On March 16, 2019 Clovis Oncology, Inc. (NASDAQ: CLVS) reported that data from post hoc exploratory analyses from the ARIEL3 Phase 3 clinical study of Rubraca will be presented during oral plenary and poster sessions at the Society of Gynecologic Oncology 2019 Congress (SGO), March 16 -19, 2019 in Honolulu, Hawaii (Press release, Clovis Oncology, MAR 16, 2019, View Source [SID1234534394]). Data to be presented will highlight ARIEL3 results in different patient demographics, including age and deleterious germline mutation status.

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"The results from these post hoc analyses of the ARIEL3 study data underscore the safety and efficacy of Rubraca across a broad range of women with recurrent ovarian cancer," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "We hope that our continuing exploration, analysis and publication of ARIEL3 data will help inform treatment decisions as well as the management of advanced ovarian cancer."

Included in the SGO 2019 Congress Scientific Plenary 1 session is the following:

Title: The effect of age on efficacy and safety outcomes with rucaparib: a post hoc exploratory analysis of ARIEL3, a phase 3, randomized, placebo-controlled maintenance study in patients with recurrent ovarian carcinoma

Presenter: Jonathan A. Ledermann

Session: Scientific Plenary I: Snap, Crackle, PARP

Date/Time: March 16, 2019; 6:45 – 7:45am (HST) // 12:45 – 11:45pm (EDT)

Location: Kamehameha 3

Summary: The efficacy and safety of Rubraca maintenance treatment was investigated in three age-based sub-groups from ARIEL3 in a post-hoc exploratory analysis. In the intent-to-treat (ITT) population, investigator-assessed median PFS for patients aged <65 years was 11.1 months (n=237) in the Rubraca arm vs 5.4 months (n=117) in the placebo arm (hazard ratio [HR], 0.33; 95% confidence interval [CI], 0.25–0.43); for patients aged 65–74 years, median PFS was 8.3 months (n=113) vs 5.3 months (n=64) (HR, 0.43; 95% CI, 0.29–0.64); and for patients aged ≥75 years, median PFS was 9.2 months (n=25) vs 5.5 months (n=8) (HR, 0.47; 95% CI, 0.16–1.35).

In this dataset, maintenance treatment with Rubraca improved median PFS and reduced the risk of progression vs placebo regardless of age subgroup. In general, the safety profile of Rubraca was consistent across the three age subgroups.

"As we continue to explore and expand our use of PARP inhibitors for the maintenance treatment of recurrent ovarian cancer, it’s helpful for physicians to know how individual factors such as patient age may impact treatment decisions," said Professor Jonathan Ledermann, MD, Professor of Medical Oncology, UCL Cancer Institute and UCL Hospitals, London, Global Principal Investigator for non-US sites in the ARIEL3 study. "In our analysis of the ARIEL3 study, we found that maintenance treatment with Rubraca improved median PFS, reduced the risk of progression and had a consistent safety profile regardless of age, suggesting that patient age should not discourage physicians from considering Rubraca in this setting."

Included in an SGO 2019 Congress poster presentation session is the following:

Title: Post hoc exploratory analysis of rucaparib in patients with platinum-sensitive recurrent ovarian carcinoma from the randomized, placebo-controlled phase 3 study ARIEL3: effect of a deleterious germline or no germline BRCA mutation on efficacy and safety

Presenter: Robert L. Coleman

Date/Time: March 18, 2019; 6:00 – 10:00am and 3:30 – 5:00pm (HST)// 12:00 – 4:00pm and 9:30 –11pm (EDT)

Location: Kamehameha 2

Summary: For this analysis, researchers assessed PFS in the subgroup of patients with a deleterious germline BRCA mutation (germline BRCA mutation) and in patients without a deleterious germline BRCA mutation (no germline BRCA mutation). In these subgroups, Rubraca significantly improved PFS vs placebo regardless of BRCA mutation status. Although the reduction in risk was numerically greater in the germline BRCA mutation subgroup (hazard ratio [HR], 0.25; 95% confidence interval [CI], 0.16–0.39) than in the no germline BRCA mutation subgroup (HR, 0.41; 95% CI, 0.32–0.52), the reduction in risk between the two subgroups did not differ by a statistically significant margin. The safety profile of Rubraca vs placebo in the germline BRCA mutation and no germline BRCA mutation subgroups was consistent with the safety profile of Rubraca in the overall safety population reported previously.

