On May 3, 2018 Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) reported consolidated financial results for the first quarter ended March 31, 2018 (Press release, Pacira Pharmaceuticals, MAY 3, 2018, View Source;p=RssLanding&cat=news&id=2346741 [SID1234526024]).

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"2018 is off to a terrific start with EXPAREL daily sales volumes accelerating from 6 percent in January to 15 percent in March, as well as a recently expanded label that now includes interscalene brachial plexus block," said Dave Stack, chairman and chief executive officer of Pacira Pharmaceuticals. "As the only long-acting, single-dose nerve block commercially available, EXPAREL has the potential to eliminate cumbersome delivery technologies, like catheters and pumps, and shift more procedures to the outpatient setting. We believe this expanded label along with our robust educational initiatives and strong coalition of like-minded collaborators, including Johnson & Johnson, will fuel positive sales trends as we continue to drive meaningful change toward eliminating the role of the operating room as a gateway to opioid use and abuse."

First Quarter 2018 Financial Results

EXPAREL net product sales were $74.0 million in the first quarter of 2018, a 9% increase over the $67.7 million reported for the first quarter of 2017.

Total operating expenses were $81.5 million in the first quarter of 2018, compared to $83.3 million in the first quarter of 2017.

GAAP net loss was $10.7 million, or $(0.26) per share (basic and diluted), in the first quarter of 2018, compared to a GAAP net loss of $19.9 million, or $(0.52) per share (basic and diluted), in the first quarter of 2017.

Non-GAAP net income was $0.9 million, or $0.02 per share (basic and diluted) in the first quarter of 2018, compared to a non-GAAP net loss of $7.3 million, or $(0.19) per share (basic and diluted) in the first quarter of 2017.

Pacira ended the first quarter of 2018 with cash, cash equivalents, short-term and long-term investments ("cash") of $361.5 million.

Pacira had 40.7 million basic weighted average shares of common stock outstanding in the first quarter of 2018.

For non-GAAP measures, Pacira had 41.6 million diluted weighted average shares of common stock outstanding in the first quarter of 2018.
2018 Outlook

Pacira reiterated its full year 2018 financial guidance as follows. Pacira expects:

EXPAREL net product sales of $300 million to $310 million.

Non-GAAP gross margins of 70% to 72%.

Non-GAAP research and development (R&D) expense of $50 million to $60 million.

Non-GAAP selling, general and administrative (SG&A) expense of $150 million to $160 million.

Stock-based compensation of $30 million to $35 million.
See "Non-GAAP Financial Information" and "Reconciliations of GAAP to Non-GAAP 2018 Financial Guidance" below.

Today’s Conference Call and Webcast Reminder

The Pacira management team will host a conference call to discuss the company’s financial results and recent developments today, Thursday, May 3, at 8:30 a.m. ET. The call can be accessed by dialing 1-877-845-0779 (domestic) or 1-720-545-0035 (international) ten minutes prior to the start of the call and providing the Conference ID 6585169.

A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing 1-855-859-2056 (domestic) or 1-404-537-3406 (international) and providing the Conference ID 6585169. The replay of the call will be available for two weeks from the date of the live call.

The live, listen-only webcast of the conference call can also be accessed by visiting the "Investors & Media" section of the company’s website at investor.pacira.com. A replay of the webcast will be archived on the Pacira website for two weeks following the call.

Non-GAAP Financial Information

This press release contains financial measures that do not comply with U.S. generally accepted accounting principles (GAAP), such as non-GAAP net income, non-GAAP cost of goods sold, non-GAAP gross margins, non-GAAP research and development (R&D) expense and non-GAAP selling, general and administrative (SG&A) expense, because such measures exclude stock-based compensation, amortization of debt discount, loss on early extinguishment of debt and exit costs related to the discontinuation of DepoCyt(e) production.

These measures supplement the company’s financial results prepared in accordance with GAAP. Pacira management uses these measures to better analyze its financial results, estimate its future cost of goods sold, gross margins, R&D expense and SG&A expense outlook for 2018 and to help make managerial decisions. In management’s opinion, these non-GAAP measures are useful to investors and other users of our financial statements by providing greater transparency into the operating performance at Pacira and the company’s future outlook. Such measures should not be deemed to be an alternative to GAAP requirements or a measure of liquidity for Pacira. Non-GAAP measures are also unlikely to be comparable with non-GAAP disclosures released by other companies. See the tables below for a reconciliation of GAAP to non-GAAP measures, and a reconciliation of our GAAP to non-GAAP 2018 financial guidance for gross margins, R&D expense and SG&A expense.

On May 3, 2018 Cerus Corporation (Nasdaq: CERS) reported that Dr. Laurence M. Corash, co-founder and chief scientific officer, and Lainie Corten, vice president of global marketing, are scheduled to present a corporate update at the Deutsche Bank 43rd Annual Health Care Conference at the InterContinental Hotel Boston on Wednesday, May 9th at 1:30 pm ET (Press release, Cerus, MAY 3, 2018, View Source [SID1234526053]).

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A live webcast of the presentation will be available from the Investor Relations page of the Cerus web site at View Source A replay will be available for approximately two weeks following the completion of the event.

On May 3, 2018 Moleculin Biotech, Inc., (Nasdaq:MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company focused on the development of oncology drug candidates, all of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported that it has engaged Voisin Consulting Life Sciences ("VCLS"), as an additional regulatory consulting firm and contract research organization ("CRO") to prepare for expansion of its clinical trial to study Annamycin for the treatment of relapsed or refractory acute myeloid leukemia ("AML") (Press release, Moleculin, MAY 3, 2018, View Source [SID1234526079]).

