On November 10, 2021 KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company focused on the discovery and development of proprietary prodrugs, reported its financial results for the third quarter ended September 30, 2021 (Press release, KemPharm, NOV 10, 2021, View Source [SID1234595279]). In addition, the Company announced that Richard W. Pascoe, lead independent director on the Board of Directors, has been named Executive Chairman to support execution of the Company’s strategic growth objectives to expand its pipeline and commercialization capabilities. Travis C. Mickle, Ph.D., remains the Company’s President and Chief Executive Officer, and as a member of the Board of Directors.

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"I am delighted to partner with Rich in his new role as Executive Chairman as we build upon our successful track record of clinical development and U.S. regulatory approvals to create an innovative biopharmaceutical company with an expanded pipeline and commercial capabilities," stated Dr. Mickle. "Rich and I have built a strong working relationship since he joined our Board in 2014, and I am proud of our many accomplishments at KemPharm to date. Working together to expand the Company’s growth opportunities will be exciting as together we pursue our shared goal to increase shareholder value."

"I am excited for the opportunity to continue my service to KemPharm as its Executive Chairman and to partner with Travis and the executive team as we seek to grow into a profitable, fully integrated, biopharmaceutical company," said Mr. Pascoe. "Travis, the Board of Directors, and I are committed to this objective which we will seek to accomplish by successfully building, developing, and commercializing a pipeline of innovative product candidates focused on the treatment of neurodegenerative/central nervous system indications."

Mr. Pascoe has a strong track record building and leading life sciences organizations. He has served in key leadership roles in companies that successfully raised over $300 million in equity capital, taken private companies public, closed more than $2 billion of value in business development transactions, obtained regulatory approvals for two products in both the U.S. and Europe, and led commercial launches of prescription drugs in the U.S. across multiple therapeutic categories.

Most recently, Mr. Pascoe served as Chief Executive Officer of Histogen Inc., and his prior experiences include serving as Chief Executive Officer at Apricus Biosciences Inc. and Somaxon Pharmaceuticals, Inc. Mr. Pascoe’s career is also highlighted by several senior management roles, including Chief Operating Officer at ARIAD Pharmaceuticals, Inc., and Senior Vice President of the Neuroscience Division at King Pharmaceuticals, Inc. In addition to serving as Executive Chairman of KemPharm, Inc., Mr. Pascoe is currently a member of the board of directors of Seelos Therapeutics, Inc., and the board of directors of the Johnny Mac Soldiers Fund, a charity for military veterans. Mr. Pascoe is a graduate of the Unites States Military Academy at West Point.

Q3 2021 Corporate and Financial Results:

"The third quarter of 2021 was highlighted by the U.S. commercial launch of AZSTARYS, a seminal event in KemPharm’s history, which occurred during a year with numerous transformative milestones for the company," said Dr. Mickle. "Corium’s commercialization of AZSTARYS continues to proceed as planned, and their team has recently reported to us their estimate that more than 50 million commercial and Medicaid lives now have access to AZSTARYS with more progress expected in the coming months. Additionally, research involving AZSTARYS and serdexmethylphenidate (SDX) was presented at three recent ADHD medical conferences, including data from the pivotal study of AZSTARYS demonstrating the drug’s 30-minute onset-of-action and 13-hour duration-of-effect. At only 100 days post-launch, we are encouraged by the early progress, and we believe that Corium’s commercialization efforts will continue to gain traction with payors, providers, prescribers and patients."

Dr. Mickle continued, "In addition to Rich’s appointment as Executive Chairman, we also announced several other corporate advancements, including the appointment of Tamara Seymour to our Board of Directors and the uplisting of our common stock to The Nasdaq Global Select Market. These developments continue a period of transformation for KemPharm as we position ourselves to capitalize on pipeline development opportunities that, we believe, will ultimately translate to enhanced shareholder value. The advancement of our SDX program is also moving ahead, with data from the ongoing SDX clinical trial expected to be announced prior to year-end. This information will provide valuable insights into the potential path forward for developing SDX-based product candidates designed for therapeutic indications with underserved patient populations."

