On May 7, 2018 Diplomat Pharmacy, Inc. (NYSE: DPLO), the nation’s largest independent provider of specialty pharmacy services, reported financial results for the quarter ended March 31, 2018 (Press release, Diplomat Speciality Pharmacy, MAY 7, 2018, View Source [SID1234526166]). All comparisons, unless otherwise noted, are to the quarter ended March 31, 2017.

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!

First Quarter 2018 Highlights include:

Revenue of $1,342 million, compared to $1,079 million, an increase of 24%
Specialty segment revenue of $1,153 million, compared to $1,079 million
PBM segment revenue of $191 million, which was not part of the business in the prior year period
Specialty segment total prescriptions dispensed of 223,000, compared to 220,000
PBM segment total volume, adjusted to 30-day equivalent, of 2,181,000
Gross margin of 8.2% versus 7.9%
Specialty segment gross margin of 8.1% versus 7.9%
PBM segment gross margin of 9.2%
EPS of $(0.01) per diluted common share versus $0.06
Adjusted EPS of $0.20 versus $0.19
Adjusted EBITDA of $39.6 million, compared to $26.8 million
Adjusted EBITDA margin of 3.0% versus 2.5%
Net cash provided by operating activities was $48.6 million, compared to $44.3 million
Net debt, including contingent consideration, reduced to $601.5 million, from $648.7 million at December 31, 2017
Jeff Park, Interim CEO, commented "Diplomat reached a new high mark this quarter in which the incredible team we’ve built executed on our plan and achieved record revenues. Our first quarter demonstrated strong performance in both our Specialty segment and our PBM segment – relaunched last week under its new brand, CastiaRx. Our PBM integration has progressed rapidly, and as our innovation, growth and profitability initiatives continue to gain momentum, we believe we can drive substantial market share gains over time and generate long term value for all our stakeholders."

First Quarter Financial Summary:

Revenue for the first quarter of 2018 was $1,342 million, compared to $1,079 million in the first quarter of 2017, an increase of $263 million or 24%. Revenue was comprised of $1,153 million and $191 million from our Specialty segment and our newly formed Pharmacy Benefit Management ("PBM") segment, respectively. There was a $2.0 million inter-company elimination of revenue, and associated cost of sales, between the segments. The increase in our Specialty segment revenue was primarily driven by $31 million of revenue from our other acquisitions as well as manufacturer price increases, access to dispense drugs that were new in the past year and increased volume through payor relationships. These increases were partially offset by a decrease in hepatitis C business versus the prior year period and drug mix.

Gross profit in the first quarter of 2018 was $110.6 million and generated an 8.2% gross margin, compared to $85.0 million gross profit and 7.9% gross margin in the first quarter of 2017. Gross profit was comprised of $93.0 million and $17.6 million from our Specialty segment and PBM segment, respectively. The gross margin increase in the quarter was primarily due to the impact of our PBM acquisitions, which includes all contracts reflected on a net revenue basis with associated product and service cost of goods, as well as the impact of the acquired entities in our Specialty segment, and manufacturer price increases in the first quarter of 2018 versus the prior year period.

Selling, general, and administrative expenses ("SG&A") for the first quarter of 2018 were $101.9 million, an increase of $25.4 million, compared to $76.5 million in the first quarter of 2017. This increase is primarily driven by $11.5 million related to employee cost, including employee cost for our acquired entities and stock option compensation. Also contributing to the SG&A expense increase was a $7.5 million increase in amortization expense from definite-lived intangible assets, including the capitalized software for internal use, associated with our acquired entities and a one-time $2.1 million severance and merger and acquisition expense associated with our acquired entities. We also experienced increases in other SG&A; including, freight, building and equipment, travel, insurance, and other miscellaneous expenses.

Net (loss) income attributable to Diplomat for the first quarter of 2018 was $(0.5) million compared to $4.4 million in the first quarter of 2017. This decrease was primarily driven by an $8.4 million increase in interest expense due to a significant increase in outstanding debt to fund our PBM acquisitions, partially offset by an income tax benefit of $0.9 million in the first quarter of 2018 versus income tax expense of $2.3 million in the prior year period. The income tax benefit during the first quarter of 2018 was inclusive of a $0.3 million excess tax benefit related to share-based awards. Adjusted EBITDA for the first quarter of 2018 was $39.6 million compared to $26.8 million in the first quarter of 2017, an increase of $12.8 million.