This post hoc exploratory analysis demonstrated that the reduction in risk was numerically greater in the germline BRCA mutation subgroup than in the no germline BRCA mutation subgroup. In the no germline BRCA mutation subgroup, the observed improvement in PFS was not driven solely by the somatic BRCA mutation + wild-type BRCA/high LOH subgroup as demonstrated by the analysis of patients with wild-type BRCA tumors.

"While it is evident that women whose tumors possess a BRCA mutation derive the greatest benefit from rucaparib therapy, the data presented in this poster demonstrate the meaningful and clinically relevant benefit that eligible patients, including those without a BRCA mutation, may receive as a result of maintenance treatment," said Robert L. Coleman, MD, Professor, Gynecologic Oncology and Reproductive Medicine at The University of Texas MD Anderson Cancer Center in Houston and co-Coordinating Investigator in the ARIEL3 clinical trial program. "These data further reinforce the importance of maintenance treatment for women with recurrent ovarian cancer versus the previous standard of observation following treatment with chemotherapy."

About the ARIEL3 Clinical Trial

The ARIEL3 pivotal study of rucaparib is a confirmatory randomized, double-blind study comparing the effects of rucaparib against placebo to evaluate whether rucaparib given as a maintenance treatment to platinum-sensitive ovarian cancer patients can extend the period of time for which the disease is controlled after a complete or partial response to platinum-based chemotherapy. The study enrolled 564 patients with high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer. To be eligible for the study, participants had to have received at least two prior platinum-based treatment regimens, been sensitive to the penultimate platinum regimen, and achieved a complete or partial response to their most recent platinum-based regimen. There were no genomic selection criteria for this study. Trial participants were randomized 2:1 to receive 600 milligrams of rucaparib twice daily (BID) or placebo. The study achieved its primary endpoint of improved PFS by investigator review in each of three populations. PFS was also improved in the rucaparib group compared with placebo by independent review, a key secondary endpoint, in all three populations. In addition, rucaparib improved objective response rate vs placebo among evaluable trial participants in all three study populations.

About Rubraca (rucaparib)

Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian, metastatic castration-resistant prostate, and bladder cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway.

Clovis holds worldwide rights for Rubraca. Rubraca is an unlicensed medical product outside of the U.S. and the EU.

Rubraca U.S. FDA Approved Indications and Important Safety Information

Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

Rubraca is indicated as monotherapy for the treatment of adult patients with deleterious BRCA mutations (germline and/or somatic) associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic for Rubraca.

Select Important Safety Information

Myelodysplastic Syndrome (MDS)/Acute Myeloid Leukemia (AML) occur uncommonly in patients treated with Rubraca, and are potentially fatal adverse reactions. In approximately 1100 treated patients, MDS/AML occurred in 12 patients (1.1%), including those in long-term follow-up. Of these, five occurred during treatment or during the 28-day safety follow-up (0.5%). The duration of Rubraca treatment prior to the diagnosis of MDS/AML ranged from 1 month to approximately 28 months. The cases were typical of secondary MDS/cancer therapy-related AML; in all cases, patients had received previous platinum-containing regimens and/or other DNA-damaging agents. Do not start Rubraca until patients have recovered from hematological toxicity caused by previous chemotherapy (≤ Grade 1).

Monitor complete blood counts for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment. For prolonged hematological toxicities (> 4 weeks), interrupt Rubraca or reduce dose (see Dosage and Administration [2.2] in full Prescribing Information) and monitor blood counts weekly until recovery. If the levels have not recovered to Grade 1 or less after 4 weeks, or if MDS/AML is suspected, refer the patient to a hematologist for further investigations, including bone marrow analysis and blood sample cytogenetic analysis. If MDS/AML is confirmed, discontinue Rubraca.

Based on its mechanism of action and findings from animal studies, Rubraca can cause fetal harm when administered to a pregnant woman. Apprise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of Rubraca.

Most common adverse reactions in ARIEL3 (≥ 20%; Grade 1–4) were nausea (76%), fatigue/asthenia (73%), abdominal pain/distention (46%), rash (43%), dysgeusia (40%), anemia (39%), AST/ALT elevation (38%), constipation (37%), vomiting (37%), diarrhea (32%), thrombocytopenia (29%), nasopharyngitis/upper respiratory tract infection (29%), stomatitis (28%), decreased appetite (23%) and neutropenia (20%).

