Entry into a Material Definitive Agreement.

On August 11, 2021, ImmunoGen, Inc. (the "Company") reported that entered into a Securities Purchase Agreement (the "Securities Purchase Agreement") with RA Capital Healthcare Fund, L.P. (the "Investor"), pursuant to which the Company agreed to sell to the Investor a pre-funded warrant (the "Pre-Funded Warrant") to purchase up to an aggregate of 5,434,782 shares of the Company’s common stock, par value $0.01 per share ("Common Stock"), for aggregate consideration of $29,945,648.82, or $5.51 per share of Common Stock underlying the Pre-Funded Warrant, which, together with the per share exercise price, is equal to $5.52, the closing price of our Common Stock as reported on the Nasdaq Global Select Market on August 4, 2021, the date the Company and the Investor first discussed a potential investment (Filing, 8-K, ImmunoGen, AUG 11, 2021, View Source [SID1234586420]).

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The issuance and sale of the Pre-Funded Warrant under the Securities Purchase Agreement (and the shares of Common Stock issuable upon exercise of the Pre-Funded Warrant) are registered pursuant to the Company’s shelf registration statement on Form S-3 (File No. 333-251502).

The Securities Purchase Agreement contains certain representations, warranties, and covenants for the benefit of the parties to the Securities Purchase Agreement and should not be relied upon by any of our investors who are not parties to Securities Purchase Agreement, nor should any such investor rely upon any descriptions thereof as characterizations of the actual state of facts or condition. Such investors are not third-party beneficiaries under the Securities Purchase Agreement.

Pre-Funded Warrant

Pursuant to the Securities Purchase Agreement, the Company will issue the Pre-Funded Warrant to the Investor. The Pre-Funded Warrant entitles the Investor to purchase shares of Common Stock at an exercise price equal to $0.01 per share. The Pre-Funded Warrant will be exercisable at any time beginning on the date of issuance. The number of shares of the Company’s Common Stock issuable upon exercise of the Pre-Funded Warrant is subject to adjustment upon certain corporate events, including certain stock dividends and splits, combinations, reclassifications, and certain other events.

The Investor may exercise the Pre-Funded Warrant by delivering an exercise notice, completed and duly signed, and payment in cash of the exercise price for the number of shares of the Company’s Common Stock for which the Pre-Funded Warrant is being exercised. The Investor may also satisfy its obligation to pay the exercise price through a "cashless exercise," in which the Investor receives the net value of the Pre-Funded Warrant in shares of Common Stock determined according to the formula set forth in the Pre-Funded Warrant.

The Investor will not be entitled to exercise any portion of the Pre-Funded Warrant that, upon giving effect to such exercise, would cause the aggregate number of shares of Common Stock beneficially owned by the Investor (together with its affiliates and any other persons whose beneficial ownership of Common Stock would be aggregated with the Investor for purposes of Section 13(d) of the Securities Exchange Act of 1934, as amended) to exceed 9.99% of the total number of then issued and outstanding shares of Common Stock, as such percentage ownership is determined in accordance with the terms of the Pre-Funded Warrant. This threshold is subject to the Investor’s rights under the Pre-Funded Warrant to increase or decrease such percentage to any other percentage not in excess of 19.99% upon at least 61 days’ prior notice from the Investor to the Company.

Immunetune Strengthens Team by Appointing Sijme Zeilemaker as Chief Executive Officer

On August 11, 2021 Immunetune, a preclinical-stage biotech developing next-generation DNA vaccines against cancer and infectious diseases, reported the appointment of Sijme Zeilemaker as Chief Executive Officer (Press release, ImmuneTune, AUG 11, 2021, View Source [SID1234586282]). With his experience in several oncology biotech companies ranging from preclinical to Phase II clinical development and skillset in business development and investor relations, he will be responsible for bringing Immunetune into the next phase of the company.

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"It is great to be joining a biotech working on truly differentiated technologies to bring a potentially best-in-class program into the clinic. Having seen the forefront of innovation in immuno-oncology the last few years, Immunetune has the right approach and results to make a difference. Gerben and his team have done an impressive amount of work and it is such an exciting phase to be joining them," stated Sijme Zeilemaker.