Earnings per share for the first quarter of 2018 was $(0.01), compared to $0.07 for the first quarter of 2017. On a diluted basis, earnings per share was $(0.01) in the first quarter of 2018, compared to $0.06 in the prior year period. Diluted non-GAAP adjusted earnings per share ("Adjusted EPS") was $0.20 in the first quarter of this year compared to $0.19 in the first quarter of 2017.

2018 Financial Outlook

For the full-year 2018, we are increasing our revenue guidance to account for the earlier than anticipated transition to account for revenue in our PBM segment on a gross basis. We are maintaining our previous financial guidance on all other financial measures:

Revenue between $5.5 and $5.9 billion, versus the previous range of $5.3 and $5.6 billion
Net income attributable to Diplomat between $4.5 and $13.0 million
Adjusted EBITDA between $164 and $170 million
Diluted EPS between $0.06 and $0.17
Adjusted EPS between $0.87 and $0.97
Our EPS and Adjusted EPS expectations assume approximately 74,900,000 weighted average common shares outstanding on a diluted basis and a tax rate of 24% and 27%, for the low- and high-end of the range, respectively, for the full year 2018, which could differ materially.

Earnings Conference Call Information

The Company will now hold a conference call to discuss its first quarter performance tomorrow morning, May 8, 2018, at 8:00 a.m. Eastern Time. Shareholders and interested participants may listen to a live broadcast of the conference call by dialing 833-286-5805 (647-689-4450 for international callers) and referencing participant code 5178318 approximately 15 minutes prior to the call. A webcast and audio file of the conference call will be available on the investor relations section of the Company’s website for approximately 90 days at ir.diplomat.is

On May 7, 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for TECENTRIQ (atezolizumab), in combination with Avastin (bevacizumab), paclitaxel and carboplatin (chemotherapy), for the initial (first-line) treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) (Press release, Hoffmann-La Roche, MAY 7, 2018, View Source [SID1234526147]). The FDA is expected to make a decision on approval by 5 September 2018. A Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.

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!

"Our phase III results showed TECENTRIQ in combination with Avastin, paclitaxel and carboplatin has the potential to provide a significant survival benefit in the initial treatment of metastatic non-squamous non-small cell lung cancer," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "We are working closely with the FDA to bring this treatment regimen to people with this type of lung cancer as soon as possible."

This sBLA is based on results from the Phase III IMpower150 study, which met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) in the initial treatment of people with advanced non-squamous NSCLC. The safety profile of the combination was consistent with the safety profiles of the individual medicines, and no new safety signals were identified.

TECENTRIQ is currently approved by the FDA to treat people with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumour has ALK and EGFR mutations.

About the IMpower150 study
IMpower150 is a multicentre, open-label, randomised, controlled Phase III study evaluating the efficacy and safety of TECENTRIQ in combination with carboplatin and paclitaxel with or without Avastin in people with stage IV non-squamous NSCLC who had not been treated with chemotherapy for their advanced disease. It enrolled 1,202 people, of which those with ALK and EGFR mutations were excluded from the primary intention-to-treat (ITT) analysis. People were randomised (1:1:1) to receive:

TECENTRIQ plus carboplatin and paclitaxel (Arm A), or
TECENTRIQ and Avastin plus carboplatin and paclitaxel (Arm B), or
Avastin plus carboplatin and paclitaxel (Arm C, control arm)
The co-primary endpoints were OS and PFS, as determined by the investigator using Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1). The primary analysis of the co-primary PFS endpoint in IMpower150 was assessed in two populations: all randomised people without an ALK or EGFR genetic mutation (intention-to-treat wild-type) and in a subgroup of people who had a specific biomarker (T-effector "Teff" gene signature expression). The co-primary OS endpoint was assessed in all randomised people without an ALK or EGFR genetic mutation (intention-to-treat wild-type). Key secondary endpoints included investigator-assessed PFS and OS, safety in the ITT population and in EGFR and ALK mutation subgroups.

About NSCLC
Lung cancer is the leading cause of cancer death globally1. Each year 1.59 million people die as a result of the disease; this translates into more than 4,350 deaths worldwide every day2. Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases2.

