On November 4, 2020 bluebird bio, Inc. (NASDAQ: BLUE) reported financial results and business highlights for the third quarter ended September 30, 2020 and shared recent operational progress (Press release, bluebird bio, NOV 4, 2020, View Source [SID1234569859]).

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"While 2020 continues to present unprecedented challenges, bluebird has continued to advance our innovative cell and gene therapy programs. Looking to 2021 and beyond, this is a catalyst-rich period for bluebird as we are on the cusp of multiple approvals in the U.S. and EU," said Nick Leschly, chief bluebird. "In the near term, we look forward to collaborating with FDA to find innovative approaches to help advance these complex therapies. We know that the role of a pioneer in science is never easy, but we are driven by the patients we hope to help. As always, I would like to thank our birds for their passion and resiliency, and for their relentless commitment to the people we serve. The way our employees continue to show up is incredibly inspiring."

RECENT HIGHLIGHTS

SICKLE CELL DISEASE

BIOLOGICS LICENSE APPLICATION (BLA) SUBMISSION – Today, bluebird bio announces confirmation of its general agreement with the U.S. Food and Drug Administration (FDA) that the clinical data package required to support a BLA submission for LentiGlobin for sickle cell disease (bb1111) will be based on data from a portion of patients in the HGB-206 study Group C that have already been treated. bluebird bio is also announcing today that it has reached general agreement with FDA on its path to transition to commercial manufacturing using an analytical comparability strategy, including suspension-based lentiviral vector (sLVV). These developments meaningfully de-risk the bb1111 program and bring clarity on the path to approval. However, FDA requested the use of drug product manufactured from sickle cell disease (SCD) patient cells in addition to healthy donors as well as commercial lentiviral vector to demonstrate drug product comparability. Given this feedback, alongside COVID-19 related shifts and contract manufacturing organization COVID-19 impacts, bluebird is adjusting its submission timing to late 2022. The company looks forward to continuing to work with the Agency to find an innovative approach to reviewing the CMC portion of a BLA submission and address the high unmet need in sickle cell disease.
LENTIGLOBIN FOR SICKLE CELL DISEASE PRIME DESIGNATION – On September 23, 2020, bluebird bio announced that its investigational treatment for SCD, LentiGlobin for SCD gene therapy, was granted eligibility to the Priority Medicines (PRIME) program by the European Medicines Agency (EMA). The EMA’s PRIME initiative provides enhanced support and increased interaction to companies, with the goal of optimizing development plans and speeding regulatory evaluations to potentially bring innovative medicines to patients more quickly.
TRANSFUSION DEPENDENT β-THALASSEMIA

BIOLOGICS LICENSE APPLICATION (BLA) SUBMISSION – Today, bluebird bio announces that based on continued and ongoing discussions with the FDA in the context of bluebird bio’s Fast Track and Breakthrough Therapy designations, the company intends to seek approval for all patients with transfusion dependent β-thalassemia across all genotypes (including non-β0/β0 genotypes and β0/β0 genotypes). The company remains on track to complete the rolling BLA submission for betibeglogene autotemcel (beti-cel; formerly LentiGlobin for β-thalassemia) in mid-2021.
HGB-212 FINAL INFUSION – Today, bluebird bio announces the completion of treatment in the ongoing phase 3 Northstar-3 (HGB-212) clinical study of beti-cel in patients with transfusion-dependent β-thalassemia who have a β0/β0 genotype or IVS-I-110 mutation.
MULTIPLE MYELOMA

CRB-402 FINAL INFUSION – Today, bluebird bio announces the completion of treatment in the ongoing Phase 1 study (CRB-402) of bb21217, an investigational BCMA-targeted chimeric antigen receptor (CAR) T cell therapy being studied in patients with relapsed/refractory multiple myeloma (R/RMM).
IDE-CEL BIOLOGICS LICENSE APPLICATION (BLA) ACCEPTANCE AND PRIORITY REVIEW – On September 22, 2020, bluebird bio and BMS announced that the U.S. FDA has accepted for Priority Review their BLA for idecabtagene vicleucel (ide-cel; bb2121), the companies’ investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of March 27, 2021.
CEREBRAL ADRENOLEUKODYSTROPHY