"We are thrilled bringing Sijme on board to strengthen our team at this pivotal point in time. With his experience with both big pharma partners and international life science investors, he knows exactly what data and technologies they will be looking for," says Gerben Zondag, founder of Immunetune, who will take on the role of Chief Operating Officer. "With the rest of the management team in place, we are confident to move our company and programs forward into the clinic."

Sijme Zeilemaker is joining Immunetune having previously acted as Chief Operating Officer, Director Business Development and Head of Investor Relations at Immunicum AB, a clinical-stage biotech developing cell therapies against cancer, publicly listed at the Nasdaq Stockholm. He joined Immunicum in 2017 as part of a small team and supported the growth of the company through a collaboration with Pfizer and Merck KGaA, three financing rounds, and the merger with DCprime. Before Immunicum, Sijme was Director Business Development at InteRNA Technologies, and held business development roles at to-BBB technologies and 2-BBB Medicines, transitioning these companies from preclinical to clinical-stage.

VolitionRx Limited Announces Second Quarter 2021 Financial Results and Business Update

On August 11, 2021 VolitionRx Limited (NYSE AMERICAN: VNRX) ("Volition") reported financial results and a business update for the second quarter ended June 30, 2021 (Press release, VolitionRX, AUG 11, 2021, View Source [SID1234586330]). Volition management will host a conference call tomorrow, August 12 at 8:00 a.m. U.S. Eastern Time to discuss these results. Conference call details may be found below.

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"We have made significant progress on many fronts during the first half of 2021, in particular on all four of the Company’s key pillars: Nu.Q, Nu.Q Vet, Nu.Q NETs and Nu.Q Capture," commented Cameron Reynolds, President and Chief Executive Officer of Volition. "We have also significantly strengthened our balance sheet, our intellectual property portfolio, and our executive team to drive our commercial focus."

View Source

An interview with Cameron Reynolds, President and Chief Executive Officer of Volition, Terig Hughes, Chief Financial Officer of Volition, and Dr. Tom Butera, Chief Executive Officer of Volition Veterinary Diagnostics Development LLC

Mr. Reynolds continued, "I am delighted that the Nu.Q Vet beta launch has not only been very successful in providing invaluable real-world learnings for our first veterinary product but has also generated a high level of interest in both the licensing and distribution of our veterinary products, and we are actively negotiating potential arrangements on multiple fronts."

Company Highlights

Financial

Cash and cash equivalents as of June 30, 2021, totalled approximately $27.9 million compared with $19.4 million as of December 31, 2020.
Net loss for the second quarter of 2021 was $5.6 million and net cash used in operating activities was $5.4 million for the quarter.
Grant income earned in the second quarter of 2021 was approximately $0.4 million.
Volition received approximately $0.9 million of net proceeds through its at-the-market equity distribution program during the second quarter of 2021.
Continued to manage expenditures carefully with a cash burn rate of approximately $2 million per month.
Personnel

On May 1, Dr. Tom Butera, a seasoned veterinary executive with an extensive commercial track record, and former Non-Executive Director of Volition, joined the team full time as Chief Executive Officer of Volition’s veterinary subsidiary to drive its product launches.
Intellectual Property

27 patent families (plus three in-licensed families) covering both human and animal use of Volition’s Nucleosomics platform.
71 granted patents (ten in the U.S., 14 in Europe and 47 rest of world).
89 patents pending.
Continued focus on filings during the second quarter of 2021 and expect portfolio to grow in the quarters and years ahead.
Publications

Volition’s list of publications and abstracts continues to grow.
Year to date data for Nu.Q has been presented at three international conferences and Volition has collaborated on four clinical papers, three of which have already been published with the other pending publication.
These publications are another very important step forward for the Company.
Nu.Q Vet Cancer Screening Test Beta Launch

Volition has received strong indications of interest in the whole Nu.Q Vet platform, from a range of smaller and very large companies, and it is progressing potential licensing negotiations with several well-known major players in the veterinary space around the world.
The Company aims to have a very meaningful deal signed before the end of 2021.
Clinical – NETosis including COVID-19

