Acepodia Appoints Thorsten Graef, M.D., Ph.D., as Chief Medical Officer and Michael Brock as Chief Strategy Officer

On May 11, 2021 Acepodia, a biotechnology company developing next generation solid tumor and hematologic cancer cell therapies, reported the appointments of Thorsten Graef, M.D., Ph.D., as chief medical officer and Michael Brock as chief strategy officer (Press release, Acepodia, MAY 11, 2021, View Source [SID1234579658]). These key executive hires add to Acepodia’s growing management team, which comprises a deep bench of leading industry experts. Both Dr. Graef and Mr. Brock will be based at the company’s headquarters in San Mateo, California.

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"These experienced and accomplished industry executives add to the strategic expansion of our world class leadership team and will play pivotal roles in the company’s development as we continue to pioneer next generation natural killer cell therapies," said Sonny Hsiao, Ph.D., co-founder and chief executive officer of Acepodia. "Dr. Graef’s strong expertise in clinical drug development and knowledge of global regulatory environments will be invaluable as we advance our pipeline of novel antibody cell conjugation investigational therapies, and Mr. Brock’s decades of experience guiding public and private biopharmaceutical companies, financially and operationally, will be an asset to the company as we develop, focus, and execute on overall strategy."

"As Acepodia progresses toward corporate and clinical development milestones this year, we are committed to building a strong infrastructure of top people and key capabilities on which we will continue to grow the business," said Patrick Yang, Ph.D., co-founder and executive chairman of Acepodia.

Thorsten Graef, Chief Medical Officer

Dr. Graef brings to Acepodia more than a decade of experience as a global drug development leader across top-tier public life sciences companies building and overseeing broad clinical development organizations, global multidisciplinary groups and cross-functional teams. Most recently, Dr. Graef served as vice president of Oncology Early Development at AbbVie, Inc., overseeing clinical activities, including the development and regulatory preparations of 20+ clinical assets. In addition, he held a series of senior leadership roles at Pharmacyclics LLC prior to AbbVie, Inc.’s acquisition of the company in May of 2015, and also served as medical director of Merck Research Lab, Oncology at Merck & Co., Inc. Prior to his time in the life sciences industry, Dr. Graef was an attending physician in the hematology, oncology and immunology department at the University Hospital of Düsseldorf in Germany. He received his M.D. in internal medicine and his Ph.D. in molecular medicines from Heinrich-Heine University Medical School in Düsseldorf and completed his postdoctoral research fellowship at the Stanford University School of Medicine. Dr. Graef has published more than 50 original peer-reviewed publications, including in top journals such as NEJM, Lancet, Blood, PNAS and Journal of Experimental Medicine.

Michael Brock, Chief Strategy Officer

Mr. Brock brings to Acepodia more than 20 years of strategic healthcare investment banking experience and leadership, including expertise in industry capital raising, M&A, business development, and strategic analysis. For the past decade, Mr. Brock was a managing director in Wells Fargo Securities’ Healthcare Investment Banking group, where he was responsible for the coverage of public and private biopharmaceutical companies. Prior to that, he was a director in Bank of America Merrill Lynch’s Healthcare Investment Banking group, and he held a series of roles of increasing responsibility and leadership within the department, which followed his time as an associate in Healthcare Investment Banking at SG Cowen Securities Corporation. Mr. Brock received his Bachelors of Science degree from Clemson University and his Masters of Business Administration degree from the Mason School of Business at the College of William & Mary.

Acepodia previously announced the appointment of Jimmy Lai as chief financial officer. Anita Kawatra recently joined the company as an advisor on corporate affairs.

These four individuals join the company’s strong and experienced management team, including Mark Gilbert, M.D., executive vice president of Research & Development, Joe McCracken, D.V.M., senior vice president of Business Development, Bill Mackin, Ph.D., vice president of Regulatory Affairs and Michael Kurman, M.D., vice president of Clinical Operations.

