Morphic Announces Corporate Highlights and Financial Results for the Full Year 2020

On March 1, 2021 Morphic Therapeutic (Nasdaq: MORF), a biopharmaceutical company developing a new generation of oral integrin therapies for the treatment of serious chronic diseases, reported corporate highlights and financial results for the full year 2020 (Press release, Morphic Therapeutic, MAR 1, 2021, View Source [SID1234575814]).

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2020 and Recent Corporate Highlights

Filed first IND of an oral integrin drug candidate, MORF-057, generated by Morphic’s MInT Platform and initiated first clinical study of MORF-057 in healthy volunteers in Phase 1 clinical trial of oral IBD candidate, MORF-057, after acceptance of IND by Food and Drug Administration
Announced positive preliminary results from Phase 1 single ascending dose portion of MORF-057 Phase 1 clinical trial including:
MORF-057 well tolerated in all five dose cohorts ranging from 25 mg to 400 mg
MORF-057 achieved greater than 95% mean receptor occupancy of α4β7 at the three highest dose levels
Phase 1 multiple ascending dose and food effect trials ongoing with full data anticipated to be presented mid-year 2021
Received $20 million payment upon AbbVie exercise of a license option under the companies’ research and development collaboration agreement to develop Morphic’s αvβ6 integrin inhibitors, including the compounds MORF-720 and MORF-627
Expanded research and development collaboration with Janssen through a third integrin program
Presented promising preclinical data supporting MORF-057 as an oral integrin targeting α4β7 at UEG Week 2020, Digestive Disease Week 2020, European Crohn’s and Colitis Organization (ECCO)
Advanced novel integrin-targeted candidates generated by the MInT Platform against integrins αvβ1 and αvβ8 for the treatment of fibrosis and cancer
Ended the year with $228.3 million in cash and equivalents and marketable securities, providing runway into 2023
"The past year challenged how we work and live but the Morphic team came together to drive tremendous advances in the creation of oral integrin therapies. Most notably in 2020, our lead oral candidate in IBD, MORF-057, completed preclinical testing with strong proof-of-concept and entered the clinic. In an important milestone for Morphic, we have already delivered positive preliminary results from the MORF-057 Phase 1 trial. The data show a favorable tolerability profile as well as strong pharmacodynamic data that suggest α4β7 inhibition may be on par with the approved intravenous blockbuster, vedolizumab. Further, we expanded our strategic collaborations with AbbVie and Janssen to explore a broader scope of integrin drug targets and potentially boost our partnered pipeline," commented Praveen Tipirneni, M.D., president and chief executive officer of Morphic Therapeutic. "In the year ahead, with a strong financial base, we are able to focus on advancing the clinical development of MORF-057 and our promising preclinical programs targeting αvβ1 and αvβ8, as well as continuing to expand the MInT Platform that generates this pipeline of novel integrin therapeutic candidates."

Financial Results for the Full Year 2020

Net loss for the year ended December 31, 2020, was $45.0 million or $1.47 per share compared to a net loss of $43.3 million or $2.69 per share
Revenue was $44.9 million for the year ended December 31, 2020 compared to $17.0 million for the year ended December 31, 2019. The increase was mainly due to AbbVie’s option exercise on our αvβ6 integrin inhibitor program in the third quarter of 2020 for $20 million
Research and development expenses were $73.6 million for the year ended December 31, 2020 as compared to $53.7 million for the year ended December 31, 2019. The increase was primarily attributable to higher development and manufacturing costs associated with our lead product candidates, MORF-057 and MORF-720, as well as increased personnel-related costs to support continued progress with the company’s pipeline
General and administrative expenses were $18.5 million for the year ended December 31, 2020, compared to $10.2 million for the year ended December 31, 2019. The increase was primarily attributable to increased headcount and higher professional and consulting fees associated with ongoing business activities and Morphic’s operating as a public company
As of December 31, 2020, Morphic had cash, cash equivalents and marketable securities of $228.3 million, compared to $237.0 million as of December 31, 2019. Morphic believes its cash, cash equivalents and marketable securities as of December 31, 2020, will be sufficient to fund operating expenses and capital expenditure requirements into 2023.