Volition believes that the versatility of the Nu.Q platform and the range of applications for which these assays can be leveraged may help increase diagnostic power and monitor disease progression and potentially treatment response across a broad range of diseases that involve the over production of NETs, such as COVID-19, pneumonia, influenza and sepsis.
Volition previously reported preliminary results demonstrating that its Nu.Q NETs assay correlated well with current COVID-19 disease severity.  
Recently published posters (at the International Society on Thrombosis and Haemostasis Congress) showed that results on admission using the same Nu.Q NETs assay could predict future COVID-19 disease severity and that serial results correlate with disease progression including 28-day mortality.
From a sepsis product development perspective, to date Volition has completed animal studies in the monitoring of disease progress and treatment efficacy which have demonstrated the effective use of Nu.Q NETs.
The Company has additional large studies in progress related to COVID-19, sepsis and other diseases, some due for completion soon, with the publication of further data expected in the coming months.
Clinical – Cancer

Volition has also been in active and continuing negotiations in Asia this year on its first human cancer launch in China.
The Company has completed preliminary analysis of the lung cancer study conducted with the National Taiwan University and looks forward to reviewing the data with Professor Chen and his team ahead of publication either through clinical paper or conference abstract. Collection has also been completed for the colorectal cancer study also conducted with the National Taiwan University. Volition anticipates the data will be analysed this year, with findings to be presented at a conference in 2022.
After a 15 month pause, EDRN (a large-scale U.S. colorectal cancer study) re-initiated enrolment in June and aims to be enrolling at full capacity in September 2021. The study collection completion date has been extended to the fourth quarter of 2022.
With regards to Volition’s two U.S. blood cancer studies, the timing of expected completion for each has been impacted by the COVID-19 pandemic due to sample collection and protocol issues.
– For the 1,500 subject NHL diagnostic study, all preliminary protocol development and study preparation has been completed. The Company aims to begin collection in late 2021, protocols and pandemic permitting, and to submit the first data to the FDA in late 2022.
– COVID-19 restrictions have also made sequential therapy-matched specimen collections exceptionally difficult in the DLBCL Treatment Monitoring Study. The Company aims to issue interim analysis results later this year.
Volition has installed a Service Lab in Silver One, which will undertake sample processing for external parties such as pharmaceutical companies, biotech companies and academic researchers. This service, branded as Nu.Q Discover, has already generated interest and the Company has provided quotes to multiple pharma and biotech companies. Volition anticipates that it will generate revenue from this activity in 2021 with continued growth in the future.
Upcoming Milestones

Volition expects to achieve the following milestones during 2021 and beyond, pandemic permitting:

Drive revenue in the coming quarters in the following key areas:
– Licensing of its technology, with a particular but not exclusive focus on Nu.Q Vet, with the aim of signing the first deal this year,
– Processing samples at Silver One using its Nu.Q Discovery assays, and
– Disease monitoring tests (e.g. COVID-19, Sepsis).
Continue to progress the research program for the use of Nu.Q in NETosis, in monitoring disease progression of COVID-19, sepsis and potentially other diseases and as a possible companion diagnostic for a treatment for sepsis.
Continue to advance its previously announced large-scale blood, lung and colorectal cancer trials in Europe, Asia and the U.S.
Publish several abstracts and peer-reviewed scientific papers with clinical results showing the robustness and utility of its Nu.Q platform.
Advance the development of Nu.Q Capture.
Continue to file patents to expand and extend its intellectual property portfolio.
VolitionRx Limited Second Quarter 2021 Financial Results and Business Update

Cameron Reynolds, President and Chief Executive Officer of Volition, will host the call along with Terig Hughes, Chief Financial Officer of Volition, Dr. Tom Butera, Chief Executive Officer of Volition Veterinary Diagnostics Development LLC, and Scott Powell, Executive Vice President, Investor Relations of Volition.

A live audio webcast of the conference call will also be available on the investor relations page of Volition’s corporate website at View Source

In addition, a telephone replay of the call will be available until August 26, 2021. The replay dial-in numbers are 1-844-512-2921 (toll-free) in the U.S. and Canada and 1-412-317-6671 (toll) internationally. Please use replay pin number 13722250.

IMV Inc. Announces Second Quarter 2021 Financial and Operational Results

On August 11, 2021 IMV Inc. (the "Company" or "IMV") (TSX: IMV; NASDAQ: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of immunotherapies, reported its financial and operational results and provided an update for the second quarter ended June 30, 2021 (Press release, IMV, AUG 11, 2021, View Source [SID1234586346]).

