VBI Vaccines Announces Second Quarter 2018 Financial Results and Provides Corporate Update

On July 26, 2018 VBI Vaccines Inc. (NASDAQ: VBIV) ("VBI"), a commercial-stage biopharmaceutical company developing next-generation infectious disease and immuno-oncology vaccines, reported financial results for the second quarter ending June 30, 2018, and provided a corporate update (Press release, VBI Vaccines, JUL 26, 2018, View Source [SID1234527881]).

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"We continue to make strong progress in all three of our lead clinical programs," said Jeff Baxter, President and CEO of VBI. "Our pivotal Phase 3 program of Sci-B-Vac, our hepatitis B vaccine, is advancing well towards topline data from the PROTECT study expected mid-year 2019. Our eVLP technology-based pipeline showed exciting results in the clinic in May, when we reported positive final safety and immunogenicity data from our Phase 1 randomized study of VBI-1501 for CMV. This study was the first in-human study of a vaccine developed with our eVLP technology. We were excited to be able to demonstrate a robust immunologic response at a dose that is one-tenth the amount of other organizations’ CMV vaccine candidates. For our immuno-oncology pipeline, also developed with our eVLP technology, we look forward to reporting initial immunologic data from the Phase 1/2a study of VBI-1901 in recurrent GBM patients, which we expect in the second half of this year."

Recent Highlights and Upcoming Milestones
Sci-B-Vac for Hepatitis B
Sci-B-Vac, the Company’s Hepatitis B vaccine, is currently being studied in a pivotal Phase 3 clinical program in the U.S., Europe, and Canada. This program consists of two concurrent Phase 3 studies, the PROTECT study and the CONSTANT study.
Topline data from the PROTECT study are expected mid-year 2019, with topline data from the CONSTANT study expected in the second half of 2019.
The results from this pivotal Phase 3 program are intended to support future regulatory filings in the U.S., Europe, and Canada.

VBI-1501 for Congenital Cytomegalovirus (CMV)
In May 2018, VBI reported positive safety and immunogenicity data from a Phase 1 randomized, observer-blind, placebo-controlled study designed to evaluate the safety, tolerability, and immunogenicity of VBI-1501 in 128 CMV-negative, healthy adults aged 18-40 years.

Subjects were randomized into five arms to receive various dose levels of a modified form of the CMV gB antigen, gB-g, with or without the adjuvant alum, or to receive placebo. The highest does of antigen tested was 2.0μg of gB-g content with alum (VBI-1501A 2.0μg).
The final Phase 1 study results demonstrated that VBI-1501A was safe and well-tolerated at all doses.
VBI-1501A 2.0μg elicited CMV-neutralizing antibodies against fibroblast cell infection in 100% of subjects after the third vaccination (85% after two vaccinations), inducing titers comparable to those observed in patients protected as a result of natural infection (CMV-positive controls).
In epithelial cells, which have historically been the much harder cell type to protect against infection, VBI-1501A 2.0μg demonstrated a 31% neutralizing antibody seroconversion rate after three vaccinations, up from 17% after two vaccinations.
Discussions with regulatory bodies are planned for the second half of 2018 to discuss the next stage of development for VBI-1501A.

VBI-1901 for Glioblastoma (GBM)
A Phase 1/2a Clinical Study of VBI-1901 for the treatment of recurrent glioblastoma (rGBM) is ongoing.
The multi-center, open-label, two-part study will enroll up to 28 patients and is designed to evaluate safety, tolerability, and the optimal therapeutic dose level of VBI-1901.
Extensive biomarker testing and tumor imaging is built into this clinical protocol to enable the Company to assess the robustness of the immune response induced by VBI-1901.
In the second half of 2018, VBI hopes to be able to correlate this immunologic and biomarker data with initial clinical outcomes from the low and mid dose cohorts, and expects 6-month overall survival (OS) and progression-free survival (PFS) data in the first half of 2019.

First Quarter 2018 Financial Results
VBI ended the second quarter of 2018 with $41.1 million in cash and cash equivalents compared with $67.7 million as of December 31, 2017. Net cash used in operations for the six months ended June 30, 2018 was $24.5 million.
Revenue for the second quarter of 2018 was $0.2 million and was primarily attributable to sales of Sci-B-Vac in Israel and in Europe, on a named-patient basis. Revenue for the second quarter of 2017 was $0.3 million and was primarily attributable to sales of Sci-B-Vac in Israel and to a services agreement that was completed during that time frame.
Research and development expenses were $10.9 million for the second quarter of 2018, as compared to $4.5 million for the same period in 2017. The increase was primarily due to the continuation of the Phase 3 program for Sci-B-Vacand the Phase 1/2a clinical study for VBI-1901 in recurrent GBM patients, but was partially offset by the reduction in research expenses due to the advancement of VBI-1901 into clinical development from pre-clinical development.

