Ionis Pharmaceuticals to hold second quarter 2019 financial results webcast

On July 30, 2019 Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) reported that it will host a live webcast on Wednesday, August 7th at 11:30 a.m. Eastern Time to discuss its second quarter 2019 financial results and report on pipeline and business progress (Press release, Ionis Pharmaceuticals, JUL 30, 2019, View Source [SID1234537920]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Interested parties may listen to the call by dialing 877-443-5662 or access the webcast at www.ionispharma.com. A webcast replay will be available for a limited time at the same address.

Rigel Announces Conference Call and Webcast to Report Second Quarter 2019 Financial Results

On July 30, 2019 Rigel Pharmaceuticals, Inc. (Nasdaq:RIGL) reported that it will report its second quarter 2019 financial results after market close on Tuesday, August 6, 2019 (Press release, Rigel, JUL 30, 2019, View Source [SID1234537919]). Rigel senior management will follow the announcement with a live conference call and webcast at 4:30pm Eastern Time (1:30pm Pacific Time) to discuss the financial results and give a company update.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Participants can access the live conference call by dialing (877) 407-8309 (domestic) or (201) 689-8057 (international). The conference call and accompanying slides will also be webcast live and can be accessed from Rigel’s website at www.rigel.com. The webcast will be archived and available for replay for 90 days after the call via the Rigel website.

Lipocine to Present at the Canaccord Genuity 39th Annual Growth Conference

On July 30, 2019 Lipocine Inc. (NASDAQ: LPCN), a clinical-stage biopharmaceutical company focused on metabolic and endocrine disorders, reported that Dr. Mahesh Patel, Chairman, President and CEO, will provide a corporate overview at the Canaccord Genuity 39th Annual Growth Conference, being held August 7-8, 2019 at the InterContinental Boston Hotel in Boston, MA (Press release, Lipocine, JUL 30, 2019, View Source [SID1234537918]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Presentation Details
Date: Thursday, August 8th
Time: 1:00pm Eastern Time
Webcast: View Source

Significant Regulatory Milestone Towards Phase 2 in Recurrent GBM

On July 30, 2019 Bexion Pharmaceuticals, Inc. an oncology-focused company reported the completion of a Type B End-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA) to discuss the End of Phase 1 and the design of a Phase 2 clinical trial for BXQ-350, the Company’s lead candidate, for the treatment of recurrent Glioblastoma Multiforme (rGBM) (Press release, Bexion, JUL 30, 2019, View Source [SID1234537917]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In the Type B meeting, the FDA provided guidance on various design aspects of Bexion’s proposed Phase 2 clinical trial. The trial is expected to enroll 55-60 patients.

"An End of Phase 1 meeting with the FDA is a significant regulatory milestone for any new clinical development program," said Dr. Richard Schwen, Regulatory Consultant for Bexion. "Such meetings are granted by the FDA only when significant data on the drug are available. Bexion’s recent meeting signals the FDA’s interest in the BXQ-350 program, and an opportunity for Bexion to obtain input to refine the remaining studies required for an FDA approval."

The Phase 2 trial is designed with learnings from the Phase 1 program, which dosed 93 patients, with 21 having rGBM. The Phase 1 program reached the highest planned dose and demonstrated a strong safety profile for BXQ-350.

Based upon the FDA’s feedback, Bexion will submit a Phase 2 clinical trial protocol and statistical analysis plan along with the requested Chemistry, Manufacturing and Controls (CMC) information to the Investigational New Drug (IND) application.

"The FDA has provided us very valuable advice on the design of the Phase 2 trial, and we are grateful for their comprehensive feedback," said Dr. Ray Takigiku, CEO of Bexion Pharmaceuticals. "Recurrent GBM remains an urgent unmet medical need, and we believe the initiation of a Phase 2 clinical trial of BXQ-350 for this devastating disease is a major milestone for both patients and Bexion. We are working diligently to incorporate the FDA’s comments into the IND, with the expectation of initiating the Phase 2 trial in the first quarter of 2020."

NuVasive Announces Second Quarter 2019 Financial Results

On July 30, 2019 NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, reported financial results for the quarter ended June 30, 2019 (Press release, NuVasive, JUL 30, 2019, View Source [SID1234537916]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Second Quarter 2019 Highlights

Revenue increased 3.7% to $292.1 million, or 4.7% on a constant currency basis;
GAAP operating profit margin of 10.3%; Non-GAAP operating profit margin of 16.3%; and
GAAP diluted earnings per share of $0.29; Non-GAAP diluted earnings per share of $0.63.
"NuVasive continued to deliver consistent revenue growth in the second quarter 2019, with a notably solid performance from the U.S. Hardware business," said J. Christopher Barry, chief executive officer of NuVasive. "We saw meaningful case volume growth driven by increased surgeon adoption of lateral single-position surgery and NuVasive’s innovative X360 system. Our strong profitability results over the first half of the year demonstrate the clear initiatives and focused execution throughout the business and are reflected in our raised full-year 2019 non-GAAP guidance for operating margin and earnings per share."

A full reconciliation of GAAP to non-GAAP financial measures can be found in the tables of this news release.

Second Quarter 2019 Results
NuVasive reported second quarter 2019 total revenue of $292.1 million, a 3.7% increase compared to $281.6 million for the second quarter 2018. On a constant currency basis, second quarter 2019 total revenue increased 4.7% compared to the same period last year.

For the second quarter 2019, both GAAP and non-GAAP gross profit was $214.5 million and GAAP and non-GAAP gross margin was 73.4%. These results compared to the second quarter 2018 GAAP and non-GAAP gross profit of $204.5 million and $204.9 million, respectively, and GAAP and non-GAAP gross margin of 72.6% and 72.8%, respectively.

On a GAAP basis, the Company reported net income of $15.0 million, or diluted earnings per share of $0.29, for the second quarter 2019 compared to a net income of $11.5 million, or diluted earnings per share of $0.22, for the second quarter 2018. On a non-GAAP basis, the Company reported net income of $32.8 million, or diluted earnings per share of $0.63 per share, for the second quarter 2019 compared to net income of $30.3 million, or diluted earnings per share of $0.58 per share, for the second quarter 2018.

The Company maintains full-year 2019 revenue guidance to be in the range of $1.14 billion to $1.16 billion, which now includes approximately $5 million in year-over-year currency headwinds compared to prior guidance of $4 million. This reflects reported growth in the range of 3.4% to 5.4%, compared with prior guidance of 3.5% to 5.5%. Revenue growth on a constant currency basis remains unchanged at 3.8% to 5.8%;
Non-GAAP diluted earnings per share in a range of $2.25 to $2.35, compared with prior guidance of $2.20 to $2.30;
Non-GAAP operating profit margin of 15.3% to 15.7%, compared with prior guidance of 15.0% to 15.5%;
EBITDA margin of 25.5% to 25.9%, compared with prior guidance of 25.2% to 25.7%; and
Non-GAAP effective tax expense rate of approximately 23%.