Integra LifeSciences Reports Third Quarter 2022 Financial Results

On October 26, 2022 Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, reported financial results for the third quarter ending September 30, 2022 (Press release, Integra LifeSciences, OCT 26, 2022, View Source [SID1234622401]).

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Third Quarter 2022 Highlights

Third quarter revenues of $385 million decreased 0.4% on a reported basis and increased 3.5% on an organic basis compared to the prior year.

Third quarter GAAP earnings per diluted share of $0.60, compared to $0.51 in the prior year; adjusted earnings per diluted share of $0.86, compared to $0.86 in the prior year.

The Company completed the sale of its non-core traditional wound care ("TWC") business at the end of August 2022.

The Company is raising its earnings per share outlook to a range of $3.29 to $3.33 and reaffirming its full-year 2022 revenue guidance at the midpoint of its prior guidance with a tightened range of $1,551 million to $1,563 million. The revenue range represents reported growth of 0.5% to 1.3%, inclusive of the divestiture of the TWC business and an updated foreign currency outlook, with organic growth of 3.7% to 4.5%.
"We are pleased with our sales performance in the third quarter. Our diverse portfolio continues to deliver solid, profitable growth for our shareholders," said Jan De Witte, Integra’s president and chief executive officer. "We continue to see strong demand for our products globally and are focused on our execution in achieving our short- and long-term targets."

Third Quarter 2022 Consolidated Performance

Total reported revenues of $385.2 million decreased 0.4% on a reported basis and increased 3.5% on an organic basis compared to the prior year.

The Company reported GAAP gross margin of 61.5%, compared to 62.7% in the third quarter of 2021. Adjusted gross margin was 66.7%, compared to 68.3% in the prior year.

Adjusted EBITDA for the third quarter of 2022 was $105.3 million, or 27.3% of revenue, compared to $104.3 million, or 27.0% of revenue, in the prior year.

The Company reported GAAP net income of $49.9 million, or $0.60 per diluted share, in the third quarter of 2022, compared to a GAAP net income of $43.2 million, or $0.51 per diluted share, in the prior year.

Adjusted net income for the third quarter of 2022 was $71.7 million, or $0.86 per diluted share, compared to $73.1 million, or $0.86 per diluted share, in the prior year.

Third Quarter 2022 Segment Performance

Codman Specialty Surgical (~65% of Revenues)

Total revenues were $249.8 million, representing reported decline of 2.6% and organic growth of 1.6% compared to the third quarter of 2021, driven by strength in both advanced energy and CSF management partially offset by the impact of the CereLink recall in neuro monitoring.
Tissue Technologies (~35% of Revenues)

Total revenues were $135.4 million, representing reported growth of 3.9% and organic growth of 7.2% compared to the third quarter of 2021, driven by sales of Integra skin, amniotics and ACell MicroMatrix.
Key Products and Business Highlights

Advancing Key Products

Return-to-market plans for the CereLink ICP monitor are progressing, targeting first half of 2023.
Third quarter results include a $1.5 million recall returns provision and a $0.8 million rework accrual in cost of goods sold, both of which impacted gross margin.

Expanded the CUSA Clarity portfolio
CUSA Clarity extended laparoscopic tip launched in the U.S., bringing the benefits of ultrasonic ablation technology to minimally invasive laparoscopic liver procedures.

CUSA single-sided bone tip received 510(k) approval. Commercial launch is expected in the first quarter of 2023.

Advanced the science for the Aurora Surgiscope with the publication, in Operative Neurosurgery, of the first peer-reviewed journal article. The Aurora Surgiscope is intended for use in neurosurgery and endoscopic neurosurgery and pure neuroendoscopy (i.e., ventriculoscopy) for visualization, diagnostic and/or therapeutic procedures such as ventriculostomies, biopsies and removal of cysts, tumors and other obstructions.
Business Highlights

Completed the previously announced sale of the non-core TWC business to Gentell, LLC for $28.8 million, which consists of $27.8 million in cash plus $1.0 million in contingent consideration which may be received upon achieving certain revenue-based performance milestones. The transaction included the sale of the Company’s TWC products, such as sponges, gauze and conforming bandages, and certain advanced wound care dressings, such as supportive, calcium alginate, hydrogel, and foam dressings.