Financial results for Q3 2021 included revenue of $2.0 million, as compared to Q3 2020 revenue of $1.9 million, which was derived primarily from service fee revenue. The service fee revenue is being earned under consulting arrangements which contractually continue through March 2022.

KemPharm’s net loss for Q3 2021 was $1.8 million, or $0.05 per basic share, compared to a net loss of $3.0 million, or a loss of $0.68 per basic and diluted share for the same period in 2020. Net loss for Q3 2021 was driven primarily by operating loss of $2.2 million, partially offset by non-cash fair value adjustment income of $0.3 million related to derivative and warrant liability and net interest income and other items of $0.1 million. The net operating loss of $2.2 million for Q3 2021 was a change of $1.0 million compared to net operating loss of $1.2 million in the same period in 2020, which was primarily due to increases in operating expenses period over period. The net increase in operating expenses was primarily due to increases in research and development expense of $0.5 million and general and administrative expenses of $0.5 million.

As of September 30, 2021, total cash and cash equivalents was $131.5 million, which was a decrease of $0.8 million compared to $132.3 million as of June 30, 2021.

As of September 30, 2021, total shares of common stock outstanding was 35,317,313 shares, and fully diluted common shares outstanding was 46,553,727 shares, which included 4,252,600 shares issuable upon exercise of warrants. In addition, no preferred stock is outstanding as of September 30, 2021.

Conference Call Information:

KemPharm will host a conference call and live audio webcast with slide presentation on Wednesday, November 10, 2021, at 4:30 p.m. ET, to discuss its corporate and financial results for the third quarter 2021.

Telephone Access: To access the conference call telephonically, interested participants and investors will be required to register via the following online form: View Source

Once registered, all individuals will be provided with participant dial-in numbers, a passcode and a registrant ID, which can then be used to access the conference call.

Participants may register at any time. It is recommended that the registration process be completed at least 15 minutes prior to the start of the call.
Webcast Access: The live audio webcast with slide presentation will be accessible via the Investor Relations section of KemPharm’s website, View Source An archive of the webcast and presentation will be available for 90 days beginning at approximately 5:30 p.m. ET, on November 10, 2021.

About AZSTARYS:

AZSTARYS is an FDA-approved, once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years or older. AZSTARYS consists of SDX, KemPharm’s prodrug of d-methylphenidate (d-MPH), co-formulated with immediate release d-MPH.

The complete approved prescribing information for AZSTARYS may be downloaded in PDF format here:
View Source

On November 10, 2021 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported results for the quarter ended September 30, 2021 and highlighted recent corporate progress (Press release, MEI Pharma, NOV 10, 2021, View Source [SID1234595295]).

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"Fiscal year 2022 is off to an exciting start as we look towards reporting data from the follicular lymphoma cohort in the pivotal TIDAL study evaluating zandelisib in patients with follicular and marginal zone lymphomas which, subject to discussions with FDA, we intend to use to support the submission of our first New Drug Application," said Daniel P. Gold, Ph.D., president and chief executive officer of MEI Pharma. "Beyond TIDAL, our development efforts include studies intended to expand the commercial opportunity for zandelisib in additional indications, like the Phase 3 COASTAL study evaluating follicular and marginal zone lymphoma patients after one prior line of therapy, and the Phase 2 CORAL study that will evaluate zandelisib plus venetoclax and rituximab in patients with chronic lymphocytic leukemia. Our goal is to have zandelisib incorporated as a component of standard therapy across multiple B-cell indications."

Dr. Gold continued: "We are also excited about development plans for our other pipeline candidates, such as evaluating voruciclib’s potential to synergize with venetoclax in patients with AML, and the potential of ME-344 plus bevacizumab in patients with colorectal cancer. And, with $145.5 million in cash at the end of the quarter, plus an additional $10 million milestone subsequently paid to MEI by Kyowa Kirin, as well as promising clinical data across our pipeline, we believe we are in a strong position to achieve our goals in the year ahead, continue to advance our pipeline, and develop best-in-class cancer therapies for patients in need."

