Photocure to Present at Two Upcoming Investor Conferences in June

On May 27, 2021 Photocure ASA (OSE: PHO), The Bladder Cancer Company, reported that President and Chief Executive Officer, Daniel Schneider and Chief Financial Officer, Erik Dahl are scheduled to present corporate overviews at two upcoming institutional investor conferences in June (Press release, PhotoCure, MAY 27, 2021, View Source [SID1234583248]).

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Details for the two presentations are as follows:

The MicroCap Rodeo 2021 Summer Solstice – Best Ideas from the Buyside: June 1-4, 2021. Photocure will present on Tuesday June 1 at 3:00pm CET / 9:00am ET. Management will be available for virtual 1-1 meetings with investors attending the virtual conference.
Access to the live event/webcast is available by clicking here: www.webcaster4.com/Webcast/Page/2134/41489

The MicroCap Rodeo’s third edition is a virtual conference this year focused on investors in the United States. It brings together the top 35 "best ideas from the buy side". Qualified institutional investors recommended each of the 35 companies represented as one of their "best ideas". For more information: microcaprodeo.com.

Handelsbanken Nordic Mid/Small Cap Seminar 2021: June 2-3, 2021. Photocure will present on Wednesday, June 2 at 4:15pm CET / 10:15am ET. Management will be available for virtual 1-1 meetings with investors.
Handelsbanken Capital Markets’ 12th consecutive Nordic Mid/Small Cap Seminar is a two-day intensive event featuring senior leadership speakers from an array of Nordic Mid/Small Cap companies. All presentations will be digital and presenting companies will host meetings with institutional investors signed up for the conference.

Novavax to Participate in Jefferies Virtual Healthcare Conference

On May 27, 2021 Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, reported that it will participate in a fireside chat and host meetings with investors at the upcoming Jefferies Virtual Healthcare Conference. Novavax’ COVID-19 vaccine candidate, NVX-CoV2373, will be a topic of discussion (Press release, Novavax, MAY 27, 2021, View Source [SID1234580708]).

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Fireside chat details:

Date:

Tuesday, June 1, 2021

Time:

1:30 – 1:55 p.m. Eastern Time (ET)

Novavax participants:

Gregory M. Glenn, M.D., President, Research and Development and John Trizzino, Executive Vice President, Chief Commercial Officer, Chief Business Officer and Interim Chief Financial Officer

A replay of the recorded fireside session will be available through the events page of the Company’s website at ir.novavax.com for 90 days.

Medtronic Reports Fourth Quarter and Fiscal Year 2021 Financial Results; Announces 9% Dividend Increase

On May 27, 2021 Medtronic plc (NYSE:MDT) reported financial results for its fourth quarter and fiscal year 2021, which ended April 30, 2021 (Press release, Medtronic, MAY 27, 2021, View Source [SID1234583247]). The company reported fourth quarter worldwide revenue of $8.188 billion, an increase of 37 percent as reported and 32 percent on an organic basis, which adjusts for the $241 million benefit of foreign currency translation . The company’s fourth quarter results reflect a strong recovery from the impact of the COVID-19 pandemic on elective procedures that the company experienced in April 2020. Unless otherwise stated, all quarterly revenue growth rates in this press release are stated on an organic basis, which adjusts for the impact of foreign currency translation.

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As reported, fourth quarter GAAP net income and diluted earnings per share (EPS) were $1.361 billion and $1.00, respectively. As detailed in the financial schedules included through the link at the end of this release, fourth quarter non-GAAP net income and non-GAAP diluted EPS were $2.038 billion and $1.50, respectively, increases of 162 percent and 159 percent, respectively. Adjusting for the negative 4 cent impact from foreign currency, fourth quarter non-GAAP diluted EPS increased 166 percent.

Fourth quarter U.S. revenue of $4.182 billion represented 51 percent of company revenue and increased 47 percent. Non-U.S. developed market revenue of $2.672 billion represented 33 percent of company revenue and increased 20 percent as reported and 11 percent organic. Emerging Markets revenue of $1.334 billion represented 16 percent of company revenue and increased 44 percent as reported and 41 percent organic.

Medtronic’s fiscal year 2021 revenue of $30.117 billion increased 4 percent as reported or approximately 2 percent on an organic basis, which adjusts for the $331 million benefit of foreign currency translation, the $15 million inorganic benefit of the company’s acquisition of Titan Spine in the Cranial & Spinal Technologies division in the Neuroscience Portfolio, and the approximate $360 to $390 million benefit the company received from an extra week in its first quarter compared to the first quarter of fiscal year 2020. Unless otherwise stated, all annual revenue growth rates in this press release are stated on an organic basis, which adjusts for the impact of foreign currency translation, the inorganic benefit of Titan Spine, and the estimated benefit of the extra week.