Issued our inaugural Environmental, Social and Governance (ESG) report. The report highlights 2021 performance in key areas such as employee health and safety, diversity and inclusion, community impact, ethics and compliance, and environmental responsibility. The report also includes the company’s ESG strategy and roadmap to long-term sustainability.

Appointed two new key executives

Harvinder Singh, EVP & President, International, based in Singapore with a focus on setting and executing product-market strategies and building out Integra’s local commercial capabilities in international markets.
Mark Jesser, CVP & Chief Digital Officer, based in our Princeton, N.J. headquarters with a focus on partnering with our commercial, strategic marketing and business development teams to define and execute digital proposition strategies that enhance Integra’s device portfolio and its positioning within the digital health ecosystem.
Balance Sheet, Cash Flow and Capital Allocation

The Company generated cash flow from operations of $68 million in the quarter. Net debt at the end of the quarter was $1.04 billion, and the consolidated total leverage ratio was 2.4x.

As of quarter end, the Company had total liquidity of approximately $1.75 billion, including approximately $512 million in cash and the remainder available under the revolving credit facility.

2022 Outlook

For the full year 2022, the Company is reaffirming its revenue expectations at the midpoint of its August 2022 guidance with a tightened range of $1,551 million to $1,563 million. The revenue range represents reported growth of 0.5% to 1.3%, inclusive of the divestiture of the TWC business and an updated foreign currency outlook, with organic growth of 3.7% to 4.5%. Our guidance reflects our solid revenue performance through the first 9 months while considering the macro environment, continuing supply constraints, and potential adjustments to the CereLink reserve.

Full-year 2022 reported revenue guidance reflects an additional 25 basis points of unfavorable foreign currency impact relative to guidance provided in August 2022. Foreign currency is now expected to unfavorably impact full year reported growth by approximately 250 basis points compared to the prior year due to the continuing strength of the US Dollar.

Full year 2022 adjusted EPS guidance is being raised to a range of $3.29 to $3.33, an increase of $0.15 at the mid-point compared to the Company’s August guidance.

For the fourth quarter 2022, the Company expects reported revenues in the range of $391 million to $403 million, representing reported growth of -3.5% to -0.6% and organic growth of 1.3% to 4.3%. Adjusted earnings per diluted share is expected to be in a range of $0.87 to $0.91.

The Company’s guidance for fourth quarter and full-year organic sales growth excludes acquisitions and divestitures, 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 and excludes sales from the TWC divestiture as of September 1, 2022. Adjusted earnings per share guidance reflects the impact of the divestiture of the TWC business as well as an updated foreign currency outlook.

Conference Call and Presentation Available Online

Integra has scheduled a conference call for 8:30 a.m. ET on Wednesday, October 26, 2022, to discuss third 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 866-571-0905 and using the passcode 1121226#. 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 November 7, 2022 by dialing 866-583-1035 and using the passcode 1121226#.

Thermo Fisher Scientific Reports Third Quarter 2022 Results

On October 26, 2022 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported its financial results for the third quarter ended October 1, 2022 (Press release, Thermo Fisher Scientific, OCT 26, 2022, View Source [SID1234622400]).

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Third Quarter 2022 Highlights

Third quarter revenue was $10.68 billion.
Third quarter GAAP diluted earnings per share (EPS) was $3.79.
Third quarter adjusted EPS was $5.08.
Delivered very strong financial results in the third quarter, with 14% Core organic revenue growth and $0.44 billion of COVID-19 testing revenue.
Launched a range of high-impact innovative new products, including the Orbitrap Ascend Tribrid mass spectrometer, which offers new capabilities for quantification and characterization of proteins while delivering high throughput and ease of use for diagnostic and drug discovery applications, as well as the Thermo Scientific Arctis Cryo-Plasma Focused Ion Beam, an automated microscope that streamlines cryo-electron tomography research and provides insights into how proteins and other molecules operate within cells. We also advanced our diagnostic offerings with the CE-IVD certification of the Oncomine Dx Express Test and Oncomine Reporter Dx software, which are designed to run on our Ion Torrent Genexus Next-Generation Sequencing System to advance precision oncology testing.
Continued to strengthen our unique customer value proposition with two new facilities to expand our capacity and capabilities: in Chelmsford, Massachusetts, we expanded our capacity for purification resins used in the production of biologics for a number of diseases; and in Plainville, Massachusetts, we expanded our viral vector manufacturing capacity to support cell and gene therapies.
Advanced on our environmental, social and governance priorities, signing an agreement with Enel North America to source half of our U.S. electricity needs from renewable wind power, continuing to deliver on our emissions-reduction strategy.
"We delivered another quarter of excellent financial performance driven by our proven growth strategy and powered by our PPI Business System. Our strategic investments and innovative new product launches are further enhancing our unique customer value proposition and leading to continued share gain," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "We saw broad-based strength across our businesses, including our new clinical research business, which is performing very well. Customers are excited about our expanded capabilities, the integration continues to progress smoothly, and the long-term synergies remain very compelling."