ELI-CEL MARKETING AUTHORIZATION APPLICATION (MAA) VALIDATION – On October 2, 2020, bluebird bio announced that the EMA has accepted its MAA for elivaldogene autotemcel (eli-cel, Lenti-D). Validation of the application confirms the submission is sufficiently complete to begin the EMA’s centralized review process.
ELI-CEL DATA AT EBMT – On August 29, 2020, bluebird bio presented new data suggesting durability of response and a strong safety profile post eli-cel gene therapy in patients with cerebral adrenoleukodystrophy (CALD) at the 46th EBMT annual meeting. Long-term results from the Phase 2/3 Starbeam study of eli-cel, showed that eighty-seven percent of patients are alive and free of major functional disabilities (MFDs) at 24 months or more of follow-up and there were no reports of graft failure, graft rejection, or GVHD.
COMPANY

NEW BOARD APPOINTMENT – On August 11, 2020, bluebird bio announced the appointment of Denice Torres to its Board of Directors.
UPCOMING ANTICIPATED MILESTONES

Regulatory Outlook

SCD: The company plans to complete the BLA submission to the U.S. FDA for LentiGlobin for SCD in 2022.
TDT: The company is on track to complete a rolling BLA submission to the U.S. FDA for beti-cel in mid-2021. This submission will include all patients with transfusion dependent β-thalassemia across all genotypes (including non-β0/β0 genotypes and β0/β0 genotypes).
Multiple Myeloma: The FDA has set a PDUFA goal date of March 27, 2021 for the approval of ide-cel (bb2121) in patients with relapsed and refractory multiple myeloma.
CALD: The company is on track to complete the BLA submission to the U.S. FDA for eli-cel in mid-2021.
Clinical

Today, bluebird bio announces its intention to present bb21217 clinical data from the ongoing CRB-402 study in patients with multiple myeloma by the end of 2020.
bluebird bio plans to present ide-cel clinical data from the ongoing CRB-401 study in patients with multiple myeloma by the end of 2020, in partnership with BMS.
bluebird bio plans to present updated data from the ongoing HGB-206 clinical study in patients with SCD by the end of 2020.
Commercial and Foundation Building

ZYNTEGLO first commercial patients treated in Europe by the end of 2020.
THIRD QUARTER 2020 FINANCIAL RESULTS

Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2020 and December 31, 2019 were $1.44 billion and $1.24 billion, respectively. The increase in cash, cash equivalents and marketable securities is primarily a result of proceeds received from the May 2020 public offering of the Company’s common stock and a one-time upfront payment received in connection with the Company’s amended collaboration with BMS, partially offset by cash used in support of ordinary course operating and commercial-readiness activities.
Revenues: Total revenues were $19.3 million for the three months ended September 30, 2020 compared to $8.9 million for the three months ended September 30, 2019. Total revenues were $240.0 million for the nine months ended September 30, 2020 compared to $34.7 million for the nine months ended September 30, 2019. The increase for the three month period was primarily driven by an increase in ide-cel license and manufacturing services revenue and an increase in research and development revenue under our agreement with BMS. The increase for the nine months period was primarily driven by the recent amended BMS collaboration and monetization for ex-U.S. milestones and royalties from ide-cel and bb21217, with the majority of the revenue recognized relating to ide-cel license and manufacturing services.
R&D Expenses: Research and development expenses were $140.4 million for the three months ended September 30, 2020 compared to $151.4 million for the three months ended September 30, 2019. Research and development expenses were $450.9 million for the nine months ended September 30, 2020 compared to $420.6 million for the nine months ended September 30, 2019. The decrease for the three month period was primarily driven by a decrease in manufacturing costs. The increase for the nine month period was primarily driven by an overall increase in costs incurred to advance and expand the company’s pipeline.
SG&A Expenses: Selling, general and administrative expenses were $68.0 million for the three months ended September 30, 2020 compared to $66.3 million for the three months ended September 30, 2019. Selling, general and administrative expenses were $209.9 million for the nine months ended September 30, 2020 compared to $195.2 million for the nine months ended September 30, 2019. The increase for both periods was largely attributable to costs incurred to support the Company’s ongoing operations and growth of its pipeline.
Net Loss: Net loss was $194.7 million for the three months ended September 30, 2020 compared to $206.0 million for the three months ended September 30, 2019. Net loss was $418.8 million for the nine months ended September 30, 2020 compared to $566.3 million for the nine months ended September 30, 2019.
CONFERENCE CALL DETAILS

bluebird bio will hold a conference call to discuss business updates and third quarter 2020 financial results on Wednesday, Nov 4 at 4:30PM ET. Investors may listen to the call by dialing (844) 825-4408 from locations in the United States or +1 (315) 625-3227 from outside the United States. Please refer to conference ID number 545-6725

