Integra LifeSciences Reports First Quarter 2022 Financial Results

On April 27, 2022 Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, reported financial results for the first quarter ending March 31, 2022 (Press release, Integra LifeSciences, APR 27, 2022, View Source [SID1234613016]).

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First Quarter 2022 Highlights
•Revenues of $376.6 million increased 4.6% on a reported basis and 5.6% on an organic basis compared to the prior year.
•GAAP earnings per diluted share of $0.39, compared to $0.53 in the first quarter of 2021; adjusted earnings per diluted share of $0.74, compared to $0.69 in the prior year.
•The Company is raising its previous full-year 2022 organic growth guidance of 3.5% to 5% to a new range of 3.8% to 5.2%, reflecting the better than expected first quarter revenue results. Reported revenue growth is reaffirmed at 2.5% to 3.5%. Adjusted earnings per share guidance range reaffirmed at $3.27 to $3.35.

"I am pleased with the resilience shown by Integra colleagues as we navigated the COVID-19 Omicron wave early in the quarter," said Jan De Witte, Integra’s president and chief executive officer. "With global procedure volumes improving in March, our strong execution enabled us to deliver better-than-expected first quarter revenue with organic growth exceeding five percent."

First Quarter 2022 Consolidated Performance

Total reported revenues of $376.6 million increased 4.6% on a reported basis and 5.6% on an organic basis compared to the prior year.
The Company reported GAAP gross margin of 62.1%, compared to 59.5% in the first quarter of 2021. Adjusted gross margin was 67.7%, compared to 67.3% in the prior year.
Adjusted EBITDA for the first quarter of 2022 was $93.5 million, or 24.8% of revenue, compared to $89.9 million, or 25.0% of revenue, in the prior year.
The Company reported GAAP net income of $32.9 million, or $0.39 per diluted share, in the first quarter of 2022, compared to a GAAP net income of $45.4 million, or $0.53 per diluted share, in the prior year. GAAP net income for the first quarter 2021 included a gain of $42.9 million from the divestiture of the Extremity Orthopedics business, which was completed in January of 2021.
Adjusted net income for the first quarter of 2022 was $62.0 million, or $0.74 per diluted share, compared to $59.0 million, or $0.69 per diluted share, in the prior year.

First Quarter 2022 Segment Performance
•Codman Specialty Surgical (66% of Revenues)
•Total revenues were $247.3 million, representing reported growth of 2.5% and organic growth of 5.0% compared to the first quarter of 2021, driven by strength in Neurosurgery. Sales in the first quarter benefited from our recently-launched CereLink ICP Monitoring System, as well as a late quarter recovery in neurosurgery procedures.

•Tissue Technologies (34% of Revenue)
•Total revenues were $129.3 million, representing reported growth of 8.8% and organic growth of 6.9% compared to the first quarter of 2021, driven by favorable timing in Private Label customer orders and growth in Wound Reconstruction and Care led by sales in our Integra Dermal Matrices and SurgiMend.

Strategic Initiatives and Key Developments
•Advancing key products

•NeuraGen 3D, the Company’s new peripheral nerve repair product, launched late in the first quarter. This innovative product is a nerve guide matrix designed to optimize the environment for nerve regeneration and may allow for more complete functional recovery following mid-gap nerve repair when compared to hollow nerve conduits alone.

•Following our U.S. and Europe launch of CereLink in the third quarter of 2021, we expanded market coverage to Canada and Australia as well as several indirect markets through the first quarter.

Balance Sheet, Cash Flow and Capital Allocation
The Company generated cash flow from operations of $44 million in the quarter. Net debt at the end of the quarter was $1.15 billion, and the consolidated total leverage ratio was 2.5x.
As of quarter end, the Company had total liquidity of approximately $1.66 billion, including approximately $407 million in cash and the remainder available under the revolving credit facility.
The Company completed the previously announced $125 million accelerated share repurchase program (ASR) in the first quarter. The Company received 1.48 million shares at inception of the ASR on January 14, 2022, which represented approximately 80% of the expected total shares. Upon settlement of the ASR in March 2022, the Company received an additional 0.46 million shares determined using the volume-weighted average price of the Company’s common stock during the term of the transaction.

In addition, on April 26, 2022, the Board of Directors authorized the Company to repurchase up to $225 million of the Company’s common stock. The program allows the Company to repurchase its shares opportunistically from time to time. The repurchase authorization expires in December 2024. This stock repurchase authorization replaces the previous $225 million stock repurchase authorization, of which $100 million remained authorized at the time of its replacement, and which was otherwise set to expire on December 31, 2022. Purchases may be effected through one or more open market transactions, privately negotiated transactions, transactions structured through investment banking institutions, accelerated share repurchases, tender offers or open market solicitations for shares, some of which may be effected through Rule 10b5-1 plans, or a combination of the foregoing. The timing of repurchases will depend upon several factors, including market and business conditions, and repurchases may be discontinued at any time.

2022 Outlook
For the second quarter 2022, the Company expects reported revenues in the range of $392 million to $400 million, representing reported growth of approximately 0.5% to 2.5% and organic growth of approximately 2.8% to 4.8%. Adjusted earnings per diluted share are expected to be in a range of $0.78 to $0.82.