About the TECENTRIQ and Avastin combination
There is a strong scientific rationale to support further investigation of TECENTRIQ plus Avastin in combination. We are investigating this combination in a broad range of cancers, including first-line advanced NSCLC. Avastin, in addition to its anti-angiogenic effects, may further enhance TECENTRIQ’s ability to restore anti-cancer immunity by inhibiting VEGF-related immunosuppression, promoting T cell tumour infiltration and enabling priming and activation of T cell responses against tumour antigens.

About TECENTRIQ
TECENTRIQ is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, TECENTRIQ may enable the activation of T cells. TECENTRIQ has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.

Currently, Roche has eight Phase III lung cancer studies underway, evaluating TECENTRIQ alone or in combination with other medicines.

TECENTRIQ is already approved in the European Union, United States and more than 60 countries for people with previously treated metastatic NSCLC and for people with locally advanced or metastatic urothelial cancer (mUC) who are not eligible for cisplatin chemotherapy, or who have had disease progression during or following platinum-containing therapy.

About Avastin
Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called vascular endothelial growth factor (VEGF) that plays an important role throughout the lifecycle of the tumour to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumour blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumour blood supply is thought to be critical to a tumour’s ability to grow and spread in the body (metastasise).

About Roche in cancer immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.

By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with TECENTRIQ to a greater number of people living with cancer. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients.

To learn more about the Roche approach to cancer immunotherapy please follow this link: View Source

On May 7, 2018 MabVax Therapeutics Holdings, Inc. (NASDAQ: MBVX), a clinical-stage oncology drug development company, reported that the May 3rd presentation from David Hansen, MabVax’s President and Chief Executive Officer, at VirtualInvestorConferences.com is now available for on-demand viewing at VirtualInvestorConferences.com (Press release, MabVax, MAY 7, 2018, View Source [SID1234526150]).

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!

Mr. Hansen provided a corporate overview, as well as a clinical update and outlined anticipated milestones for its Phase 1 clinical programs including the MVT-5873 clinical trial in combination with a standard of care chemotherapy as a first line therapy for patients newly diagnosed with pancreatic cancer, and the MVT-1075 radioimmunotherapy clinical trial for the treatment of pancreatic, colon and lung cancers.

MabVax Therapeutics’ presentation will be available for 90 days. Investors and advisors may download additional information and materials from the "virtual trade booth" for the next three weeks.

About VirtualInvestorConferences.com

Since 2010, VirtualInvestorConferences.com, created by BetterInvesting (NAIC) and PRNewswire, has been the only monthly virtual investor conference series that provides an interactive forum for presenting companies to meet directly with investors using a graphically-enhanced online platform.

Designed to replicate the look and feel of location-based investor conferences, Virtual Investor Conferences unites PR Newswire’s leading-edge online conferencing and investor communications capabilities with BetterInvesting’s extensive retail investor audience network. To learn more, please visit www.VirtualInvestorConferences.com.

On May 7, 2018 Lipocine Inc. (NASDAQ: LPCN), a specialty pharmaceutical company, reported financial results for the first quarter ended March 31, 2018 (Press release, Lipocine, MAY 7, 2018, View Source [SID1234526168]).

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!

First Quarter and Recent Corporate Highlights

The Company received $10 million through a Loan and Security Agreement with Silicon Valley Bank ("SVB Loan").
·The Bone, Reproductive and Urologic Drugs Advisory Committee ("BRUDAC") of the U.S. Food and Drug Administration ("FDA") met to discuss the New Drug Application ("NDA") for TLANDO, Lipocine’s oral testosterone product candidate for the proposed indication of testosterone replacement therapy in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.
BRUDAC voted six in favor and thirteen against the acceptability of the overall benefit/risk profile to support approval of TLANDO as a testosterone replacement therapy ("TRT").
·The Company and the other defendants entered into a memorandum of understanding to settle the purported securities class action litigation captioned In re Lipocine Inc. Securities Litigation.
·The Company initiated a phlebotomy clinical study under the TLANDO investigational new drug ("IND") Application to confirm no ex-vivo conversion of testosterone undecanoate to testosterone.
·The Company submitted a draft protocol for an ambulatory blood pressure monitoring ("ABPM") clinical study to the FDA for review under the TLANDO IND.
The FDA’s assigned Prescription Drug User Fee Act ("PDUFA") goal date for the TLANDO NDA is May 8, 2018.