To access the live webcast of bluebird bio’s presentation, please visit the "Events & Presentations" page within the Investors & Media section of the bluebird bio website at View Source Replays of the webcast will be available on the bluebird bio website for 90 days following the event.

On November 4, 2020 MorphoSys AG (FSE: MOR; Prime Standard Segment, MDAX & TecDAX; NASDAQ: MOR) reported that it will publish its results for the third quarter and first 9-month of 2020 on November 11, 2020 at 10:00pm CET (9:00pm GMT; 4:00pm EST) (Press release, MorphoSys, NOV 4, 2020, View Source [SID1234569858]).

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MorphoSys’ Management team will host a conference call and webcast on November 12, 2020 at 2:00pm CET (1:00pm GMT; 8:00am EST) to present the third quarter and first 9-month financial results 2020 and the further outlook for 2020.

Please dial in 10 minutes before the beginning of the conference.

A live webcast and slides will be made available at www.morphosys.com.

Approximately two hours after the call, a slide-synchronized audio replay of the conference and a transcript of the prepared remarks will be available on www.morphosys.com.

On November 4, 2020 ChromaDex Corp. (Nasdaq:CDXC) reported third quarter financial results (Press release, ChromaDex, NOV 4, 2020, View Source [SID1234569857]).

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2020 Third Quarter and Recent Highlights

Total net sales of $14.2 million, up 18% from $12.1 million from the year ago quarter.
Tru Niagen net sales of $11.9 million, a 22% increase from the year ago quarter.
Net loss was ($4.2) million or ($0.07) per share, an improvement of $0.05 per share year-over-year.
Adjusted EBITDA excluding total legal expense, a non-GAAP measure, was a loss of ($0.1) million, a $1.7 million improvement year-over-year.
Announced Phase 2 results from study in Turkey showing nutritional protocol including nicotinamide riboside ("NR") plus local standard of care reduced recovery time in COVID-19 patients by nearly 30%.
Growing body of clinical research suggests that nicotinamide riboside (Niagen) may support areas of human health with broad addressable markets, including cardiovascular and immune health, with additional studies underway.
Nestlé Health Science’s new Celltrient Cellular Energy products featuring Tru Niagen launched in the United States, following the launch of Tru Niagen capsules on Persona, a Nestlé Health Science company and leading personalized vitamin subscription program, earlier this year.
"We delivered strong third quarter sales of Tru Niagen with sequential growth in our e-commerce business and with Watsons, and our partner Nestlé Health Science released their new product line Celltrient, featuring Tru Niagen," says ChromaDex CEO Rob Fried. "Our scientists and research partners also published important new data furthering our understanding of increased NAD+ levels and immune health, including research on COVID-19."

Results of operations for the three months ended September 30, 2020

For the three months ended September 30, 2020 ("Q3 2020"), ChromaDex reported net sales of $14.2 million, up 18% compared to $12.1 million in the third quarter of 2019 ("Q3 2019"). The increase in Q3 2020 revenues was driven by growth in sales of Tru Niagen.

Gross margin increased by 360 basis points to 59.6% in Q3 2020 compared to 56.0% in Q3 2019. The increase in gross margin was largely driven by the positive impact of increased Tru Niagen consumer product sales and product cost saving initiatives.

Operating expenses decreased by $1.0 million to $12.7 million in Q3 2020, compared to $13.6 million in Q3 2019. The decrease in operating expenses was driven by a decrease of $1.4 million in general and administrative expense, and a decrease of $0.2 million of research and development expense, partially offset by $0.6 million of higher selling and marketing expense. The decrease in general and administrative expense was driven by $1.0 million of lower legal expenses.

The net loss for Q3 2020 was ($4.2) million or ($0.07) per share compared to a net loss of ($7.2) million or ($0.12) per share for Q3 2019.

