On July 24, 2019 United Therapeutics Corporation (Nasdaq: UTHR) reported that it will report its second quarter 2019 financial results before the market opens on Wednesday, July 31, 2019 (Press release, United Therapeutics, JUL 24, 2019, View Source [SID1234537722]).

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United Therapeutics will host a teleconference on Wednesday, July 31, 2019, at 9:00 a.m. Eastern Time. The teleconference is accessible by dialing 1-877-351-5881, with international callers dialing 1-970-315-0533. A rebroadcast of the teleconference will be available for one week and can be accessed by dialing 1-855-859-2056, with international callers dialing 1-404-537-3406, and using access code: 3066089.

On July 24, 2019 Boston Scientific Corporation (NYSE: BSX) reported its sales of $2.631 billion during the second quarter of 2019 (Press release, Boston Scientific, JUL 24, 2019, View Source [SID1234537721]). This represents growth of 5.6 percent on a reported basis, 8.0 percent on an operational1 basis and 6.3 percent on an organic2 basis, all compared to the prior year period. The company reported GAAP earnings of $154 million or $0.11 per share (EPS), compared to GAAP earnings of $555 million or $0.40 per share a year ago, and achieved adjusted earnings per share of $0.39 for the period, compared to $0.41 a year ago.

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"The consistent execution of our global teams continues to help us grow the majority of our businesses faster than the market while delivering adjusted EPS at the high end of guidance," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "As highlighted at our Investor Day last month, we are excited for our long-term outlook and our robust pipeline of unique innovations to address unmet patient needs."

Second quarter financial results and recent developments:

Reported second quarter sales of $2.631 billion, representing an increase of 5.6 percent on a reported basis, compared to the company’s guidance range of 5 to 7 percent; 8.0 percent on an operational basis; and 6.3 percent on an organic basis, compared to the company’s guidance range of 6 to 7 percent, all compared to the prior year period.
Reported GAAP earnings of $0.11 per share compared to the company’s guidance range of $0.23 to $0.25 per share, due to acquisition-related charges in the quarter primarily associated with the proposed acquisition of BTG plc. Achieved adjusted earnings per share of $0.39 compared to the guidance range of $0.37 to $0.39 per share.
Achieved second quarter revenue growth in all segments, compared to the prior year period:
MedSurg: 9.0 percent reported, 10.9 percent operational and 7.4 percent organic
Rhythm and Neuro: 1.4 percent reported, 3.3 percent operational and 2.8 percent organic
Cardiovascular: 6.3 percent reported, 9.2 percent operational and 8.1 percent organic
Reported second quarter revenue growth in all regions, compared to the prior year period:
U.S.: 6.0 percent reported and operational
EMEA (Europe, Middle East and Africa): 2.3 percent reported and 8.3 percent operational
APAC (Asia-Pacific): 8.9 percent reported and 13.2 percent operational
Emerging Markets3: 12.3 percent reported and 20.0 percent operational
Initiated randomized study assessing the safety and effectiveness of the ACURATE neo2 Aortic Valve System in intermediate, high and extreme-risk patients indicated for transcatheter aortic valve replacement (TAVR). The results of this trial are expected to serve as the basis of the company’s premarket approval submission to the U.S. Food and Drug Administration (FDA).
Began the global OPTION trial, a study of patients with non-valvular atrial fibrillation who undergo a cardiac ablation procedure, to compare the safety and effectiveness of the next-generation WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device to first-line oral anticoagulants for stroke risk reduction.
Announced and closed the acquisition of Vertiflex, Inc., a privately-held company that developed and commercialized the Superion Indirect Decompression System, a minimally-invasive device used to improve physical function and reduce pain in patients with lumbar spinal stenosis.
Presented two-year results from the INTREPID randomized controlled trial at the 18th Meeting of the World Society for Stereotactic and Functional Neurosurgery. Data demonstrated the safety and effectiveness of the Vercise Deep Brain Stimulation (DBS) System for the treatment of patients with Parkinson’s disease symptoms.
Presented real world data at the International Neuromodulation Society World Congress from 420 chronic pain patients using the Spectra WaveWriter Spinal Cord Stimulation (SCS) System. Results showed two-thirds of patients reported a pain score of two or less at last follow-up, as measured on the zero to 10 numeric rating scale.
Announced acute results from the UNTOUCHED study of the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) System for primary prevention of sudden cardiac death specifically in patients with a left ventricular ejection fraction (LVEF) ≤35 percent, the most common population to be indicated for ICD therapy.4,5 Data presented at the Heart Rhythm Society’s 40th Annual Scientific Sessions demonstrated S-ICD therapy had a complication-free rate of 95.8 percent at 30 days post-procedure and high conversion efficacy (99.2 percent) of induced ventricular fibrillation, rates comparable to those seen in previous S-ICD and transvenous implantable cardioverter-defibrillator (TV-ICD) studies.
Commenced controlled launch in the U.S. and Europe of the LOTUS Edge Aortic Valve System, a minimally invasive TAVR technology for patients with severe aortic stenosis considered to be at high risk for surgical valve replacement via open heart surgery.
Received approval from the United Kingdom’s National Health Service for inclusion of the SpaceOAR Hydrogel in its Innovation and Technology Payment program, expanding treatment access to men undergoing radiotherapy for prostate cancer.
Received FDA clearance for the Tactra Next-Generation Malleable Penile Prosthesis, the first and only penile implant for men with erectile dysfunction to include a nitinol core to optimize rigidity, durability and concealment.
Received FDA approval and launched in the U.S. the VICI VENOUS STENT System for the treatment of iliofemoral venous obstructive disease.
Announced the divestiture of the existing Boston Scientific drug-eluting and bland embolic microsphere portfolio to Varian Medical Systems for an upfront cash payment of $90 million, subject to the successful completion of the company’s proposed acquisition of BTG plc.
1. Operational revenue growth excludes the impact of foreign currency fluctuations.