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"IMV is undergoing a critical transformation and focusing on delivering tangible clinical and scientific data to support further development and commercialization of our unique programs and DPX platform technology," said Andrew Hall, interim Chief Executive Officer of IMV. "The recent results obtained with the translational analyses in ovarian cancer further validate our lead compound and DPX technology. We are also very excited by the overall expansion of our clinical pipeline across a range of tumor antigens and indications. Our recent financing has strengthened our balance sheet and provided us with the runway to deliver additional confirmatory data to investors and the scientific community."

"Based on clinical results and a continued deeper understanding of the mechanism of action of our distinctive delivery platform we believe we are in an exceptional position to deliver sustainable shareholder value supported by an enhanced financial position and our ability to attract quality talent at every level of the organization," concluded Mr. Hall.

Corporate Updates

Appointment of Andrew Hall as Interim Chief Executive Officer (CEO)

On August 4, 2021, the Corporation announced that Frederic Ors stepped down as Chief Executive Officer and that the IMV Board appointed Andrew Hall, formerly of Celgene, the Company’s Chief Business Officer, as Interim CEO. The Company’s Board is commencing a comprehensive search process to identify a permanent CEO.

Appointment of a Chief Scientific Officer (CSO)

Jeremy R. Graff, Ph.D., formerly of Lilly, was recently appointed Chief Scientific Officer of IMV and brings over 20 years of experience in preclinical and clinical research and translational analysis for novel immune-activating therapeutics in oncology.

Development of IMV’s Clinical Advisory Committee

Stanley Frankel, M.D, an industry veteran, was appointed clinical advisor to support development of MVP-S in diffuse large B-cell lymphoma (DLBCL) and the initiation of the Company’s next clinical trial in advanced ovarian cancer.

Dr. Frankel brings a wealth of experience and knowledge in hematology, cell therapy and immuno-oncology accumulated at Bristol-Myers Squibb (BMS) where he was Senior Vice President, Cellular Therapy Development, and responsible for late development portfolio of cellular therapy assets including Breyanzi (lisocabtagene maraleucel) and Abecma (idecabtagene vicleucel). Prior to this experience, Dr. Frankel was Corporate Vice President, Head, Immuno-Oncology & Cellular Therapy, Clinical Research and Development Head, Cell Therapy Clinical Center of Excellence at Celgene and served on joint steering and/or joint development committees for alliances with JW Therapeutics, Jounce Therapeutics, AstraZeneca/MedImmune, Juno Therapeutics, and BeiGene.

Jose Iglesias, M.D., another renowned expert in the Immuno-Oncology space, was recently appointed as Clinical Advisor. Dr. Iglesias brings decades of expertise in clinical development strategy, clinical trial design, biomarker-guided pharmacodynamics, proof of principle and proof of concept studies, drug approval strategies, studies to support commercialization, academic research collaborations and liaisons with worldwide centers of excellence and oncology cooperative groups. Dr. Iglesias served as Chief Medical Officer at Senti Biosciences, Biothera Pharmaceuticals, Bionomics Ltd., Abraxis Bioscience Inc. and as Vice President, Clinical Development at Celgene.

Operational Expansion in the USA

IMV has now established a U.S. subsidiary and an office in Cambridge, Massachusetts, a world-leading biotech research hub with a large geographical concentration of biotech and pharmaceutical companies, world-renowned universities, research centers, and a highly skilled talent pool.

This new corporate office will serve as a springboard to accelerate future business development and other initiatives.

Clinical Programs with Maveropepimut-S (MVP-S, Formerly Named DPX-Survivac)

Phase 2B Study in Relapsed/Refractory DLBCL ("r/r DLBCL")

In the previous Phase 2 clinical study (SPiReL), MVP-S in combination with Merck’s KEYTRUDA and intermittent low dose cyclophosphamide (CPA) showed promising data with 50% Overall Response Rate (ORR) and 78.6% Disease Control Rate (DCR) in evaluable patients. Also, PD-L1 expression has been identified as a potential predictive biomarker of response, as PD-L1+ patients demonstrated 85.7% ORR and 85.7% DCR. Most commonly reported events are Grade 1 and 2 injection site reactions, 20.8% subjects reported Grade 3 or above adverse events.

The Company announced in April that it entered into an agreement with Merck (NYSE: MRK) to initiate a Phase 2B clinical trial to evaluate its lead compound, MVP-S, in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in a Phase 2B study r/r DLBCL.