General and administrative expenses were $4.0 million for the second quarter of 2018, as compared to $2.8 million for the same period in 2017. The increase was primarily due to human resources expenses, stock-based compensation expenses, and impairment related to leasehold improvements and manufacturing equipment no longer being utilized in the business as a result of the renovation and capacity increases of our manufacturing facility in Rehovot, Israel.

Net loss and net loss per share for the second quarter of 2018 were $16.7 million and $0.26, respectively, compared to a net loss of $9.0 million and a net loss per share of $0.22 for the second quarter of 2017.

Halozyme Therapeutics To Participate In Upcoming Healthcare Conference

On July 26, 2018 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that it will be presenting at the Canaccord Genuity 38th Annual Growth Conference in Boston on Thursday, August 9 at 12:00 p.m. ET/9:00 a.m. PT. Laurie Stelzer, senior vice president and chief financial officer, will provide a corporate overview (Press release, Halozyme, JUL 26, 2018, View Source [SID1234527903]).

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A webcast of the presentation can be accessed through the "Investors" section of www.halozyme.com, and a recording will be made available for 90 days following the event. To access a live webcast, please visit Halozyme’s website approximately 15 minutes prior to the presentation to register and download any necessary audio software.

West Announces Second-Quarter 2018 Results

On July 26, 2018 West Pharmaceutical Services, Inc. (NYSE: WST) reported its financial results for the second-quarter 2018 and reaffirmed financial guidance for full-year 2018 (Press release, West Pharmaceutical Services, JUL 26, 2018, View Source [SID1234527882]).

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Executive Summary

Second-quarter 2018 reported net sales of $447.5 million grew 12.6% over the prior-year quarter. At constant currency, organic sales growth was 9.0%.
Second-quarter 2018 reported-diluted EPS was $0.75, as compared to $0.51 in the same period last year. Excluding restructuring charges and a non-recurring tax benefit, second-quarter 2018 adjusted-diluted EPS was $0.70, as compared to adjusted-diluted EPS of $0.66 in the same period last year.
The Company reaffirms full-year 2018 net sales guidance range of $1.720 billion to $1.730 billion and full-year 2018 adjusted-diluted EPS range of $2.80 to $2.90.
Last week, West officially opened its Waterford, Ireland facility, a global center of excellence for West’s advanced manufacturing network. The Waterford site will also be among the first in West’s global manufacturing network to commercialize Westar Select, the latest in its portfolio of high-value product solutions.
"Adjusted-diluted EPS," "net sales at constant currency" and "organic sales" are Non-GAAP measurements. See discussion under the heading "Non-GAAP Financial Measures" in this release.

Executive Commentary

"Second-quarter 2018 sales performance was fueled by solid Proprietary Products segment sales, led by double-digit high-value products growth, and robust growth in the Contract-Manufactured Products segment," said Eric M. Green, President and Chief Executive Officer. "The Generics market unit generated double-digit sales growth and, as expected, the Pharma and Biologics market units had improved sales growth over the first-quarter 2018.

"We expanded both gross profit and reported- and adjusted-operating profit margins. A combination of high-value product sales growth and cost efficiencies more than offset unabsorbed overhead at our Waterford facility, as well as start-up costs and low-margin tooling sales associated with increasing customer demand in our Contract-Manufactured Products segment."

Mr. Green concluded, "With a solid second-quarter, we are on track to achieve our full-year 2018 organic sales growth and adjusted earnings targets. Our markets are stable, and West continues to address the needs of our customers by providing the quality, availability and scientific excellence required to support their regulated injectable and diagnostic products."

Second-Quarter Financial Results (comparisons to prior-year period)

Second-quarter 2018 reported net sales of $447.5 million grew 12.6% over the prior-year quarter. At constant currency, organic sales growth was 9.0%.

Proprietary Products segment organic sales growth was 6.9%. By market unit, second-quarter 2018 Proprietary Products segment sales growth was led by double-digit growth in Generics and high-single digit growth in Pharma, along with low-single digit growth in Biologics. High-value products returned to double-digit organic sales growth, led by solid adoption in the Pharma and Generics market units.

