Innovus Pharmaceuticals Reports Preliminary Q1 2019 Sales Revenue of Approximately $5.4 million

On May 6, 2019 Innovus Pharmaceuticals, Inc., ("Innovus Pharma") (OTCQB: INNV), reported preliminary first quarter 2019 net revenue is estimated to be $5.4 million or an approximate 12.8% increase from the fourth quarter of 2018 and 18.0% increase from the first quarter of 2018 (Press release, Innovus Pharmaceuticals, MAY 6, 2019, View Source [SID1234535765]). Innovus Pharma’s first quarter 2019 anticipated revenue results are preliminary and based on the most current information available and are subject to completion of the condensed consolidated financial statements for the first quarter of 2019, which are to be filed with the SEC no later than May 15, 2019.

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"We continue to execute on our controlled growth and profitability plan with focusing our growth in profitable sales channels only," stated Bassam Damaj, President and Chief Executive Officer of Innovus Pharma. "The market should also expect to see a more robust ANDA OTC pipeline very soon," continued Dr. Damaj.

The Company will host a conference call on Wednesday, May 15, 2019 at 4:15 p.m. ET/1:15 p.m. PT to discuss the financial results and recent business developments. To participate in the call, please dial 1-877-883-0383 for domestic callers or 1-412-902-6506 for international callers or 1-877-885-0477 for Canadian callers. Participant Elite Entry Number: 0678670. A replay of the call will be available for 30 days. To access the replay, dial 1-877-344-7529 domestically or 1-412-317-0088 internationally or 1-855-669-9658 for Canada and reference Replay Access Code: 10131471. The replay will be available shortly after the end of the conference call

Xencor Doses First Patient in Phase 1 Study of XmAb®23104 for the Treatment of Patients with Advanced Solid Tumors

On May 6, 2019 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer, autoimmune diseases, asthma and allergic diseases, reported that the first patient has been dosed in XmAb23104-01 (DUET-3), a Phase 1 clinical study to evaluate the safety and tolerability of XmAb23104, a bispecific antibody that simultaneously targets the immune receptors PD-1 and ICOS, for the treatment of patients with advanced solid tumors (Press release, Xencor, MAY 6, 2019, View Source [SID1234535764]).

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"Despite the success of checkpoint inhibitors, the benefit of therapy is not universal. We designed XmAb23104 to improve anti-tumor responses through a novel mechanism of action that activates and induces proliferation of T cells through simultaneous checkpoint inhibition and co-stimulation," said Paul Foster, M.D., senior vice president and chief medical officer at Xencor. "Both PD-1 and ICOS are more highly expressed on T cells in the tumor microenvironment than on those in the periphery, and through preferential targeting of cells that express both of these receptors, we hope to be able to drive a stronger anti-tumor response than anti-PD-1 monotherapy with improved tolerability for patients."

DUET-3 is a Phase 1, multiple-dose, dose-escalation study that will characterize the safety and tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and preliminary anti-tumor activity of intravenous administration of XmAb23104 in patients with selected advanced solid tumors. For more information about DUET-3, please visit View Source (identifier: NCT03752398).

About XmAb23104

XmAb23104 is a bispecific antibody that simultaneously targets PD-1, an immune checkpoint receptor, and ICOS, an immune co-stimulatory receptor, and is designed to promote tumor-selective T-cell activation. Xencor’s XmAb bispecific Fc domain serves as the scaffold for these two antigen binding domains and confers long circulating half-life, stability and ease of manufacture. XmAb bispecific Fc domains have been engineered to eliminate Fc gamma receptor (FcγR) binding, with the intent to prevent activation and/or depletion of T cells via engagement by FcγR-expressing cells. XmAb23104 is being evaluated in XmAb23104-01 (DUET-3), a Phase 1 study for the treatment of advanced solid tumors.

VBL Therapeutics to Report First Quarter 2019 Financial Results on May 15

On May 6, 2019 VBL Therapeutics (Nasdaq: VBLT), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class treatments for cancer, reported that it will host a conference call and live audio webcast on Wednesday, May 15 at 8:30am Eastern Time to report first quarter ended March 31, 2019 financial results and to provide a corporate update (Press release, VBL Therapeutics, MAY 6, 2019, View Source [SID1234535763]).