The trial was initiated in June 2021, and the first sites have since been activated. PD-L1 will be assessed for every potential patient considered for enrollment.

Phase 2 DeCidE1 Study in Advanced, Recurrent Ovarian Cancer

IMV has recently completed the DeCidE1 clinical trial evaluating MVP-S in association with CPA in patients with advanced recurrent ovarian cancer. The final patient completed the study after more than 2 years of clinical benefit with MVP-S. In this study, many subjects have been through several lines of prior treatment and 57.9% patients were platinum resistant. Overall, the treatment was well tolerated with most adverse events being injection site reactions. At the 2-year cut-off, the overall survival rate in this cohort was 44.9% with a median overall survival of 19.9 months, results that support further clinical evaluation of this treatment.

Translational analyses from this trial confirm generation of tumor-antigen directed T cells by MVP-S. The details of these translational analyses have been submitted for presentation at upcoming scientific meetings. These data will also inform the discussion and design of a Phase 2B clinical study to be submitted to the FDA.

Recent Financing Strengthens IMV’s Financial Position

All dollar amounts noted herein are denominated in United States dollars (unless otherwise noted herein).

Public Offering

On July 20, 2021, IMV announced the closing of a public offering of 14,285,714 units at a price to the public of $1.75 per Unit, for aggregate gross proceeds to the Corporation of approximately $25 million (Estimated net proceeds are $23 million). Each unit is comprised of one common share and three-quarters of one common share purchase warrant. Each Warrant entitles the holder thereof to purchase one common share at a price of $2.10 per common share, subject to adjustment in certain events, for five years until July 20, 2026. If the warrants are fully exercised, they can represent approximately $22.5M of additional gross proceeds.

Overview of Second Quarter 2021 Financial Results

On June 30, 2021, the Company had cash and cash equivalents of $22.8 million and working capital of $24.6 million, compared with $36.3 million and $35.6 million, respectively at December 31, 2020. Subsequent to June 30, 2021, the Company completed the above-mentioned public offering of 14,285,714 units at $1.75 per unit for gross process of $25 million (estimated net proceeds of $23 million) resulting in pro-forma cash and cash equivalents of $45.8 million as of June 30, 2021. Based on its current plan, IMV expects its current cash position will be sufficient to fund operations for more than 12 months.

Research and development expenses were $5.2 million for the three months ended June 30, 2021, compared with $3.8 million for the three months ended June 30, 2020. This increase of $1.4 million was mainly due to startup costs for the Phase 2B trial in DLBCL, the timing of manufacturing activities for MVP-S and DPX-SurMAGE, and an increase in headcount. These increases were partly offset by a decrease in costs for the pre-clinical development of DPX-COVID-19 and costs for the ongoing basket trial of MVP-S in several cancer indications.

General and administrative expenses were $3.4 million for the three months ended June 30, 2021, compared with $2.2 million for the three months ended June 30, 2020. This increase of $1.2 million was mainly attributable an increase in the Company’s Directors and Officers insurance premium as a result of rate increases in mid-2020, an increase in headcount and an increase in recruiting fees for new executives and board members.

Government assistance totaled $1.2 million for the three months ended June 30, 2021, compared with $1 million in Q2 2020. This increase in mainly driven by the revaluation of the Nova Scotia loan upon receipt of the 2-year deferral of repayments partly offset by a decrease in various government grants for the development of DPX-COVID-19, consistent with the decrease in development expenses described above.

The net loss and comprehensive loss of $7.4 million ($0.11 per share) for the three months ended June 30, 2021, was $2.6 million higher than the net loss and comprehensive loss of $4.8 million ($0.08 per share) for the three months ended June 30, 2020.

For the six-month period ended June 30, 2021, the net loss and comprehensive loss of $14.3 million ($0.21 per share) was $2.3 million higher than the net loss and comprehensive loss of $12.0 million ($0.24 per share) for the six-month period ended June 30, 2020. The higher net loss is primarily the result of a $1.1 million increase in R&D expenses and a $2 million increase in general and administrative expenses partly compensated by a $1 million increase in government assistance mainly towards COVID-19 vaccine development as well as the revaluation of the loan with the province of Nova Scotia upon receipt of the above-mentioned amendment.

As of August 10, 2021, the number of issued and outstanding common shares was 82,142,629 and a total of 15,705,452 stock options, warrants and deferred share units were outstanding.