As reported, fiscal year 2021 net earnings were $3.606 billion or $2.66 per diluted share. As detailed in the link at the end of this release, fiscal year 2021 non-GAAP earnings and diluted EPS were $6.005 billion and $4.44, respectively, both decreases of 3 percent. Adjusting for the negative 22 cent impact from foreign currency, fiscal year 2021 non-GAAP diluted EPS increased 2 percent.

Fiscal year 2021 cash flow from operations was $6.240 billion. Fiscal year 2021 free cash flow was $4.885 billion, representing free cash flow conversion from non-GAAP net earnings of 81 percent.

"We reported a strong end to our fiscal year, with our fourth quarter results demonstrating continued momentum. Our recovery improved throughout the quarter, with most of our markets returning to near normal, pre-COVID growth rates," said Geoff Martha, Medtronic chairman and chief executive officer. "In addition to supporting our employees, customers, and communities during the pandemic, we accomplished important milestones, including launching new products, investing in our pipeline, and changing our operating model, just to name a few. As we look ahead, these actions set us up to drive accelerated revenue growth in the year ahead and over the long term."

Cardiovascular Portfolio
The Cardiovascular Portfolio, formerly reported as the Cardiac and Vascular Group (CVG), includes the Cardiac Rhythm & Heart Failure (CRHF), Structural Heart & Aortic (SHA), and Coronary & Peripheral Vascular (CPV) divisions. Cardiovascular fiscal year 2021 revenue of $10.772 billion increased 2.9 percent as reported and was approximately flat organic. Cardiovascular fourth quarter revenue of $2.908 billion increased 45 percent as reported and 41 percent organic, driven by high-fifties organic growth in CRHF and mid-twenties organic growth in both SHA and CPV.

Cardiac Rhythm & Heart Failure fourth quarter revenue of $1.539 billion increased 64 percent as reported and 59 percent organic. Cardiac Rhythm Management revenue increased in the mid-fifties, driven by mid-seventies growth in Leadless Pacemakers on the continued global adoption of the Micra transcatheter pacing system. Cardiac Ablation Solutions revenue more than doubled, with strong growth in Arctic Front Advance cryoballoon catheters and consoles. Cardiovascular Diagnostics revenue grew in the mid-eighties on procedure volume recovery. Mechanical Circulatory Support grew in the mid-teens.
Structural Heart & Aortic fourth quarter revenue of $744 million increased 30 percent as reported and 25 percent organic. Structural Heart grew in the low-fifties, driven by low-fifties growth in transcatheter aortic valves (TAVR), including low-nineties TAVR growth in the United States. Cardiac Surgery grew in the low-double digits, with broad based growth across the business. Aortic grew in the low-single digits, as the company experienced the financial impact of the previously announced global recall of the Valiant Navion thoracic stent graft system.
Coronary & Peripheral Vascular fourth quarter revenue of $624 million increased 27 percent as reported and 24 percent organic. Coronary & Renal Denervation grew in the mid-teens, including mid-teens growth in drug-eluting stents (DES). Peripheral Vascular Health grew in the mid-thirties, with mid-eighties growth in VenaSeal closure systems and low-thirties growth in IN.PACT drug-coated balloons.
Medical Surgical Portfolio
The Medical Surgical Portfolio, formerly reported as the Minimally Invasive Therapies Group (MITG), includes the Surgical Innovations (SI) and the Respiratory, Gastrointestinal & Renal (RGR) divisions. Medical Surgical fiscal year 2021 revenue of $8.737 billion increased 4.6 percent as reported and in the low-single digits organic. Medical Surgical fourth quarter revenue of $2.338 billion increased 21 percent as reported and 17 percent organic, with high-twenties organic growth in SI and low-single digit organic growth in RGR.