BriaCell to Participate at Upcoming Conferences and Appoints Senior R&D Director

On May 11, 2021 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX-V:BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer, reported that Dr. William V. Williams, President & CEO of BriaCell, is scheduled to participate in the following virtual conferences (Press release, BriaCell Therapeutics, MAY 11, 2021, View Source [SID1234579657]):

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• Benzinga Global Small Cap Investor Conference: May 13-14, 2021
o Dr. Williams will deliver his corporate presentation at 12:20pm ET on May 13, 2021.
o Dr. Williams will also participate in a panel discussion titled "Investing Post COVID – Back to the Fundamentals" at 11:50am ET on May 13, 2021. The panel will discuss healthcare investing in the post COVID world.
o Investors may request one-on-one meetings with Dr. Williams.
o Investors may register for the conference here: View Source

• Q2 Investor Summit: May 17-18, 2021
o Dr. Williams will deliver his corporate presentation at 2:00pm ET on May 17, 2021.
o Investors may request one-on-one meetings with Dr. Williams.
o Investors may register for the conference here: View Source

• 2021 LD Micro Invitational Investor Conference: June 8-10, 2021
o Dr. Williams will deliver his corporate presentation at 12:00pm ET on June 9, 2021.
o Investors may request one-on-one meetings with Dr. Williams.
o Investors may register for the conference here: View Source

• MarketsandMarkets 4th Annual Next Gen Immuno-Oncology Virtual Congress-US Edition: June 28-30, 2021
o Dr. Williams will be speaking at the scientific conference at 11:30am ET on June 29, 2021.
o The topic is "Personalized, off-the-shelf cellular immunotherapy for cancer".
o A copy of the presentation will be posted here: View Source
o For additional information on the conference and the speaker, please visit:
View Source

Separately, BriaCell has recently appointed Miguel A. Lopez-Lago, Ph.D. as Senior Director, Research and Development. Since 2000, Dr. Lopez-Lago has been working as a cancer scientist at Memorial Sloan-Kettering Cancer Center, New York (MSKCC). Specifically, he has investigated various aspects of tumor biology, including the development of targeted therapies for Mesothelioma and the characterization of the biological mechanisms underlying cancer metastasis. More recently, Dr. Lopez-Lago has been interested in the study of the tumor immune-microenvironment and in the development of immunotherapies for thoracic cancers using chimeric antigen receptor (CAR) T cell technologies. Since 2013, Dr. Lopez-Lago has been working as Senior Research Scientist at MSKCC. Dr. Lopez-Lago received his Bachelor of Science in Bio-Sciences and his doctorate in Molecular Biology from Santiago of Compostela University, Spain.

Quanterix Appoints Masoud Toloue as President of Quanterix and Diagnostics

On May 11, 2021 Quanterix Corporation (NASDAQ: QTRX), a company helping to transform healthcare with digital protein biomarker technology enabling precision health, reported it has named Masoud Toloue to the position of President of Quanterix and Diagnostics, effective June 9, 2021 (Press release, Quanterix, MAY 11, 2021, View Source [SID1234579656]).

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"We are excited to welcome Masoud to our team at such an important moment for Quanterix," said Kevin Hrusovsky, Chairman and Chief Executive Officer Quanterix. "We are making important strides in advancing our diagnostic capability and assays, given the NIH RADx funding, our COVID-19 Emergency Use Authorizations and advances in our neurology suite of assays for Multiple Sclerosis, Alzheimer’s and Parkinson’s research as well as phase III drug trials. Masoud’s strong growth track record of doubling PerkinElmer’s diagnostics franchise, wealth of experience, deep roots in the life sciences and business acumen will be instrumental as we continue implementing our value creation strategy of entering phase III drug trials with leading protein biomarkers, such as Neurofilament Light (Nf-L), Phosphorylated Tau, Amyloid Beta 40 / 42, GFAP and others, that we believe will ultimately have productive diagnostic and health screen utility in the fields of infectious disease, neurology and immunology."

Toloue brings a wealth of industry experience and high growth track record to Quanterix. He joins Quanterix from PerkinElmer, where he most recently served as senior vice president, diagnostics. He previously led that company’s applied genomics business. Prior to this role, he founded and led Bioo Scientific’s next generation sequencing business which was acquired by PerkinElmer in 2016. He also co-founded and led Genohub, where he transformed that company from a supplier of next generation sequencing matching technology to a leading platform provider for manging sequencing projects globally. He holds a doctoral degree in molecular cell biology from the University at Buffalo and was a postdoctoral fellow in biochemistry at The University of Texas Health Science Center at San Antonio.

In his new role, Toloue will oversee Quanterix’ growing diagnostics (Dx) business and assume responsibility for the Company’s Accelerator Lab Services, strategic partnerships and corporate development.

