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
International: 201-493-6784
Conference ID: 13690495
Webcast: View Source

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:

0806644

Replay Dial-in:

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

+1 (412) 317-0088 (International)

+1 (855) 669-9658 (Canada)

Replay Passcode:

10129984 (replay available until May 13, 2019)

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

On May 6, 2019 Syndax Pharmaceuticals, Inc. (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported its financial results for the first quarter ended March 31, 2019. In addition, the Company provided a clinical and business update (Press release, Syndax, MAY 6, 2019, View Source [SID1234535760]). As of March 31, 2019, Syndax had $92.7 million in cash, cash equivalents and short-term investments.

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"We are pleased to report that E2112, our Phase 3 registration trial of entinostat plus exemestane in HR+, HER2- breast cancer, has passed its fourth interim overall survival analysis," said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax. "E2112 was designed to replicate the compelling overall survival results obtained in the Phase 2b ENCORE 301 trial which led to Breakthrough Therapy designation. The next overall survival assessment is expected in the fourth quarter of this year. We remain confident in the potential that the addition of entinostat to exemestane will result in a positive survival benefit, which would allow us to file for full regulatory approval in this indication."

Dr. Morrison added, "We also look forward to filing an IND for SNDX-5613, our targeted menin inhibitor, later this quarter. Supported by a robust preclinical dataset, we believe this therapeutic class has the potential to make a meaningful impact for patients with genetically-defined acute leukemias for whom limited effective therapies exist."

Pipeline Updates

Entinostat

ECOG-ACRIN has informed the Company that following its fourth preplanned interim overall survival (OS) analysis, the E2112 trial will continue as planned until either an OS benefit is observed, or the final target number of events occur. E2112 is Syndax’s NCI-sponsored, ECOG-ACRIN led Phase 3 registration trial of entinostat, a Class I selective HDAC inhibitor, plus exemestane in advanced hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+, HER2-) breast cancer. The next interim analysis for the OS endpoint is scheduled for 4Q19, with a final OS assessment, if necessary, to be conducted in 2Q20. Any positive OS assessment would enable the Company to file for full regulatory approval. The E2112 trial design was informed by the Phase 2b ENCORE 301 trial, the results of which led to entinostat’s Breakthrough Therapy designation in HR+, HER2- breast cancer, in which patients receiving the entinostat/exemestane combination demonstrated a statistically significant OS benefit.

At the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting held March 29 – April 3, 2019, Syndax presented data from the non-small cell lung cancer (NSCLC) and melanoma cohorts of the ENCORE 601 trial of entinostat in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy. These data provided further evidence that the addition of entinostat to pembrolizumab may overcome resistance to immunotherapy in melanoma and NSCLC patients whose disease progressed on or after anti-PD-1 therapy. As the Company has previously indicated, following availability of positive E2112 OS results, it will determine whether to advance its entinostat-PD-1 combination programs into one or more registration trials.

SNDX-5613

Syndax continues to expect to file an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for its targeted menin inhibitor, SNDX-5613, later this quarter, with the initiation of a Phase 1 clinical trial in a defined subset of acute leukemia patients expected to follow shortly thereafter.

SNDX-6352

The Company continues to anticipate initial results from the Phase 1 dose escalation trial of SNDX-6352, Syndax’s anti-CSF-1R monoclonal antibody, in patients with chronic graft versus host disease (cGVHD) in the second half of the year. The objectives of this trial are to evaluate the safety and preliminary efficacy of SNDX-6352 in cGVHD and to identify a recommended Phase 2 dose and schedule.

First Quarter 2019 Financial Results

As of March 31, 2019, Syndax had cash, cash equivalents and short-term investments of $92.7 million and 31.6 million shares and share equivalents issued and outstanding.

In March 2019, Syndax issued 4.5 million shares of its common stock and prefunded warrants at an offering price of $6.00, as well as warrants to purchase up to 4.5 million shares of its common stock, with half at an exercise price of $12.00 per share and the remaining half at an exercise price of $18.00 per share. As a result of the offering, Syndax received aggregate net proceeds of approximately $27.4 million.

First quarter 2019 research and development expenses decreased to $11.3 million from $15.3 million. The first quarter decrease was primarily due to reduced CMC activities and decreased clinical activities.