2. Organic revenue growth excludes the impact of foreign currency fluctuations and sales from the recent acquisitions of NxThera, Inc. (NxThera), Claret Medical, Inc. (Claret), Augmenix, Inc. (Augmenix) and Vertiflex, Inc. (Vertiflex), each with no prior year comparable sales.

3. We define Emerging Markets as the 20 countries that we believe have strong growth potential based on their economic conditions, healthcare sectors and our global capabilities. Periodically, we assess our list of Emerging Markets; effective January 1, 2019, we updated our list of Emerging Market countries. We have revised prior year amounts to the current year’s presentation (as denoted with † throughout). The revision had an immaterial impact on prior year Emerging Markets sales.

4. Friedman, DJ, Parzynski, CS, Varosy, PD, et al., Trends and In-Hospital Outcomes Associated With Adoption of the Subcutaneous Implantable Cardioverter Defibrillator in the United States. JAMA Cardiol, 2016. 1(8): p. 900-911.

5. Haugaa, KH, Tilz, R, Boveda, S, et al., Implantable cardioverter defibrillator use for primary prevention in ischaemic and non-ischaemic heart disease-indications in the post-DANISH trial era: results of the European Heart Rhythm Association survey. Europace, 2017. 19(4): p. 660-664.

Amounts may not add due to rounding. Growth rates are based on actual, non-rounded amounts and may not recalculate precisely.

Sales growth rates that exclude the impact of foreign currency fluctuations and/or the impact of recent aforementioned acquisitions
are not prepared in accordance with U.S. GAAP.

Guidance for Full Year and Third Quarter 2019

The company estimates revenue growth for the full year 2019, versus the prior year period, to be in a range of approximately 7 to 8 percent on a reported basis (consistent with prior guidance), and a growth range of approximately 7 to 8 percent on an organic basis (consistent with prior guidance). Full year organic guidance excludes the impact of foreign currency fluctuations and contribution of approximately 140 basis points from the acquisitions of NxThera, Claret, Augmenix and Vertiflex, each with no prior period related net sales. The company now estimates income on a GAAP basis in a range of $0.94 to $0.98 per share (compared to prior guidance of $1.09 to $1.13 per share) and estimates adjusted earnings, excluding certain charges (credits), in a range of $1.54 to $1.58 per share (consistent with prior guidance).