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Wednesday, May 15th @ 8:30am Eastern Time
From the US: 877-407-9208
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Conference ID: 13690495
Webcast: View Source

Bausch Health Companies Inc. Announces First-Quarter 2019 Results And Raises Full-Year Guidance

On May 6, 2019 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company" or "we") reported its first-quarter 2019 financial results (Press release, Valeant, MAY 6, 2019, View Source [SID1234535762]).

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"Bausch Health is off to a strong start in 2019 with the continued growth of XIFAXAN which grew 11% in the quarter, the launch of BRYHALI, the successful acquisition of TRULANCE, and the approval of DUOBRII and expected launch in June. We believe that our promising pipeline and focus on Project CORE (cost optimization and revenue enhancements) has positioned the Company to build on our growth in 2019 and beyond. Strong operational execution is leading us to raise our full-year 2019 revenue and adjusted EBITDA (non-GAAP)1 guidance," said Joseph C. Papa, chairman and CEO, Bausch Health.

"With nearly 60% of our revenues coming from a diversified mix of medical devices, OTC products and prescription and branded generic products that are not exposed to the U.S. branded prescription drug pricing environment, we believe that Bausch Health is uniquely positioned to grow in health care," Mr. Papa continued.

Company Highlights

Executing on Core Businesses and Advancing Pipeline

The Bausch + Lomb/International segment comprised approximately 55% of the Company’s revenue in the first quarter of 2019
Reported revenue in the Bausch + Lomb/International segment increased by 1% compared to the first quarter of 2018; revenue in this segment grew organically1,2 by 8% compared to the first quarter of 2018, due to an increase in volume across all business units particularly in Global Vision Care, Global Consumer and International Rx
The U.S. Food and Drug Administration (FDA) approved LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38%, a new gel formulation for the treatment of postoperative inflammation and pain following ocular surgery, and LOTEMAX SM 0.38% has now launched
Received 510(k) clearance for use of the Tangible Hydra-PEG custom contact lens coating technology with some of its leading Boston gas permeable materials, the Boston XO, Boston XO2, Boston EO and Boston ES lenses, including those utilized in the Zenlens scleral lens family
Acquired the U.S. rights to Eton Pharmaceuticals’ EM-100, an investigational eye drop that, if approved, will be the first over-the-counter preservative-free formulation eye drop for the treatment of ocular itching associated with allergic conjunctivitis
The Salix segment comprised approximately 22% of the Company’s revenue in the first quarter of 2019
XIFAXAN revenue increased by 11% compared to the first quarter of 2018
RELISTOR revenue increased by 30% compared to the first quarter of 2018
Completed the acquisition of certain assets of Synergy Pharmaceuticals Inc. ("Synergy"), including TRULANCE, a treatment for adults with chronic idiopathic constipation and irritable bowel syndrome with constipation (IBS-C), and dolcanatide, an investigational compound that has demonstrated proof-of-concept in treating patients with multiple gastrointestinal conditions, for a cash purchase price, including restructuring, of approximately $190 million and the assumption of certain liabilities
The Ortho Dermatologics segment comprised approximately 7% of the Company’s revenue in the first quarter of 2019
Revenues in the Global Solta business increased by 31% compared to the first quarter of 2018, driven by strong demand of Thermage FLX in Asia Pacific following the launch in the region
BRYHALI has experienced rapid prescription uptake by dermatologists within four months of launch3
The FDA approved DUOBRII Lotion for the topical treatment of plaque psoriasis in adults. DUOBRII is expected to be launched in June 2019
Strategic Capital Allocation and Debt Management

Increased research and development investment by approximately 30% in the first quarter of 2019 vs. the first quarter of 2018
Refinanced $1.5 billion of 2021 and 2023 Senior Unsecured Notes
Reduced debt by >$100 million in the first quarter of 2019 using cash on hand, while still completing the acquisition of certain assets of Synergy
First-Quarter 2019 Revenue Performance
Total reported revenues were $2.016 billion for the first quarter of 2019, as compared to $1.995 billion in the first quarter of 2018, an increase of $21 million, or 1%. Excluding the unfavorable impact of foreign exchange of $59 million, the impact of 2019 acquisition of $6 million and the impact of the 2018 divestitures and discontinuations of $18 million, revenue grew organically1,2 by 5% compared to the first quarter of 2018, driven by organic growth1,2 across the Bausch + Lomb/International and Salix segments.

