Intellia Therapeutics to Hold Conference Call to Discuss Second Quarter 2022 Earnings and Company Updates

On July 27, 2022 Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage genome editing company focused on developing potentially curative therapeutics leveraging CRISPR-based technologies, reported that it will present its second quarter 2022 financial results and operational highlights in a conference call on August 4, 2022, at 8 a.m. ET (Press release, Intellia, JUL 27, 2022, View Source [SID1234616988]).

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To join the call:

U.S. callers should dial 1-833-316-0545 and international callers should dial 1-412-317-5726, approximately five minutes before the call. All participants should ask to be connected to the Intellia Therapeutics conference call.
Please visit this link for a simultaneous live webcast of the call.
A replay of the call will be available through the Events and Presentations page of the Investors & Media section on Intellia’s website at www.intelliatx.com, beginning on August 4, 2022, at 12 p.m. ET.

Integra LifeSciences Reports Second Quarter 2022 Financial Results

On July 27, 2022 Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, reported financial results for the second quarter ending June 30, 2022 (Press release, Integra LifeSciences, JUL 27, 2022, View Source [SID1234616987]).

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Second Quarter 2022 Highlights

Second quarter revenues of $398 million increased 2.0% on a reported basis and 4.8% on an organic basis compared to the prior year.
Six-month revenues for 2022 were $774 million and increased 3.3% on a reported basis and 5.2% on an organic basis compared to the prior year.
Second quarter GAAP earnings per diluted share of $0.54, compared to $0.41 in the prior year; adjusted earnings per diluted share of $0.82, compared to $0.79 in the prior year.
The Company entered into an agreement for the sale of its non-core traditional wound care ("TWC") business.
The Company is tightening its previous full-year 2022 organic growth guidance of 3.8% to 5.2% to an updated range of 4.0% to 5.2%, reflecting better than expected first half performance. Full-year 2022 reported revenue guidance is updated to a range of $1,557 million to $1,575 million representing reported growth of 1.0% to 2.1%, inclusive of the planned sale of the TWC business and an updated foreign currency outlook. Adjusted earnings per share guidance range is updated accordingly to $3.21 to $3.29.
"We are pleased with our strong sales performance in the first half of the year. Our balanced portfolio continues to deliver solid, profitable growth in a challenging environment and we are on track to deliver our full-year organic growth expectations," said Jan De Witte, Integra’s president and chief executive officer. "We are encouraged by the momentum we see in our key markets, while our growth initiatives and operational focus further strengthens our ability to deliver on our long-term financial targets."

Second Quarter 2022 Consolidated Performance

Total reported revenues of $397.8 million increased 2.0% on a reported basis and 4.8% on an organic basis compared to the prior year.

The Company reported GAAP gross margin of 62.7%, compared to 61.2% in the second quarter of 2021. Adjusted gross margin was 68.0%, compared to 68.1% in the prior year.

Adjusted EBITDA for the second quarter of 2022 was $102.8 million, or 25.8% of revenue, compared to $101.0 million, or 25.9% of revenue, in the prior year.

The Company reported GAAP net income of $44.8 million, or $0.54 per diluted share, in the second quarter of 2022, compared to a GAAP net income of $35.1 million, or $0.41 per diluted share, in the prior year.

Adjusted net income for the second quarter of 2022 was $68.3 million, or $0.82 per diluted share, compared to $67.4 million, or $0.79 per diluted share, in the prior year.

Second Quarter 2022 Segment Performance

Codman Specialty Surgical (65% of Revenues)

Total revenues were $257.9 million, representing reported growth of 0.4% and organic growth of 4.3% compared to the second quarter of 2021, driven by strength in both Instruments and Neurosurgery. Neurosurgery growth was driven by advanced energy and CSF management.
Tissue Technologies (35% of Revenue)

Total revenues were $140.0 million, representing reported growth of 5.1% and organic growth of 5.9% compared to the second quarter of 2021, driven by 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

Launched the Aurora Evacuator with Coagulation device in the U.S., designed to be used in conjunction with our Aurora Surgiscope to safely address and evacuate blood in the brain caused by hemorrhagic stroke.

