On February 7, 2018 pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release drug products and technologies, today reported financial results for its fiscal 2018 second quarter and six months ended December 31, 2017 and provided an update on its continued operating progress (Press release, pSivida, FEB 7, 2018, View Source [SID1234523802]).

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Recent Operating Highlights

Submitted the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Durasert three-year treatment for posterior segment uveitis
Obtained from the FDA a small business waiver of the Prescription Drug User Fee Act (PDUFA) fee of approximately $2.4 million in connection with the NDA filing
Newly released second Phase 3 study data for Durasert three-year treatment for posterior segment uveitis continued to demonstrate positive efficacy and safety profile at 12 months
Presented Phase 3 data at several medical conferences, including the American Academy of Ophthalmology (AAO) annual meeting and the American Uveitis Society (AUS) winter meeting
Reported positive Phase 1 knee osteoarthritis pain study data indicating that the implant was well tolerated and showed potential for pain reduction through the six-month study period
"We achieved several milestones in the fiscal second quarter and the past few weeks and continue to make material progress in the transformation of pSivida into a fully integrated commercial stage pharmaceutical enterprise," commented Nancy Lurker, President & CEO. "Our highest priority was the NDA submission for Durasert three-year treatment for posterior segment uveitis, which we accomplished in early January. We are also pleased with the continued positive read out of our clinical uveitis data and look forward to presenting these data at upcoming congresses. Meanwhile, we will continue to refine our go-to-market plan in the U.S. and I am confident we have the experienced team and strategy to execute our launch plan with precision."

Fiscal Second Quarter and Six-Month Results

Revenue for the second fiscal quarter ended December 31, 2017 totaled $933,000 compared to $6.0 million for the prior year quarter. The year-ago second quarter included the recognition of deferred collaborative research and development revenue totaling $5.6 million resulting from termination of the Pfizer collaboration agreement. Excluding the Pfizer termination, revenue from feasibility study agreements and royalty income increased to $933,000 for the three months ended December 31, 2017 compared to $387,000 in the prior year quarter. Current period revenues included $196,000 of royalty income received from Alimera Sciences, representing the first quarterly reporting under our July 2017 restructured collaboration agreement. Operating expenses for the three months ended December 31, 2017 increased to $6.7 million from $6.1 million a year earlier, due primarily to professional services costs associated with the NDA filing for Durasert three-year uveitis. Net loss for the quarter ended December 31, 2017 was $5.8 million, or $0.13 per share, compared to net loss of $67,000, or break-even per share, for the prior year quarter.

Revenue for the six months ended December 31, 2017 was $1.3 million compared to $6.2 million for the six months ended December 31, 2016. Excluding the $5.6 million revenue recognized in the prior year period upon termination of the Pfizer agreement, revenues from feasibility study agreements and royalty income increased to $1.3 million for the six months ended December 31, 2017 compared to $664,000 in the prior year six-month period. Operating expenses for the first six months of fiscal 2018 were $13.1 million compared to $13.5 million a year earlier. Higher professional services costs related to the Company’s NDA filing were substantially offset by the absence in the current year-to-date period of severance costs and professional fees related to the Company’s CEO transition and elimination of the position of Vice President, Corporate Affairs and General Counsel in the prior year-to-date period. Net loss for the six months ended December 31, 2017 was $11.8 million, or $0.28 per share, compared to a net loss of $7.2 million, or $0.21 per share for the corresponding fiscal 2017 year-to-date period.

At December 31, 2017, the Company’s cash and cash equivalents totaled $12.9 million.

Anticipated Calendar 2018 Milestones:

FDA acceptance for review of the NDA for Durasert three-year treatment for posterior segment uveitis in calendar Q1
Present 12-month efficacy and safety data from the second Phase 3 clinical study at leading medical conferences
Continue business development efforts and enter into one or more new collaboration agreements with biopharmaceutical companies and other third parties
Expect to complete the GLP safety and pharmacokinetic study for a shorter duration product for posterior segment uveitis
Conference Call

pSivida Corp. will host a live webcast and conference call today, February 7, 2018 at 4:30pm ET. The conference call may be accessed by dialing (877) 312-7507 from the U.S. and Canada, or (631) 813-4828 from international locations. The conference ID is 8399835. A live webcast will be available on the Investor Relations section of the corporate website at View Source

A replay of the call will be available beginning February 7, 2018, at approximately 7:30 p.m. ET and ending on February 14, 2018, at 11:59 p.m. ET. The replay may be accessed by dialing (855) 859-2056 within the U.S. and Canada or (404) 537-3406 from international locations, Conference ID Number: 8399835. A replay of the webcast will also be available on the corporate website during that time.

