1stOncology™: Cancer Intelligence Service – Page 14325 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

BioMarin has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, BioMarin, 2018, FEB 26, 2018, View Source [SID1234524159]).

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!

OncBioMune Provides Updates on Two Phase 2 Clinical Trials of ProscaVax for Prostate Cancer

On February 26, 2018 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary immunotherapy cancer vaccine technology and targeted cancer therapies, reported an update on the status of the two planned clinical trials of ProscaVax for prostate cancer (Press release, Oncbiomune, FEB 26, 2018, View Source [SID1234524354]). ProscaVax is OncBioMune’s lead immunotherapy candidate consisting of a combination of prostate cancer associated prostate specific antigen (PSA) with the biological adjuvants interleukin-2 (IL-2) and granulocyte-macrophage colony-stimulating factor (GM-CSF). The Company has successfully completed a Phase 1a clinical trial of ProscaVax in hormone-naïve and hormone-independent recurrent prostate cancer patients with increasing PSA and the patients continue to be followed for additional endpoints.

OncBioMune is moving forward with two separate clinical trials evaluating ProscaVax. One clinical trial is in advanced cancer patients in conjunction with the Urology Clinics of North Texas ("UCNT") and the second is front-line therapy in early-stage cancer patients, which is to be hosted at a teaching hospital of Harvard University Medical School in Boston, MA.

With respect to the Phase 2 clinical trial hosted by UCNT, the company is preparing the protocol for FDA submission. For FDA approval the company will use a central IRB (Institutional Review Board), as central IRBs move much faster than most university IRBs.

As for the Phase 2 clinical trial at the Harvard University teaching hospital, the Protocol has been approved by the Nursing Committee, Pharmacists, the Regulatory Committee and is under review by the Scientific Review Committee. After approval patient enrollment will begin.

Company Chief Financial Officer Andrew Kucharchuk added, "We are excited to be building such great momentum in 2018. Having a clinical trial in both early and late stage prostate cancer that will be enrolling patients in the coming months, combined with the progress we are making on our other platform therapies, particularly OvcaVaxTM, shows we are moving full speed ahead in 2018.

Diplomat Announces 4th Quarter and 2017 Year End Financial Results; Provides 2018 Guidance

On February 26, 2018 Diplomat Pharmacy, Inc. (NYSE: DPLO), the nation’s largest independent provider of specialty pharmacy services, reported financial results for the quarter and year ended December 31, 2017 (Press release, Diplomat Speciality Pharmacy, FEB 26, 2018, View Source [SID1234524178]). All comparisons, unless otherwise noted, are to the quarter or year ended December 31, 2016.

Know more, wherever you are:
Latest on Diplomat Pharmacy’s Cancer Pipeline, book your free 1stOncology demo here.

Fourth Quarter 2017 Highlights include:

Revenue of $1,155 million, compared to $1,145 million
Total prescriptions dispensed of 248,000, compared to 242,000
Gross margin of 8.1%, compared to 7.3%
Gross profit per prescription dispensed of $353, compared to $342
Net income (loss) attributable to Diplomat of $6.5 million, compared to $(1.1) million
Adjusted EBITDA of $26.6 million, compared to $26.1 million
Adjusted EBITDA margin of 2.3%, compared to 2.3%
EPS of $0.09 per diluted common share, compared to $(0.02)
Adjusted EPS of $0.18, compared to $0.08

Full Year 2017 Highlights include:

Revenue of $4,485 million, compared to $4,410 million
Total prescriptions dispensed of 910,000, compared to 981,000
Gross margin of 7.8%, compared to 7.4%
Gross profit per prescription dispensed of $367, compared to $325
Net income attributable to Diplomat of $15.5 million, compared to $28.3 million
Adjusted EBITDA of $101.8 million, compared to $107.4 million
Adjusted EBITDA margin of 2.3%, compared to 2.4%
EPS of $0.23 per diluted common share, compared to $0.42
Adjusted EPS of $0.84, compared to $0.75

Jeff Park, Interim CEO, commented "Our strong performance for the fourth quarter and full year reflects the successful execution of our strategy, as well as the actions we took to position Diplomat for long-term growth, including entering the PBM market and bolstering our bench of talent. As evidenced by our 2018 outlook, we are confident in our ability to build on this momentum and capture the growth opportunities ahead. As we execute on our go-to-market strategies across specialty, infusion and PBM, we are focused on continuing to accelerate growth and profitability, and enhance value for our shareholders while keeping our patients at the center of everything that we do."