Surgical Innovations fourth quarter revenue of $1.542 billion increased 32 percent as reported and 27 percent organic. The division had low-thirties growth in both Advanced Stapling and Vessel Sealing, driven by the continued adoption of the company’s Tri-Staple, LigaSure, and Sonicision technologies. Surgical Robotics had first revenue from Hugo robotic-assisted surgery system placements at hospitals outside the U.S. during the quarter. These systems will collect clinical data to support regulatory approvals around the world.
Respiratory, Gastrointestinal & Renal fourth quarter revenue of $796 million increased 4 percent as reported and 1 percent organic. Patient Monitoring increased in the mid-single digits, with high-single digit growth in the company’s Nellcor pulse oximetry sensors. Respiratory Interventions decreased in the high-teens, with sales of ventilators declining in the high-twenties as demand, particularly in developed markets, is returning to pre-pandemic levels. Gastrointestinal revenue increased in the high-forties, with broad-based growth across the portfolio on procedure recovery. Renal Care Solutions increased in the mid-single digits on strong growth in renal access products.
Neuroscience Portfolio
The Neuroscience Portfolio, formerly reported as the Restorative Therapies Group (RTG), includes the Cranial & Spinal Technologies (CST), Specialty Therapies, and Neuromodulation divisions. Neuroscience fiscal year 2021 revenue of $8.195 billion increased 6.1 percent as reported and in the mid-single digits organic. Neuroscience fourth quarter revenue of $2.295 billion increased 54 percent as reported and 51 percent organic, with high-forties growth in CST, low-fifties growth in Specialty Therapies, and low-sixties growth in Neuromodulation, all on an organic basis.

Cranial & Spinal Technologies fourth quarter revenue of $1.192 billion increased 50 percent as reported and 47 percent organic. Spine & Biologics, as well as Neurosurgery grew in the high-forties, with strong sales of spine implants utilizing Titan nanoLOCK surface technology, as well as record sales of StealthStation navigation, O-arm imaging systems, Midas Rex capital, and advanced energy products. CST also delivered strong growth in Mazor robotics with the launch of Mazor 5.0, utilizing the company’s Midas Rex drills, navigated disc prep, and interbodies with the Mazor robotic guidance system.
Specialty Therapies fourth quarter revenue of $654 million increased 56 percent as reported and 52 percent organic. Neurovascular increased in the low-twenties and ENT increased in the mid-forties. Pelvic Health increased 165%, driven by continued strong adoption of the InterStim Micro sacral neuromodulation system.
Neuromodulation fourth quarter revenue of $449 million increased 65 percent as reported and 61 percent organic. Pain Stim & Early Interventions increased in the mid-seventies, with low-seventies growth in spinal cord stimulation on strong uptake of Intellis with DTM SCS therapy. Brain Modulation increased in the high-fifties, driven by the launch of the Percept PC deep brain stimulation system. Interventional grew in the low-forties, and Targeted Drug Delivery increased in the mid-sixties.
Diabetes
Diabetes fiscal year 2021 revenue of $2.413 billion increased 1.9 percent as reported and was approximately flat organic. Diabetes fourth quarter revenue of $647 million increased 14 percent as reported and 9 percent organic. Diabetes quarterly revenue performance was driven by low-sixties growth in durable pumps on the continued launches of the MiniMed 780G system in international markets and the MiniMed 770G system in the U.S. This was offset by high-single digit declines in consumables, while continuous glucose monitoring (CGM) sales increased in the mid-single digits.

Guidance
The company today issued its fiscal year 2022 revenue and EPS growth guidance.

The company expects revenue growth in its fiscal year 2022 to approximate 9 percent on an organic basis. If current exchange rates hold, revenue growth in fiscal year 2022 would be positively affected by approximately $400 to $500 million.

In fiscal year 2022, the company expects diluted non-GAAP EPS in the range of $5.60 to $5.75, including an estimated 10 to 15 cent positive impact from foreign currency based on current exchange rates.

"Our fiscal 2022 revenue guidance that we are issuing for the first time today is about a point higher than Street estimates, as we anticipate strong organic revenue growth driven by new product launches and end market recovery from the impact of the pandemic," said Karen Parkhill, Medtronic chief financial officer. "At the same time, we’re investing at the front end of major product launches, including surgical robotics and renal denervation, to fully realize their potential. We’re also planning for the largest increase in R&D spend in our company’s history, as we invest to accelerate long-term growth and capitalize on a long list of opportunities."

Dividend Increase
The company reported that on May 26, 2021, the Medtronic board of directors approved an increase in Medtronic’s cash dividend for the first quarter of fiscal year 2022, raising the quarterly amount to $0.63 per ordinary share. This would translate into an annual amount of $2.52 per ordinary share, a 9 percent increase from the prior $2.32. Medtronic has a long history of dividend growth, and the company is a constituent of the S&P 500 Dividend Aristocrats index. Today’s announcement marks the 44th consecutive year of an increase in the dividend payment. Including today’s increase, Medtronic’s dividend per share has grown 47 percent over the past 5 years and has grown at a 16 percent compounded annual growth rate over the past 44 years.

