Geron to Announce Third Quarter 2018 Financial Results on November 1, 2018

On October 25, 2018 Geron Corporation (Nasdaq: GERN) reported that it will release its third quarter 2018 financial results after the market closes on Thursday, November 1, 2018 (Press release, Geron, OCT 25, 2018, View Source [SID1234530148]). The financial press release will be available on the Company’s website at www.geron.com/investors. Geron will host a conference call to discuss the third quarter results and recent events at 4:30 p.m. ET the same day.

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Participants may access the conference call live via telephone by dialing domestically +1 (877) 303-9139 or internationally +1 (760) 536-5195. The passcode is 7133129. Participants are advised to dial in at least 10 minutes prior to minimize any delay in joining the call. A live, listen-only webcast will also be available on the Company’s website at www.geron.com/investors/events. If you are unable to listen to the live call, an archived webcast will be available on the Company’s website for 30 days.

West Announces Third-Quarter 2018 Results

On October 25, 2018 West Pharmaceutical Services, Inc. (NYSE: WST) reported its financial results for the third-quarter 2018 and reaffirmed net sales and adjusted-diluted EPS guidance for full-year 2018 (Press release, West Pharmaceutical Services, OCT 25, 2018, View Source [SID1234530149]).

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Executive Summary

Third-quarter 2018 reported net sales of $431.7 million grew 8.4% over the prior-year quarter. At constant currency, organic sales growth was 9.6%.
Third-quarter 2018 reported-diluted EPS was $0.73, as compared to $0.67 in the same period last year. Excluding restructuring-related and other charges, third-quarter 2018 adjusted-diluted EPS was $0.76, a 13% increase over the same period last year.
The Company reaffirms full-year 2018 net sales and adjusted-diluted EPS guidance. The Company expects full-year 2018 capital spending to be in a new range of between $110 million and $120 million, compared to a prior range of between $120 million and $130 million.
"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

"We had solid third-quarter 2018 organic sales growth driven by a high-single digit Proprietary Products segment increase and a strong double-digit increase in the Contract-Manufactured Products segment," said Eric M. Green, President and Chief Executive Officer. "Our high-value product (HVP) portfolio continues to do well, led by strong double-digit sales growth in our Westar RS and RU, NovaPure and Crystal Zenith products.

"I am pleased with the performance of our Global Operations team, which is successfully executing on all of their planned initiatives. The Company continues to raise the bar on industry-leading quality and service targets, and the team is expanding capacity to support long-term demand forecasts by increasing plant utilization within our worldwide network. As a result, we are revising our capital spending guidance to be in a new range of between $110 million and $120 million, down from prior projections of $120 million to $130 million."

Mr. Green concluded, "We remain on track to achieve our full-year 2018 financial 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."

Third-Quarter 2018 Financial Results (comparisons to prior-year period)

Third-quarter 2018 reported net sales of $431.7 million grew 8.4% over the prior-year quarter sales of $398.2 million. At constant currency, organic sales growth was 9.6%.

Proprietary Products segment organic sales growth was 6.6%. By market unit, third-quarter 2018 Proprietary Products segment sales growth was led by double-digit growth in the Pharma Market Unit. Generics Market Unit organic sales growth was mid-single digits, and Biologics Market Unit organic sales declined mid-single digits. Biologics sales were impacted by a decline in self-injection delivery device sales associated with lower than expected commercial sales of the underlying drug product. Contract-Manufactured Products segment organic sales growth was 20.1%. This growth was driven by continued escalation of demand for diabetes-related diagnostic and drug delivery devices.

Third-quarter 2018 gross profit margin was 31.4%, in line with the same period last year. Proprietary Products segment gross margin increased by 120 basis points, due to higher efficiencies, favorable volume/mix and increased sales prices, partially offset by increased labor costs, unabsorbed overhead from the start-up of our Waterford facility and higher raw material costs. Contract-Manufactured Products segment gross margin declined by 200 basis points mainly due to unabsorbed overhead from plant consolidation activities and start-up costs associated with the expediting of the launch of new programs. We expect margins in that segment to revert to more normal levels going forward.

As of January 1, 2018, the Company 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.