Fourth Quarter Financial Summary:

Revenue for the fourth quarter of 2017 was $1,155 million, compared to $1,145 million in the fourth quarter of 2016, an increase of $10 million or 1%. The increase was principally driven by acquisitions completed in 2017. This increase was partially offset by a business decision to exit less profitable contracts at the end of 2016 and a decrease in the demand for hepatitis C drugs versus the prior year period.

Gross profit in the fourth quarter of 2017 was $93.5 million and generated 8.1% gross margin, compared to $83.8 million and 7.3% gross margin in the fourth quarter of 2016. The gross margin increase was primarily due to the impact of acquisitions and a business decision to exit less profitable contracts at the end of 2016.

Selling, general, and administrative expenses ("SG&A") for the fourth quarter of 2017 were $90.6 million, an increase of $13.6 million, compared to $77.0 million in the fourth quarter of 2016. Of this change, $9.0 million related to employee cost, which was principally driven by acquisitions. Also contributing to the increase was a one-time $1.7 million increase in the fair value of contingent consideration and an increase in amortization expense from definite-lived intangible assets, both of which are associated with our acquired entities. As a percentage of revenue, SG&A, excluding change in fair value of contingent consideration, was 7.7% for the three months ended December 31, 2017 compared to 6.7% in the prior year period.

Net income (loss) attributable to Diplomat for the fourth quarter of 2017 was $6.5 million compared to $(1.1) million in the fourth quarter of 2016. The increase was driven by a $10.0 million improvement in income taxes primarily driven by the Tax Cuts and Jobs Act (the "Tax Act") due to the impact of the federal tax rate reduction reducing our net deferred tax liabilities, the revenue and gross profit explanations above, and a one-time $4.7 million impairment expense that occurred in the prior year period. These increases were partially offset by additional SG&A and increased interest expense due to our new financing arrangement as well as the one-time expense of $1.4 million of debt issuance costs in accordance with debt modification accounting standards versus the prior year period. Adjusted EBITDA for the fourth quarter of 2017 was $26.6 million compared to $26.1 million in the fourth quarter of 2016.

Earnings per common share for the fourth quarter of 2017 was $0.09 per basic/diluted share, compared to $(0.02) per basic/diluted common share for the fourth quarter of 2016. Diluted non-GAAP adjusted earnings per share ("Adjusted EPS") was $0.18 in the fourth quarter of this year compared to $0.08 in the fourth quarter of 2016.

Full Year 2017 Financial Summary:

Revenue for 2017 was $4,485 million, compared to $4,410 million in 2016, an increase of $75 million or 2%. The increase was principally driven by the acquisitions completed in 2017, partially offset by a business decision to exit less profitable contracts at the end of 2016 and a decrease in the demand for hepatitis C drugs versus the prior year.

Gross profit in 2017 was $348.7 million and generated a 7.8% gross margin, compared to $324.8 million and a 7.4% gross margin in 2016. The gross margin increase was primarily due to the impact of acquisitions and a business decision to exit less profitable contracts at the end of 2016.

Selling, general, and administrative expenses ("SG&A") for 2017 were $330.1 million, an increase of $52.3 million, compared to $277.8 million in 2016. Of this increase, $26.9 million related to employee cost, which was principally driven by acquisitions. We also experienced a one-time increase of $12.5 million in the fair value of contingent consideration and a $10.0 million increase in amortization expense from definite-lived intangible assets, both associated with our recently acquired entities. As a percentage of revenue, SG&A, excluding change in fair value of contingent consideration, was 7.3% for 2017 compared to 6.4% in the prior year.

Net income attributable to Diplomat for 2017 was $15.5 million compared to $28.3 million for 2016, a decrease of $12.8 million. The decrease was driven by a $28.5 million decrease in income from operations and a $4.1 million increase in interest expense as we entered into a new financing arrangement during the fourth quarter of 2017, which increased our outstanding debt and caused us to expense $1.4 million of debt issuance costs in accordance with debt modification accounting standards. These decreases were partially offset by an improvement in income taxes primarily driven by the Tax Act due to the impact of the federal tax rate reduction reducing our net deferred tax liabilities, a one-time definite-lived asset impairment and the write down of a cost method investment that occurred in the prior year. Adjusted EBITDA for 2017 was $101.8 million versus $107.4 million for 2016.

Earnings per common share for 2017 was $0.23, compared to $0.43 per common share for 2016. On a diluted basis, earnings per share was $0.23 per common share for 2017, compared to $0.42 per common share in the prior year. Adjusted EPS was $0.84 in 2017 compared to $0.75 for 2016. Compared to the prior year, diluted weighted average common shares outstanding in 2017 were approximately 1.0% higher, impacted by the use of shares as partial consideration for acquisitions and stock option exercise activity.