The Corporation’s audited annual consolidated results of operations, financial condition and cash flows for the year ended December 31, 2020 and the related management’s discussion and analysis (MD&A) are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar as well as the Company’s website at View Source

Selected Upcoming Milestones

Maveropepimut-S (MVP-S):

Q3 2021: Initiation of investigator-led study in breast cancer
H2 2021: Design of Phase 2 clinical study in ovarian cancer for FDA meeting
Q4 2021: Clinical update for the basket trial (Bladder & MSI-hi tumor cancers)
H1 2022: Clinical update for the breast trial
DPX-SurMAGE:

H2 2021: Initiation of a Phase 1 clinical study in bladder cancer
Conference Call and Webcast Information

Management will host a conference call and webcast today August 11, 2021, at 8:00 a.m. ET. Financial analysts are invited to join the conference call by dialing (866) 211-3204 (U.S. and Canada) or (647) 689-6600 (international) using the conference ID# 2877244

Other interested parties will be able to access the live audio webcast at this link: View Source The webcast will be recorded and will then be available on the IMV website for 30 days following the call.

Perrigo Reports Second Quarter 2021 Financial Results From Continuing Operations

On August 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 second quarter of fiscal year 2021 ended July 3, 2021 (Press release, Perrigo Company, AUG 11, 2021, View Source [SID1234586283]). 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 second quarter, unless otherwise noted.

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President and CEO, Murray S. Kessler commented, "Self-care has never been more important and with our portfolio reconfiguration completed and the investments made in technology, capabilities, talent and manufacturing capacity, as a pure-play consumer company Perrigo is in a great position to capitalize on this trend."

Kessler continued, "I am proud of how the Perrigo team continues to adjust during these challenging times, which have significantly impacted sales mix, channel dynamics and input costs. As a result, Perrigo net sales increased on most of our businesses, with the exception of OTC in the U.S., which was negatively impacted by year-over-year customer inventory reductions and a historically weak cough/cold season. Most importantly, consumer take away rebounded sharply in Q2 on all businesses including cough/cold, according to IRI MULO, which bodes well for the second half. The decline in earnings this quarter was the result of these factors, the reinstatement of brand building support to pre-COVID-19 levels and higher input costs."

Kessler further noted, "We are reaffirming our fiscal 2021 net sales guidance based on the strong rebound in consumer take away. Current consumer trends, along with an expected increase in cough/cold illnesses and the benefit of new products, are expected to result in higher volumes and accelerating growth, which will be compared to a weak year ago second half. However, we now expect adjusted EPS towards the lower end of our guidance range as productivity improvements and Project Momentum cost savings are only expected to partially offset higher input costs, which we now see continuing into early next year. For the first time in a number of years, price increases will also play a role in mitigating inflationary headwinds."

Kessler concluded, "Unless markets begin to shut down again due to a surge in COVID-19, we believe most of the volatility created by the pandemic is behind us. Perrigo is moving forward in a strong position with significant resources to drive returns for shareholders through base business growth, disciplined M&A and reducing uncertainty."

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.

Second Quarter 2021 Financial Highlights From Continuing Operations

Perrigo second quarter net sales were $981 million, an increase of 3.4%, due primarily to growth in most businesses and favorable currency movements, partially offset by year-over-year customer inventory reductions and a historically weak cough/cold season. Organic(1) net sales growth was 0.5%, including a negative 2.3 percentage point impact from lower cough/cold-related net sales.
CSCI second quarter net sales of $359 million were 11.7% higher versus the prior year quarter, with strong organic growth of 4.3%; CSCA second quarter net sales of $622 million were 0.9% lower compared to the prior year quarter, with organic sales down 1.4%.
Reported diluted loss per share ("EPS") for the second quarter of 2021 was $0.84 per diluted share, due primarily to $1.17 per diluted share in impairment charges related to the announced sale of the Latin American business, as compared to EPS of $0.09 per diluted share in the prior year quarter.
Adjusted diluted EPS, which among other adjustments, excludes certain costs required to operate the RX business(2) prior to the sale closing on July 6, 2021, for the second quarter of 2021 decreased 15.3% to $0.50 per diluted share as compared to $0.59 per diluted share in the prior year quarter due primarily to reinstatement of brand and marketing investments.
First Half 2021 Financial Highlights From Continuing Operations