Most common laboratory abnormalities in ARIEL3 (≥ 25%; Grade 1–4) were increase in creatinine (98%), decrease in hemoglobin (88%), increase in cholesterol (84%), increase in alanine aminotransferase (ALT) (73%), increase in aspartate aminotransferase (AST) (61%), decrease in platelets (44%), decrease in leukocytes (44%), decrease in neutrophils (38%), increase in alkaline phosphatase (37%) and decrease in lymphocytes (29%).

Most common adverse reactions in Study 10 and ARIEL2 (≥ 20%; Grade 1–4) were nausea (77%), asthenia/fatigue (77%), vomiting (46%), anemia (44%), constipation (40%), dysgeusia (39%), decreased appetite (39%), diarrhea (34%), abdominal pain (32%), dyspnea (21%) and thrombocytopenia (21%).

Most common laboratory abnormalities in Study 10 and ARIEL2 (≥ 35%; Grade 1–4) were increase in creatinine (92%), increase in alanine aminotransferase (ALT) (74%), increase in aspartate aminotransferase (AST) (73%), decrease in hemoglobin (67%), decrease in lymphocytes (45%), increase in cholesterol (40%), decrease in platelets (39%) and decrease in absolute neutrophil count (35%).

Co-administration of Rubraca can increase the systemic exposure of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, which may increase the risk of toxicities of these drugs. Adjust dosage of CYP1A2, CYP3A, CYP2C9, or CYP2C19 substrates, if clinically indicated. If co-administration with warfarin (a CYP2C9 substrate) cannot be avoided, consider increasing frequency of international normalized ratio (INR) monitoring. Because of the potential for serious adverse reactions in breast-fed children from Rubraca, advise lactating women not to breastfeed during treatment with Rubraca and for 2 weeks after the last dose. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Clovis Oncology, Inc. at 1-844-258-7662.

Click here for full Prescribing Information and additional Important Safety Information.

Rubraca ▼ (rucaparib) EU Authorized Use and Important Safety Information

Rucaparib is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.

Rucaparib is indicated as monotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated (germline and/or somatic), high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum-based chemotherapy, and who are unable to tolerate further platinum-based chemotherapy.

Summary warnings and precautions: Haematological toxicity: Patients should not start Rubraca until they have recovered from haematological toxicities caused by previous chemotherapy (≤ CTCAE Grade 1). Complete blood count testing prior to starting treatment with Rubraca and monthly thereafter is advised. Rubraca should be interrupted or dose reduced and blood counts monitored weekly until recovery for the management of low blood counts. Myelodysplastic syndrome/acute myeloid leukaemia (MDS/AML): If MDS/AML is suspected, the patient should be referred to a haematologist for further investigation. If MDS/AML is confirmed, Rubraca should be discontinued. Photosensitivity: Patients should avoid spending time in direct sunlight as they may burn more easily. When outdoors, patients should wear protective clothing and sunscreen with SPF of 50 or greater. Gastrointestinal toxicities: Low grade (CTCAE Grade 1 or 2) nausea and vomiting may be managed with dose reduction or interruption. Additionally, antiemetics may be considered for treatment or prophylaxis.

Click here to access the current Summary of Product Characteristics. Healthcare professionals should report any suspected adverse reactions via their national reporting systems.

On March 15, 2019 March 15, 2019 (GLOBE NEWSWIRE) — Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage, immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers, reported financial results and recent corporate highlights for the full year ended December 31, 2018 (Press release, Checkpoint Therapeutics, MAR 15, 2019, http://checkpointtx.com/press-releases/checkpoint-therapeutics-reports-full-year-2018-financial-results-and-recent-corporate-highlights/ [SID1234534375]).

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James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "During 2018, we continued to advance our lead clinical programs, CK-101, a third-generation epithelial growth factor receptor ("EGFR") tyrosine kinase inhibitor ("TKI"), and CK-301, a fully human anti-PD-L1 antibody, and presented our first interim clinical data for CK-101 in an oral presentation at the World Conference on Lung Cancer. We look forward to presenting our first interim safety and efficacy data from the ongoing CK-301 study in the second quarter as we continue to enroll potential registration-enabling expansion cohorts in endometrial and colorectal cancers, and plan to initiate a registration trial for CK-101 by year-end."