Adjusted EBITDA excluding total legal expense, a non-GAAP measure, was a loss of ($0.1) million for Q3 2020, compared to a loss of ($1.9) million for Q3 2019, a $1.7 million improvement.

ChromaDex defines Adjusted EBITDA excluding total legal expense as net income or (loss) which is adjusted for interest, income tax, depreciation, amortization, non-cash stock compensation costs, severance and restructuring expense, bad debt expense related to Elysium Health and total legal expense.

For Q3 2020, the net cash used in operating activities was ($3.8) million versus ($7.8) million in Q3 2019.

2020 Outlook

The Company’s full year financial outlook is unchanged from last quarter. Based on the Company’s current financial outlook, revenue growth will be driven by its U.S. ecommerce business, new international market launches with its partners and distributors, such as in the U.K. and Australia, new online platforms, including Persona Nutrition, a Nestlé Health Science company, and the Company’s new product, Tru Niagen Beauty. The Company expects continued gross margin improvement driven by a higher mix of Tru Niagen sales, product design changes implemented in late 2019, and additional supply chain cost savings initiatives in 2020. The Company expects lower selling, marketing and advertising as well as general and administrative expenses as a percentage of net sales driven by strong growth from returning customers and scale on our fixed overhead costs driven by organizational realignment initiatives, as well as new systems and processes. The Company does not expect any supply chain disruption related to the impact of COVID-19 at this time and, while the revenue impact is difficult to predict, the Company is managing expenses to mitigate the bottom-line impact.

Investor Conference Call

ChromaDex management will host an investor conference call to discuss the third quarter results and provide a general business update on Wednesday, November 4, at 4:30 p.m. ET.

Participants should call in at least 10 minutes prior to the call. The dial-in information is as follows:

The conference call will be broadcast live and available for replay here and via the investor relations section of the Company’s website at www.chromadex.com.

A replay of the conference call will be available after 7:30 p.m. ET.

About Non-GAAP Financial Measures:

Adjusted EBITDA excluding total legal expense excludes interest, income tax, depreciation, amortization, non-cash share-based compensation costs, severance and restructuring expense, bad debt expense related to Elysium Health, and total legal expense. ChromaDex used these non-GAAP measures when evaluating its financial results as well as for internal resource management, planning and forecasting purposes. ChromaDex believes the presentation of its non-GAAP financial measures enhances the overall understanding of the company’s historical financial performance. These non-GAAP measures should not be viewed in isolation from or as a substitute for ChromaDex’s financial results in accordance with GAAP. Reconciliation of GAAP to non-GAAP measures are attached to this press release.

On November 4, 2020 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported financial results for the quarter ended September 30, 2020 (Press release, MacroGenics, NOV 4, 2020, View Source [SID1234569856]).

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"MacroGenics continued the advancement of its portfolio of multiple clinical molecules during the third quarter of 2020, with three investigational programs currently in pivotal studies: margetuximab, flotetuzumab and retifanlimab. The PDUFA action date for margetuximab in breast cancer is December 18. Just prior, we look forward to our next presentation of flotetuzumab clinical data at ASH (Free ASH Whitepaper) in December, following the publication of data in three separate journals this year highlighting the medical and scientific interest in this DART molecule," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "At ESMO (Free ESMO Whitepaper) in September, we and our partner, Incyte, presented clinical data on MGD019 and retifanlimab, respectively. And on the heels of MGC018 data presented at ASCO (Free ASCO Whitepaper), we recently commenced the enrollment of patients with mCRPC, TNBC and NSCLC. More near-term, we look forward to providing an update on tebotelimab plus margetuximab in HER2-positive patients at the upcoming SITC (Free SITC Whitepaper) Annual Meeting this month. Finally, we look forward to updating you on continued progress through the rest of 2020 and into 2021."

Key Highlights from Investigational Product Candidates in Pivotal Studies:

Margetuximab (Fc-engineered, anti-HER2 mAb): A Biologics License Application (BLA) for margetuximab, in combination with chemotherapy as a treatment for patients with metastatic HER2-positive breast cancer, is being reviewed by the U.S. Food and Drug Administration (FDA). The Prescription Drug User Fee Act (PDUFA) target action date is December 18, 2020. Based on the current accrual rate of overall survival (OS) events in the Phase 3 SOPHIA study, MacroGenics now anticipates accrual of the 385th OS event, which triggers the final OS analysis, in the second half of 2021.