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Moleculin engaged Voisin Consulting Life Sciences, headquartered in Paris, France to evaluate additional countries for the potential expansion of its AML clinical trial. VCLS is a multinational regulatory consulting firm and contract research organization with 150 life science professionals. The Moleculin engagement is intended to evaluate Australia and selected Western European countries to provide additional clinical sites.

"Now that our AML trial is underway, we are focused on expanding the opportunity for AML patients to participate in the trial," commented Walter Klemp, Moleculin’s Chairman and CEO. "Our strategy is to choose countries with the best possible balance between an efficient clinical trial authorization process, solid AML clinical trial experience and a population of qualified AML patients."

About Voisin Consulting Life Sciences

From discovery to product launch and life cycle management

AT Voisin Consulting Life Sciences (VCLS), regulatory science guides Biotechnology, Pharmaceutical and Medtech manufacturers throughout product development and commercialization. Starting early in the process, from discovery to patient, VCLS assists innovators in designing optimized product development plans and regulatory strategies, combining the health ecosystem with commercial success. With a presence in seven locations across three continents and over 150 employees, VCLS serves a broad range of developers and their investors.

For more information, visit www.voisinconsulting.com

On May 3, 2018 Odonate Therapeutics, Inc. (NASDAQ: ODT), a pharmaceutical company dedicated to the development of best-in-class therapeutics that improve and extend the lives of patients with cancer, reported financial results for the three months ended March 31, 2018 (Press release, Odonate Therapeutics, MAY 3, 2018, View Source [SID1234526098]).

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As of March 31, 2018, Odonate had $195.2 million in cash, compared to $198.1 million as of December 31, 2017. This decrease in cash resulted primarily from net cash used in operating activities of $12.5 million, less net proceeds of $9.8 million from the sale of common stock to the underwriters in our initial public offering in connection with the exercise of their option to purchase additional shares of common stock. Odonate’s net loss for the three months ended March 31, 2018 was $16.9 million, or $0.69 per share, compared to $2.7 million, or $0.26 per share, for the same period in 2017.

"We are excited to have recently initiated CONTESSA, our Phase 3 study investigating tesetaxel in the treatment of locally advanced or metastatic breast cancer," said Kevin Tang, Chairman and Chief Executive Officer of Odonate. "Despite recent advances in the treatment of advanced breast cancer, there remains a significant need for new therapies that allow patients to maintain a better quality of life. We are hopeful that tesetaxel’s oral bioavailability, low pill burden, lack of history of hypersensitivity reactions and robust activity against chemotherapy-resistant tumors seen in prior studies may translate into significant benefits for patients."

About Tesetaxel

Tesetaxel is an investigational, orally administered chemotherapy agent that belongs to a class of drugs known as taxanes, which are widely used in the treatment of cancer. Tesetaxel has several potential therapeutic advantages over currently available taxanes, including: oral administration with a low pill burden and a patient-friendly dosing regimen; no history of hypersensitivity (allergic) reactions; and robust activity against chemotherapy-resistant tumors. More than 500 patients have been treated with tesetaxel across 22 clinical studies. In patients with locally advanced or metastatic breast cancer (MBC), tesetaxel was shown to have robust single-agent antitumor activity in two, multicenter, Phase 2 studies.

About CONTESSA

CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel, an investigational, orally administered taxane, in patients with locally advanced or metastatic breast cancer (MBC). CONTESSA will compare tesetaxel dosed orally at 27 mg/m2 on the first day of a 21-day cycle plus a reduced dose of capecitabine (1,650 mg/m2/day dosed orally on days 1-14 of a 21-day cycle) to the approved dose of capecitabine alone (2,500 mg/m2/day dosed orally on days 1-14 of a 21-day cycle) in approximately 600 patients randomized 1:1 with human epidermal growth factor receptor 2 (HER2) negative, hormone receptor (HR) positive MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. Capecitabine is an oral chemotherapy agent that is considered a standard-of-care treatment in MBC. Where indicated, patients must have received endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor. The primary endpoint is progression-free survival (PFS) assessed by an Independent Radiologic Review Committee (IRC). CONTESSA’s secondary efficacy endpoints are overall survival, objective response rate (ORR) assessed by IRC, disease control rate assessed by IRC and patient-reported outcomes. To learn more, please visit www.contessastudy.com.

On May 3, 2018 Coherus BioSciences, Inc. (NASDAQ:CHRS), reported the re-submission of its biologics license application (BLA) for CHS-1701, a pegfilgrastim (Neulasta) biosimilar candidate, to the U.S. FDA under the 351(k) pathway (Press release, Coherus Biosciences, MAY 3, 2018, View Source [SID1234531702]).

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The BLA is supported by similarity data from analytical, pharmacokinetic, pharmacodynamics, and immunogenicity studies comparing CHS-1701 and Neulasta and integrates new immunogenicity data obtained from using a more revised immunogenicity assay.

"The CHS-1701 BLA re-submission marks a significant milestone in our ongoing transition to a commercial company as we tightly focus on execution of our strategic plan," said Denny Lanfear, President and CEO of Coherus BioSciences. "Pegfilgrastim is the largest selling oncology product in the U.S., and CHS-1701 is the cornerstone of our oncology franchise. We believe we have a strong competitive position with this product, exemplified by our comprehensive clinical immunogenicity data as well as our excellent analytical biosimilarity data."