"We look forward to learning the FDA outcome on our PDUFA goal date for TLANDO. We continue to believe that as an oral drug TLANDO offers significant benefits to patients compared to topical gels and injections. These benefits include overcoming the inadvertent testosterone transference risk to children and partners that exist with topical gels," said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine.

First Quarter 2018 Financial Results

Lipocine reported a net loss of $2.7 million, or ($0.13) per diluted share, for the quarter ended March 31, 2018, compared with a net loss of $4.9 million, or ($0.26) per diluted share, in the quarter ended March 31, 2017.

License revenues were $428,000 during the three months ended March 31, 2018, compared to no revenue being received during the three months ended March 31, 2017. License revenue relates to royalty payments received from Spriaso, LLC under a licensing agreement for the cough and cold field.

Research and development expenses were $1.4 million in the quarter ended March 31, 2018, compared with $3.1 million in the quarter ended March 31, 2017. The decrease in research and development expenses was primarily due to reduced contract research organization costs for TLANDO and lower personnel costs offset by increased outside service costs primarily related to the TLANDO BRUDAC meeting in January 2018 and increased contract manufacturing costs for LPCN 1107.

General and administrative expenses were $1.7 million in the quarter ended March 31, 2018, compared with $1.8 million in the quarter ended March 31, 2017. The decrease in general and administrative expenses was primarily due to decreased personnel costs and overhead costs offset by increased professional fees related to legal, intellectual property and commercial activities.

As of March 31, 2018, the Company had cash, cash equivalents, and marketable securities of $27.8 million, compared to cash, cash equivalents, and marketable securities of $21.5 million at December 31, 2017. In the event TLANDO is not approved by the FDA on or prior to May 31, 2018, the SVB loan requires $5.0 million of cash to be restricted and held as cash collateral until such time as TLANDO is approved by the FDA.

On May 7, 2018 Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS) and CrystalGenomics, Inc. (KOSDAQ:083790) reported that Aptose exercised its option under the 2016 Option Agreement to exclusively license CG-806, a first-in-class, non-covalent pan-inhibitor of the Bruton’s tyrosine kinase (BTK) and FMS-like tyrosine kinase 3 (FLT3) from CrystalGenomics, Inc (Press release, CrystalGenomics, MAY 7, 2018, View Source [SID1234539163]). CG-806 is being developed as a highly potent, oral small molecule for acute myeloid leukemia (AML), B-Cell malignancies and other hematologic malignancies.

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!

With the early exercise of the option, Aptose owns global rights to develop and commercialize CG-806 for all indications outside of Korea and China – the Licensed Territory. The exercise triggers a payment of US $2.0 million to CrystalGenomics. CrystalGenomics is eligible for regulatory and sales milestone payments, as well as royalties on product sales in the Licensed Territory.

Aptose has been conducting Investigational New Drug (IND) enabling studies with CG-806, as well as numerous preclinical studies. When tested against fresh bone marrow samples from patients with AML, CG-806 demonstrated superior potency and range of activity relative to all other FLT3 inhibitors evaluated. Likewise, CG-806 demonstrated superiority over ibrutinib when tested against samples from CLL patients. The superior potency and breadth of activity against patient-derived hematologic malignancy cells is due to the ability of CG-806 to target all wild type (WT) and all known mutant forms of FLT3 and BTK, and to suppress multiple signaling pathways that can rescue hematologic cancers from other agents. Once-daily oral dosing of CG-806 in murine xenograft models of human hematologic malignancies demonstrated tumor eradication in the absence of observable toxicity, and dose range finding studies have shown CG-806 to have a robust safety profile. Aptose expects to submit an IND in late 2018 and initiate clinical trials immediately thereafter.

"CG-806 has the potential to serve as a transformational agent for AML, chronic lymphocytic leukemia (CLL) and other hematologic malignancies," said William G. Rice, Ph.D., Chairman, President and Chief Executive Officer of Aptose. "Recent pre-clinical studies, just highlighted at the 2018 AACR (Free AACR Whitepaper) Annual Meeting, demonstrated CG-806’s superior potential to other FLT3 inhibitors on AML patient samples and superior potential to ibrutinib on CLL patient samples."

"Aptose has made the clinical development of CG-806 a priority, and we are pleased to be working with them," said Joong Myung Cho, Ph.D., Chairman and Chief Executive Officer of CrystalGenomics. "Aptose and its clinical advisors clearly recognize the potential of CG-806 as an exciting therapeutic option for patients with AML, CLL and other malignancies."