FibroGen Reports Fourth Quarter and Full Year 2020 Financial Results

On March 1, 2021 FibroGen, Inc. (NASDAQ: FGEN) reported financial results for the fourth quarter and full year 2020 and provided an update on the company’s recent developments (Press release, FibroGen, MAR 1, 2021, View Source [SID1234575842]).

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"While disappointed with the news today, FibroGen and AstraZeneca remain confident in the efficacy and safety profile of roxadustat based on positive results from a global Phase 3 program encompassing more than 8,000 patients," said Enrique Conterno, Chief Executive Officer, FibroGen. "With strong roxadustat commercial results in China, we continue to drive forward in our three main areas of focus: ensuring the regulatory and commercial success of roxadustat; accelerating the development of pamrevlumab in the three high-value indications of locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and idiopathic pulmonary fibrosis (IPF); and building our research capabilities in both hypoxia-inducible factor (HIF) and connective tissue growth factor (CTGF) biology while adding to our clinical development pipeline."

Key Events in 2020 and Other Developments

Roxadustat

Regulatory:
The Cardiovascular and Renal Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will hold an advisory committee (AdCom) meeting to review the new drug application (NDA) for roxadustat in the U.S. The companies have not received a confirmed AdCom meeting date from the FDA.
In November 2020, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved EVRENZO (roxadustat) for the treatment of anemia of CKD in adult patients not on dialysis.
The Marketing Authorization Application (MAA) for roxadustat for the treatment of anemia in adult patients with CKD was accepted for regulatory review by the European Medicines Agency (EMA) in May 2020, with an expected decision by mid-2021.
Clinical:
Enrollment was completed in the WHITNEY US Phase 2 roxadustat clinical trial in chemotherapy-induced anemia (CIA) in 4Q 2020.
Enrollment continued in the MATTERHORN Phase 3 roxadustat clinical trial in anemia associated with myelodysplastic syndromes (MDS).
Enrollment was completed in the ASPEN and DENALI Phase 3b roxadustat clinical trials in dialysis patients with anemia of CKD.
Publications / Presentations:
Roxadustat data was presented at the following scientific meetings in 2020:
The National Kidney Foundation Spring Clinical Meeting
The 57th European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) Virtual Congress
The American Society of Nephrology (ASN) Kidney Week 2020 Reimagined
The 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition
Roxadustat Phase 3 manuscripts on the treatment of anemia of CKD were published in peer-reviewed medical journals:
Pooled Analysis of Roxadustat for Anemia in Patients with Kidney Failure Incident to Dialysis Kidney International Reports
Roxadustat for Chronic Kidney Disease-related Anemia in Non-dialysis Patients Kidney International Reports
Roxadustat for Treating Anemia in Patients with CKD Not on Dialysis: Results from a Randomized Phase 3 Study Journal of the American Society of Nephrology
Roxadustat for the Treatment of Anemia in Chronic Kidney Disease (CKD) Patients Not on Dialysis: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study (ALPS) Nephrology Dialysis Transplantation
Roxadustat for anemia in patients with end-stage renal disease incident to dialysis Nephrology Dialysis Transplantation
Pamrevlumab

Enrollment continued in the LAPIS Phase 3 clinical trial of pamrevlumab in patients with locally advanced unresectable pancreatic cancer (LAPC).
Enrollment continued in the LELANTOS Phase 3 clinical trial of pamrevlumab in non-ambulatory patients with Duchenne muscular dystrophy (DMD).
Enrollment continued in the ZEPHYRUS Phase 3 clinical trial of pamrevlumab in patients with idiopathic pulmonary fibrosis (IPF).
In December, we initiated a second Phase 3 clinical trial of pamrevlumab, ZEPHYRUS-2, in patients with idiopathic pulmonary fibrosis (IPF).
Upcoming Data Catalysts