Enrollment of the global Phase 2/3 MAHOGANY study of margetuximab plus checkpoint blockade, with or without chemotherapy, as a potential first-line treatment for patients in front-line gastric and gastroesophageal junction cancer is ongoing. MacroGenics’ partner in Greater China, Zai Lab, recently announced dosing of the first patient in that region. MacroGenics anticipates providing a clinical update on Module A of the study in the first half of 2021.

Flotetuzumab (bispecific CD123 × CD3 DART molecule): During the third quarter, two manuscripts were published in Blood and Blood Advances, two publications of the American Society of Hematology (ASH) (Free ASH Whitepaper). The first publication reported on clinical results as of November 2019, while the most recent publication reported on the potential role of flotetuzumab in the immunotherapy of TP53-positive acute myeloid leukemia (AML). In addition, six flotetuzumab and AML abstracts were accepted for presentation at the upcoming ASH (Free ASH Whitepaper) Annual Meeting.

MacroGenics continues to enroll the single-arm, registrational study to evaluate flotetuzumab in up to 200 AML patients with primary induction failure or early relapse (PIF/ER) AML, with complete remission (CR) and CR with partial hematological recovery (CRh) as the primary endpoint.

Retifanlimab (anti-PD-1 mAb previously known as MGA012 or INCMGA0012): At the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 in September, data from potentially registration-enabling monotherapy studies in patients with squamous cell carcinoma of the anal canal and Merkel cell carcinoma were presented. Also in September, a $15 million milestone payment to MacroGenics was triggered under the Company’s exclusive global collaboration and license agreement with Incyte Corporation. This milestone was triggered by Incyte’s initiation of the Phase 3 clinical trial evaluating the efficacy and safety of retifanlimab with platinum-based chemotherapy in patients with metastatic squamous and non-squamous non-small cell lung cancer (NSCLC).
Key Highlights from Other Investigational Product Candidates:

MGC018 (B7-H3 antibody-drug conjugate): Encouraged by the MGC018 interim clinical dose escalation data presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) meeting in May, the Company recently commenced the enrollment of patients with metastatic castration-resistant prostate cancer (mCRPC), triple negative breast cancer (TNBC) and non-small cell lung cancer (NSCLC) in the dose expansion portion of the Phase 1 clinical study. The Company expects to provide an update on this study in the first half of 2021.

Enoblituzumab (Fc-engineered, anti-B7-H3 mAb): In the first quarter of 2021, MacroGenics expects to initiate a Phase 2 study of enoblituzumab in a chemo-free regimen in combination with either retifanlimab in front-line patients with squamous cell carcinoma of the head and neck (SCCHN) who are PD-L1 positive or with tebotelimab in SCCHN patients who are PD-L1 negative.

Tebotelimab (also known as MGD013, a bispecific PD-1 × LAG-3 DART molecule): The Company will present updated data via poster presentation from the ongoing Phase 1 dose expansion study of tebotelimab in combination with margetuximab in a cohort of patients with advanced HER2-positive tumors at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting. 

MGD019 (bispecific PD-1 × CTLA-4 DART molecule): In September, data from the Phase 1 dose escalation study of MGD019 was presented during an oral session at the ESMO Virtual Congress 2020. Based on the results presented, the Company has expanded the study initially in patients with microsatellite stable colorectal cancer (MSS CRC) and checkpoint-naïve NSCLC at the recommended Phase 2 dose of 6.0 mg/kg.

 IMGC936 (ADAM9 antibody-drug conjugate): IMGC936 is an ADC that targets ADAM9, a cell surface protein over-expressed in several solid tumor types. IMGC936 is being advanced under a co-development agreement with ImmunoGen, Inc. Under the 50/50 collaboration, ImmunoGen is leading clinical development and they are currently screening patients for the Phase 1 dose escalation study in patients with select advanced solid tumors.
Third Quarter 2020 Financial Results

Cash Position: Cash, cash equivalents and marketable securities as of September 30, 2020, were $280.7 million, compared to $215.8 million as of December 31, 2019. During the quarter ended September 30, 2020, $74.0 million in net proceeds were received from the sale of 2,552,333 shares of the Company’s common stock pursuant to its at-the-market (ATM) offering. The $15.0 million milestone payment from Incyte was received after September 30, 2020.