The company estimates revenue growth for the third quarter of 2019, versus the prior year period, to be in a range of approximately 8 to 10 percent on a reported basis and a growth range of approximately 7.5 to 9 percent on an organic basis. Third quarter organic guidance excludes the impact of foreign currency fluctuations and contribution of approximately 180 basis points from the acquisitions of Claret, Augmenix and Vertiflex, each with no prior period related net sales. The company estimates earnings on a GAAP basis in a range of $0.23 to $0.25 per share and adjusted earnings, excluding certain charges (credits), in a range of $0.37 to $0.39 per share.

Conference Call Information

Boston Scientific management will be discussing these results with analysts on a conference call today at 8:00 a.m. EDT. The company will webcast the call to interested parties through its website: www.bostonscientific.com. Please see the website for details on how to access the webcast. The webcast will be available for approximately one year on the Boston Scientific website.

On July 24, 2019 Varian Medical Systems reported that its Third Quarter 2019 Summary:

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Oncology Systems gross orders grew 2% in dollars, or 4% in constant currency; Trailing twelve months gross orders grew 11% in dollars, or 13% in constant currency
Total company revenues grew 16% in dollars, or 19% in constant currency, to $826 million
GAAP operating earnings declined 48% at 6.5% of revenues; Non-GAAP operating earnings grew 22% at 17.5% of revenues
GAAP net earnings per diluted share of $0.32; Non-GAAP net earnings per diluted share of $1.32
GAAP net earnings include a $51 million impairment charge to Proton Solutions goodwill and $31 million in acquisition related costs
US/China tariffs negatively impacted revenue growth by $10 million or 140 basis points and GAAP operating earnings growth by $15 million and as a percentage of revenues by 170 basis points
Updating fiscal year 2019 guidance; raising revenue growth range to 9% to 10% and narrowing Non-GAAP net earnings per diluted share range to $4.58 to $4.63
Closed the acquisitions of CyberHeart, Cancer Treatment Services International, Endocare, and Alicon
Varian (NYSE: VAR) reported its third quarter fiscal year 2019 results.

"In the third quarter, our team delivered exceptional performance growing Non-GAAP operating earnings faster than revenue," said Dow Wilson, Chief Executive Officer of Varian. "We are also excited about the progress we made in the quarter toward our long-term strategy with additions to our portfolio in technology-enabled services, interventional oncology, and cardiac radioablation."

Non-GAAP net earnings and Non-GAAP net earnings per diluted share are defined as GAAP net earnings and GAAP net earnings per diluted share adjusted to exclude the amortization of intangible assets and amortization of inventory step-up, acquisition-related expenses or benefits and in-process research and development, impairment charges, significant litigation charges or benefits and legal costs, gains and losses on equity investments, and significant non-recurring tax expense or benefit.

The company ended the quarter with $523 million in cash and cash equivalents and $401 million in debt. Net cash provided by operating activities was $130 million, up $28 million, due to increased operating profit and strong collection momentum in the Oncology business. During the quarter, the company invested $49 million to repurchase three hundred and fifty thousand shares of common stock.

Oncology Systems Segment

In the third quarter, Oncology revenues totaled $793 million, up 19%. Operating earnings were $149 million, up 18%. Oncology orders were $778 million, up 2%. Orders in the Americas decreased 1%. In EMEA, orders rose 8%, the eighth consecutive quarter of double-digit growth on a constant currency basis for the region. In APAC, orders decreased 1% with softness across the region except in China, which saw strong double-digit growth.

Proton Solutions Segment

In the third quarter, Proton Solutions revenues totaled $31 million, down 26%. Operating earnings were negatively impacted by a goodwill impairment. Three new orders were taken in the quarter totaling $108 million.

Non-GAAP Adjustments

Varian’s GAAP net earnings include an impairment of $51 million related to the Proton Solutions business, a $21 million charge associated with the write-off of in-process research and development acquired in the CyberHeart acquisition, and $10 million of costs related to the acquisitions of Cancer Treatment Services International, Endocare, Alicon, and the anticipated asset purchase of the Boston Scientific beads portfolio. Together, these costs, and their associated tax effects, reduced Varian’s net earnings in the third quarter of fiscal 2019 by $0.88 per diluted share on a GAAP basis and were excluded from non-GAAP results.