General and administrative expenses for the first quarter 2019 decreased to $3.9 million from $4.8 million. The decrease was primarily due to decreased pre-commercialization expenses and decreased professional fees.

For the three months ended March 31, 2019, Syndax reported a net loss attributable to common stockholders of $14.3 million or $0.53 per share compared to $19.4 million or $0.79 per share for the prior year period.

Financial Guidance

Today the Company provided operating expense guidance for the second quarter and full year 2019. For the second quarter and full year 2019, research and development expenses are expected to be $9 to $10 million and $46 to $50 million, respectively, and total operating expenses are expected to be $13 to $14 million and $60 to $64 million, respectively.

Conference Call and Webcast

In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Monday, May 6, 2019.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website at www.syndax.com. Alternatively, the conference call may be accessed through the following:

Conference ID: 4292817
Domestic Dial-in Number: 855-251-6663
International Dial-in Number: 281-542-4259
Live Webcast: View Source

For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors section of the Company’s website, www.syndax.com.

On May 6, 2019 Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx, reported its financial results for the three months ended March 31, 2019 and provided a corporate update (Press release, Protalix, MAY 6, 2019, View Source;p=RssLanding&cat=news&id=2397172 [SID1234535759]).

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"In the first three months of 2019, we have continued to execute on enrollment in our PRX-102 studies and have worked to prepare ourselves for a potential accelerated approval path," said Mr. Moshe Manor, Protalix’s President and Chief Executive Officer. "In addition, we are encouraged by the initial pharmacokinetic (PK) data from our BRIGHT study, which were presented at the 15th Annual WORLDSymposiumTM 2019 in February 2019, that demonstrate the potential for PRX-102 to be infused once-monthly, compared to the current treatment regimen of every two weeks."

First Quarter 2019 and Recent Clinical and Corporate Highlights

The Company’s BRIGHT phase III clinical trial of pegunigalsidase alfa, or PRX-102, for the treatment of Fabry disease is currently one patient away from completion of enrollment.

The Company’s BALANCE phase III clinical trial of pegunigalsidase alfa for the treatment of Fabry disease is currently eleven patients away from completion of enrollment.

The Company presented results from the BRIGHT Study at the 15th Annual WORLD Symposium showing that infusion of pegunigalsidase alfa every 4 weeks results in the presence of continuous active enzyme throughout the entire infusion interval.

The Company is scheduled to present three posters during the 6th Update on Fabry Disease international conference being held in Prague, Czech Republic, on May 26-28, 2019.

To date, more than 40 patients are being treated in the Company’s various extension studies after opting to continue treatment with pegunigalsidase alfa after they completed an initial study.

The Company plans to meet with the U.S. Food and Drug Administration (FDA) for a follow up meeting during the second quarter of 2019 in connection with the potential accelerated approval filing path for pegunigalsidase alfa.
First Quarter 2019 Financial Results

The Company recorded total revenues of $10.4 million during the three months ended March 31, 2019, compared to $6.7 million for the same period of 2018. The increase is primary attributable to the recognition of $6.9 million of license revenues in the three months ended on March 31, 2019 compared to the recognition of $2.2 million in the same period of 2018.

Research and development expenses for the three months ended March 31, 2019, were $11.7 million, compared to $7.3 million for the same period in 2018. Selling, general and administrative expenses for the three months ended March 31, 2019 were $2.2 million, compared to $2.5 million incurred during the same period in 2018.

Net loss for the three months ended March 31, 2019 was $7.3 million compared to $7.2 million for the three months ended March 31, 2018.
On March 31, 2019, the Company had $30.4 million of cash and cash equivalents, compared to $37.8 million at March 31, 2018, which is currently projected to fund operations into mid-2020. As of March 31, 2019, the Company had outstanding $57.9 million of its 7.50% convertible promissory notes due November 2021.
Conference Call and Webcast Information

The Company will host a conference call on Monday, May 6, 2019, at 8:30 am ET to review the clinical, corporate and financial highlights.

To participate in the conference call, please dial the following numbers prior to the start of the call: United States: +1-844-358-6760; International: +1-478-219-0004. Conference ID number 6169584.

The conference call will also be broadcast live and available for replay for two weeks on the Company’s website, www.protalix.com, in the Events Calendar of the Investors section. Please access the Company’s website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software.