For the full year 2022, the Company is raising its organic growth expectations from an initial range of 3.5% to 5% to now 3.8% to 5.2%. This reflects the better-than-expected first quarter 2022 revenue performance but also reflects current uncertainty in global markets as well as continuing supply constraints. 2022 full year reported revenue guidance remains unchanged, within a range of $1,580 million to $1,600 million, representing reported growth of approximately 2.5% to 3.5%. This revenue guidance reflects absorbing an additional 30 basis points unfavorable currency impact, principally driven by the continuing strengthening of the US dollar against other currencies we transact sales.

Organic sales growth excludes acquisitions and divestitures as well as the effects of foreign currency and the year-over-year change in revenue from discontinued products. Organic growth includes ACell as of January 20, 2022.

Full year 2022 adjusted earnings per diluted share guidance is unchanged and is expected to be in a range of $3.27 to $3.35.

The Company is providing forward-looking guidance regarding adjusted earnings per diluted share but is not providing a reconciliation to GAAP earnings per share, because certain GAAP expense items are highly variable, and management is unable to predict them with reasonable certainty and without unreasonable effort. Specifically, the financial impact and timing of divestitures, acquisitions, integrations, structural optimization and efforts to comply with the EU Medical Device Regulation are uncertain, depend on various dynamic factors and are not reasonably ascertainable at this time. These expense items could have a material impact on GAAP results. Adjusted earnings per diluted share also excludes the impact of intangible asset amortization associated with prior business acquisitions, which we expect to be approximately $0.76 per diluted share for the full-year 2022.

Conference Call and Presentation Available Online
Integra has scheduled a conference call for 8:30 a.m. ET on Wednesday, April 27, 2022, to discuss first quarter 2022 financial results, and forward-looking financial guidance. The conference call will be hosted by Integra’s senior management team and will be open to all listeners. Additional forward-looking information may be discussed in a question-and-answer session following the call. Integra’s management team will reference a presentation during the conference call, which can be found on the Investor section of the website at investor.integralife.com.
Access to the live call is available by dialing (800)-289-0720 and using the passcode 5706502. A simultaneous webcast of the call will be available via the Company’s website at www.integralife.com. A webcast replay of the call can be accessed through the Investor Relations homepage of Integra’s website at www.integralife.com. A replay of the call will be available until May 7, 2022 by dialing (888) 203-1112 and using the passcode 5706502.

GSK delivers strong Q1 2022 sales of £9.8 billion, +32% AER, +32% CER; Total EPS 35.9p +67% AER, +66% CER and Adjusted EPS 32.8p +43% AER, +43% CER

On April 27, 2022 GlaxoSmithKline reported that strong Q1 2022 sales of £9.8 billion, +32% AER, +32% CER; Total EPS 35.9p +67% AER, +66% CER and Adjusted EPS 32.8p +43% AER, +43% CER (Press release, GlaxoSmithKline, APR 27, 2022, View Source [SID1234613015])

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Highlights
Strong sales growth across Biopharma and Consumer Healthcare
Biopharma: £7.1 billion +40% AER, +40% CER;+14% AER, +15% CER excluding COVID-19 solutions
Specialty Medicines £3.1 billion +98% AER, +97% CER; HIV +15% AER, +14% CER; Oncology +15% AER, +15% CER; Immuno-inflammation, respiratory and other +18% AER, +18% CER; COVID-19 solutions (Xevudy) sales £1.3 billion
Vaccines £1.7 billion +36% AER, +36% CER; Shingrix £698 million >100% AER, >100% CER
General Medicines £2.3 billion +2% AER, +3% CER
Consumer Healthcare £2.6 billion +14% AER, +14% CER
Sales growth also benefited from favourable comparison to Q1 2021
Continued R&D delivery and strengthening of pipeline
US FDA regulatory approvals: Cabenuva treatment of virologically supressed adolescents living with HIV; Triumeq dispersible single tablet regimen for treatment of children with HIV
US FDA regulatory submission acceptance of daprodustat for anaemia of chronic kidney disease (PDUFA action date 1 February 2023)
Benlysta approved in China for adults with active lupus nephritis
EU regulatory submission acceptance for Sanofi-GSK COVID-19 vaccine (Vidprevtyn) and Canadian regulatory approval for Medicago-GSK COVID-19 vaccine (Covifenz)
Proposed acquisition of Sierra Oncology Inc. strengthens late-stage specialty pipeline. Momelotinib has potential to address significant unmet medical need of myelofibrosis patients with anaemia
Multiple pipeline catalysts in next nine months, including phase III data read outs for the RSV Older Adults and meningitis (MenABCWY) vaccine candidates, Blenrep, Jemperli and otilimab, and phase IIb data for bepirovirsen
Cost discipline supports delivery of improved operating margin and Adjusted EPS of 32.8p
Total Group operating margin 28.6%. Total EPS 35.9p +67% AER, +66% CER
Adjusted Group operating margin 26.7%. Adjusted EPS 32.8p +43% AER, +43% CER. This included a contribution to growth from COVID-19 solutions of approximately +15% AER, +15% CER for Q1 2022
Q1 2022 cash generated from operations £2.8 billion. Q1 2022 free cash flow £1.7 billion
On track to demerge and list Haleon, a new global leader in consumer healthcare, in July 2022
New growth outlooks set out in Q1 2022, for annual organic revenue growth of 4-6% and sustainable moderate expansion of adjusted operating margin over medium term at CER
Reconfirming 2022 guidance
GSK expected to deliver growth in 2022 sales of between 5% to 7% at CER and growth in 2022 Adjusted operating profit of between 12% to 14% at CER
2022 guidance excludes any contribution from COVID-19 solutions
Dividend of 14p declared for Q1 2022