First Quarter Fiscal Year 2022 Financial and Drug Candidate Pipeline Highlights

Initiated COASTAL, a Phase 3 study evaluating zandelisib in combination with rituximab in follicular and marginal zone lymphoma patients who received one or more prior lines of treatment. This study is intended to support FDA approval for additional indications and act as the required confirmatory study for the potential accelerated approval of zandelisib in patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma.
Received a $10,000,000 milestone payment from Kyowa Kirin Co. pursuant to the 2020 global license, development and commercialization agreement between the companies triggered in August 2021 by the dosing of the first patient in the Phase 3 COASTAL study.
Triggered an additional $10,000,000 milestone payment from Kyowa Kirin Co. pursuant to the 2020 global license, development and commercialization agreement between the companies for the dosing in September 2021 of the first patient in Japan in the Phase 3 COASTAL study. The milestone payment was received in October 2021, and was recorded as a receivable in the company’s financial statements as of September 30, 2021.
Expected Drug Candidate Pipeline Developments

Zandelisib – Oral PI3K delta inhibitor for the treatment of various B-cell malignancies

Report data from the Phase 2 TIDAL study by the end of calendar year 2021 from the follicular lymphoma cohort of the study. Data from the follicular lymphoma cohort of the Phase 2 TIDAL study data are intended, subject to discussions with the U.S. Food and Drug Administration, to be submitted in support of an initial accelerated approval marketing application.
Initiate a Phase 2 study evaluating zandelisib plus venetoclax and rituximab in patients with chronic lymphocytic leukemia in the first half of calendar year 2022.
Provide an update from the arm of a Phase 1b study evaluating zandelisib plus zanubrutinib, including in expansion cohorts enrolling patients with relapsed or refractory mantle cell and follicular lymphomas in mid calendar year 2022.
Voruciclib – Oral CDK9 inhibitor for the treatment of B-cell malignancies and acute myeloid leukemia

Program update at the 63rd Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, reporting safety and pharmacokinetic data from the monotherapy portion of the Phase 1 program evaluating voruciclib in patients with acute myeloid leukemia and B-cell malignancies.
ME-344 – Tumor selective mitochondrial inhibitor

Initiate a Phase 2 study of ME-344 in relapsed colorectal cancer in the mid calendar year 2022.
Pracinostat – Oral HDAC Inhibitor

MEI and Helsinn have mutually agreed to terminate the Helsinn License Agreement. MEI does not intend to develop pracinostat further for any use and does not anticipate any future material financial obligations regarding the compound.
First Quarter Fiscal Year 2022 Financial Results

As of September 30, 2021, MEI had $145.5 million in cash, cash equivalents, and short-term investments with no outstanding debt.
For the quarter ended September 30, 2021, cash used in operations was $7.7 million, compared to $9.1 million for 2020. The decrease in cash used reflects the receipt of a $10.0 million milestone payment from Kyowa Kirin Co., partially offset by increased costs associated with our clinical development programs.
Research and development expenses were $20.0 million for the quarter ended September 30, 2021, compared to $13.0 million for 2020. The increase was primarily related to increased development costs associated with zandelisib, including increased activity in the TIDAL study and start-up costs related to the Phase 3 COASTAL study, as well as increased personnel costs to support clinical trial activities.
General and administrative expenses were $7.9 million for the quarter ended September 30, 2021, compared to $5.9 million for 2020. The increase primarily relates to personnel costs and general corporate expenses to support our activities, including preparation for commercial launch of zandelisib.
MEI recognized revenues of $13.4 million for the quarter ended September 30, 2021, compared to $3.8 million for 2020. The increase in revenue primarily related to the license agreement with Kyowa Kirin and reflects the recognition of fees allocated to research and development obligations.
Net loss was $11.9 million, or $0.11 per share, for the quarter ended September 30, 2021, compared to net loss of $2.1 million, or $0.02 per share for 2020. The Company had 112,678,498 shares of common stock outstanding as of September 30, 2021, compared with 112,522,001 shares as of September 30, 2020.
The adjusted net loss for the quarter ended September 30, 2021, excluding non-cash expenses related to changes in the fair value of the warrants (a non-GAAP measure), was $14.5 million, compared to an adjusted net loss of $15.3 million for 2020.