Bausch + Lomb/International Segment
Bausch + Lomb/International segment revenues were $1.118 billion for the first quarter of 2019, as compared to $1.103 billion for the first quarter of 2018, an increase of $15 million. Excluding the unfavorable impact of foreign exchange of $58 million and the impact of the 2018 divestitures and discontinuations of $14 million, the Bausch + Lomb/International segment grew organically1,2 by approximately 8% compared to the first quarter of 2018, primarily due to higher volumes. Bausch + Lomb/International reported the highest quarter of organic revenue growth2 since the Bausch + Lomb acquisition.

Salix Segment
Salix segment revenues were $445 million for the first quarter of 2019, as compared to $422 million for the first quarter of 2018, an increase of $23 million despite the loss of exclusivity of UCERIS. The increase was primarily driven by XIFAXAN, which grew 11% in the quarter as compared to the first quarter of 2018.

Ortho Dermatologics Segment
Ortho Dermatologics segment revenues were $138 million for the first quarter of 2019, as compared to $140 million for the first quarter of 2018, a decrease of $2 million, or 1%, due to lower volumes primarily driven by the loss of exclusivity of ELIDEL, ZOVIRAX and SOLODYN, mostly offset by 31% revenue growth in the Global Solta business.

Diversified Products Segment
Diversified Products segment revenues were $315 million for the first quarter of 2019, as compared to $330 million for the first quarter of 2018, a decrease of $15 million, or 5%. The decrease was primarily attributable to the previously reported loss of exclusivity for a basket of products.

Operating Income/Loss
Operating income was $287 million for the first quarter of 2019, as compared to an operating loss of $2.281 billion for the first quarter of 2018, an increase in operating results of $2.568 billion. The increase in the Company’s operating results for the first quarter of 2019 reflects: (i) lower impairments and amortization and (ii) the increase in reported revenues and higher gross margins in 2019 as compared to 2018, partially offset by increased research and development spend and increased advertising and promotion spend following the launch of several new products.

Net Loss
Net loss for the three months ended March 31, 2019 was $52 million, as compared to net loss of $2.581 billion for the same period in 2018, a decrease of $2.529 billion. The decrease in net loss is primarily due to: (i) the increase in operating results discussed above, (ii) lower interest expense and (iii) lower loss on extinguishment of debt.

Adjusted net income (non-GAAP)1 for the first quarter of 2019 was $358 million, as compared to $312 million for the first quarter of 2018, an increase of $46 million, or 15%.

Operating Cash
The Company generated $413 million of cash from operations in the first quarter of 2019, as compared to $438 million in the first quarter of 2018, a decrease of $25 million, or 6%, primarily driven by the increase in working capital related to the timing of anticipated sales demand and new product launches, partially offset by the improved operating results discussed above.

EPS
GAAP Earnings Per Share (EPS) Diluted for the first quarter of 2019 was ($0.15), as compared to ($7.36) for the first quarter of 2018.

Adjusted EBITDA (non-GAAP)1
Adjusted EBITDA (non-GAAP) 1 was $851 million for the first quarter of 2019, as compared to $832 million for the first quarter of 2018, an increase of $19 million, or 2%.

2019 Financial Outlook
Bausch Health raised its full-year revenue and Adjusted EBITDA (non-GAAP)1 guidance ranges for 2019:

Raised Full-Year Revenues from $8.30 – $8.50 billion to the range of $8.35 – $8.55 billion
Raised Full-Year Adjusted EBITDA (non-GAAP)1 from $3.35 – $3.50 billion to the range of $3.40 – $3.55 billion
Other than with respect to GAAP Revenues, the Company only provides guidance on a non-GAAP basis. The Company does not provide a reconciliation of forward-looking Adjusted EBITDA (non-GAAP)1 to GAAP net income (loss), due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation. In periods where significant acquisitions or divestitures are not expected, the Company believes it might have a basis for forecasting the GAAP equivalent for certain costs, such as amortization, which would otherwise be treated as non-GAAP to calculate projected GAAP net income (loss). However, because other deductions (such as restructuring, gain or loss on extinguishment of debt and litigation and other matters) used to calculate projected net income (loss) vary dramatically based on actual events, the Company is not able to forecast on a GAAP basis with reasonable certainty all deductions needed in order to provide a GAAP calculation of projected net income (loss) at this time. The amount of these deductions may be material and, therefore, could result in projected GAAP net income (loss) being materially less than projected Adjusted EBITDA (non-GAAP)1. The guidance provided in this section represents forward-looking information, and actual results may vary. Please see the risks and assumptions referred to in the Forward-looking Statements section of this news release. The primary reasons for our change in our 2019 full-year guidance ranges are better than expected base performance and the inclusion of our expectations regarding the newly acquired TRULANCE product.