Casper added, "With a strong nine months behind us, we are on track to deliver another outstanding year."

Third Quarter 2022

Revenue for the quarter grew 14% to $10.68 billion in 2022. Organic revenue was 1% lower; acquisitions increased revenue by 20% and currency translation decreased revenue by 5%. Core organic revenue growth was 14%. COVID-19 testing revenue was $0.44 billion.

GAAP Earnings Results

GAAP diluted EPS in the third quarter of 2022 was $3.79, versus $4.79 in the same quarter last year. GAAP operating income for the third quarter of 2022 was $1.71 billion, compared with $2.28 billion in the year-ago quarter. GAAP operating margin was 16.0%, compared with 24.4% in the third quarter of 2021.

Non-GAAP Earnings Results

Adjusted EPS in the third quarter of 2022 was $5.08, versus $5.77 in the third quarter of 2021. Adjusted operating income for the third quarter of 2022 was $2.37 billion, compared with $2.78 billion in the year-ago quarter. Adjusted operating margin was 22.2%, compared with 29.8% in the third quarter of 2021.

Annual Guidance for 2022

The company will provide updated 2022 financial guidance during its earnings conference call this morning at 8:30 a.m. Eastern Time.

Use of Non-GAAP Financial Measures

Adjusted EPS, adjusted net income, adjusted operating income, adjusted operating margin, free cash flow, organic revenue growth and Core organic revenue growth are non-GAAP measures that exclude certain items detailed after the tables that accompany this press release, under the heading "Supplemental Information Regarding Non-GAAP Financial Measures." The reconciliations of GAAP to non-GAAP financial measures are provided in the tables that accompany this press release.

Conference Call

Thermo Fisher Scientific will hold its earnings conference call today, October 26, 2022, at 8:30 a.m. Eastern Time. To listen, dial (844) 200-6205 within the U.S. or (929) 526-1599 outside the U.S. The conference ID is 406803. You may also listen to the call live on our website, www.thermofisher.com, by clicking on "Investors." You will find this press release, including the accompanying reconciliation of non-GAAP financial measures and related information, in that section of our website under "Financials." An audio archive of the call will be available under "News & Events" through Friday, November 11, 2022.

Aileron Therapeutics Presents Results from Phase 1 Study in Healthy Volunteers Demonstrating ALRN-6924 Induced Cell Cycle Arrest in Bone Marrow Stem Cells and Hair Follicles at EORTC-NCI-AACR International Conference

On October 26, 2022 Aileron Therapeutics (Nasdaq: ALRN), a chemoprotection oncology company focused on fundamentally transforming the experience of chemotherapy for cancer patients, reported that detailed results from its completed Phase 1 study of ALRN-6924 in healthy volunteers at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) 2022 taking place in Barcelona October 26 – 28, 2022 (Press release, Aileron Therapeutics, OCT 26, 2022, View Source [SID1234622399]). The poster titled, "ALRN-6924 Induces Cell Cycle Arrest in Bone Marrow Stem Cells and Hair Follicles with Dose-Dependent Degree and Duration of Effects after a Single Infusion in Healthy Volunteers" (Poster #136) is also available in the Scientific Resources section of Aileron’s website linked here.

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ALRN-6924 is a first-in-class MDM2/MDMX dual inhibitor that is currently in development as a novel, selective chemoprotective agent for patients with p53-mutated cancer. The findings presented at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) conference, which showed that ALRN-6924 induced p53-mediated cell cycle arrest in bone marrow stem cells and hair follicles, demonstrate the potential of ALRN-6924 to prevent chemotherapy-induced neutropenia, thrombocytopenia, and anemia, as well as chemotherapy-induced alopecia.