Third-quarter 2018 reported operating profit margin was 14.1%, as compared to 15.8% in the same period last year. Excluding restructuring costs and other charges, third-quarter 2018 adjusted operating profit margin was 14.6%. In the third-quarter 2017, the Company had a benefit from reimbursed costs associated with a technology that was subsequently licensed to a third party, which increased other operating income in the period by $9.1 million. Excluding this prior year benefit, third-quarter 2018 adjusted operating profit margin would have expanded by 110 basis points.

For the third-quarter 2018, reported income tax expense was $8.0 million, representing a reported effective tax rate of 13.1%. Tax benefits from stock-based compensation were $7.7 million in the third-quarter 2018, as compared to $4.8 million in the same period last year. This amount was higher-than-expected for the quarter, as prior Company guidance anticipated $9 million for the second-half of 2018. The Company expects the remainder to come in the fourth-quarter 2018. Excluding the impact of tax benefits from stock-based compensation, the reported effective tax rate would have been 25.7%.

Full-Year 2018 Financial Guidance and Long-Term Outlook

The Company is reaffirming its 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 remainder of the year.

The Company is also reaffirming its full-year 2018 adjusted-diluted EPS guidance to be in a range of between $2.80 to $2.90. The lower end of the guidance range reflects the Company’s expected performance and approximately $1 million of tax benefits from stock-based compensation in the fourth-quarter of 2018.

The Company is revising its full-year 2018 capital spending guidance. The new range is expected to be in a range of between $110 million and $120 million, which is below the prior range of between $120 million and $130 million.

For 2019 and beyond, the Company reiterates its long-term financial construct and expectations for above-market sales growth with expanding gross and operating profit margins. As has been its practice, the Company will provide full-year 2019 guidance on its Q4 2018 conference call.

Third-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 8341499.

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, November 1, 2018, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International) and entering conference ID 8341499.

Can-Fite to Present on its Liver Cancer Drug Namodenoson at the NYC Oncology Investor Conference

On October 25, 2018 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address liver and inflammatory diseases, reported that its CEO, Dr. Pnina Fishman, will present at The NYC Oncology Investor Conference 2018 View Source to take place on October 30-31 (Press release, Can-Fite BioPharma, OCT 25, 2018, View Source [SID1234530150]). Her lecture will be delivered on the 31st at 11:40 am.

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Dr. Fishman will present the molecular mechanism mediating the anti-cancer effects of Namodenoson and will describe clinical data from the Company’s earlier Phase I/II liver cancer study. In addition, she will present the status of the current Phase II study in patients with advanced hepatocellular carcinoma, Child Pugh B.

The global Phase II study is being conducted in the U.S., Europe and Israel. Patients with advanced HCC, Child Pugh B, who failed Nexavar (sorafenib) as a first line treatment are treated twice daily with 25 mg of oral Namodenoson or placebo using a 2:1 randomization. The primary endpoint of the Phase II study is Overall Survival (OS). Secondary endpoints include Progression Free Survival (PFS), safety, and the relationship between outcomes and A3AR expression.

Advanced liver cancer is categorized into 3 subclasses including Child Pugh A, mostly treated with Nexavar, Child Pugh B and Child Pugh C. Although a few drugs for the treatment of advanced liver cancer have recently launched, none are specifically aimed at treating patients who have reached the Child Pugh B stage. This represents a major unmet need and potentially positions Namodenoson as an important drug candidate to treat this patient population.

Accumulated safety data to date continues to indicate a favorable safety profile, with no clinically significant novel or emerging events attributed to chronic treatment with Namodenoson.

"We are pleased to present at the NYC Oncology Conference and share with investors our unique approach to treat patients with advanced HCC. This tumor is resistant to chemotherapy whereas Namodenoson has shown in an earlier pre-clinical study to induce specific apoptosis towards the liver cancer cells while sparing the normal liver cells," commented Dr. Pnina Fishman, company CEO.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

Aurinia Pharmaceuticals to Release Third Quarter Financial Results and General Business Updates on November 8, 2018

On October 25, 2018 Aurinia Pharmaceuticals Inc., (NASDAQ:AUPH) (TSX:AUP) reported that it will release its third quarter 2018 financial results on Thursday, November 8, 2018, after the market closes (Press release, Aurinia Pharmaceuticals, OCT 25, 2018, View Source [SID1234530151]). Aurinia’s management will host a conference call to discuss the company’s third quarter 2018 financial results and provide a general business update.