Financial Results:

Cash Position: As of December 31, 2018, Checkpoint’s cash and cash equivalents totaled $22.0 million, compared to $19.2 million at December 31, 2017, an increase of $2.8 million.
R&D Expenses: Research and development expenses for the year ended December 31, 2018 were $33.7 million, compared to $19.1 million for the year ended December 31, 2017, an increase of $14.6 million.
G&A Expenses: General and administrative expenses for the year ended December 31, 2018 were $6.6 million, compared to $5.4 million for the year ended December 31, 2017, an increase of $1.2 million.
Net Loss: Net loss attributable to common stock holders for the year ended December 31, 2018 was $36.4 million, or $1.27 per share, compared to a net loss of $22.7 million, or $1.00 per share, for the year ended December 31, 2017.
2018 and Recent Corporate Highlights:

In March 2018, Checkpoint completed an underwritten public offering that raised net proceeds of $20.8 million.
Also in March 2018, Checkpoint completed the dose escalation portion of the ongoing Phase 1 trial of CK-301, a fully human anti-PD-L1 antibody, in selected recurrent or metastatic cancers, and initiated the first dose expansion cohort, which is evaluating an 800 mg dose of CK-301 administered every two weeks.
In April 2018, preclinical data were presented on Checkpoint’s BET inhibitor, CK-103, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. CK-103 demonstrated combinatorial effects in an in vivo model with anti-PD-1 antibodies, which may support the development of CK-103 as an anti-cancer agent alone and in combination with CK-301.
In September 2018, Checkpoint announced interim safety and efficacy data from its Phase 1/2 clinical trial of CK-101, a third-generation EGFR TKI being evaluated in advanced NSCLC. The data were presented in an oral presentation at the International Association for the Study of Lung Cancer ("IASLC") 19th World Conference on Lung Cancer in Toronto. CK-101 was well tolerated across multiple dose groups and safe. Durable anti-tumor activity was observed, particularly in treatment-naïve EGFR mutation-positive NSCLC patients.
In October 2018, Checkpoint appointed Christian Béchon to its Board of Directors.
In January 2019, Checkpoint announced that the ongoing multi-center clinical trial of anti-PD-L1 antibody CK-301 was expanded to enroll patients in three endometrial and colorectal cohorts intended to support requests for accelerated approval and BLA submissions to the FDA. The ongoing trial is also enrolling cohorts of patients with NSCLC and cutaneous squamous cell carcinoma.
In March 2019, Checkpoint announced two new patent issuances by the U.S. Patent and Trademark Office and the European Patent Office for CK-101. The patents cover CK-101 in the U.S. and Europe through at least August 2034, not including any potential patent term extensions.

On March 15, 2019 Adamis Pharmaceuticals Corporation (NASDAQ: ADMP) reported financial results for the year ended December 31, 2018 and provided a business update (Press release, Adamis Pharmaceuticals, MAR 15, 2019, View Source [SID1234534400]).

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Dr. Dennis J. Carlo, President and Chief Executive Officer of Adamis Pharmaceuticals, stated, "There were several significant developments for our company during 2018. I view the marketing and distribution agreement with Sandoz for our SYMJEPI products, approval of the SYMJEPI 0.15mg product and submission of a new drug application (NDA) for our higher dose naloxone injection product to be the most significant developments, laying the groundwork for what I hope will be a transformative year for the company. We are also encouraged by the performance of US Compounding in early 2019 and we look forward to expanding our production capacity."

Select Events Since Last Business Update:

First commercial product delivered to Sandoz;

NDA submitted to the FDA and accepted for review for the higher dose naloxone injection product candidate;

NDA submitted to the FDA and received a refusal to file letter for the tadalafil product candidate;

Drug Outsourcing Facility (U.S. Compounding) increased revenue by 15%; and

Sandoz announces launch of SYMJEPI 0.3mg product to the institutional market in the U.S.
Product Updates

SYMJEPI (epinephrine) Injection (0.3mg and 0.15mg)

As announced in the third quarter of 2018, the company entered into a commercialization and distribution agreement with Sandoz, a division of Novartis, to market and sell SYMJEPI (epinephrine) Injection 0.3mg and SYMJEPI (epinephrine) Injection 0.15mg (upon approval) in the U.S. The company also granted Sandoz a right of first negotiation for territories outside the U.S. On September 27, 2018, the FDA approved the SYMJEPI 0.15mg product. In January 2019, Sandoz announced the launch of SYMJEPI 0.3mg product for the institutional market in the U.S.