Launched the Neutus EVD system, our first external ventricular drain in China. The Neutus EVD system is manufactured in China by Shanghai Haoju Medical Technology Co., Ltd. and commercialized by the Company under an exclusive distribution arrangement. The device is used in the management of cerebrospinal fluid and is highly complementary to our Bactiseal catheter and advanced intercranial pressure monitoring products.

Key developments

Closed a manufacturing facility located in France; transfer of production to the Company’s existing Switzerland facility is in process.

Announced plans to outsource certain transactional back-office finance and customer service activities to enhance customer quality, build scale for future growth, and capture cost efficiencies. The transition is expected to be completed by year end 2022.

Recognized as a Great Place to Work-Certified Organization in China and voted to 2022 Best Places to Work in NJ list.
Balance Sheet, Cash Flow and Capital Allocation

The Company generated cash flow from operations of $66 million in the quarter. Net debt at the end of the quarter was $1.12 billion, and the consolidated total leverage ratio was 2.5x.

As of quarter end, the Company had total liquidity of approximately $1.69 billion, including approximately $447 million in cash and the remainder available under the revolving credit facility.

Divestiture of the Traditional Wound Care Business

On May 20, 2022, the Company signed a definitive agreement to sell its TWC business, which includes sponges, gauze and conforming bandages and advanced wound care dressings, to Gentell, a leading manufacturer and distributor of advanced wound, skin, and personal care products, for $28.8 million, consisting of $27.8 million in cash plus $1.0 million in milestone payments. Revenues for the TWC business were approximately $27 million in 2021.

The transaction is expected to close at or around the end of August 2022, subject to the satisfaction of customary closing conditions.

"Our portfolio optimization actions over the past two years have allowed us to increase our focus on Integra’s core portfolio of market-leading products in neurosurgery, surgical instrumentation and regenerative tissue and moves us closer to achieving our long-term organic growth and profitability targets," said Jan De Witte.

2022 Outlook

For the full year 2022, the Company is tightening its organic growth expectations from a prior range of 3.8% to 5.2% to an updated range of 4.0% to 5.2%. This reflects the strong first half 2022 revenue performance, while also balancing the uncertainty in global markets and continuing supply constraints.

Full year 2022 reported revenue guidance has been revised to a range of $1,557 million to $1,575 million, representing reported growth of 1.0% to 2.1%, to reflect the pending sale of the TWC business and an additional 115 basis points of unfavorable foreign currency impact compared to guidance provided in April 2022. Foreign currency is now expected to unfavorably impact full year reported growth by approximately 225 basis points compared to the prior year due to the continuing strength of the USD compared to other currencies in which we transact sales.

Full year 2022 adjusted earnings per diluted share guidance is updated to a range of $3.21 to $3.29 reflecting the planned divestiture of the TWC business and an updated foreign currency outlook.

For the third quarter 2022, the Company expects reported revenues in the range of $383 million to $391 million, representing reported growth of -1.0 to 1.0% and organic growth of 2.6% to 4.8%. Adjusted earnings per diluted share is expected to be in a range of $0.78 to $0.82. Guidance reflects the impacts from the planned divestiture of the TWC business, as well as an updated foreign currency outlook on reported revenue and adjusted earnings per share.

The Company’s guidance for the third quarter and full year 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 and excludes sales from the pending TWC divestiture as of September 1, 2022.

Conference Call and Presentation Available Online

Integra has scheduled a conference call for 8:30 a.m. ET on Wednesday, July 27, 2022, to discuss second 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 2688312. 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 August 7, 2022 by dialing (888) 203-1112 and using the passcode 2688312 .

IDEAYA Announces Clinical Trial Collaboration with Amgen to Evaluate MAT2A-PRMT5 Synthetic Lethality Combination in MTAP Deleted Tumors

On July 27, 2022 IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a synthetic lethality focused precision medicine oncology company committed to the discovery and development of targeted therapeutics, reported it has entered into a clinical trial collaboration and supply agreement with Amgen Inc. to evaluate the efficacy and safety of IDE397, its investigational, potential best-in-class, small molecule MAT2A inhibitor, with Amgen’s AMG 193, an investigational small molecule MTA-cooperative inhibitor of PRMT5, in a Phase 1 clinical trial (Press release, Ideaya Biosciences, JUL 27, 2022, View Source [SID1234616986]).

