage points from the divested Latin American businesses, partially offset by higher demand for children’s analgesics products.

Oral Care
Net sales of $84 million increased 9.0% due primarily to Plackers and REACH, in addition to growth in store brand offerings, primarily manual toothbrushes.

Healthy Lifestyle
Net sales of $74 million increased 2.4% 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 5.4% due primarily to the addition of HRA brands, including Mederma and Compeed, partially offset by the unfavorable impact of 3.0 percentage points from the divested Latin American businesses and ScarAway brand, and discontinued products.

Women’s Health
Net sales of $12 million increased 19.2% due primarily to the addition of HRA brands, including ella.

Vitamins, Minerals, and Supplements ("VMS") and Other
Net sales of $23 million decreased 44.8% due primarily to the unfavorable impact of 17.0 percentage points from the divested Latin American businesses.

Reported operating income was $75 million compared to operating income of $90 million in the prior year quarter. Adjusted operating income decreased $1 million to $104 million due primarily to 1) a $31 million impact from inflation, including higher freight & distribution expenses, 2) higher operating expenses primarily related to the inclusion of HRA, 3) lower profitability of contract sales to the divested Rx business, and 4) the impact of divested businesses. These factors were offset by higher gross profit flow-through resulting from net sales growth and the addition of HRA.

Consumer Self-Care International Segment

Third Quarter 2022 Net Sales Change Compared to Prior Year

Reported

Net Sales

Net Acquisitions
& Divestitures
Adjustment

Foreign

Exchange
Adjustment

Organic

Net Sales

CSCI

8.4 %

(20.3) %

20.2 %

8.3 %

CSCI reported net sales increased 8.4%, constant currency net sales increased 28.6% and organic net sales increased 8.3%. Organic net sales growth was driven by strategic price increases and higher sales volumes led by new product launches. Primary category drivers are provided below.

Skin Care
Net sales of $132 million increased 15.9%, or 37.2% excluding the impact of currency, driven primarily by the addition of HRA brands, including Compeed, strategically priced new products in the Sebamed and ACO skincare lines, and higher net sales of anti-parasite offerings that are outpacing strong category growth.

Upper Respiratory
Net sales of $63 million increased 20.8%, or 43.8% excluding the impact of currency, led by strong demand for cough/cold products, including Bronchostop, Bronchonolo, Coldrex and U.K. store brands.

VMS
Net sales of $46 million decreased 15.9%, or 0.2% excluding the impact of currency, due primarily to lower overall category consumption and lower sales of the nutraceutical products including Granufink and Zaffranax were mostly offset by the restocking of the Abtei brand in Germany following the third quarter 2021 recall of certain batches.

Women’s Health
Net sales of $30 million increased 123.1%, or 163.4% excluding the impact of currency, due primarily to the addition of HRA brands, including ellaOne and NorLevo.

Pain & Sleep-Aids
Net sales of $29 million decreased 13.9%, or an increase of 2.4% excluding the impact of currency, due primarily to higher demand for Solpadeine, a paracetamol-based analgesics product.

Healthy Lifestyle
Net sales of $25 million decreased 32.6%, or 19.9% excluding the impact of currency, due primarily to lower category consumption in weight management and smoking cessation, impacting XLS Medical and NiQuitin, respectively.

Digestive Health, Oral Care and Other
Net sales of $53 million increased 21.5%, or 44.2% excluding the impact of currency, due primarily to the addition of the HRA Rare Diseases portfolio in the Other category.

Reported operating income was $1 million for the quarter compared to $4 million in the prior year. Adjusted operating income increased $17 million, or 36.5%, to $62 million. Constant currency adjusted operating income grew 66.8%, driven by 1) higher gross profit flow-through resulting from higher net sales growth and the addition of HRA, and 2) improved manufacturing productivity. This growth was partially offset by inflation and higher operating expenses, primarily driven by the inclusion of HRA.

Fiscal 2022 Outlook

The Company reiterates its fiscal 2022 organic net sales growth range outlook of 9.0%-10.0% versus the prior year. The Company also reiterates its fiscal 2022 total net sales growth range outlook of 8.5%-9.5%, as expected accretion from the Gateway plant, along with the U.S. and Canadian rights to the Good Start infant formula brand, are expected to offset the worsening impact of currency translation. If foreign currency exchange rates hold near current levels, we now expect net sales in the full year to be unfavorably impacted by 5%-6%.

The Company is updating its fiscal 2022 adjusted EPS range outlook to $2.00-$2.10 from $2.25-$2.35, as solid year-to-date performance in CSCI and accretion from the purchase of the Gateway plant, along with the U.S. and Canadian rights to the Good Start infant formula brand, are expected to be more than offset by lower sales volumes in CSCA, and $0.10 from the worsening impact of currency translation. If foreign currency exchange rates hold near current levels, we now expect adjusted diluted EPS in the full year to be unfavorably impacted by approximately $0.25. The Company now expects to achieve a constant currency adjusted diluted EPS range outlook of $2.25-$2.35.

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.

Glycotope Presents GlycoTarget Platform and New Data on Platform-Derived anti-LYPD3 Antibody at 2022 Society for Immunotherapy of Cancer (SITC) Meeting

On November 8, 2022 Glycotope GmbH, a biotechnology company with a proprietary platform technology for developing antibodies against proteins carrying tumor-specific carbohydrate structures, reported that it will present new data at the 2022 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting, being held in Boston, United States, between 8-12 November 2022 (Press release, Glycotope, NOV 8, 2022, View Source [SID1234623341]).