On November 10, 2021 Epigenomics AG (FSE: ECX, OTCQX: EPGNY, the "Company") reported financial results (IFRS, unaudited) for the first nine months of 2021 (Press release, Epigenomics, NOV 10, 2021, View Source [SID1234594995]).

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9M 2021 FINANCIAL RESULTS

Total revenue in the first nine months of 2021 increased to EUR 6,022 thousand (9M 2020: EUR 541 thousand), due to the sale of samples from the Company’s "biobank" in the amount of EUR 5,675 thousand. Product revenue decreased from EUR 453 thousand to EUR 330 thousand in the reporting period compared to the same period of the previous year due to the Covid-19 pandemic.
Research and development costs decreased from EUR 3,412 thousand to EUR 2,226 thousand in the nine-month period due to a reduction in clinical study costs related to Covid-19; however, patient enrollment for the Epi pro Colon post-approval study has recently begun to increase closer to pre Covid 19 levels.
Selling and administrative expenses increased slightly from EUR 5,442 thousand to EUR 5,809 thousand primarily due to the costs associated with the sale of the Biobank samples.
EBITDA (before share-based payment costs) improved significantly to EUR -209 thousand in the reporting period compared to EUR -8,090 thousand in the same period of the previous year. This is also primarily due to the biobank samples sale.
The net loss for the period also decreased significantly to EUR -691 thousand (9M 2020: EUR -9,109 thousand); accordingly, the loss per share decreased from EUR 1.59 to EUR 0.07 compared to the same period of the previous year.
Cash consumption decreased to EUR 3,598 thousand in the first nine months of 2021 (9M 2020: EUR 7,492 thousand).
As of 30 September 2021, the Company had cash and cash equivalents (including marketable securities) of EUR 23,555 thousand (31 December 2020: EUR 3,566 thousand).
OPERATIONAL DEVELOPMENTS

Epigenomics initiated clinical trial plans for Epi proColon "Next-Gen", an updated version of the assay that meets CMS reimbursement criteria based upon performance from prospectively collected banked clinical samples. The Company plans to begin enrollment in the summer of 2022.
In addition, Epigenomics executed a EUR 5.7 million sale of samples from the Company’s extensive biobank. The Company has retained the necessary samples to complete development activities for Epi proColon "Next-Gen".
In September the company successfully completed the placement of a subordinated non-interest-bearing mandatory convertible bond that raised EUR 16.5 million in gross proceeds.
OUTLOOK 2021

Revenue

As a result of the sale of the biobank to New Horizon Health Limited, the revenue and earnings guidance for the full year 2021 was adjusted on August 17, 2021: The Company expects revenues of EUR 6.0 million for the financial year 2021 (previously: EUR 0.4 million to EUR 1.0 million).
EBITDA / cash consumption

For EBITDA before share-based payment costs, Epigenomics forecasts a range of EUR -3.0 million to EUR -4.0 million (previously: EUR -7.0 million to EUR -9.0 million) for the full year 2021. Based on the Company’s 2021 business plan, cash consumption is expected to range between EUR 3.5 million to EUR 4.5 million (previously: EUR 7.0 million to EUR 9.0 million).
Further information

The financial report for the first nine months of 2021 is available on the Epigenomics’ website at: View Source." target="_blank" title="View Source." rel="nofollow">View Source

Conference call for analysts and investors

Epigenomics AG will host a conference call for analysts and investors today at 4.00 pm (CET) / 10.00 am (EDT). The webcast can be accessed at the following link: View Source

The dial-in numbers for the conference call are (for registered participants):

Dial-in number Germany: +49 30 232531508
Dial-in number UK: +44 1635 598058
Dial-in number U.S.A.: +1 516-269-8975

Participants are asked to dial in 10 minutes prior to the start of the conference call and to register using the link above.

An audio replay of the conference call will be provided on the Company’s website following the call.