Perrigo first half net sales were $2.0 billion, a decrease of 2.0%, which included a benefit from the pandemic-related pantry load benefit in the prior year period and a negative 4.4 percentage point impact from lower cough/cold-related net sales this year due to the historically weak cough/cold season.
On a two-year CAGR basis, Perrigo net sales grew 4.0%, while organic growth declined 0.1%, including a negative 2.5 percentage point impact from lower cough/cold-related net sales in the first half of 2021.
CSCA first half net sales of $1.3 billion were down 4.9% compared to the prior year period, with organic sales down 6.9%, of which 3.9 percentage points came from the negative impact of lower cough/cold-related net sales; CSCI first half net sales of $728 million were 3.5% higher versus the prior year period, with organic growth down 3.0%, of which 5.5 percentage points came from the negative impact of lower cough/cold-related net sales.
On a two-year CAGR basis, CSCA first half net sales grew 4.2%, while organic growth was flat, as lower cough/cold-related net sales had a negative 2.5 percentage point impact. On a two-year CAGR basis, CSCI first half net sales grew 3.6%, while organic growth declined 0.4%, as lower cough/cold-related net sales also had a negative 2.5 percentage point impact.
Reported diluted loss per share ("EPS") for the first half of 2021 was $0.82 per diluted share as compared to EPS of $0.51 in the prior year period, due primarily to $1.17 per diluted share in impairment charges related to the announced sale of the Latin American business.
Adjusted diluted EPS for the first half of 2021 decreased 20.6% to $1.00 per diluted share as compared to $1.26 per diluted share in the prior year period. The current period was negatively impacted by an estimated $0.18 per diluted share from lower cough/cold-related net sales while the prior year period benefited from the pandemic-related pantry load.

(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 now divested 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.

Second Quarter 2021 Perrigo Results From Continuing Operations

Perrigo net sales for the second quarter were $981 million, an increase of $32 million or 3.4%, including positive impacts of 0.8 percentage points and 3.7 percentage points from acquisitions and favorable currency movements, respectively, partially offset by a negative impact of 1.5 percentage points from divestitures. Organic net sales increased 0.5%, including a negative 2.3 percentage points impact from lower cough/cold-related net sales.

Net sales in the quarter were driven by 1) organic growth of $4 million, which included $21 million from lower cough/cold-related net sales due to the historically weak cough/cold season, 2) $7 million from the acquisition of Eastern European dermatology brands, and 3) $35 million in net favorable currency movements. These gains were partially offset by 1) the lowering of inventories at U.S. retail customers, impacting CSCA’s OTC business, and 2) a reduction of $14 million from divested businesses.

Second quarter reported operating loss was $126 million in 2021 compared to reported operating income of $63 million in 2020. Adjusted operating income was $118 million in 2021 and $132 million in 2020, a decrease of $14 million or 10.7%. This decrease was due primarily to 1) higher operating expenses due primarily to the reinstatement of brand and marketing investments to pre-COVID-19 levels, 2) lower volumes and unfavorable plant overhead absorption in CSCA’s OTC business due to lower cough/cold-related net sales and the lowering of inventories at U.S. retail customers, 3) higher input costs, including freight and commodities, and 4) divestitures. These factors were partially offset by 1) improved base business performance, outside of cough/cold, 2) lower corporate expenses due partially to Project Momentum savings, and 3) procurement actions and price increases initiated during the quarter.

Reported net loss was $112 million, or $0.84 per diluted share, compared to net income of $12 million, or $0.09 per diluted share in the prior year period. Excluding certain charges as outlined in Table I, second quarter 2021 adjusted net income was $68 million, or $0.50 per diluted share, compared to $82 million, or $0.59 per diluted share, last year due to the factors described above and a negative $0.04 per diluted share impact from a higher tax rate.

Second Quarter 2021 Business Segment Results From Continuing Operations

Consumer Self-Care Americas Segment

CSCA second quarter net sales of $622 million were 0.9%, or $5 million, lower than the prior year period, including a 0.6 percentage point benefit from favorable currency movements. Organic net sales decreased 1.4%, including a negative 2.7 percentage point impact from lower cough/cold-related net sales.