Data from the Phase 2 WHITNEY study of roxadustat in chemotherapy-induced anemia (CIA) expected 2H 2021.
Data from the Phase 3 MATTERHORN study of roxadustat in anemia of myelodysplastic syndromes (MDS) expected 1H 2022.
Resection data from the Phase 3 LAPIS study of pamrevlumab in locally advanced pancreatic cancer (LAPC) expected 2H 2022.
Data from the Phase 3 LELANTOS study of pamrevlumab in Duchenne muscular dystrophy (DMD) expected 2H 2022.
2020 Key Executive Additions

Percy Carter, Ph.D., was appointed to the newly created position of Chief Scientific Officer.
Mark Eisner, M.D., M.P.H., was appointed as Chief Medical Officer.
Thane Wettig was appointed to the newly created position of Chief Commercial Officer.
Financial

Total revenue for the fourth quarter of 2020 was $65.0 million, as compared to $8.0 million for the fourth quarter of 2019. The current quarter revenue consists of net product revenues of $29.2 million for roxadustat sales in China, $21.5 million in development revenue, and $14.3 million in license revenue related to NDD approval in Japan. Total net roxadustat sales in China for 2020 were $72.5 million.
Net loss for the fourth quarter of 2020 was $58.6 million, or $0.64 net loss per basic and diluted share, compared to a net loss of $98.1 million, or $1.12 net loss per basic and diluted share one year ago.
Net loss for the year was $189.3 million, or $2.11 net loss per basic and diluted share, compared to a net loss of $77.0 million, or $0.89 net loss per basic and diluted share one year ago.
At December 31, 2020, FibroGen had $732.1 million in cash, restricted time deposits, cash equivalents, investments, and receivables.
Based on our latest forecast, we estimate our 2021 ending cash to be in the range of $660 to $670 million.
The China Agreement with AstraZeneca was amended in July 2020 to maximize the economic value of the roxadustat franchise for both parties with more predictable economics and profitability for FibroGen.
Conference Call and Webcast Details
FibroGen will host a conference call and webcast today, Monday, March 1, 2021, at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time) to discuss financial results and provide a business update. A live audio webcast of the call may be accessed in the investor section of the company’s website, www.fibrogen.com. To participate in the conference call by telephone, please dial 1 (877) 658-9081 (U.S. and Canada) or 1 (602) 563-8732 (international), reference the FibroGen fourth quarter and full year 2020 financial results conference call, and use confirmation number 3055327. A replay of the webcast will be available shortly after the call for a period of four weeks. To access the replay, please dial 1 (855) 859-2056 (domestic) or 1 (404) 537-3406 (international), and use passcode 3055327.

About Roxadustat
Roxadustat, an oral medicine, is the first in a new class of medicines, HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin; improved iron absorption and mobilization; and downregulation of hepcidin. Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA).

Roxadustat is approved in China, Japan, and Chile for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). In Europe, the Marketing Authorization Application for roxadustat for the treatment of anemia in with chronic kidney disease (CKD) in NDD and DD patients was filed by Astellas Pharma Inc. (Astellas) and accepted by the European Medicines Agency for review in May 2020. Several other licensing applications for roxadustat have been submitted by Astellas and AstraZeneca to regulatory authorities across the globe, and are currently in review.

Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in territories including Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East, and South Africa. FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia in the U.S., China, other markets in the Americas, in Australia/New Zealand, and Southeast Asia.

About Pamrevlumab
Pamrevlumab is a first-in-class antibody developed by FibroGen that inhibits the activity of connective tissue growth factor (CTGF), an important biological mediator in fibrotic and proliferative disorders. Pamrevlumab is in Phase 3 clinical development for the treatment of locally advanced unresectable pancreatic cancer (LAPC), Duchenne muscular dystrophy (DMD), and idiopathic pulmonary fibrosis (IPF). For information about pamrevlumab studies currently recruiting patients, please visit www.clinicaltrials.gov.