"Quanterix is empowering a truly innovative approach to highly-sensitive diagnostics that has incredible potential to change the way healthcare in administered," said Toloue. "I am eager to roll up my sleeves and join this exceptional leadership team to support the company’s continued diagnostics expansion."

Alexion Shareholders Approve Acquisition by AstraZeneca

On May 11, 2021 Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) reported that its shareholders have voted to adopt and approve the previously announced agreement to be acquired by AstraZeneca at a special meeting of shareholders held today (Press release, Alexion, MAY 11, 2021, View Source [SID1234579655]).

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Ludwig Hantson, Ph.D., Chief Executive Officer, Alexion, said: "We’re very pleased with today’s affirmative shareholder vote, which brings us one step closer to completing a transaction that will accelerate the combined company’s ability to develop and provide access to life-changing medicines for patients with rare and devastating diseases around the world."

Subject to receipt of additional regulatory clearances, the acquisition is expected to close in the third quarter of 2021.

Perrigo Reports First Quarter 2021 Financial Results From Continuing Operations

On May 11, 2021 Perrigo Company plc (NYSE; TASE: PRGO), a leading global provider of Consumer Self-Care Products, reported financial results from continuing operations for the first quarter of fiscal year 2021 ended April 3, 2021 (Press release, Perrigo Company, MAY 11, 2021, View Source [SID1234579640]). The Consumer Self-Care Americas ("CSCA") segment, the Consumer Self-Care International ("CSCI") segment and Corporate are included in results from continuing operations. Financial results from the generic Rx pharmaceuticals business are reported as discontinued operations. All comparisons are against the prior-year fiscal first quarter, unless otherwise noted.

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President and CEO, Murray S. Kessler commented, "Two years ago, we began our journey to transform Perrigo from a healthcare to a consumer self-care company and with the actions taken this quarter, that transformation is now nearly complete. On March 1, 2021, we announced the divestment of our generic Rx business, our tenth transaction over the last two years, essentially completing our portfolio reconfiguration. We have made the necessary investments in infrastructure, capabilities, talent and capacity, and as a result have restored Perrigo to growth, all while weathering the storm of a horrific global pandemic. From where I sit, Perrigo is re-born."

Kessler further noted, "The reported declines in the first quarter were distorted by consumer pantry loading in the year ago quarter and by a historically weak cough/cold season this year, both of which were the result of COVID-19. Our business remains strong, even during this volatile environment, as evidenced by Perrigo’s first quarter 2021 two-year reported and organic compound annual growth rates, compared to the pre-COVID first quarter of 2019. Additionally, Perrigo’s first quarter performance results were in line with our expectations. Looking ahead to the rest of the year, we are encouraged to see the recent increases in retail store foot traffic, more people traveling again, and children returning to school in the fall. Further, according to leading sources, the 2021-2022 cough/cold season is expected to be more normal. That, in combination with Perrigo’s durable business fundamentals, strong pipeline of new product launches, productivity improvements in progress and e-commerce leadership, provides us confidence in our ability to deliver a strong second half and is why we are reaffirming our ‘3/5/7’ growth guidance for 2021."

Kessler concluded, "Perrigo is now a pure-play consumer self-care company that is on-trend and growing. When the Rx deal closes, we will have approximately $2 billion in cash to support the growth of the business and strengthen our balance sheet. We believe this represents a significant value creation opportunity, as Perrigo’s forward price-to-earnings multiple continues to trade at a significant discount to our CPG peers with similar growth profiles. I am more excited than ever about the future of Perrigo and am grateful to all of our teams around the world who have helped to transform Perrigo."

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.

Given the difficulty in comparing first quarter 2021 net sales results to the first quarter of 2020 due to the pandemic-related pantry load and subsequent destock in the second quarter of 2020, two-year compound annual growth rates (CAGRs) are provided below, offering further insight into underlying growth trends.