On February 7, 2018 Johnson & Johnson (NYSE: JNJ) reported that it will participate in the RBC Capital Markets 2018 Global Healthcare Conference on Wednesday, Feb. 21, at the Lotte New York Palace in New York City (Press release, Johnson & Johnson, FEB 7, 2018, View Source [SID1234523797]). Dominic Caruso, Executive Vice President, Chief Financial Officer will represent the Company in a session scheduled at 1:30 p.m. (Eastern Time).

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This webcast will be available to investors and other interested parties by accessing the Johnson & Johnson website at www.investor.jnj.com.

A webcast and podcast replay will be available approximately two hours after the live webcast.

On February 7, 2018 Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, reported that Will Lewis, President and Chief Executive Officer of Insmed, will present at the Leerink Partners 7th Annual Global Healthcare Conference in New York on Wednesday, February 14, 2018 at 11:30 a.m. ET (Press release, Insmed, FEB 7, 2018, View Source [SID1234523796]).

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The presentation will be webcast live and can be accessed by visiting the investor relations section of the company’s website at www.insmed.com. The webcast will be archived for a period of 90 days following the conclusion of the live event.

On February 7, 2018 GSK reported improvements in sales, margins and cash flow in 2017 (Press release, GlaxoSmithKline, FEB 7, 2018, View Source [SID1234523795]).

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Total EPS 31.4p, +67% AER, +36% CER; Adjusted EPS 111.8p, +11% AER, +4% CER

2017 financial highlights

Turnover £30.2 billion, +8% AER, +3% CER

Sales growth across all 3 businesses: Pharmaceuticals £17.3 billion, +7% AER, +3%, CER; Vaccines £5.2 billion, +12% AER, +6% CER; Consumer Healthcare £7.8 billion, +8% AER, +2% CER

Improved Adjusted Group operating margin of 28.4% (2016: 27.5%). Pharmaceuticals 34.3%; Vaccines 31.9%; Consumer Healthcare 17.7%

Total EPS 31.4p, after accounting charges of £1.6 billion related to US tax reform

Adjusted EPS 111.8p, +11% AER, +4% CER, in line with 2017 guidance

2017 free cash flow of £3.4 billion (2016: £3.0 billion)

23p dividend declared for quarter; 80p for 2017

2018 financial guidance

2018 Adjusted EPS Guidance: Growth is subject to uncertainty of timing and impact of possible generic competition to Advair in the US:

In the event of no substitutable generic competitor to Advair in the US, expect 2018 Adjusted EPS growth to be 4 to 7% CER

In the event of a mid-year introduction of a substitutable generic competitor to Advair in the US, expect full year 2018 US Advair sales of around £750 million at CER (US$1.30/£1) with Adjusted EPS flat to down 3% CER

Both scenarios reflect the benefit of US tax reform with expected 2018 effective tax rate on Adjusted profits of 19-20%

Continue to expect 80p dividend for 2018

Product and pipeline highlights

New product sales of £6.7 billion, +51% AER, +44% CER, driven by strong performances from Tivicay and Triumeq in HIV, the inhaled Ellipta portfolio and Nucala in Respiratory and meningitis vaccines

Three key approvals: Shingrix vaccine for shingles; Trelegy Ellipta, once-daily single inhaler triple therapy for COPD; Juluca (dolutegravir and rilpivirine), first 2-drug regimen, once-daily, single pill for HIV

Preferential recommendation for Shingrix received from US CDC

Trelegy Ellipta approved in Europe for COPD

Nucala filed in US for eosinophilic COPD

Phase III HIV treatment study initiated investigating long-acting 2-drug regimen of cabotegravir plus rilpivirine administered every two months

In Oncology, Breakthrough Therapy Designation received from FDA for BCMA antibody-drug conjugate for relapsed and refractory multiple myeloma. Positive BCMA data presented at ASH (Free ASH Whitepaper) meeting.

Emma Walmsley, Chief Executive Officer, GSK said:

"In 2017 GSK delivered encouraging results from across the company with sales growth in each of our three global businesses, an improved Group operating margin, Adjusted EPS growth of 4% (CER) and stronger free cash flow.

"We are focused on competing effectively across our current portfolio and delivering three new launches which bring significant benefits to patients: Trelegy Ellipta which provides three medicines in a single inhaler to treat COPD; Juluca, the first 2-drug regimen, once-daily, single pill for HIV, helping to reduce the amount of medicines needed, and Shingrix, our new vaccine which represents a new standard for the prevention of shingles.

"Improving our Pharmaceuticals business remains our main priority and we are strengthening our pipeline with a focus on priority assets in two current therapy areas, Respiratory and HIV, and two potential areas, Oncology and Immuno-inflammation. We will provide a further update to investors at Q2 on our plans for R&D.