Medtronic has a strong track record of returning capital to its shareholders, including returning $3.3 billion in fiscal year 2021. The company remains committed to returning a minimum of 50 percent of its free cash flow to shareholders, primarily through dividends, and to a lesser extent, share repurchases. The dividend is payable on July 16, 2021, to shareholders of record at the close of business on June 25, 2021.

"We’re pleased to be able to increase our dividend by 9% during the pandemic," said Martha. "Today’s dividend increase is a strong sign of our commitment to providing robust returns for our shareholders and of the confidence that our Board of Directors has in Medtronic’s financial strength and future growth opportunities."

Webcast Information
Medtronic will host a webcast today, May 27, at 8:00 a.m. EDT (7:00 a.m. CDT) to provide information about its businesses for the public, investors, analysts, and news media. This webcast can be accessed by clicking on the Investor Events link at investorrelations.medtronic.com and this earnings release will be archived at news.medtronic.com. Medtronic will be live tweeting during the webcast on its Newsroom Twitter account, @Medtronic. Within 24 hours of the webcast, a replay of the webcast and transcript of the company’s prepared remarks will be available by clicking on the Investor Events link at investorrelations.medtronic.com.

Medtronic plans to report its fiscal year 2022 first, second, third, and fourth quarter results on August 24, 2021, November 23, 2021, February 22, 2022, and May 26, 2022, respectively. Confirmation and additional details will be provided closer to the specific event.

Financial Schedules
To view the fourth quarter and fiscal year 2021 financial schedules and non-GAAP reconciliations, click here. To view the fourth quarter and fiscal year 2021 earnings presentation, click here. Both documents can also be accessed by visiting news.medtronic.com.

CASI Pharmaceuticals, Inc. To Participate In Jefferies Virtual Healthcare Conference

On May 27, 2021 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported that Dr. Wei-Wu He, Chairman and Chief Executive Officer of CASI Pharmaceuticals, will be presenting at the Jefferies Virtual Healthcare Conference (Press release, CASI Pharmaceuticals, MAY 27, 2021, View Source [SID1234583246]). Details for the virtual conferences are as follows.

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Jefferies Virtual Healthcare Conference
Date: Friday, June 4th
Time: 9:30 AM (EST)

Webcast or external link of the company presentations will be available under "Events & Presentations" in the "Investors Relations" section of CASI’s website. Archived replays will be available for approximately 30 days following the event.

enGene Announces First-in-Human Dosing of EG-70 for the Treatment of Non-Muscle Invasive Bladder Cancer in Phase 1/2 Clinical Trial

On May 27, 2021 enGene Inc., a clinical-stage biotechnology company developing non-viral gene therapies for local administration into mucosal tissues enabled by its proprietary DDX platform, reported the dosing of the first patient in the LEGEND study, a first-in-human Phase 1/2 clinical trial of EG-70 in patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) (Press release, enGene, MAY 27, 2021, View Source [SID1234583245]).

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Based on enGene’s DDX platform, EG-70 is a non-viral gene therapy encoding two RIG-I agonists to stimulate the innate immune system, and IL-12 to stimulate the adaptive immune system. By stimulating both arms of the immune system, intravesically administered EG-70 yields remarkable tumor regression in preclinical models of bladder cancer, with induction of effective immunological memory and minimal signs of toxicity.

"Initiating our first clinical study of EG-70 is an important milestone for enGene, validating the potential of our platform to develop novel therapeutics towards clinically meaningful outcomes," said Jason Hanson, Chief Executive Officer at enGene. "This is the first time a non-viral gene therapy directly activating both innate and adaptive immunity is being evaluated as an anti-tumor agent in humans, and we are excited about the outcome of this trial towards positively impacting the lives of patients battling difficult-to-treat cancers."

"Patients with BCG-unresponsive high risk NMIBC have limited treatment options other than radical cystectomy which is associated with significant morbidity and quality of life alterations. Based on our understanding of high grade bladder cancer, the mechanism of BCG resistance/relapse, and the EG-70 mechanism of action, I strongly believe that this novel intravesical therapy has the potential, with few side effects, to make a meaningful difference for patients," said Dr. Gary Steinberg, Professor and Director at the Perlmutter Cancer Center Goldstein Urology Bladder Cancer Program of NYU Langone Health, and lead Principal Investigator for the EG-70 Phase 1/2 study.

The LEGEND study, both first-in-human and first-in-class, is an open-label, monotherapy, multi-center, dose-escalation trial evaluating safety and tolerability, pharmacokinetics, pharmacodynamics, and efficacy of EG-70 administered by intravesical instillation. To learn more about the first-in-human clinical trial of EG-70 in BCG-unresponsive NMIBC, please visit ClinicalTrials.gov.