"While we previewed some of these new findings from our now completed Phase 1 study of ALRN-6924 in healthy volunteers earlier this year, we’re pleased to present the comprehensive results at an international scientific conference," said Manuel Aivado, M.D., Ph.D., President and Chief Executive Officer at Aileron. "These results contribute to the substantial body of scientific evidence that we believe has reliably and reproducibly demonstrated ALRN-6924’s potential as a biomarker-driven chemoprotective agent, driving us to work diligently to address the significant impact chemotherapy-induced toxicities have on cancer patients’ treatment experience and outcomes."

ALRN-6924 is designed to activate p53, which in turn upregulates p21, a known inhibitor of the cell replication cycle, thereby inducing cell cycle arrest to protect normal, healthy cells from chemotherapy-induced damage. The Phase 1 study in healthy volunteers was conducted to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ALRN-6924. Aileron previously presented data from the study showing that a 0.3 mg/kg and 0.6 mg/kg 1-hour intravenous (IV) ALRN-6924 infusion was well tolerated, and transiently upregulated p21 in human bone marrow cells with minimal signal for apoptosis (n=37; Voors-Pette et al., ESMO (Free ESMO Whitepaper) 2021).

In the new findings presented today, cell cycle arrest was directly measured in the bone marrow and hair follicles of an additional 41 females. ALRN-6924 was administered as a single 1-hour IV infusion or 3-minute bolus injection at 0.3, 0.6, or 0.9 mg/kg to cohorts of 3 to 9 subjects and compared to placebo. Plasma and serum samples were obtained to determine PK and levels of macrophage inhibitory cytokine-1 (MIC-1), a biomarker of p53 activation. Bone marrow was sampled 12 hours post-dose to directly measure cell cycle arrest by flow cytometry in CD34+, lineage-negative bone marrow stem cells. Occipital scalp skin was sampled by a 2 mm punch biopsy for p21 immunohistochemistry in hair follicles.

In addition to the cell cycle arrest findings, ALRN-6924 continued to demonstrate a favorable tolerability profile, with subjects experiencing only mild, transient adverse events (AEs), with nausea/vomiting as the most frequent related AE. The degree and duration of serum MIC-1 elevation was dose-dependent, indicating more durable p53 activation at higher ALRN-6924 doses. At 12 hours post-dose, the proportion of cycling bone marrow stem cells was significantly reduced at all dose levels. Blinded pathology review suggested ALRN-6924-dependent p21 induction in anagen-phase hair follicles. Safety profiles, PK and PD were similar for both the 3-minute bolus and 1-hour infusion, providing rationale for future development of ALRN-6924 bolus administration.

"These findings are particularly compelling as they support our selection of the 1.2 mg/kg dose for our ongoing Phase 1b trial in patients with p53-mutated breast cancer, as well as our evaluation of protection against both chemotherapy-induced neutropenia and alopecia in that trial," said Allen Annis, Ph.D., Senior Vice President, Research at Aileron. "Beyond informing the dose and schedule for our current trial evaluating ALRN-6924 in breast cancer patients being treated with docetaxel, doxorubicin and cyclophosphamide, or TAC, these results suggest this dosing regimen can be uniformly applied when developing ALRN-6924 as a chemoprotective agent with other chemotherapies and for patients with other p53-mutated cancer indications."

United Therapeutics Corporation to Report Third Quarter 2022 Financial Results Before the Market Opens on Wednesday, November 2, 2022

On October 26, 2022 United Therapeutics Corporation (Nasdaq: UTHR) reported that it will report its third quarter 2022 financial results before the market opens on Wednesday, November 2, 2022 (Press release, United Therapeutics, OCT 26, 2022, View Source [SID1234622398]).

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United Therapeutics will host a public webcast Wednesday, November 2, 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.

Ligand to Report Third Quarter Financial Results on November 7

On October 26, 2022 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported that it will report third quarter 2022 financial results after the close of the U.S. financial markets on Monday, November 7, 2022 and will hold a conference call that same day beginning at 4:30 p.m. Eastern time (Press release, Ligand, OCT 26, 2022, View Source [SID1234622397]). Speakers on the call will include Ligand’s CEO John Higgins, President and COO Matt Korenberg and CFO Tavo Espinoza.

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