Revenue: Total revenue, consisting primarily of revenue from collaborative agreements, was $18.2 million for the quarter ended September 30, 2020, compared to $18.7 million for the quarter ended September 30, 2019.

R&D Expenses: Research and development expenses were $44.7 million for the quarter ended September 30, 2020, compared to $44.9 million for the quarter ended September 30, 2019.

G&A Expenses: General and administrative expenses were $9.7 million for the quarter ended September 30, 2020, compared to $11.8 million for the quarter ended September 30, 2019. This decrease is primarily due to a decrease in external costs, including consulting.

Net Loss: Net loss was $36.0 million for the quarter ended September 30, 2020, compared to net loss of $44.6 million for the quarter ended September 30, 2019.

Shares Outstanding: Shares outstanding as of September 30, 2020 were 56,174,932.
Conference Call Information

MacroGenics will host a conference call today at 4:30 p.m. ET to discuss financial results for the quarter ended September 30, 2020 and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) ten minutes prior to the start of the call and provide the Conference ID: 5986584.

The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

On November 4, 2020 Perrigo Company plc (NYSE; TASE: PRGO), a leading provider of Quality, Affordable Self-Care Products, reported financial results for the third quarter ended September 26, 2020 (Press release, Perrigo Company, NOV 4, 2020, View Source [SID1234569855]).

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President and CEO, Murray S. Kessler commented, "Results for the first nine months of this year reflect the strength of Perrigo’s diversified business model, the successful execution of our transformational activities and the dedication and agility of our 11,000 team members worldwide who are successfully navigating this horrific global pandemic."

Kessler continued, "Year to date, Worldwide Consumer net sales have grown high-single-digits, and importantly, organic growth is well above our 3% net sales goal. Consumer Self-Care Americas once again led the way with robust growth in all major franchises, resulting in record third quarter net sales as the segment benefited from channel shifting to e-Commerce and successful new product launches. Better than expected recoveries in both the CSC International and RX base businesses also contributed as our branded self-care and generic prescription product categories that were negatively impacted by consumer/patient buying dynamics surrounding COVID-19 lock-downs improved to near pre-COVID-19 levels. I am pleased that the strength of our businesses allowed us to reaffirm guidance, despite the disappointing RX albuterol recall."

Kessler concluded, "Our self-care evolution has accelerated Perrigo’s growth over the past 18 months and has us very well positioned in a ‘New World’ where self-care, value and e-Commerce will be more important than ever before. While there is still work to be done on our transformation, our team is energized about the future and remains committed to our long-term growth targets. Looking ahead, we will continue to leverage our unique and durable capabilities, along with more than $1 billion in committed investments to date, to recapture the Perrigo Advantage and create long-term value for our shareholders."

Third Quarter Financial Highlights

Consolidated third quarter net sales were $1.2 billion, an increase of 1.3% compared to the prior year quarter.
Worldwide Consumer third quarter net sales grew 3.6% compared to the prior year. Excluding the impact of currency and divested businesses, net sales increased 4.2%. Organic net sales grew 1.6%.
Consumer Self-Care Americas ("CSCA") achieved record third quarter net sales of $664 million, up 7.3% versus the prior year. Organic net sales grew 4.0% as consumer demand in the U.S. remained strong.
Consumer Self-Care International ("CSCI") third quarter net sales of $339 million were down 2.9% versus the prior year quarter, due primarily to European consumer dynamics surrounding COVID-19.
Reported diluted net loss per share for the third quarter was $1.13 as compared to EPS of $0.67 in the prior year, due primarily to a $202 million dollar impairment of goodwill in the RX segment.
Adjusted diluted EPS for the third quarter of 2020 decreased 10.6% to $0.93 as compared to $1.04 per diluted share in the prior year. Diluted EPS included a $0.14 charge from the third quarter RX albuterol recall.
Year-to-Date 2020 Financial Highlights

Consolidated year to date net sales were $3.8 billion, up 7.8% compared to the prior year. Excluding the impact of currency and divested businesses, net sales increased 9.7%. Organic net sales grew 4.4%.
Worldwide Consumer net sales increased 8.9% compared to the prior year. Excluding the impact of currency and divested businesses, net sales were 11.3% higher year-over-year. Organic net sales grew 4.6%.
CSCA achieved year-to-date net sales of $2.0 billion, 13.2% higher versus the prior year, or 14.9% higher excluding the impact of currency and divested businesses. Organic net sales grew 6.7%.
CSCI year-to-date net sales increased 1.5% versus the prior year, or 5.0% higher excluding divested businesses and the impact of currency. Organic new sales grew 1.0%.
Cash flow from operations as a percentage of adjusted net income was 124%.