OTC net sales in the quarter were driven by 1) total OTC market growth, led by a rebound in in-store foot traffic, 2) new product sales, including the store brand version of diclofenac, which more than offset purposeful discontinued product sales, and 3) growth in the Skin & Personal Hygiene category, due primarily to higher demand for the minoxidil franchise. More than offsetting these drivers were 1) lower cough/cold-related net sales due to the historically weak cough/cold season, which impacted the Upper Respiratory and Pain and Sleep Aids categories, and 2) the lowering of inventories at U.S. retail customers.

High-teens percentage net sales growth in the Oral Self-Care category was driven by a rebound in in-store consumer demand for both the Company’s branded and store brand products compared to the prior year period, which was impacted by the pandemic.

In the Nutrition category, low double-digit percentage net sales growth was driven by new products, greater consumer demand for oral electrolyte solutions and the success of third-party infant formula contract manufacturing partners. These factors were partially offset by the pandemic-related pantry load benefit in the prior year quarter.

Reported operating loss for CSCA was $72 million, due primarily to $159 million in impairment charges related to the announced sale of the Latin American business. Adjusted operating income decreased $17 million to $107 million due primarily to 1) lower volumes in OTC leading to unfavorable plant overhead absorption, 2) higher operating expenses, including brand and marketing investments and distribution costs, and 3) higher input and freight costs. These factors were partially offset by procurement actions and price increases initiated during the quarter.

Consumer Self-Care International Segment

CSCI net sales of $359 million increased $38 million, or 11.7%, including a positive impact of 9.9 percentage points from favorable currency movements, a positive 2.3 percentage point impact from acquisitions and a negative 4.8 percentage point impact from divestitures. Organic net sales grew 4.3%, including a negative 1.3 percentage point impact from lower cough/cold-related net sales.

Net sales in the quarter were driven by 1) incremental new product sales from brands, including XLS Medical Forte 5 sticks in the Healthy Lifestyle category, the introduction of the Probify probiotics brand in the Vitamins, Minerals & Supplements (VMS) category and the launch of Plackers into new markets in the Oral Self-Care category, 2) the acquisition of three Eastern European OTC Dermatology Brands, 3) higher net sales in the U.K. store brand business, and 4) $32 million in favorable currency movements. These drivers were partially offset by 1) lower cough/cold-related net sales due to the historically weak cough/cold season, which impacted the Upper Respiratory category, 2) lower demand for anti-parasite products within the Skincare & Personal Hygiene category due primarily to a slow start to the mosquito summer season, and 3) divested businesses of $14 million.

Reported operating income was $1 million. Adjusted operating income decreased $3 million to $47 million as procurement actions, favorable currency movements and positive pricing were more than offset by the reinstatement of brand and marketing investments to pre-COVID-19 levels and divested businesses.

Completed Divestiture of Generic Prescription Pharmaceuticals Business (Rx)

On July 6, 2021, Perrigo announced that it completed the sale of its RX Pharmaceuticals business to Altaris Capital Partners, LLC for $1.55 billion, establishing Perrigo as a leading pure-play global consumer self-care company.

Irish Revenue Notice of Amended Assessment ("NoA")

On July 9, 2021, Irish Revenue issued a letter acknowledging that not all relevant facts were known to them when they issued the NoA in 2018 and that, accordingly, they would not object if the Appeal Commissioner were to make certain adjustments reducing Irish Revenue’s original assessment. Such adjustments would reflect contingent royalty payments that were never received by Elan Pharma, deductions for acquisition and development costs incurred, and allowable losses and reliefs, and would, if allowed, result in an aggregate reduction of more than €660.0 million from the income taxes claimed in the NoA as issued. The reduced claim is not a settlement proposal or compromise by Irish Revenue, but rather a confirmation that Irish Revenue would not object to certain adjustments to the underlying assessment given facts now known to Irish Revenue that were not known to Irish Revenue when they issued the NoA in 2018. Accordingly, Perrigo believes that the maximum amount of income tax claims in dispute is now reduced to less than €1.0 billion, not including any interest or penalties, if applicable. There can be no assurances that any settlement is possible on terms acceptable to the Company. Unless and until a final settlement is reached, the Company will vigorously pursue its tax appeal concurrently with any settlement discussions that may occur.

Fiscal 2021 Outlook From Continuing Operations

The Company reaffirmed its fiscal 2021 organic net sales growth outlook of 3% and now expects adjusted diluted EPS towards the lower end of its 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.