Perrigo Reports Fourth Quarter & Fiscal Year 2020 Financial Results

On March 1, 2021 Perrigo Company plc (NYSE; TASE: PRGO), a leading provider of Quality, Affordable Self-Care Products, reported financial results for the fourth quarter and fiscal year ended December 31, 2020 (Press release, Perrigo Company, MAR 1, 2021, View Source [SID1234575860]).

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President and CEO, Murray S. Kessler commented, "I am deeply proud of how our Perrigo team safely managed through the complications brought on by the COVID-19 pandemic and, at the same time, continued to make major progress on our Consumer Self-Care transformation. Thanks to their relentless dedication, we were able to provide our essential and affordable products to consumers who needed them, while delivering value to customers and growing our business. Our 2020 financial results reflect strong performance across the business as we delivered record Worldwide Consumer net sales, despite the fourth quarter impact from the extremely low incidence of cough/cold illnesses worldwide and the incremental costs associated with keeping our facilities safely running without interruption. We remain focused on creating value for shareholders through our commitment to delivering 3% net sales growth, 5% adjusted operating income growth and 7% adjusted earnings per share growth from continuing operations in 2021 and beyond."

Kessler continued, "With today’s agreement to divest the RX Pharmaceuticals business, we have now completed our portfolio reconfiguration to return Perrigo to a pure-play consumer self-care company, while providing us with the financial flexibility to build our business and deliver on our growth targets."

Kessler concluded, "At this point all of the commercial pieces of our transformation are in place and Perrigo is poised to create significant value. That is why I have agreed to the Board’s request to extend my contract by 3 years – to finish the job on Perrigo’s transformation. I am excited about what we have accomplished to date, and even more excited by all that remains to accomplish going forward."

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.

Fourth Quarter 2020 Consolidated Results Versus Fourth Quarter 2019

Consolidated net sales for the fourth quarter were $1.3 billion, a decrease of $33 million or 2.5%. Organic net sales declined 4.7%, which included a negative 5.0 percentage points impact due to lower worldwide net sales of cough/cold products.

Consolidated net sales gains were driven by 1) $30 million from the Dr. Fresh and Eastern European dermatology brands acquisitions, 2) organic growth in Worldwide Consumer, excluding the impact from cough/cold, of $23 million, and 3) $17 million in net favorable currency movements. These consolidated gains were more than offset by 1) a decline of $65 million across all segments due to lower cough/cold net sales, 2) a $19 million decline in the RX Pharmaceuticals ("RX") segment, excluding cough and cold prescription products, and 3) $19 million from divested businesses.

Reported net loss was $175 million, or $1.29 per diluted share, versus a net loss of $19 million, or $0.14 per diluted share in the prior year period. Excluding certain charges as outlined in Table I, fourth quarter 2020 adjusted net income was $127 million, or $0.93 per diluted share, versus $145 million, or $1.06 per diluted share, for the same period last year resulting in a 12.3% decrease in adjusted diluted EPS. This decrease was due primarily to the impact from cough/cold products of approximately $0.11 per diluted share and divested businesses of $0.05 per diluted share.

Fourth Quarter 2020 Worldwide Consumer Self-Care Results Versus Fourth Quarter 2019

Worldwide Consumer is comprised of the CSCA segment, the Consumer Self-Care International ("CSCI") segment and Corporate.

Worldwide Consumer Self-Care fourth quarter net sales decreased $14 million, or 1.3%, to $1.1 billion. Organic net sales decreased 3.8%, which included a negative 6.0 percentage point impact due to lower net sales of cough/cold products compared to the prior year.

Fourth quarter reported gross profit margin was 36.5%. Adjusted gross profit margin of 38.7%, was 60 basis points lower year-over-year as favorable product mix was more than offset by higher input costs and the impact from divested businesses.

Reported operating margin was 4.2%. Adjusted operating margin decreased 320 basis points year-over-year to 11.1% due primarily to gross profit flow-through, higher advertising and promotion expenditures in CSCI and higher corporate expenses.