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Patrik Kehler, Chief Scientific Officer of Glycotope GmbH commented: "We are looking forward to providing an update on the progress of our lead antibody program, GT-002, at SITC (Free SITC Whitepaper). The glycosylation-dependent binding of LYPD3 by GT-002 leads to markedly improved tumor-selectivity compared to protein binding antibodies resulting in reduced binding to healthy tissues. In addition, we will deliver a presentation on our GlycoTarget platform, showcasing how, by utilizing the same principle, our technology can be applied to significantly improve selectivity across other targets beside LYPD3."

About GT-002

Antibodies targeting LYPD3 (C4.4A) with increased tumor-specificity. LYPD3 is expressed in various cancer indications with high medical need, including squamous cell carcinoma of the head and neck (HNSCC). Upon binding to LYPD3, the antibody is effectively internalized. The improved tumor-specificity of GT-002 results in reduced binding to healthy-tissue expressed LYPD3 making it suitable for the development of highly potent therapies like ADCs, CARs or radio pharmaceutics.

PR: Heidelberg Pharma’s Partner Telix Reports Positive Data on the Pivotal ZIRCON Study

On November 7, 2022 Heidelberg Pharma AG (FSE: HPHA) reported that its licensing partner Telix Pharmaceuticals Limited, Melbourne, Australia, (Telix) presented positive top-line data on its pivotal ZIRCON Phase III study with the imaging agent TLX250-CDx, reporting that the study has meet all of its primary and secondary endpoints (Press release, Heidelberg Pharma, NOV 7, 2022, View Source [SID1234626220]).

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TLX250-CDx (89Zr-DFO-girentuximab) is an antibody radioactively labeled with zirconium-89 and has been tested by Telix in the ZIRCON study for imaging diagnostics of renal cancer using PET since August 2019. The study was carried out as a global multicenter Phase III trial at 36 study sites in Europe, Turkey, Australia, Canada and the USA. A total of 300 renal cell cancer patients were dosed with TLX250-CDx resulting in 284 evaluable patients. Each patient received a single dose of TLX250-CDx followed by imaging, and a histological tumor sample from surgical resection was provided. The study determined the sensitivity and specificity of TLX250-CDx PET imaging to detect clear cell renal cell cancer (ccRCC) in comparison with histology as standard of truth determined from surgical resection specimens.

The study results delivered a sensitivity of 86% and specificity of 87%, thus exceeding the thresholds required to demonstrate the ability of TLX250-CDx to reliably detect the clear cell phenotype and provide a non-invasive method of diagnosing the presence and spread of ccRCC.

The study has also met the key secondary endpoint, achieving 85% sensitivity and 89% specificity in detecting ccRCC in tumors <4 cm ("T1a" classification), currently a significant clinical challenge in the diagnosis of ccRCC.

These highly positive results demonstrate that TLX250-CDx provides a way to non-invasively diagnose clear cell renal cancer – until now this could only be determined by invasive biopsy or surgery which presents a higher burden or danger for patients.

TLX250-CDx has received "Breakthrough Designation" for TLX250-CDx from the US Food and Drug Administration (FDA). Based on these positive results Telix intends to file a Biologics License Application (BLA) for regulatory approval with the FDA and global regulatory agencies as a positron emission tomography/computed tomography (PET/CT) imaging agent for use in the characterization of indeterminate renal masses previously identified on CT or MRI as ccRCC or non-ccRCC. Potential future utility may include active surveillance, surgical staging and treatment response assessment. Telix is actively engaged in clinical research at leading cancer centres to demonstrate the potential of these indications.

Furthermore, Telix is preparing to launch an Expanded Access Program (EAP) to enable eligible patients to access TLX250-CDx to address unmet need and requests for access under the healthcare professional responsibility prior to marketing authorization.

Dr Colin Hayward, Chief Medical Officer at Telix said: "The excellent sensitivity and specificity demonstrated in the ZIRCON study, validates that the CAIX target could be just as ground-breaking in ccRCC, as PSMA[1] and its application in PSMA-PET imaging has been for prostate cancer. It could optimize surgical intervention – particularly in the incidence of very small renal masses. These results provide confidence that TLX250-CDx is an important tool not only for diagnosis but for active surveillance and disease staging."

Dr. Jan Schmidt-Brand, Chief Executive and Chief Financial Officer of Heidelberg Pharma AG commented: "We are thrilled about the positive outcome of the ZIRCON study and congratulate the entire Telix team for this outstanding effort in managing this multicenter trial during the pandemic. We at Heidelberg Pharma were aware of the excellent potential of this breakthrough imaging agent for renal cancer and are very pleased to have placed this promising product candidate in the hands of our highly valued partner Telix."

Heidelberg Pharma AG is entitled to milestone payments and double-digit royalties if the product receives marketing approval.

Consolidated Financial Report for Second Quarter Financial Results for the Fiscal Year Ending March 31, 2023

Eisai reported its consolidated financial report for second quarter financial results for the Fiscal Year ending March 31, 2023 (Presentation, Eisai, NOV 7, 2022, View Source [SID1234624486]).

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Onconova Therapeutics To Provide Corporate Update And Announce Third Quarter Financial Results On November 14, 2022

On November 7, 2022 Onconova Therapeutics, Inc. (NASDAQ: ONTX), ("Onconova"), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported that the Company intends to release its third quarter 2022 financial results on Monday, November 14, 2022 (Press release, Onconova, NOV 7, 2022, View Source [SID1234623449]). Management plans to host a conference call and live webcast at 4:30 p.m. ET on the same day to discuss these results and provide an update on its pipeline programs.

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Conference Call and Webcast Information

Interested parties who wish to participate in the conference call may do so by dialing (800) 715-9871 for domestic and (646) 307-1963 for international callers and using conference ID 6078502.

Those interested in listening to the conference call via the internet may do so by visiting the investors and media page on the Company’s website at www.onconova.com and clicking on the webcast link. In addition to the live webcast, a replay will be available on the Onconova website for 90 days following the call.