On November 10, 2021 Perrigo Company plc (NYSE: PRGO; TASE) ("Perrigo" or the "Company"), a leading provider of Consumer Self-Care Products, reported financial results for the third quarter of fiscal year 2021 ended October 2, 2021 (Press release, Perrigo Company, NOV 10, 2021, View Source [SID1234595046]). All comparisons are against the prior year fiscal third quarter, unless otherwise noted.

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President and CEO, Murray S. Kessler commented, "Major initiatives were completed in the third quarter that will secure Perrigo a bright future. The RX generic prescription business divestiture was completed, the acquisition of the highly successful HRA Pharma business was announced, and a major overhang on the business was removed through a favorable settlement of the Irish tax dispute paid for with proceeds from the successful arbitration in Belgium. Perrigo is now a solely focused consumer self-care company, poised for strong growth, unencumbered by the major overhangs of the past. Our team is intently focused on driving long-term profitable growth."

Kessler continued, "Our disappointing third quarter results reflect the continuing impacts of the challenging operating environment caused by the global COVID-19 pandemic that began in 2020, have continued in 2021 and are not indicative of our future growth potential. These challenges fall into three categories for Perrigo: a historically weak cough/cold season affecting first quarter sales and manufacturing efficiencies, higher input costs and the sudden supply chain disruption, primarily in the form of a shortage of truck drivers, which began in the third quarter. In combination, these factors are forecasted to negatively impact total year adjusted diluted EPS by $0.79, which could only be partially offset, leading us to lower our earnings guidance."

Kessler also noted, "Importantly, third quarter consumer off-take was very strong, as were factory orders on almost all of our businesses. This included a strong rebound in cough/cold sales. Unfortunately, we exited the quarter with record unshipped orders as there were not enough trucks or drivers to fulfill those orders in the U.S. Supply chain disruptions impacted CSCA net sales growth in the quarter by 5.7 percentage points."

Kessler concluded: "Our cough/cold business is rebounding, which will positively impact sales and manufacturing efficiencies. We have taken multiple steps to adjust our supply chain during this unusual period, which has already resulted in a significant improvement in October. And, we are taking action to mitigate higher input costs, including price increases on approximately 75% of the Company’s portfolio and delivering on project momentum cost savings. Through the combination of these actions, along with the anticipated closing and successful integration of HRA expected in the first half of next year, we still believe we will deliver on our original 2023 EPS transformation plan targets."

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 2021 Financial Highlights from Continuing Operations

Perrigo third quarter net sales were $1.04 billion, an increase of 4.0%. Organic(1) net sales growth was 2.6%, despite an increase in unfulfilled orders of 4.3 percentage points as a result of supply chain disruptions.

CSCA third quarter net sales of $694 million increased 4.6%, with organic growth of 4.2%; CSCI third quarter net sales of $349 million increased 2.8%, with organic net sales down by 0.6%.

Reported diluted loss per share was $0.40, compared to reported diluted earnings per share ("EPS") of $0.19 in the prior year quarter.

Adjusted diluted EPS, which excludes certain charges as outlined in Table I, decreased 25.0% to $0.45 per diluted share. Adjusted diluted EPS was negatively impacted by approximately $0.22 per diluted share from lower operating efficiencies, higher materials and freight costs, and two product recalls, as compared to the prior year quarter. The increase in unfulfilled orders depressed adjusted EPS by $0.08 per diluted share.
Year-to-Date 2021 Financial Highlights from Continuing Operations(2)

Perrigo year-to-date net sales were $3.03 billion, or flat, compared to the prior year period, including a negative impact of 3.4 percentage points from lower cough/cold-related net sales due to the historically weak 2020/2021 cough/cold season. Unfulfilled orders due to supply chain disruptions depressed growth by 1.4 percentage points.

CSCA year-to-date net sales of $1.96 billion were 1.8% lower compared to the prior year period; organic net sales were down 3.2%, including a negative 3.2 percentage points impact from lower cough/cold-related net sales. Unfulfilled orders due to supply chain disruptions depressed growth by 1.9 percentage points.