2018 Financial Outlook

For the full-year 2018, we provide financial guidance as follows:

Revenue between $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

As previously announced, the Company will hold a conference call to discuss its fourth quarter and full year performance today, February 26, 2018, at 5:00 p.m. Eastern Time. Shareholders and interested participants may listen to a live broadcast of the conference call by dialing 833-640-6814 and referencing participant code 5992797 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.

Bristol-Myers Squibb Announces Expansion of the International Immuno-Oncology Network (II-ON) with Addition of Yale Cancer Center

On February 28, 2018 Bristol-Myers Squibb Company (NYSE:BMY) reported that Yale Cancer Center has joined the International Immuno-Oncology Network (II-ON), a global peer-to-peer collaboration between Bristol-Myers Squibb and academia that aims to advance translational Immuno-Oncology (I-O) science (Press release, Bristol-Myers Squibb, FEB 26, 2018, View Source [SID1234524637]). Formed in 2012 by Bristol-Myers Squibb, the II-ON was one of the first networks to bring academia and industry together to further the scientific understanding of I-O, and has since expanded from 10 to 16 sites across North America, Europe, Japan and Australia.Today, the partners collaborate to generate innovative I-O science, launch biology-driven trials and apply cutting-edge technologies with the goal of translating research findings into clinical trials and, ultimately, supporting efforts to improve survival outcomes across tumor types.

"The II-ON gives us the chance to work more efficiently and collaboratively with Bristol-Myers Squibb and the other II-ON academic centers to address scientific questions in I-O," said Roy Herbst, M.D., Ph.D., director of the Center of Immuno-Oncology at Yale Cancer Center and Yale’s principal investigator of the II-ON team. "The hope is this early research can someday inform clinical trials and ultimately help us to achieve our goal of transforming the way we treat people affected by cancer."

The II-ON was formed on the foundation of three fundamental scientific pillars aimed at addressing key research priorities in I-O: understanding the mechanisms of resistance to immunotherapy; identifying patient populations likely to benefit from immunotherapy; and exploring novel combination therapies that may enhance anti-tumor response through complementary mechanisms of action. By providing a streamlined framework for peer-to-peer collaboration among global cancer research leaders, the network is able to more rapidly facilitate I-O innovation and drug discovery.

"Translational medicine and the understanding of cancer biology are foundational to our oncology R&D program, which is why we’re invested in furthering our understanding of early I-O science through the II-ON," said Nils Lonberg, head of Oncology Biology Discovery at Bristol-Myers Squibb. "By adding Yale Cancer Center to the network, we are strengthening our collective ability to address essential scientific questions and advance clinical discovery, which we hope will eventually translate to meaningful outcomes for patients."

Bristol-Myers Squibb believes the future of cancer research is dependent on investments in science and partnerships. In addition to the II-ON, the company has invested in several other models of scientific collaboration with academic partners across the globe, including the Global Expert Centers Initiative (GECI), the Immuno-Oncology Integrated Community Oncology Network (IO-ICON) and the Oncology Academic Research (OAR) Group.

TESARO Announces Collaboration to Evaluate Combination of ZEJULA® (Niraparib) and Anti-PD-L1 Cancer Immunotherapy in Metastatic Bladder Cancer

On February 26, 2018 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported that it has entered into a clinical collaboration with Genentech, a member of the Roche Group, to evaluate the combination of the PD-L1 antibody atezolizumab (TECENTRIQ) and TESARO’s PARP-inhibitor ZEJULA (niraparib) in patients with metastatic bladder cancer (Press release, TESARO, FEB 26, 2018, View Source [SID1234524184]).

"This collaboration enables us to expand the clinical assessment of niraparib and PD(L)-1 combinations beyond ovarian, breast and lung cancer," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "The combination of these two therapies could provide a potential option for patients with advanced bladder cancer, for whom mechanisms of immune escape, despite significant recent advances with anti-PD(L)-1 agents, remain a clinically relevant unmet need."

The collaboration includes testing the experimental combination in MORPHEUS, Roche’s novel cancer immunotherapy development platform. MORPHEUS is a Phase 1b/2 adaptive platform to develop combinations of cancer immunotherapies more rapidly and efficiently. The planned trial will be conducted by Genentech and is expected to begin mid-2018.

TECENTRIQ (atezolizumab) is a registered trademark of Genentech, a member of the Roche Group.