"We continue to make changes across GSK to drive improvements in performance and we have made several new appointments to key leadership positions.

"Looking ahead, in 2018 we could see a potential generic version of Advair in the US and our 2018 guidance reflects this. With the sales momentum we anticipate from new and recent launches and focused improvements in operating performance we are increasingly confident in our ability to deliver mid to high single digit growth in Adjusted EPS CAGR (2016-2020 at 2015 CER).

"Cash generation also continues to be a key focus with free cash flow for the year improving to £3.4 billion. We met our commitment to pay a total dividend of 80p for 2017 and continue to expect to pay 80p for 2018.

"Finally, I would like to thank all our customers, suppliers and employees for their support and hard work in 2017 and look forward to working with them in 2018 and beyond to deliver our strategic priorities and improved performance for GSK."

2018 guidance

The Group expects to make continued progress in 2018, although the expectation for Adjusted EPS growth is impacted by a number of factors including, in particular, uncertainties relating to the timing and extent of potential generic competition to Advair in the US.

In the event that no substitutable generic competitor to Advair is introduced to the US market in 2018, the Group expects 2018 Adjusted EPS growth of 4 to 7% at CER. This is based on an expected decline in 2018 US Advair sales of 20-25% at CER.

In the event of a mid-year introduction of a substitutable generic competitor to Advair in the US, the Group expects full year 2018 US Advair sales of around £750 million at CER (US$1.30/£1), with Adjusted EPS flat to down 3% at CER.

The effective tax rate for 2018 is expected to be approximately 19-20% of Adjusted profits after the impact of US tax reform which is expected to benefit the Group effective tax rate by two to three percentage points.

GSK is not able to give guidance for Total results as it cannot reliably forecast certain material elements of our Total results such as the future fair value movements on contingent consideration and put options. It should be noted that contingent consideration cash payments are made each quarter primarily to Shionogi by ViiV Healthcare which reduce the balance sheet liability and are hence not recorded in the income statement. An explanation of the acquisition-related arrangements with ViiV Healthcare, including details of cash payments to Shionogi, is set out on page 59.

If exchange rates were to hold at the average rates for January 2018 ($1.39/£1, €1.13/£1 and Yen 154/£1) for the rest of 2018, the estimated negative impact on full-year 2018 Sterling turnover growth would be around 4% and if exchange gains or losses were recognised at the same level as in 2017, the estimated negative impact on 2018 Sterling Adjusted EPS growth would be around 6%.

US tax reform

The enactment of the US Tax Cuts and Jobs Act in December 2017 is expected to have a positive impact on the future after tax earnings of GSK’s US businesses. This is primarily due to the reduction in Federal corporation tax rates from 1 January 2018, which is expected to benefit the Group effective tax rate on Adjusted profits in 2018 by two to three percentage points.

The implementation of the new law has resulted in a number of additional charges in 2017, which reduced Total earnings by £1,630 million.

Firstly, increased valuations of the HIV and Consumer Healthcare businesses due to lower US tax rates resulted in an increase in the related liabilities for contingent consideration and the put options of £666 million.

Secondly, an additional tax charge of £1,078 million comprised a reduction in the value of US deferred tax assets held against future liabilities, such as pensions, of £730 million, and a charge of £348 million arising on the reserves of subsidiaries of US entities in the Group. The cash impact of this latter charge will be spread over eight years from 2018, with approximately 60% expected to be payable in years six to eight.

These charges were partly offset by an allocation to non-controlling interests amounting to £114 million, as many of the adjustments related to ViiV Healthcare and the Consumer Healthcare Joint Venture.

These charges represent management’s estimates of the impact of US tax reform on the Group based on the information currently available. As more information on the detailed application of the Act becomes available, the assumptions underlying these estimates could change, with consequent adjustments to the charges taken that could have a material impact on the results of the Group.

On February 6, 2018 Diffusion Pharmaceuticals Inc. (NASDAQ:DFFN) ("Diffusion" or "the Company"), a clinical-stage biotechnology company focused on extending the life expectancy of cancer patients, reported that David Kalergis, Chairman and Chief Executive Officer, will present an overview of the Company and recent advancements of its lead product candidate, trans sodium crocetinate (TSC), at the BIO CEO & Investor Conference to be held on February 12 – 13, 2018 at the New York Marriott Marquis (Press release, Diffusion Pharmaceuticals, FEB 7, 2018, View Source [SID1234523794]).

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Mr. Kalergis is scheduled to present on Tuesday, February 13, 2018 at 2:45 p.m. Eastern time.

To listen to the presentation live, investors may visit the investor relations section of Diffusion Pharmaceuticals’ website at www.diffusionpharma.com. An archived webcast of the presentation will also be available on the Company’s website for 90 days.