CSCI year-to-date net sales of $1.08 billion grew 3.3% compared to the prior year period; organic net sales were down 2.2%, including a negative 3.9 percentage points impact from lower cough/cold-related net sales. Unfulfilled orders due to supply chain disruptions depressed growth by 0.5 percentage points.

Reported diluted loss per share year-to-date was $1.22 per diluted share as compared to EPS of $0.70 in the prior year period.

Adjusted diluted EPS year-to-date decreased 22.5% to $1.45 per diluted share as compared to $1.87 per diluted share in the prior year period. Adjusted diluted EPS was negatively impacted by lower cough/cold-related net sales, lower operating efficiencies and higher materials and freight expenses.

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

In addition to other non-GAAP adjustments as described in the attached appendix, adjusted profit measures, including adjusted EPS and adjusted operating income, exclude from both periods certain costs, which are reported in GAAP continuing operations but were previously allocated to the RX business. On a go-forward basis, such costs are either covered by the transition services agreement or have been eliminated following closing. We do not believe such operational costs are representative of the future expenses of our continuing operations. See attached appendix for additional details.

Third Quarter 2021 Perrigo Results from Continuing Operations

Perrigo net sales for the third quarter were $1.04 billion, an increase of $40 million, or 4.0%. Favorable currency movements and acquisitions contributed 0.9 and 0.5 percentage points, respectively. Organic net sales growth was 2.6%, despite an increase in unfulfilled orders as a result of supply chain disruptions, including a lack of truck drivers in the U.S. and record backups at global shipping ports, which held back growth by 4.3 percentage points.

Net sales in the quarter were driven by 1) strong growth in e-commerce, primarily in CSCA, 2) contract manufacturing sales to the now-divested RX business, 3) increased pricing, 4) a rebound in cough/cold in the U.S., 5) the November 2020 acquisition of Eastern European dermatology brands in CSCI, and 6) $9 million in net favorable currency movements. These increases were partially offset by 1) discontinued products of $11 million, 2) lost distribution within the Healthy Lifestyle category in CSCA, 3) lower net sales in the CSCI contract manufacturing business, and 4) $4 million from a product recall.

Third quarter reported operating income was $438 million in 2021 compared to $79 million in 2020. Adjusted operating income was $112 million in 2021 and $141 million in 2020, a decrease of $29 million, or 20.6%. This decrease was driven by 1) $29 million from lower operating efficiencies resulting from the weak 2020/2021 cough/cold season, and higher materials and freight expenses, and 2) $9 million of costs from two product recalls. These results were partially offset by lower operating expenses, including project momentum cost savings.

Reported net loss was $54 million, or $0.40 per diluted share, compared to net income of $26 million, or $0.19 per diluted share in the prior year period. Excluding certain charges as outlined in Table I, third quarter 2021 adjusted net income was $61 million, or $0.45 per diluted share, compared to $83 million, or $0.60 per diluted share, last year due to the factors described above.

Third Quarter 2021 Business Segment Results from Continuing Operations

Consumer Self-Care Americas Segment

CSCA third quarter net sales of $694 million grew 4.6%, including a 0.4 percentage point positive impact from favorable currency movements. Organic net sales increased 4.2%, despite an increase in unfulfilled orders slowing growth by 5.7 percentage points as a result of supply chain disruptions, including a lack of truck drivers in the U.S. and record backups at global shipping ports.

OTC net sales were driven by 1) strong growth in e-commerce, 2) contract manufacturing sales to the now divested RX business, 3) higher incidences of cough/cold illness as society returns to in-person activities, benefiting the Cough/Cold and Pain categories, 4) a double-digit percentage increase in the branded OTC business, and 5) increased pricing stemming from management actions taken earlier in the year. These gains were partially offset by 1) lost distribution within the Healthy Lifestyle category, 2) $10 million in discontinued products, primarily from the discontinuation of diabetes care products in the Healthy Lifestyle category, and 3) lower net sales in the Allergy category due primarily to the recall of third-party manufactured product.