Contract-Manufactured Products segment organic sales growth was 16.9%, despite the loss of a consumer-product contract manufacturing customer in early 2018. This growth was fueled by demand for diagnostic and drug delivery devices, offsetting declines in the mature consumer-product category. Second-quarter 2018 performance also benefited from timing of tooling orders, as well as initial orders from recent competitive takeaways.

Second-quarter 2018 gross profit margin was 31.8%, compared to 31.4% in the same period last year, an increase of 40 basis points. Correlated with double-digit sales of high-value products, Proprietary Products segment gross margin increased year-over-year by 180 basis points, more than offsetting unabsorbed overhead from the start-up of our Waterford facility. Contract-Manufactured Products segment gross margin declined year-over-year by 370 basis points due to unabsorbed overhead from plant consolidation activities and start-up costs associated with the launch of new programs.

The Company has adopted new rules for pension accounting. Instead of recognizing pension gains or losses in the "Selling, general and administrative expenses" line on the income statement, these gains or losses are now located "below the line" in nonoperating income. The Company has restated all prior periods to allow year-over-year comparisons with 2018 performance.

Second-quarter 2018 reported operating profit margin was 13.5%, as compared to 10.6% in the same period last year. Excluding restructuring charges and charges associated with the Venezuela deconsolidation last year, second-quarter 2018 adjusted operating profit margin was 14.0%, compared to 13.4% in the same period last year. Higher gross profit margin, coupled with lower other expense, more than offset moderately higher SG&A expense as a percentage of reported net sales. SG&A expense in the second-quarter 2018 was higher than the same period last year due to increased accruals for incentive compensation and the impact of changes in foreign currency exchange rates.

For the second-quarter 2018, reported income tax expense was $6.0 million, representing a reported effective tax rate of 9.9%. Excluding benefits associated with a reduction in the estimated liability that we recorded in 2017 in anticipation of U.S. tax reform and the impact of restructuring charges, the adjusted income tax expense in the quarter was $11.4 million. Tax benefits from stock-based compensation were $3.4 million in the second-quarter 2018, as compared to $9.6 million in the same period last year. Excluding tax benefits from stock-based compensation and restructuring and related charges, the adjusted income tax rate would have been 24% in the second-quarter 2018.

During the second-quarter 2018, the Company repurchased 260,000 shares of common stock at a cost of $22.9 million under its share repurchase program. The second-quarter 2018 repurchase completes the 800,000 share repurchase program authorized by our Board of Directors.

Full-Year 2018 Financial Guidance

The Company reaffirms full-year 2018 net sales guidance range of $1.720 billion to $1.730 billion. The Company assumes an expected translation exchange rate of $1.15 per Euro for the second half of 2018, as compared to a prior expectation of $1.20 per Euro.

The Company also reaffirms full-year 2018 adjusted-diluted EPS guidance to be in a range of $2.80 to $2.90. The Company estimates, excluding tax benefits from stock-based compensation, a full-year effective tax rate of 24.5%.

The Company is revising its 2018 capital spending guidance to be in a range of between $120 million and $130 million, as compared to prior guidance of less than $150 million. Successful progress by our Global Operations team in managing our worldwide network of manufacturing plants in a consolidated, comprehensive system is driving efficiencies and better capacity utilization. This also results in lower infrastructure capital spending requirements to support the same future sales and profit growth goals of the Company.

Second-Quarter Conference Call

The Company will host a conference call to discuss the results and business expectations at 9:00 a.m. Eastern Time today. To participate on the call please dial 877-930-8295 (U.S.) or 253-336-8738 (International). The conference ID is 6196359.

A live broadcast of the conference call will be available at the Company’s website, www.westpharma.com, in the "Investors" section. Management will refer to a slide presentation during the call, which will be made available on the day of the call. To view the presentation, select "Presentations" in the "Investors" section of the Company’s website.

An online archive of the broadcast will be available at the website three hours after the live call and will be available through Thursday, August 2, 2018, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International) and entering conference ID 6196359.