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"This clinical collaboration with Amgen builds on IDEAYA’s ongoing clinical evaluation of IDE397 as monotherapy and in selected combinations in our Phase 1/2 clinical trial, including with taxanes and pemetrexed. We are pleased to collaborate with Amgen to also evaluate the MAT2A-PRMT5 synthetic lethality combination in the clinic," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.

"Mechanistically, each of MAT2A and PRMT5 are synthetic lethal with MTAP gene deletion in tumors. The synthetic lethality of each of these targets provides a complementary approach for targeting MTAP-null tumors," said Dr. Michael White, Ph.D., Senior Vice President and Chief Scientific Officer, IDEAYA Biosciences.

IDE397 is a potent and selective small molecule inhibitor targeting methionine adenosyltransferase 2a (MAT2A), in patients having solid tumors with methylthioadenosine phosphorylase (MTAP) deletion. The MTAP deletion patient population is estimated to represent approximately 15% of solid tumors, including approximately 15% of NSCLC, 28% of esophageal, 26% of bladder, and 10% of esophagogastric cancers.

IDEAYA is evaluating IDE397 in an ongoing Phase 1/2 clinical trial. The company has initiated and is actively enrolling patients into monotherapy expansion and combination cohorts of the IDE397 Phase 1 clinical trial, including in combination with docetaxel in NSCLC, paclitaxel in esophagogastric cancer and pemetrexed in NSCLC. IDEAYA is leading early clinical development of IDE397 in collaboration with GSK. Subject to exercise of its option, GSK will lead later-stage clinical development of IDE397.

Amgen is developing AMG 193, an investigational small molecule methylthioadenosine (MTA) cooperative inhibitor targeting protein arginine methyltransferase 5 (PRMT5), as monotherapy and in combination with docetaxel in MTAP null solid tumors, in an ongoing Phase 1 clinical trial.

Under the mutually non-exclusive clinical trial collaboration and supply agreement, IDEAYA will provide IDE397 drug supply to Amgen, who will be the sponsor of the Phase 1 clinical combination trial. IDEAYA and Amgen will jointly share external costs of the clinical trial and will jointly oversee clinical development of the combination therapy. IDEAYA and Amgen each retain all commercial rights to their respective compounds, including as monotherapy or as combination therapies.

GSK delivers strong Q2 2022 sales of £6.9 billion +19% at AER, +13% at CER and Total EPS* from continuing operations** 17.5p -42% AER, -58% CER; Adjusted EPS of 34.7p +23% AER, +6% CER

On July 27, 2022 GSK reported that strong Q2 2022 sales of £6.9 billion +19% at AER, +13% at CER and Total EPS* from continuing operations** 17.5p -42% AER, -58% CER; Adjusted EPS of 34.7p +23% AER, +6% CER (Press release, GlaxoSmithKline, JUL 27, 2022, View Source [SID1234616985])

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Highlights
Strong commercial execution across Specialty Medicines, Vaccines and General Medicines drives double-digit sales growth
• Total sales: £6.9 billion +19% AER, +13% CER, excluding COVID-19 solutions +16% AER, +10% CER
– Specialty Medicines £2.7 billion +44% AER, +35% CER; HIV +14% AER, +7% CER; Oncology +29% AER, +23% CER; Immuno-inflammation and other specialty +32% AER +24% CER; COVID-19 solutions (Xevudy) sales £0.5 billion
– Vaccines £1.7 billion +9% AER, +3% CER; Shingrix £731 million >100% AER, >100% CER
– General Medicines £2.5 billion +5% AER, +2% CER

Continued cost discipline supports delivery of improved adjusted operating margin
• Total continuing operating margin 16%. Total EPS 20.8p -40% AER, -53% CER; Total continuing EPS 17.5p
-42% AER, -58% CER; primarily reflecting increased contingent consideration charges driven by exchange rates and adverse comparison due to a credit for the revaluation of deferred tax in Q2 2021
• Adjusted operating margin 29%. Adjusted operating profit growth +22% AER, +7% CER. The impact on growth from lower margin COVID-19 solutions was approximately -16% AER, -14% CER
• Adjusted EPS 34.7p +23% AER, +6% CER. The impact on growth from lower margin COVID-19 solutions was approximately -20% AER, -18% CER
• Q2 2022 continuing cash generated from operations £1.6 billion. Free cash flow £0.3 billion