Net sales in the Oral Self-Care category declined mid-single digits due primarily to delayed receipt of ex-U.S. manufactured product, leading to record unfulfilled customer orders.

Net sales in the Nutrition category grew mid-single digits driven by new product launches within infant formula as well as strong growth in the oral electrolytes business.

Reported operating income was $90 million in 2021 compared to $122 million in 2020. Adjusted operating income decreased $28 million to $106 million driven by 1) lower operating efficiencies due primarily to the weak 2020/2021 cough/cold season and higher materials and freight expenses, and 2) a product recall during the quarter. These factors were partially offset by lower operating expenses, including project momentum cost savings.

Consumer Self-Care International Segment

CSCI net sales of $349 million increased $10 million, or 2.8%, including a 1.9 percentage point positive impact from favorable currency movements and a 1.5 percentage point positive impact from acquisitions. Organic net sales decreased 0.6%. Unfulfilled orders increased 1.5 percentage points as a result of supply chain disruptions, due primarily to record backups at global shipping ports.

Net sales in the quarter were driven by 1) the November 2020 acquisition of three Eastern European OTC Dermatology Brands, 2) higher net sales in the U.K. store brand business, 3) greater demand for NiQuitin smoking cessation products in the Healthy Lifestyle category, 4) increased pricing, and 5) $6 million in favorable currency movements. These drivers were more than offset by 1) lower than normal buy-in for cough/cold products by pharmacies, 2) a decline in net sales in the contract manufacturing category, 3) lower demand for weight loss products across Europe, which led to lower net sales for XLS Medical within the Healthy Lifestyle category, and 4) a product recall that negatively impacted the Vitamins, Minerals & Supplements (VMS) category.

Reported operating income was $4 million in 2021 compared to $10 million in 2020. Adjusted operating income decreased $6 million to $46 million due to a $6 million negative impact related to the VMS product recall and less favorable product mix, which were partially offset by lower operating expenses.

Settlement of the Irish Revenue Notice of Amended Assessment ("NoA")

The Company announced on September 29, 2021 that it had reached a settlement with the Irish Office of the Revenue Commissioners for the Notice of Amended Assessment ("NoA") dated November 29, 2018. As part of the settlement terms, Perrigo made a total cash payment to Irish Revenue of €266.1 million in the fourth quarter of 2021. This payment has resolved the entire €1.6 billion NoA against the Company.

Receipt in Cash of €355 million from the Belgian Arbitration Decision

Perrigo announced on September 29, 2021 that it received the entire €355 million in cash on behalf of Alychlo NV and Holdco I BE NV ("Sellers") in payment of the previously announced arbitration award issued in favor of Perrigo Ireland 2 ("Perrigo Ireland"). The award was issued August 27, 2021, by a tribunal sitting under the rules of the Belgian Centre for Arbitration and Mediation and related to claims arising under the Stock Purchase Agreement between Sellers and Perrigo Ireland dated November 6, 2014. Under Belgian law, Sellers have the right to challenge the tribunal’s award for up to three months following the date of the award. However, Perrigo does not believe that Sellers have any legal grounds for any such challenge.

Fiscal 2021 Outlook from Continuing Operations

The Company is updating its fiscal 2021 outlook to reflect third quarter results and management expectations for the remainder of the year. The Company now expects calendar year 2021 adjusted diluted EPS of between $2.00 to $2.10.

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.

On November 10, 2021 Portage Biotech Inc. (NASDAQ: PRTG) ("Portage" or the "Company"), a clinical-stage immuno-oncology company developing therapies to improve patient lives and increase survival by avoiding and overcoming cancer treatment resistance, reported that it will host a key opinion leader (KOL) webinar on the role iNKT cells play in anticancer immune response and how iNKT targeting can be leveraged to expand the immunooncology landscape, Thursday, November 18, 2021, at 10a.m. Eastern Time (Press release, Portage Biotech, NOV 10, 2021, View Source [SID1234595061]).