(1) Unless otherwise noted, all comparisons of operating results against the prior year period include the previously disclosed third quarter 2019 net sales adjustments for the market withdrawal of Ranitidine, of which $7.4 million was included in the CSCA segment and $1.8 million was included in the CSCI segment, as well as $1.8 million in operating results attributable to the then held-for-sale animal health business in our CSCA segment. See attached Appendix for additional details.

(2) See attached Appendix for details. Organic net sales growth excludes the effects of acquisitions and divestitures and the impact of currency.

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 Condensed Consolidated Statements of Operations, Balance Sheets and Statements of Cash Flows.

Third Quarter 2020 Consolidated Results Versus Third Quarter 2019

Consolidated net sales for the third quarter of calendar year 2020 were $1.2 billion, an increase of $15 million or 1.3%. Organic net sales declined 0.4% and included a 0.7 percentage point net negative impact from RX albuterol sulfate as product sales early in the quarter were more than offset by the establishment of the estimated albuterol reserve associated with the September recall.

The $15 million increase in consolidated net sales was driven by 1) $48 million in year over year growth in the CSCA segment driven by $24 million of increased demand across most product categories reflecting continued consumer channel shifting from traditional brick and mortar outlets to e-Commerce and $24 million from the Dr. Fresh oral self-care acquisition, and 2) $10 million in net favorable currency movements. These consolidated gains were partially offset by 1) a $20 million decline in the RX segment as $23 million in net sales of albuterol sulfate in the quarter were more than offset by a $31 million impact from the reserve for the estimated albuterol sulfate recall costs and $9 million in lower-margin discontinued products, 2) $15 million from divested businesses, and 3) a decline of $8 million in CSCI mainly driven by categories impacted by COVID-19 lock-downs.

Reported net loss was $155 million, or $1.13 per diluted share, versus net income of $92 million, or $0.67 per diluted share in the prior year period. Excluding certain charges as outlined in Table I, third quarter 2020 adjusted net income was $128 million, or $0.93 per diluted share, versus $142 million, or $1.04 per diluted share, for the same period last year resulting in a 10.6% decrease in adjusted diluted EPS.

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

Worldwide Consumer is comprised of the CSCA segment, the CSCI segment and Corporate.

Worldwide Consumer Self-Care third quarter net sales increased $35 million, or 3.6%, to $1.0 billion with organic net sales growth of 1.6%, driven by growth in CSCA.

Third quarter reported gross profit margin was 37.0%. Adjusted gross profit margin of 39.2%, was 120 basis points lower year-over-year due to strong growth in the lower gross margin store brand business and the net gross margin impact of acquisitions and divestitures.

Reported operating margin was 8.5%. Adjusted operating margin decreased 180 basis points year-over-year to 14.0% due primarily to gross margin flow-through and higher variable compensation costs.

CSCA Third Quarter 2020 Results Versus Third Quarter 2019

Consumer Self-Care Americas achieved record third quarter net sales of $664 million, an increase of 7.3% or $45 million, which included $24 million from the acquisition of Dr. Fresh oral self-care and unfavorable currency movements of $3 million. Organic net sales grew 4.0% driven by increased demand across most categories that benefited from robust e-Commerce growth as consumers continued to shift purchasing towards online where Perrigo has greater market share, more than offsetting lower traditional brick and mortar purchases as measured through IRI MULO.

In OTC, increased demand was led by the pain, allergy, and digestive health categories resulting from strong e-Commerce growth and incremental volume from new products including Prevacid(R) and the store brand versions of Diclofenac Gel 1% and Esomeprazole Mini. Partially offsetting these were lower net sales of cough and cold products within the upper respiratory category and normal pricing pressure.