CSCA Fourth Quarter 2020 Results Versus Fourth Quarter 2019

Consumer Self-Care Americas fourth quarter net sales of $701 million, were 1.4% or $10 million lower than the prior year. Organic net sales decreased 4.7% and included a negative 5.4 percentage point impact due to lower net sales of cough/cold products compared to the prior year and a negative 0.7 percentage point impact related to a timing benefit in the prior year of a pre-build of contract pack inventory in the infant nutrition business.

OTC net sales were driven by 1) strong e-commerce growth as consumers continued to shift purchasing towards online where Perrigo has greater market share, which more than offset lower traditional brick and mortar purchases as measured by IRI MULO, 2) favorable consumer conversion to Perrigo products in the Digestive Health category, 3) the incremental benefit from new product sales led by Prevacid, Diclofenac sodium topical gel 1%, and Esomeprazole Mini, and 4) the Skincare and Personal Hygiene category led by store brand minoxidil. More than offsetting these drivers were 1) lower cough/cold net sales resulting from extremely low levels of cough/cold and flu illnesses, which impacted the Upper Respiratory and Pain & Sleep Aids categories, and 2) normal pricing pressure.

Perrigo omnichannel POS (point of sale) declined 0.6% for the 13-weeks ending December 27, 2020, compared to an estimated decline in store brand OTC omnichannel POS data of 5.7%, leading to a Perrigo store brand share gain of 100 basis points. Total OTC omnichannel POS data declined an estimated 3.5% in the categories in which Perrigo competes, resulting in a Perrigo penetration share gain of 14 basis points versus national brands.

Net sales growth in the Oral Self-Care category were driven by 1) the Dr. Fresh acquisition, 2) base business growth led by record quarterly shipments to customers and growth in the Plackers brand, and 3) continued momentum in e-commerce.

In the Nutrition category, net sales growth in e-commerce was more than offset by 1) operational challenges that caused a shortfall in achieving normal customer service levels leading to a decline in market share, and 2) a benefit in the prior year quarter due to a pre-build of contract pack inventory.

Fourth quarter reported gross margin was 32.3%. Adjusted gross margin of 33.0% was 80 basis points lower than the prior year as favorable product mix, including higher margin new products, were more than offset by normal pricing pressure and lower manufacturing efficiencies in infant formula.

Reported operating margin was 16.8%. Adjusted operating margin decreased 160 basis points to 18.8%, due primarily to gross margin flow-through and planned investments in current and future OTC brand launches.

Fourth Quarter 2020 CSCI Results Versus Fourth Quarter 2019

Consumer Self-Care International net sales were $352 million, a decrease of $4 million, or 1.1%. Organic net sales were 1.9% lower and included a negative 7.1 percentage point impact due to lower net sales of cough/cold products compared to the prior year.

The decline in net sales was due primarily to 1) lower cough/cold net sales resulting from extremely low levels of cough/cold and flu illnesses, which impacted the Upper Respiratory category, 2) lower consumer demand for anti-parasite products within the Skincare & Personal Hygiene category due primarily to COVID-19 related school closings and limited travel, and 3) divested businesses of $19 million and discontinued products of $5 million. These were partially offset by 1) new products, including line extensions in the ACO dermatology product line, 2) higher net sales in both the VMS (vitamins, minerals and supplements) category and the Pain & Sleep Aids category, each of which benefited from consumer behavior surrounding COVID-19, and 3) $18 million in favorable currency movements.

Reported gross margin was 44.8%. Adjusted gross margin of 50.0% declined 40 basis points due primarily to the impact from divested businesses.

Reported operating margin was (3.8)%. Adjusted operating margin decreased 430 basis points to 9.6% due to higher advertising and promotion spend and the impact from divested businesses.

RX Fourth Quarter 2020 Results Versus Fourth Quarter 2019

RX net sales of $236 million were $20 million, or 7.7%, lower than the prior year due primarily to $13 million in discontinued lower-margin distribution products and $2 million due to lower net sales of cough/cold products compared to the prior year. These were partially offset by improved customer service levels and higher net sales in the Israeli distribution business.