Guidance for Full Fiscal Year 2019

Varian is pleased with the underlying operational performance, progress on tariff mitigation activities to date, and the recent approval by the U.S. Trade Representative to retroactively exclude tariffs on multi-leaf collimators sourced from China. The company is investing more in innovation to drive long-term growth, infrastructure to support the growth, and accelerating investments in recent acquisitions.

The company is raising revenue growth guidance and updating the following guidance for fiscal year 2019:

The guidance assumes a Non-GAAP effective tax rate of 21% to 22% and a weighted average diluted share count of 92 million, unchanged from our original assumptions. The guidance also assumes currency rates as of the beginning of the fiscal fourth quarter of 2019, includes the expected net impact of all tariffs currently in effect, and includes acquisitions announced to date.

Unless otherwise stated, in this release all growth rates are year-over-year, and any references to orders are gross orders. All periods referred to are fiscal periods, and all references to trailing twelve months refer to the trailing twelve months ending on the last day of our most recently completed fiscal quarter. Please refer to "Discussion of Non-GAAP Financial Measures" below for a description of items excluded from expected non-GAAP earnings.

Investor Conference Call

Varian Medical Systems is scheduled to conduct its third quarter fiscal year 2019 conference call at 1:30 p.m. Pacific Time today. To access the live webcast or replay of the call, visit the Investor Relations page on our website at www.varian.com/investors. To access the call via telephone, dial 1-877-869-3847 from inside the U.S. or 1-201-689-8261 from outside the U.S. The replay can be accessed by dialing 1-877-660-6853 from inside the U.S. or 1-201-612-7415 from outside the U.S. and entering conference ID 13691935. The teleconference replay will be available through 5:00 p.m. Pacific Time, Friday, July 26, 2019.

On July 24, 2019 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality innovative medicines for the treatment of oncology, autoimmune and other major diseases, reported that the first patient has been dosed in ORIENT-31, a trial that evaluates Tyvyt (generic name: sintilimab injection), a fully human anti-programmed cell death protein 1 (anti-PD-1) monoclonal antibody co-developed with Eli Lilly and Company, and IBI305, a recombinant humanized anti-vascular endothelial growth factor (anti-VEGF) monoclonal antibody, in combination with chemotherapy backbone in patients with EGFR-mutant non-squamous non-small cell lung cancer(NSCLC) who have progressed from prior treatment with epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) (Press release, Innovent Biologics, JUL 24, 2019, View Source [SID1234537719]).

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The ORIENT-31 study is a randomized, double-blind, multi-center, Phase III trial conducted in China to evaluate the safety and efficacy of Tyvyt and IBI305 in combination with chemotherapy backbone in patients with EGFR-mutant NSCLC who have progressed from EGFR-TKI treatment. 480 patients will be enrolled in the study.

"Lung cancer has the highest incidence and mortality among all malignancies in China. In 2018, there were 2.09 million new cases of lung cancer worldwide, including more than 770,000 new cases in China. NSCLC accounts for about 80% to 85% of all lung cancer cases, and at diagnosis about 70% of NSCLC patients are locally advanced or metastatic. Patients with advanced NSCLC with EGFR mutations are recommended to use EGFR-TKI as first line therapy. However, after progression on first-line TKI therapy, and new treatment options are urgently needed in clinical practice. Immunological checkpoint inhibitors and anti-angiogenic drugs have brought new hope to patients. We hope to validate the therapeutic potential of Tyvyt and IBI305 in combination with chemotherapy in the ORIENT-31 trial," said Professor Shun Lu, Director of the Department of Oncology, Shanghai Chest Hospital.

"China has a huge burden of lung cancer, and nearly 40% of lung cancers worldwide occur in China. The treatment options and efficacy of EGFR-positive NSCLC after EGFR-TKI failure are still very limited, so there is a huge unmet clinical need. Through ORIENT-31 study, we hope to provide effective cancer therapies for our patients," said Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent.