Forward-Looking Statements

Certain forward-looking statements are included in this release. They use such words as "reaffirmed," "reaffirms," "will," "on track," "achieve," "expected," "increasing," "to be," "continue," "continues," "assumes," "offsetting," "estimates," "revising" and other similar terminology. These statements reflect management’s current expectations regarding future events and operating performance and speak only as of the date of this release. There is no certainty that actual results will be achieved in-line with current expectations. These forward-looking statements involve a number of risks and uncertainties. The following are some of the factors that could cause our actual results to differ materially from those expressed in or underlying our forward-looking statements: customers’ changing inventory requirements and manufacturing plans; customer decisions to move forward with our new products and product categories; average profitability, or mix, of the products we sell; dependence on third-party suppliers and partners; interruptions or weaknesses in our supply chain; increased raw material costs; fluctuations in currency exchange; and the ability to meet development milestones with key customers. This list of important factors is not all inclusive. For a description of certain additional factors that could cause the Company’s future results to differ from those expressed in any such forward-looking statements, see Item 1A, entitled "Risk Factors," in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017.

Except as required by law or regulation, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise.

Non-GAAP Financial Measures

This press release and the preceding discussion of the Company’s results, financial guidance, and the accompanying financial tables use the following financial measures that have not been calculated in accordance with U.S. generally accepted accounting principles (GAAP), and therefore are referred to as Non-GAAP financial measures:

Net sales at constant currency (organic sales growth)
Adjusted operating profit
Adjusted operating profit margin
Adjusted income tax expense
Adjusted net income
Adjusted diluted EPS
Net debt
Total invested capital
Net debt-to-total invested capital
The Company believes that these Non-GAAP measures of financial results provide useful information to management and investors regarding business trends, results of operations, and the Company’s overall performance and financial position. The Company’s executive management team uses these financial measures to evaluate the performance of the Company in terms of profitability and efficiency, to compare operating results to prior periods, to evaluate changes in the operating results of each segment, and to measure and allocate financial resources to its segments. The Company believes that the use of these Non-GAAP financial measures provides an additional tool for investors to use in evaluating ongoing operating results and trends in comparing its financial measures with other companies.

The Company’s executive management does not consider such Non-GAAP measures in isolation or as an alternative to such measures determined in accordance with GAAP. The principal limitation of these financial measures is that they exclude significant expenses and income that are required by GAAP to be recorded. In addition, they are subject to inherent limitations as they reflect the exercise of judgment by management about which items are excluded. To compensate for these limitations, Non-GAAP financial measures are presented in connection with GAAP results. The Company urges investors and potential investors to review the reconciliations of its Non-GAAP financial measures to the comparable GAAP financial measures, and not to rely on any single financial measure to evaluate the Company’s business.

Net sales at constant currency translates the current-period reported sales of subsidiaries whose functional currency is other than the U.S. dollar at the applicable foreign exchange rates in effect during the comparable prior-year period. In calculating adjusted operating profit, adjusted operating profit margin, adjusted income tax expense, adjusted net income and adjusted diluted EPS, the Company excludes the impact of items that are not considered representative of ongoing operations. Such items may include restructuring and related costs, certain asset impairments, other specifically-identified gains or losses, and discrete income tax items. A reconciliation of these adjusted Non-GAAP financial measures to the comparable GAAP financial measures is included in the accompanying tables.

The following is a description of the items excluded from adjusted operating profit, adjusted income tax expense, adjusted net income, and adjusted-diluted EPS for the three and six months presented in the accompanying tables:

Restructuring and related charges – During the three months ended June 30, 2018, the Company recorded $2.2 million in restructuring and related charges, consisting of $1.3 million for severance charges, $0.3 million for non-cash asset write-downs, and $0.6 million for other charges. During the six months ended June 30, 2018, the Company recorded $5.5 million in restructuring and related charges, consisting of $3.3 million for severance charges, $0.4 million for non-cash asset write-downs, and $1.8 million for other charges. The plan will require restructuring and related charges in the range of $8.0 million to $13.0 million and capital expenditures in the range of $9.0 million to $14.0 million. Once fully completed, we expect that the plan will provide the Company with annualized savings in the range of $17.0 million to $22.0 million.

Tax law changes – During the three and six months ended June 30, 2018, the Company recorded a net tax benefit of $4.8 million to reflect a reduction to its one-time mandatory deemed repatriation tax of post-1986 undistributed foreign subsidiary earnings and profits. In April 2018, the U.S. Internal Revenue Service issued guidance, which provided that certain foreign taxes accrued by specified corporations in the toll tax year reduce post-1986 earnings and profits. In addition, during the six months ended June 30, 2018, the Company recorded a net tax charge of $0.3 million to adjust its estimated impact of the 2017 Tax Act. During the three and twelve months ended December 31, 2017, the Company had recorded a provisional charge for the estimated impact of the 2017 Tax Act, based upon its then-current understanding of the 2017 Tax Act and the guidance available at the time. The Company will continue to actively monitor the developments relating to the 2017 Tax Act and will adjust its estimate as necessary during the one-year measurement period.