Reported gross margin was 35.9% while adjusted gross margin was 44.9%, an increase of 170 basis points. The increase in adjusted gross margin was due primarily to an improvement in customer service levels and favorable product mix. These benefits were partially offset by normal pricing pressure.

Reported operating margin was (40.8)% driven primarily by a $144 million goodwill impairment charge taken in the quarter. Adjusted operating margin was 29.4%, an increase of 540 basis points due to gross margin flow-through and lower operating expenses, of which $11 million was related to the generic albuterol pre-commercialization R&D costs in the prior year that did not reoccur.

Fiscal Year 2020 Results

Consolidated Fiscal 2020 Results Versus Fiscal 2019

Consolidated net sales were $5.1 billion, an increase of 5.0% compared to the prior year. Excluding the impact of currency and divested businesses, net sales increased 6.4%. This increase was driven by 1) new product sales of $304 million, 2) net sales from acquisitions of $214 million, which included a half-year benefit from the prior year Ranir acquisition and 9-months from the Dr. Fresh acquisition, 3) strong organic growth in CSCA, and 4) robust e-commerce growth. These drivers were partially offset by 1) divested businesses of $60 million and discontinued products of $51 million, 2) normal levels of pricing pressure, and 3) lower net sales of cough/cold products compared to the prior year. Consolidated organic net sales growth of 1.9% included a negative 1.4 percentage point impact due to lower worldwide net sales of cough/cold products.

Reported net loss was $163 million, or a loss of $1.19 per diluted share, versus reported net income of $146 million, or $1.07 per diluted share, in the prior year. Excluding certain charges as outlined in Table I, fiscal 2020 adjusted net income was $552 million, or $4.02 per diluted share, versus $550 million, or $4.03 per diluted share, in fiscal 2019. Strong organic performance in CSCA, robust e-commerce growth across the portfolio and the Oral Self-Care acquisitions offset lower worldwide net sales of cough/cold products, the impact from divested businesses and COVID-19 related costs.

Fiscal 2020 Worldwide Consumer Self-Care Results Versus Fiscal 2019

Worldwide Consumer net sales were a fiscal year record $4.1 billion, an increase of 6.0% compared to the prior year. Excluding the impact of currency and divested businesses, net sales were 7.9% higher year-over-year. Organic net sales were up 2.3%, despite a negative 1.7 percentage point impact due to lower net sales of cough/cold products compared to the prior year.

Fiscal 2020 reported gross profit margin was 36.7%. Adjusted gross profit margin of 38.9% was 140 basis points lower due primarily to 1) the Oral Self-Care acquisitions, 2) changes in global product mix associated with store brand products growing at a faster rate than branded products, and 3) COVID-19 related costs.

Reported operating margin was 7.2%. Adjusted operating margin was 13.2%, or 90 basis points lower as gross profit flow-through and higher corporate costs were partially offset by cost savings from Project Momentum and lower advertising and promotion expenditures.

CSCA Fiscal 2020 Results Versus Fiscal 2019

Consumer Self-Care Americas achieved record fiscal year net sales of $2.7 billion, an increase of $222 million, or 9.0%, which included $168 million attributable to the Ranir and Dr. Fresh acquisitions and a negative $11 million impact from foreign currency. Organic net sales were up 3.4%, including a negative 1.6 percentage point impact due to lower net sales of cough/cold products compared to the prior year.

The increase in OTC net sales were driven by 1) favorable consumer conversion to products in the Digestive Health category, 2) the increase of consumer COVID-19 related demand experienced in the first half of 2020 in the Pain and Sleep Aids category, and 3) the incremental impact of new product sales led by Prevacid, Diclofenac sodium topical gel 1%, and Esomeprazole Mini, and 4) continued robust e-commerce growth. These increases were partially offset by 1) lower cough/cold net sales resulting from extremely low levels of cough/cold and flu illnesses, which impacted the Upper Respiratory and Pain & Sleep Aids categories, and 2) normal pricing pressure.