About Tyvyt (sintilimab injection)

Tyvyt (sintilimab injection) is an innovative drug jointly developed in China by Innovent and Eli Lilly and Company. Innovent is also conducting clinical studies of sintilimab injection in the United States. Tyvyt (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-1 Ligand-1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Tyvyt (sintilimab injection) is the only PD-1 antibody in China branded by both a local biopharmaceutical company and a global pharmaceutical company. Tyvyt (sintilimab injection) has been granted marketing approval by the National Medical Products Administration (NMPA) for relapsed or refractory classical Hodgkin’s lymphoma (r/r cHL) and has been included in the 2019 Guidelines of Chinese Society of Clinical Oncology (CSCO) for Lymphoid Malignancies. There are currently more than twenty clinical studies using sintilimab injection, including eight registration studies that evaluate the efficacy of sintilimab injection in other solid tumors.

About IBI305 (bevacizumab biosimilar)

IBI305 is a biosimilar product candidate of bevacizumab and a recombinant humanized anti-VEGF monoclonal antibody for injection. Vascular endothelial growth factor (VEGF) is an important factor in angiogenesis that is highly expressed by the endothelial cells in most human tumors. An anti-VEGF antibody binds VEGF selectively with high affinity and blocks its binding to VEGF receptors on the surface of vascular endothelial cells, thereby inhibiting signaling pathways such as PI3K-Akt/PKB and Ras-Raf-MEK-ERK. Bevacizumab produces anti-tumor effects by inhibiting the growth, proliferation and migration of vascular endothelial cells, blocking angiogenesis, reducing vascular permeability, blocking blood supply to tumor tissues, inhibiting the proliferation and metastasis of tumor cells and inducing apoptosis in tumor cells. The new drug application (NDA) of IBI305 was accepted by the NMPA on January 29, 2019 and has been granted with priority review status.

About ORIENT-31

The ORIENT-31 study is a randomized, double blind, multi-center, Phase III trial conducted in China to evaluate the safety and efficacy of Tyvyt and IBI305 in combination with chemotherapy in patients with EGFR-mutant NSCLC who have progressed from prior EGFR-TKI treatment. Subjects will be 1:1:1 randomized to Group A (sintilimab+IBI305+Chemotherapy backbone), Group B (sintilimab + Chemotherapy backbone) or Group C (Chemotherapy backbone). A total of 480 patients will be enrolled in to the study. The primary endpoint is Progression Free Survival.

About Combination Therapy

The combination of anti-angiogenesis and immune checkpoint inhibitors could produce synergistic antitumor effects. Anti-VEGF blockade enhances antigen-presenting cell (APC) maturation and cytotoxic T cell (CTL) activation, down-regulates myeloid suppressor cells (MDSCs) and regulatory T cell (Treg) populations, and normalizes the tumor blood vessels; all of these effects could promote tumor elimination when combined with an immune checkpoint inhibitor.

On July 24, 2019 Castle Biosciences, Inc. reported the pricing of its initial public offering of 4,000,000 shares of its common stock at a price to the public of $16.00 per share (Press release, Castle Biosciences, JUL 24, 2019, View Source [SID1234537716]). The gross proceeds to Castle Biosciences from the offering, before deducting the underwriting discounts and commissions and offering expenses, are expected to be $64.0 million. The shares are expected to begin trading on The Nasdaq Global Market on July 25, 2019 under the symbol "CSTL." All of the common stock in the offering is being offered by Castle Biosciences. The offering is expected to close on July 29, 2019, subject to customary closing conditions. In addition, Castle Biosciences has granted the underwriters a 30-day option to purchase up to an additional 600,000 shares of common stock.

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SVB Leerink and Baird are acting as joint book-running managers for the offering and as representatives of the underwriters. Canaccord Genuity and BTIG are acting as co-managers for the offering.

Registration statements relating to these securities have been filed with the Securities and Exchange Commission and became effective on July 24, 2019. The offering is being made only by means of a prospectus. Copies of the final prospectus related to the offering, when available, may be obtained from: SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone: (800) 808‐7525, ext. 6132, or by e‐mail: [email protected]; or Robert W. Baird & Co. Incorporated, Attention: Syndicate Department, 777 East Wisconsin Ave., Milwaukee, WI 53202, by telephone: (800) 792-2473, or by email: [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.