First Quarter 2021 Financial Highlights From Continuing Operations

Perrigo first quarter net sales were $1.01 billion, a decrease of 6.8%, due primarily to the pandemic-related pantry load benefit in the prior year quarter and the negative impact from the very low incidence of cough/cold related illness this year. On a two-year CAGR basis, net sales grew 4.1%, including a negative 4.5 percentage points impact from cough/cold, while organic(1) growth declined 0.4%, including a negative 4.1 percentage points impact from the weak cough/cold season.
CSCA first quarter net sales of $641 million were 8.6% lower compared to the prior year quarter, with organic growth down 11.8%; CSCI first quarter net sales of $370 million were 3.4% lower versus the prior year quarter, with organic growth down 9.1%.
Reported diluted earnings per share ("EPS") for the first quarter of 2021 was $0.02 per diluted share as compared to EPS of $0.42 in the prior year quarter.
Adjusted diluted EPS, which excludes certain costs required to operate the RX business until the sale closes(2), for the first quarter of 2021 decreased 25.4% to $0.50 per diluted share as compared to $0.67 per diluted share in the prior year quarter. The prior year quarter benefited from an estimated $0.16 per diluted share from the pandemic-related pantry load, while the current year quarter was negatively impacted by an estimated $0.14 per diluted share from the weak cough/cold season.
(1) See attached Appendix for details. Organic net sales growth excludes the effects of acquisitions and divestitures and the impact of currency.

(2) 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 will either be covered by the transition services agreement or eliminated following closing. Accordingly, as described below under "Non-GAAP Adjustments", we do not believe such operational costs are representative of the future expenses of our continuing operations. See the attached Appendix for additional details.

First Quarter 2021 Perrigo Results From Continuing Operations

Perrigo net sales for the first quarter were $1.01 billion, a decrease of $73 million or 6.8%, including positive impacts of 3.0 percentage points and 2.3 percentage points from acquisitions and favorable currency movements, respectively, offset by a negative impact of 1.2 percentage points from divestitures. Organic net sales declined 10.9%, including the estimated pandemic-related pantry load benefit in the prior year quarter of 6.8 percentage points and the estimated negative impact from the very low incidence of cough/cold related illness this year of 6.4 percentage points.

On a two-year CAGR basis, net sales grew 4.1%, including a negative 4.5 percentage points impact from the very low incidence of cough/cold related illness this year. Organic net sales declined 0.4%, including a negative 4.1 percentage points impact from the weak cough/cold season.

Net sales in the quarter were driven by 1) $32 million from the acquisitions of Dr. Fresh and Eastern European dermatology brands, 2) organic growth of $25 million, excluding the estimated impacts from the pandemic-related pantry load benefit in the prior year and the very low incidence of cough/cold related illness this year, and 3) $25 million in net favorable currency movements. These gains were more than offset by 1) the estimated impact from the pandemic-related pantry load benefit in the prior year of $73 million, 2) the estimated impact from the very low incidence of cough/cold related illness this year of $68 million, and 3) $14 million from divested businesses.

First quarter reported operating income was $51 million in 2021 and $86 million in 2020. Adjusted operating income was $118 million in 2021 and $151 million in 2020, a decrease of $33 million or 21.6%. Results were impacted by lower net sales volumes leading to lower gross profit, divestitures, and higher operating expenses including R&D investments. These factors were partially offset by lower advertising and promotion expenditures, acquisitions and positive pricing.

Reported net income was $3 million, or $0.02 per diluted share, versus net income of $58 million, or $0.42 per diluted share in the prior year period. Excluding certain charges as outlined in Table I, first quarter 2021 adjusted net income was $67 million, or $0.50 per diluted share, versus $92 million, or $0.67 per diluted share, for the same period last year. Adjusted EPS was lower as positive impacts from growth in certain base business categories, lower advertising and promotion expenditures, acquisitions and savings from Project Momentum were more than offset by the estimated pandemic-related pantry load benefit in the prior year quarter of $0.16 per diluted share, the estimated negative impact from the very low incidence of cough/cold related illness this year of $0.14 per diluted share, and divested businesses of $0.03 per diluted share.

First Quarter 2021 Business Segment Results From Continuing Operations

Consumer Self-Care Americas Segment

CSCA first quarter net sales of $641 million were 8.6%, or $60 million, lower than the prior year, including a positive 3.4 percentage points impact from the Dr. Fresh acquisition. Organic net sales decreased 11.8%, including the estimated pandemic-related pantry load benefit in the prior year quarter of 7.1 percentage points and the estimated negative impact from the very low incidence of cough/cold related illness this year of 5.0 percentage points.

On a two-year CAGR basis, net sales grew 4.9%, including a negative 3.6 percentage points impact due to the very low incidence of cough/cold related illness this year. Organic net sales grew 0.8%, including a negative 3.3 percentage points impact from the weak cough/cold season.