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The conference call and webcast is scheduled for November 8, 2018 at 4:30pm EDT. In order to participate in the conference call, please dial +1-877-407-9170 (Toll-free U.S. & Canada). An audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com. A replay of the webcast will be available on Aurinia’s website.

PROVECTUS ANNOUNCES PRESENTATION OF UPDATED RESULTS FROM PHASE 1B TRIAL OF PV-10 IN COMBINATION WITH KEYTRUDA® (PEMBROLIZUMAB) FOR TREATMENT OF ADVANCED MELANOMA AT SMR 2018 CONGRESS

On October 25, 2018 Provectus (OTCQB: PVCT) reported that interim results from the Company’s ongoing Phase 1b/2 study of small molecule oncolytic immunotherapy PV-10 in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 immune checkpoint inhibitor, were presented at the 15th International Congress of the Society for Melanoma Research (SMR 2018 Congress), held in Manchester, England from October 24-27, 2018 (Press release, Provectus Biopharmaceuticals, OCT 25, 2018, View Source [SID1234530152]). Intratumoral injection of PV-10 can yield immunogenic cell death in solid tumor cancers and stimulate tumor-specific reactivity in circulating T cells.1-4

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The Phase 1b portion of the study completed enrollment in April 2018 of 23 patients with metastatic melanoma at clinical sites in the U.S. (NCT02557321). Patients with at least one injectable lesion and who were candidates for KEYTRUDA were eligible. Eligible subjects received the combination treatment of PV-10 and KEYTRUDA every three weeks for up to five cycles (i.e., over a period of up to 12 weeks, with no further PV-10 administered after week 12), followed by only KEYTRUDA every three weeks for up to 24 months. The primary endpoint for the Phase 1b trial was safety and tolerability. Objective response rate and progression-free survival were key secondary endpoints (both assessed via RECIST 1.1 after five treatment cycles, and then every 12 weeks thereafter). Response follow-up of 6 patients (26%) is ongoing.

Interim Results from the Presentation at SMR:

Baseline characteristics: 83% men; median age of 70 years (range 28-90) and 70% > 65 years; 91% checkpoint naïve.

Disease characteristics: 13% Stage IIIC/IIID and 52% Stage IV M1b/M1c; median of 2 cutaneous/subcutaneous lesions (range 1-15)5; most subjects had substantial non-injected systemic disease burden in addition to their injectable cutaneous and/or subcutaneous lesions.

Treatment summary: Subjects received a median of 4 cycles of PV-10 (mean 3.7, range 1-5) and a median of 5 injections of PV-10 (range 1-82); PV-10 was not administered after week 12.

Preliminary safety: adverse events were consistent with the established patterns for single-agent use of each drug; there were no unexpected toxicities or evidence of significant overlapping toxicity.

Preliminary target lesion efficacy (best overall response): 43% complete response and 65% objective response.

Preliminary overall efficacy (per RECIST 1.1): 9% complete response, 65% objective response, and 70% clinical benefit; 83% objective response in M1c patients.
The Company currently plans to present durability and survival data from these study participants at a medical conference in the first half of 2019. Provectus plans to open an expansion cohort of up to 24 patients in the Phase 1b portion of the study to assess the PV-10-KEYTRUDA combination in patients who have failed to respond to initial treatment with checkpoint inhibition.

Dominic Rodrigues, Vice Chair of the Company’s Board of Directors, said, "These updated results continue to highlight the non-overlapping safety profiles of PV-10 and checkpoint inhibition by authenticating the lack of correlation of adverse events between the two drugs. The data also continue to demonstrate the promising clinical benefit of cancer combination therapy with checkpoint inhibition after minimal PV-10 intervention.6 We believe successful combination therapy is achieved by pairing drugs that each show single-agent activity."

A copy of the poster presentation is currently available on Provectus’ website at

View Source

About PV-10

Provectus’ lead investigational oncology drug, PV-10, the first small molecule oncolytic immunotherapy, can induce immunogenic cell death. PV-10 is undergoing clinical study for adult solid tumor cancers, like melanoma and cancers of the liver, and preclinical study for pediatric cancers.