Higher net sales in the Oral Self-Care category were driven by 1) a half-year benefit from the prior year Ranir acquisition and 9-months from the current year Dr. Fresh acquisition, 2) growth in the base business and the Plackers brand, and 3) continued momentum in e-commerce.

The decrease in Nutrition net sales was due primarily to the prior year pre-build of contract pack inventory and operational challenges that led to a shortfall in achieving normal customer service levels, which more than offset new product sales from the launch of infant formula at a major retailer in December 2019.

Perrigo omnichannel POS data increased 7.1% for the 52-weeks ending December 27, 2020, compared to an estimated increase in store brand OTC omnichannel POS data of 1.9%, leading to Perrigo store brand share gains versus competitors of 100 share points. Total OTC omnichannel POS data grew an estimated 4.8% in the categories in which Perrigo competes, resulting in Perrigo penetration share gains of 13 share points.

Reported gross profit margin was 31.9%. Adjusted gross profit margin of 32.7% was 90 basis points lower as favorable product mix and savings on raw materials were more than offset by normal pricing pressure, COVID-19 related costs and lower manufacturing efficiencies in infant formula.

Reported operating margin was 17.5%. Adjusted operating margin of 19.6% was 10 basis points lower as gross profit flow-through was mostly offset by cost savings from Project Momentum.

Fiscal 2020 CSCI Results Versus Fiscal 2019

CSCI net sales increased 0.8% to $1.4 billion. Excluding divested businesses of $40 million and favorable currency movements of $4 million, net sales were higher by 3.6%. Organic net sales were flat and included a negative 1.8 percentage point impact due to lower net sales of cough/cold products compared to the prior year.

Net sales growth was driven by 1) new product sales of $98 million driven by additions to the XLS-Medical Forte 5 brand and new products in the ACO dermatology portfolio, 2) an incremental $45 million in net sales from the acquisitions of Ranir and the Eastern European dermatology brands, 3) strong consumer demand in the VMS and Pain & Sleep Aids categories, each of which benefited from consumer behavior surrounding COVID-19, and 4) solid performance in the U.K. store brand business. CSCI also benefited from strong growth in e-commerce.

This growth was partially offset by 1) lower consumer demand for anti-parasite and weight management products within the Skincare & Personal Hygiene and Healthy Lifestyle categories, respectively, due primarily to consumer behavior surrounding COVID-19, including related school closings and country-specific lockdowns, 2) lower cough/cold net sales resulting from extremely low levels of cough/cold and flu illnesses, which impacted the Upper Respiratory category, and 3) divested businesses of $40 million and discontinued products of $10 million.

Reported gross margin was 45.9%. Adjusted gross margin of 50.8% declined 160 basis points due primarily to 1) the full-year inclusion of Ranir and improved performance in the U.K. store brand business, both of which have relatively lower gross margins than the overall portfolio, 2) impact from divested businesses, and 3) higher input costs on a particular OTC brand.

Reported operating margin was 2.3%. Adjusted operating margin of 14.3% declined 140 basis points as gross margin flow-through and transformation investments were offset by the relatively higher operating margin in Ranir, Project Momentum cost savings and lower advertising and promotion expense.

RX Fiscal 2020 Results Versus Fiscal 2019

RX net sales increased $8 million to $975 million due primarily to new product sales of $165 million, which were mostly offset by 1) normal pricing pressure, 2) discontinued lower-margin distribution products of $35 million, 3) a $31 million impact from the reserve for the estimated generic albuterol sulfate recall costs, and 4) fewer patient visits to dermatologists and other physicians related to COVID-19, which led to lower U.S. prescription volumes.

Reported gross margin was 32.3% and adjusted gross margin was 41.0%. The 260 basis point decline in adjusted gross margin was due primarily to less favorable product mix and costs for the generic albuterol recall in the third quarter of 2020.