As a component of transforming to a consumer self-care company, Perrigo has made investments to enhance its consumer analytical and digital capabilities. Historically, CSCA measured its market share using only IRI’s MULO or Multi-Outlet data, which does not capture certain retailers and sales through the e-commerce channel. For the first time, the Company has the capabilities to measure, analyze, and benchmark omnichannel performance for Perrigo, store brand and the overall OTC category using IRI MULO point-of-sale (POS) data, IRI panel e-commerce data and POS data from Perrigo’s leading customers.

Total Perrigo omnichannel POS data was up 3.5% for the 13-weeks ending October 4, 2020. Total OTC omnichannel POS data was estimated to be up 1.2% in the categories in which Perrigo competes, resulting in a Perrigo share gain of 70 basis points.

In Nutrition, higher net sales were led by the December 2019 store brand infant formula launch at a major retailer, greater shipments in the infant formula contract manufacturing business and growth in customer e-Commerce activities. In Oral Self-Care, net sales were driven by the Dr. Fresh acquisition and strong e-Commerce growth.

Third quarter reported gross margin was 32.7%. Adjusted gross margin of 33.5% was 50 basis points lower than the prior year as higher margin new products were more than offset by normal pricing pressure. Third quarter 2020 adjusted gross margin was 60 basis points higher and 210 basis points higher than the second and first quarters of 2020, respectively.

Reported operating margin was 18.6%. Adjusted operating margin increased 30 basis points to 20.1%, due primarily to operating leverage on gross margin flow-through.

CSCI Third Quarter 2020 Results Versus Third Quarter 2019

Consumer Self-Care International net sales were $339 million, a decrease of $10 million, or 2.9%. Organic net sales were lower by 2.7%.

The decline in net sales was due primarily to 1) divested businesses of $15 million and discontinued products of $3 million, 2) lower sell-in activities to customers of cough and cold OTC brands within the upper respiratory category, and 3) lower consumer demand for anti-parasite products within the skincare & personal hygiene category due primarily to COVID-19 related school closings. These were partially offset by gains in 1) new products, including line extensions in the ACO dermatology product line and new innovations to the XLS Forte Five weight management brand, 2) $12 million in favorable currency movements, and 3) higher net sales in the pain and VMS categories, both of which benefited from consumer behavior surrounding COVID-19.

Reported gross margin was 45.5%. Adjusted gross margin of 50.4% declined 150 basis points due primarily to divested businesses, less favorable product mix and higher input costs on a particular OTC brand.

Reported operating margin was 3.0%. Adjusted operating margin decreased 310 basis points to 15.1% due to gross profit flow-through and divested businesses.

RX Third Quarter 2020 Results Versus Third Quarter 2019

RX net sales were $211 million, $20 million or 8.5%, lower than the prior year. Net sales from albuterol sulfate in the quarter of $23 million were more than offset by a $31 million reserve for the estimated impact from the albuterol sulfate recall and $9 million in lower-margin discontinued products. The RX base business, which excludes albuterol sulfate and discontinued products in both years, was down 1.2% compared to the prior year and reflected a faster than anticipated recovery in dermatology prescriptions from the second quarter of 2020.

Reported gross margin was 27.0% and adjusted gross margin was 37.1%. The 380 basis point decline in adjusted gross margin was due primarily to impact from the reserve for the estimated albuterol sulfate recall costs.

Reported operating margin was (85.7)%, driven primarily by the $202 million goodwill impairment charge taken in the quarter. Adjusted operating margin was 20.7%, down 330 basis points as lower gross profit was partially offset by lower R&D and administration expenses.

Fiscal 2020 Outlook

The Company reaffirms its fiscal 2020 outlook with expected net sales growth of 6% to 7% with organic net sales growth of at least 3%. Adjusted diluted EPS is expected to be in the range of $3.95 to $4.15. The reaffirmed guidance reflects strong business fundamentals and a lower expected tax rate for the year, offsetting $0.12 – $0.15 per adjusted diluted share of incremental COVID-19 related costs, $0.14 per share impact from the RX albuterol sulfate recall, and $0.06 per share from the divested Rosemont Rx business, which the Company sold on June 19, 2020. Future waves of COVID-19 could present both incremental risks as well as opportunities for the Company’s business.

The Company cannot reconcile its expected adjusted diluted earnings per share to diluted earnings per share under "Fiscal 2020 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.