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The webinar will feature presentations by Mitchell Kronenberg, Ph.D., from the La Jolla Institute for Immunology, and Anastasios Karadimitris MBBS, Ph.D. MRCP FRCPath, from Imperial College London. Dr. Kroenberg will provide an overview on invariant natural killer T cell (iNKT) cells and their mechanism of action to enable multiple parts of the immune system to attack and kill cancer.

Dr. Karadimitris will discuss the current iNKT clinical data landscape. Portage Biotech’s Chief Executive Officer and Director Ian B. Walters, M.D., MBA, will then discuss the company’s novel clinical development strategy and timing of data from its ongoing clinical trials. Portage is applying its iNKT agonists, PORT-2 and PORT-3 to convert PD-L1 negative tumors to PD-L1 positive, overcome PD-1 antibody resistance, and enable checkpoint inhibitors to be used in immunologically cold tumors. A live Q&A session will follow the formal presentations. To register for the event, please click here.

Mitchell Kronenberg received a B.A. from Columbia University, a Ph.D. in Biochemistry from the California Institute of Technology (Caltech) and served on the faculty of the UCLA School of Medicine from 1986-1997. He joined the La Jolla Institute for Immunology (LJI) in 1997 and was the President at LJI from 2003-2021. He currently serves as the LJI Chief Scientific Officer. Dr. Kronenberg and his team study T cells – white blood cells responsible for recognizing and responding to microbes and cancers. His laboratory focuses on a subset of T cells, that recognize glycolipids, or combinations of sugar and fat. Their research seeks to investigate how these T cells, called natural killer T cells (NKT), survive, grow, and regulate other immune cell types. He has co-authored more than 370 publications, and is a fellow of the American Association for the Advancement of Science (AAAS), a Distinguished Fellow of the American Association of Immunologists, a recipient of an NIH MERIT award, and an Institute for Scientific Information (ISI) Highly Cited Scientist. He is an advisor to a number of organizations including serving as a member of the Board of Scientific Counselors for Basic Science at the National Cancer Institute. Anastasios Karadimitris received his degree in from at Aristotelion University, Thessaloniki, Greece. He undertook his postgraduate clinical training in the UK, first in general medicine and subsequently in haematology including in bone marrow transplantation at Hammersmith Hospital, London. He undertook his research training with Professor Lucio Luzzatto at Memorial Sloan Kettering Cancer Centre New York, USA, Professor Irene Roberts at Hammermsith Hospital, London and the late Professor Vincenzo Cerundolo at the Weatherall Institute for Molecular Medicine, Oxford. Professor Karadimitris is currently the Langmuir Chair in Haematology and Director of the Hugh and Josseline Langmuir Centre for Myeloma Research, and the Co-Director of the Centre for Haematology, Faculty of Medicine Imperial College London. He is also an honorary consultant haematologist at the Department of Haematology, Hammersmith Hospital, Imperial College Healthcare NHS Trust.

About iNKT Agonists PORT-2 and PORT-3
PORT-2 and PORT-3 contain small molecule agonists (IMM60) of invariant natural killer T-cells (iNKT cells) developed by the University of Oxford, which play an important role in anti-tumor immune responses. iNKT cells are a distinct class of T lymphocytes and recognize lipid antigens on the surface of the tumor. Our synthetic iNKT agonists are designed to optimally engage the Tcell receptor on the iNKT and facilitate its binding to dendritic cells, resulting in the secretion of a large amount of pro-inflammatory cytokines. This leads to the activation and expansion of important immune system components and primes and boosts an adaptive immune attack against cancer. We see that monotherapy treatment with iNKT agonists shows a heightened immune response and better cancer control in animal models that are resistant to PD-1 antibody treatment. Combination therapy with PD-1 antibodies is synergistic with iNKT agonists and restores sensitivity to PD-1 blockade. While treatment with iNKT agonists alone shows promising preclinical activity against cancer, data suggests that when an iNKT agonist is co-packaged with tumor-specific antigens, potency is increased by up to 5x. PORT-2 is a liposomal formulation of our IMM60 iNKT agonist while PORT-3 is a co-formulation of our IMM60 iNKT agonist with an NY-ESO-1 peptide vaccine, co-packaged into a nanoparticle