Reported operating margin of (18.2)% was driven primarily by $347 million in goodwill impairment charges. Adjusted operating margin of 26.2% was 110 basis points lower as gross margin flow-through was partially offset by lower operating expenses, of which $11 million was related to the generic albuterol pre-commercialization R&D costs in the prior year that did not reoccur.

Share Repurchase

In the fourth quarter, the Company repurchased 3.4 million of its shares for approximately $164 million under its approved $1 billion share repurchase authorization program.

Reached Agreement to Sell RX Pharmaceuticals Business

Perrigo announced today, in a separate release, a definitive agreement to sell its Generic Rx Pharmaceuticals business to Altaris Capital Partners, LLC for total consideration of $1.55 billion, including $1.5 billion in cash and more than $50 million in other considerations. This transaction establishes Perrigo as a pure-play global consumer self-care leader with top-tier Consumer Packaged Goods fundamentals.

Fiscal 2021 Outlook

For fiscal 2021, Perrigo Worldwide Consumer is committed to delivering 3% organic net sales growth, 5% adjusted operating income growth and 7% adjusted diluted EPS growth, in line with CPG peers that trade at much higher multiples. Based on a preliminary estimate of the accounting treatment to classify Rx as discontinued operations, translates to an adjusted diluted EPS range of $2.50 to $2.70.

The Company cannot reconcile its expected adjusted diluted earnings per share to diluted earnings per share under "Fiscal 2021 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.

RedHill Biopharma Announces $10 Million Bought Deal Offering of American Depositary Shares

On March 1, 2021 RedHill Biopharma Ltd. (Nasdaq: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, reported that it has entered into an underwriting agreement with H.C. Wainwright & Co., LLC under which the underwriter has agreed to purchase on a firm commitment basis 1,250,000 American Depositary Shares (ADSs) of the Company, at a price to the public of $8.00 per ADS, less underwriting discounts and commissions (Press release, RedHill Biopharma, MAR 1, 2021, View Source [SID1234575876]). Each ADS represents ten ordinary shares, par value NIS 0.01 per share, of the Company. The closing of the offering is expected to occur on or about March 4, 2021, subject to satisfaction of customary closing conditions.

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H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The Company also has granted to the underwriter a 30-day option to purchase up to additional 187,500 ADSs at the public offering price, less underwriting discounts and commissions.

The gross proceeds to RedHill, before deducting underwriting discounts and commissions and offering expenses and assuming no exercise of the underwriter’s option to purchase additional ADSs, are expected to be $10 million. The Company intends to use the net proceeds from this offering to fund its clinical development programs, commercialization activities and for acquisitions and general corporate purposes.

The securities described above are being offered by RedHill pursuant to a "shelf" registration statement on Form F-3 (File No. 333-232777) previously filed with the Securities and Exchange Commission (the "SEC") on July 24, 2019 and declared effective by the SEC on August 8, 2019. The offering of the securities is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the securities being offered will be filed with the SEC. Electronic copies of the preliminary prospectus supplement and accompanying prospectus may be obtained, when available, on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

VBI Vaccines to Present at the Raymond James 42nd Annual Institutional Investors Conference

On March 1, 2021 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported that Jeff Baxter, President and Chief Executive Officer, and David E. Anderson, Ph.D., Chief Scientific Officer, will participate in an analyst-led fireside chat at the Raymond James 42nd Annual Institutional Investors Conference on Tuesday, March 2, 2021, at 4:40 PM ET (Press release, VBI Vaccines, MAR 1, 2021, View Source [SID1234575815]).

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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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Presentation Details

Event: Raymond James 42nd Annual Institutional Investors Conference
Presenters: Jeff Baxter, President and CEO, and David E. Anderson, Ph.D., Chief Scientific Officer
Date: Tuesday, March 2, 2021
Time: 4:40 – 5:20 PM ET
Webcast: View Source

A recording of the webcast will be available on the "Events and Presentations" page of the Company’s website: View Source