OTC net sales in the quarter were driven by 1) strong e-commerce growth as consumers continued shifting purchases to online where Perrigo has greater market share than in-store, which more than offset lower in-store purchases as measured by IRI MULO, 2) double-digit percentage growth in the branded OTC product portfolio led by Prevacid and ScarAway, and 3) higher net sales in the Digestive Health category, due primarily to favorable consumer conversion to Perrigo OTC products and incremental new product sales from Esomeprazole Mini, and in the Skin & Personal Hygiene category, due primarily to higher demand in the minoxidil franchise. More than offsetting these drivers were the pandemic-related pantry load benefit in the prior year quarter and the very low incidence of cough/cold related illness this year, which impacted the Upper Respiratory and Pain & Sleep Aids categories.

Perrigo omnichannel POS (point of sale) declined 18.7% for the 13-weeks ending March 21, 2021, compared to an estimated decline in total store brand OTC omnichannel POS data of 19.8%, leading to a Perrigo share gain from store brand competitors of 27 basis points. Perrigo’s share of total OTC on an omnichannel basis was stable in categories that declined an estimated 19.1% in the categories in which Perrigo competes.

Net sales in the Oral Self-Care category were driven by the Dr. Fresh acquisition, strong growth in e-commerce net sales, which doubled compared to the prior year quarter, and new products. These drivers were partially offset by soft demand for travel-related oral care products related to COVID-19 and lower customer inventory compared to the prior year due to timing of orders.

In the Nutrition category, net sales growth in e-commerce and contract manufacturing were more than offset by the pandemic-related pantry load benefit in the prior year quarter and an increase in governmental benefits that led to a decline in store brand market share.

Reported operating income for CSCA was $96 million. Adjusted operating income decreased $26 million to $111 million due primarily to 1) gross profit flow-through on lower net sales, 2) higher input costs on certain products and unfavorable plant overhead absorption due primarily to lower production volumes compared to the prior year pandemic-related pantry load benefit, and 3) higher operating expenses, including R&D investments. These factors were partially offset by favorable product mix.

Consumer Self-Care International Segment

CSCI net sales of $370 million decreased $13 million, or 3.4%, including a positive 6.8 percentage points impact from favorable currency movements, a positive 2.3 percentage points impact from acquisitions and a negative 3.5 percentage points impact from divestitures. Organic net sales were 9.1% lower, including the estimated 9.0 percentage points negative impact from the very low incidence of cough/cold related illness this year and the estimated pandemic-related pantry load benefit in the prior year quarter of 6.2 percentage points.

On a two-year CAGR basis, CSCI net sales grew 2.6%, including a negative 6.1 percentage points impact due to the very low incidence of cough/cold related illness this year. Organic net sales declined 2.9%, including a negative 5.5 percentage points impact from the weak cough/cold season.

Net sales in the quarter were driven by 1) new products, including line extensions in the ACO dermatology product line and in the Davitamon and Granufink VMS (Vitamins, Minerals and Supplements) product lines, 2) positive pricing, 3) the acquisition of three Eastern European OTC Dermatology Brands, 4) higher net sales in the Pain & Sleep Aids category, and 5) $26 million in favorable currency movements. These drivers were more than offset by 1) the very low incidence of cough/cold related illness this year, which impacted the Upper Respiratory category, 2) comparison to the pandemic-related pantry load benefit in the prior year quarter, 3) lower demand for anti-parasite products within the Skincare & Personal Hygiene category due primarily to COVID-19 related school closings and limited travel, and 4) divested businesses of $14 million.

Reported operating income was $17 million. Adjusted operating income decreased $4 million to $60 million due primarily to gross profit flow-through on lower net sales and the impact from divested businesses. These factors were partially offset by lower advertising and promotion spend, greater operational efficiencies and favorable currency movements.

U.S. Licensing Agreement with Burt’s Bees

Perrigo announced today the existence of a licensing agreement with Burt’s Bees to offer a comprehensive, innovative line of organic baby formulas and nature-based remedies for kids under the Burt’s Bees brand. This partnership combines Perrigo’s R&D, regulatory, and sales and marketing capabilities with Burt’s Bees leading trusted and distinctive brand and deep understanding of the efficacy of nature-based ingredients to care for baby and mom, to create innovative organic and nature-based remedies.

Fiscal 2021 Outlook From Continuing Operations

The Company reaffirmed its fiscal 2021 outlook and expects to deliver 3% organic net sales growth, 5% adjusted operating income growth and 7% adjusted diluted EPS growth, translating into 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.