Additional Highlights

Bausch Health’s cash, cash equivalents and restricted cash were $784 million at March 31, 2019
The Company’s availability under the Revolving Credit Facility was approximately $1.055 billion at March 31, 2019
Conference Call Details

Date:

Monday, May 6, 2019

Time:

8:00 a.m. EDT

Webcast:

View Source

Participant Event Dial-in:

+1 (888) 317-6003 (United States)

+1 (412) 317-6061 (International)

+1 (866) 284-3684 (Canada)

Participant Passcode:

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Replay Dial-in:

+1 (877) 344-7529 (United States)

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Replay Passcode:

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Turning Point Therapeutics and Almac Diagnostic Services Announce Approval of an Investigational Device Exemption for the Companion Diagnostic Assay to the Registrational TRIDENT-1 Clinical Study

On May 6, 2019 Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing novel drugs to address treatment resistance, and Almac Diagnostic Services, a global stratified medicine company, reported approval by the U.S. Food and Drug Administration (FDA) of an investigational device exemption (IDE) for the diagnostic assay that will be used in Turning Point’s registrational phase 2 clinical study (Press release, Turning Point Therapeutics, MAY 6, 2019, View Source [SID1234535761]).

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The next-generation sequencing (NGS) assay is intended for use in identifying patients with ROS1, NTRK1-3 and ALK gene fusions in advanced solid tumors. Clinical investigators will use the diagnostic test to determine molecular eligibility for enrollment into Turning Point’s registrational Phase 2 portion of the global TRIDENT-1 clinical study.

"We are pleased to achieve this important milestone with our partner Almac, moving us closer to the start of our pivotal study for repotrectinib in the second half of 2019," said Athena Countouriotis, M.D., president and chief executive officer. "With a clear unmet medical need for therapies that target genomic alterations in different cancers, the diagnostic assay will provide clinical investigators with timely information to confirm the presence of the oncogenic drivers we continue to study in patients with advanced solid tumors."

Almac has been developing the NGS diagnostic based on Archer Dx’s Anchored Multiplex PCR (AMP) chemistry, with the intent of submitting it for regulatory approval in the United States and using it initially at Almac’s CLIA-accredited laboratory in Durham, N.C. to identify tumors with the targeted gene fusions, enabling physicians to select appropriate patients for treatment with repotrectinib.

"We are very pleased to have been granted IDE approval by the FDA for the development and validation of this complex NGS diagnostic assay for its intended use as a clinical trial assay," said Paul Harkin, president and managing director, Almac Diagnostic Services. "We are delighted to assist Turning Point Therapeutics with this important upcoming clinical study, and furthering our partnership to progress such a promising investigational therapy as repotrectinib."

Repotrectinib is an investigational, next-generation tyrosine kinase inhibitor (TKI) developed for the treatment of patients with advanced solid tumors harboring ROS1, NTRK1-3 or ALK molecular rearrangements. Repotrectinib is a rationally designed, low molecular weight, macrocyclic TKI that is much smaller than current ROS1, TRK family and ALK inhibitors with the objective to systematically overcome the clinically acquired resistance mutations of ROS1, TRK family and ALK kinases, especially the gatekeeper and solvent front mutations.

Turning Point Therapeutics’ TRIDENT-1 Phase 2 open-label, multi-cohort study is planned for initiation in the second half of 2019.

About Almac Diagnostic Services

Almac Diagnostic Services is a global stratified medicine company specializing in biomarker driven clinical trials. The company is focused on the discovery, development and commercialization of diagnostic and companion diagnostic tests. Almac partners with biopharma companies to provide solutions ranging from biomarker discovery to CDx development including regulatory submissions and commercialization. Almac also facilitates biomarker clinical trial management and clinical test delivery from its CLIA-accredited labs. The tests developed at Almac Diagnostic Services have a wide range of applications including patient selection, and are utilized in phase I to phase III registrational clinical trials. For more information visit: www.almacgroup.com/diagnostics