Strengthening late-stage R&D pipeline with positive data read-outs and strategic business development
• US FDA approval for Priorix (MMR vaccine); Vocabria plus rilpivirine approval in Japan for HIV; Cervarix approval in China for cancer-causing human papillomavirus
• Positive phase III high-level results for respiratory syncytial virus vaccine candidate in older adults. Full results to be presented at an upcoming scientific meeting with regulatory submissions anticipated in H2 2022
• Proposed acquisition of Affinivax provides access to next-generation phase II 24-valent pneumococcal vaccine candidate and innovative MAPSTM technology
• Promising phase IIb interim data presented for bepirovirsen, a potential new treatment for chronic hepatitis B. Phase III monotherapy trial is anticipated to start in H1 2023
• Completed acquisition of Sierra Oncology on 1 July 2022. Data from momelotinib’s MOMENTUM phase III trial presented at 2022 ASCO (Free ASCO Whitepaper) Annual Meeting; results showed a statistically significant and clinically meaningful benefit on symptoms, splenic response, and anaemia. NDA submitted to the US FDA
• Phase III data readouts expected in H2 2022: pentavalent (MenABCWY) meningitis vaccine candidate, otilimab in rheumatoid arthritis, Jemperli in 1L endometrial cancer, and Blenrep in 3L multiple myeloma

Improving revenues and margin support confidence in full-year outlooks
• Expect 2022 sales growth of between 6% to 8% (previously 5% to 7%) and Adjusted operating profit growth of between 13% to 15% (previously 12% to 14%); both at CER. Adjusted EPS expected to grow by around 1% lower than operating profit. 2022 guidance excludes any contribution from COVID-19 solutions
• Dividend of 16.25p/share (13p before Share Consolidation) declared for Q2 2022. No change to expected dividend of 61.25p/share (49p before Share Consolidation) for FY 2022

Successful demerger and listing of Haleon on 18 July, creating a new global leader in consumer health
• Balance sheet strengthened for GSK, through dividend of more than £7 billion from Haleon

Q2 2022 infographic
Emma Walmsley, Chief Executive Officer, GSK said:
"This is GSK’s first set of results as a newly focused biopharma company, and we have delivered an excellent second quarter performance, with strong growth in Specialty Medicines, including HIV, and a record quarter for our shingles vaccine Shingrix. With this momentum in sales and operating profit growth, we have raised our full-year guidance and are confident in delivering the long-term growth outlooks we set out for shareholders last year. We continue to strengthen our pipeline, notably with very positive high-level results from our late-stage RSV vaccine candidate, together with targeted business development acquisitions of Sierra Oncology and Affinivax. These improvements in R&D and operating performance, together with a strengthened post-demerger balance sheet, create new capacity and flexibility for GSK to invest in growth and innovation for patients and shareholders."

*Earnings per share have been retrospectively adjusted to reflect the GSK Share Consolidation on 18 July 2022, see details on page 53 of the full announcement.
**Consumer Healthcare is now accounted for as a discontinued operation, see details on page 20 of the full announcement.

Plus Therapeutics to Present at Inaugural Targeted Radiopharmaceuticals Summit

On July 27, 2022 Plus Therapeutics, Inc. (Nasdaq: PSTV) (the "Company"), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, reported that Norman LaFrance, M.D., Chief Medical Officer and SVP will give a presentation on the Company’s lead investigational targeted radiotherapeutic, Rhenium-186 NanoLiposome (186RNL), and share updates on the U.S. ReSPECT clinical trials at the inaugural Targeted Radiopharmaceuticals Summit, organized by Hanson Wade, being held July 26-28, 2022 at the Boston Park Plaza in Boston, Massachusetts (Press release, Cytori Therapeutics, JUL 27, 2022, View Source [SID1234616984]).

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Details of presentation:

Title Radiolabeled NanoLiposomes: A Novel Targeted Treatment for Rare and Central Nervous System Cancers
Date July 27, 2022 at 4:30 p.m. ET
Presenter Norman LaFrance, M.D., Chief Medical Officer and SVP at Plus Therapeutics