Emma Walmsley, Chief Executive Officer, GSK said:
"We have delivered strong first quarter results in this landmark year for GSK, as we separate Consumer Healthcare and start a new period of sustained growth. Our results reflect further good momentum across specialty medicines and vaccines, including the return to strong sales growth for Shingrix and continuing pipeline progress. We also continue to see very good momentum in Consumer Healthcare, demonstrating strong potential of this business ahead of its proposed demerger in July, to become Haleon."

Alligator Bioscience AB: Interim report January–March 2022

On April 27, 2022 Alligator Bioscience AB reported that Interim report January–March 2022 (Press release, Alligator Bioscience, APR 27, 2022, View Source [SID1234613014])

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SIGNIFICANT EVENTS JANUARY-MARCH

Pipeline:

In March, the Company successfully completed the Phase Ib part of the clinical study OPTIMIZE-1, and Phase II is now enrolling patients at the recommended dose of 900 µg/kg.
In January, Alligator initiated a sponsored research collaboration with Dr. Beatty of University of Pennsylvania to support OPTIMIZE-1, and at the same time we welcomed Dr. Beatty as advisor to Alligator.
Company:

Sumeet Ambarkhane was appointed as new Chief Medical Officer to strengthen Alligator’s efforts to further advance the development of our novel immuno-oncology pipeline in the coming year.
The Nomination Committee proposed that the Annual General Meeting 2022 re-elects the current board members, and that Staffan Encrantz and Denise Goode are elected as new board members.
SIGNIFICANT EVENTS AFTER THE END OF THE PERIOD

On April 1, Alligator announced the completion of the 600 mg dose cohort for ATOR-1017, where data indicates no significant safety concerns, with stable disease as the best tumor response. Patient enrollment and treatment for the highest planned dose cohort, 900 mg, has commenced.
FINANCIAL SUMMARY

January–March 2022

Net sales, SEK 5.4 million (0.6)
Operating profit/loss, SEK -43.0 million (-32.5)
Profit/loss for the period, SEK -43.1 million (-32.7)
Earnings per share before and after dilution, SEK -0.20 (-0.42)*
Cash flow for the period, SEK -43.8 million (40.4)
Cash and cash equivalents, SEK 234.4 million (278.1)
*) Previous periods have been adjusted, see Note 8, page 20 in the attached report.

The full report is attached as PDF available on the company’s website: View Source

The information was submitted for publication, through the agency of the contact person set out above, at 08:00 a.m. CET on April 27, 2022.

United Therapeutics Corporation to Report First Quarter 2022 Financial Results Before the Market Opens on Wednesday, May 4, 2022

On April 27, 2022 United Therapeutics Corporation (Nasdaq: UTHR) reported that it will report its first quarter 2022 financial results before the market opens on Wednesday, May 4, 2022 (Press release, United Therapeutics, APR 27, 2022, View Source [SID1234613012]).

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United Therapeutics will host a public webcast Wednesday, May 4, 2022, at 9:00 a.m. Eastern Time. The webcast will be accessible via United Therapeutics’ website at View Source A rebroadcast of the webcast will be available for one week and can be accessed at the same location.

ISA to Present at Business Conferences in May 2022

On April 27, 2022 ISA reported that its representatives will be participating and presenting at the following business conferences in May 2022 (Press release, ISA Pharmaceuticals, APR 27, 2022, View Source [SID1234613011]). If you would like to meet with our team at any of these events, please contact us through the conference partnering systems or via [email protected].

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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LSX World Leaders Congress

Date: 10-11 May 2022, London, UK

Panel Presentation by: Anton Mat, Director Business Development, ISA Pharmaceuticals

Title: Key Multi-Stakeholder Considerations In Early-Stage Commercial Deal-Making

Date & Time: Tuesday, 10 May 2022, 14.30pm BST

Bio€quity Europe

Date: 16-18 May 2022, Milan, Italy

Presentation by: Gerben Moolhuizen, Chief Executive Officer, ISA Pharmaceuticals

Date & Time: Virtual, pre-recorded presentation available any time via the partnering system

UBS Global Healthcare Conference

Date: 23-25 May 2022, New York, US

Presentation by: Gerben Moolhuizen, Chief Executive Officer, ISA Pharmaceuticals

Title: ISA Pharmaceuticals Company Presentation

Date & Time: Monday, 23 May 2022, 07.45am ET