Venezuela deconsolidation – During the three and six months ended June 30, 2017, as a result of the continued deterioration of conditions in Venezuela as well as its continued reduced access to U.S. dollar settlement controlled by the Venezuelan government, the Company recorded a charge of $11.1 million related to the deconsolidation of its Venezuelan subsidiary, following its determination that it no longer met the GAAP criteria for control of that subsidiary. As of April 1, 2017, the Company’s consolidated financial statements exclude the results of its Venezuelan subsidiary.

Histogenics Corporation to Report Second Quarter 2018 Financial Results on August 9, 2018

On July 26, 2018 Histogenics Corporation (Nasdaq:HSGX), a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function, reported it will report its second quarter 2018 financial results on August 9, 2018, before the U.S. financial markets open (Press release, Histogenics, JUL 26, 2018, View Source;p=RssLanding&cat=news&id=2360280 [SID1234527904]).

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The Company will host a conference call on Thursday, August 9, 2018 at 8:30 a.m. EDT. To access the live call, please dial (877) 930-8064 (domestic) or (253) 336-8040 (international) and provide the conference ID "6679509" five to ten minutes before the start of the call.

A live audio webcast of the presentation will be available via the "Investor Relations" page of the Histogenics website, www.histogenics.com, or by clicking here. A replay of the webcast will be archived on Histogenics’ website for approximately 45 days following the call.

Genprex Enters Agreement with the University of Texas MD Anderson Cancer Center to Study Oncoprex in Combination with Immunotherapies

On July 26, 2018 Genprex, Inc. (NASDAQ:GNPX), a clinical stage gene therapy company developing a new approach to treating cancer based upon a novel proprietary technology platform, reported that it has entered a Sponsored Research Agreement ("Agreement") with The University of Texas MD Anderson Cancer Center under which Genprex will sponsor a pre-clinical study, entitled "A Novel Therapeutic Approach for the Treatment of Cancer Using a Combination of the Multifactorial Tumor Suppressor Gene TUSC2 and Immunotherapy," to be conducted under the direction of Jack A. Roth, MD, FACS (Press release, Genprex, JUL 26, 2018, View Source [SID1234529158]). TUSC2 is the active agent in Genprex’s investigational drug candidate Oncoprex.

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The study, which is built upon strong data from pre-clinical research conducted at MD Anderson, is intended to develop a novel therapeutic approach for the treatment of cancer using a combination of the multifactorial tumor suppressor gene TUSC2 and immunotherapy, including the immune checkpoint inhibitors anti-PD1 and/or anti CTLA-4. The study will include the identification of biomarkers to predict the response to TUSC2-immunotherapy combinations.

Under the Agreement, MD Anderson will provide all necessary personnel, equipment, supplies, facilities and resources to perform the study; and Genprex will pay MD Anderson an amount equal to its expenditures and reasonable overhead in conducting the study in an amount of $2.0 million.

"This research program will evaluate the ability of TUSC2 gene therapy to synergistically enhance the effect and clinical utility of anti-PD1 and/or anti-CTLA-4 therapies," said Rodney Varner, Chairman and Chief Executive Officer of Genprex. "Identifying biomarkers that can predict response rates for Oncoprex-immunotherapy combinations may allow us to explore the utility of this treatment regimen in a broader array of cancers."

Varner added, "While immunotherapies represent an important advance in treating cancer, even in highly immunogenic tumors, the majority of patients do not respond to checkpoint inhibition. Combination therapies targeting multiple anti-cancer pathways represent a promising approach to achieving greater response rates, and may also allow the expanded use of immunotherapies in a larger population of cancer patients who are not currently candidates for these treatments."

Researchers at MD Anderson reported data from preclinical research at the 2017 meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) demonstrating that TUSC2 alone or in combination with checkpoint blockade (anti-PD-1 and/or anti-CTLA4) significantly prolonged mouse survival in a non-small cell lung cancer metastasis model compared to checkpoint blockade alone. The greatest increase in survival was seen with TUSC2 combined with checkpoint blockade. The treatment response was associated with high infiltration of natural killer (NK) cells and CD8 T cells, and low infiltration of myeloid-derived suppressor cells (MDSC) in the tumor microenvironment.