APC-6000 (naloxone)

As announced in December 2018, the company filed an NDA relating to its higher dose naloxone injection product for the treatment of opioid overdose. On March 14, 2019, the company received notice from the FDA that it had determined the NDA was sufficiently complete to permit a substantive review and provided a target agency action date of October 31, 2019. Please refer to the company’s March 14, 2019 press release for additional information.

APC-8000 (sublingual tadalafil)

In December 2018, the company announced that it had filed an NDA for a fast-disintegrating sublingual tadalafil (APC-8000) product candidate. On February 26, 2019, the company received a refusal to file letter from the FDA indicating it had determined that the submitted NDA was not sufficiently complete to permit a substantive review. The FDA requested that the company supplement and include in a resubmitted NDA additional data and information. The company continues to evaluate the FDA’s comments, and it may seek immediate guidance from the FDA, including requesting a Type A meeting, to discuss the letter and the specific deliverables the agency would require for a resubmitted NDA to be deemed complete.

APC-1000 (beclomethasone)

In 2018, the company submitted an IND application and received clearance from the FDA to begin Phase 3 efficacy studies for APC-1000. In Q4 2018, it initiated the start-up phase of the phase 3 studies of APC-1000. The company anticipates that trial enrollment will commence in 2019; however, the timing of enrollment and completion of such studies could be affected by a number of factors as described in the company’s Form 10-K.

APC-4000 (fluticasone)

During 2018, the company completed development and manufacturing work on the patented dry powder inhaler (DPI) technology that the company acquired from 3M. Adamis is now focused on continuing and completing the drug development work, which includes loading fluticasone onto the tape and into the device, in order to demonstrate the device can achieve the targeted dosing. Once completed, the company may seek a development or commercial partner to help advance the product through a regulatory pathway.

Drug Outsourcing Facility

The company’s wholly-owned subsidiary, US Compounding (USC), has continually grown its revenues year over year since Adamis acquired the division. During 2018, USC continued to make improvements in its processes and efficiencies while maintaining its focus on quality. Although net revenue grew 15% over 2017, it did not meet the company’s previously stated growth target. Therefore, during the first quarter of 2019, Adamis has made changes to USC personnel and strategy with the objective of achieving profitability for the division during 2019.

2018 Financial Results

Revenues were approximately $15.1 million and $13.1 million for the years ended December 31, 2018 and 2017, respectively. The increase of approximately $2.0 million reflected an increase in sales of USC’s compounded and non-compounded pharmaceutical formulations resulting in part from price increases, increase in unit sales production capacity in order to meet product demand, and marketing personnel efforts.

Selling, general and administrative expenses (SG&A) for the years ending December 31, 2018 and 2017 were approximately $26.0 million and $22.8 million, respectively. SG&A expenses consist primarily of depreciation and amortization, legal fees, accounting and audit fees, professional/consulting fees and employee compensation. Compensation expense for SG&A employees increased by approximately $2.0 million for 2018 compared to 2017, primarily due to new hires, increases in salary expenses and bonus accruals, and expenses associated with equity compensation and other employee benefits. Approximately $0.5 million of the increase for 2018 was due to PDUFA fees, marketing, selling, insurance, consulting, outside services and travel expenses; approximately $0.3 million of the increase was due to increases in patent fees; and approximately $0.4 million of the increase was due to increases in occupancy costs, insurance, supplies, taxes, and other related expenses.

Research and development expenses (R&D) were approximately $18.8 million and $7.5 million for the years ended December 31, 2018 and 2017, respectively. The increase in R&D for 2018, compared to 2017 was primarily due to an increase of approximately $8.8 million in development costs of the company’s product candidates, including APC-1000, APC-4000, APC-6000 and APC-8000. Compensation for R&D employees, consulting, and other operating expenses increased by approximately $1.6 million for 2018 compared to 2017, primarily due to new hires and cash and equity compensation expenses. As noted in its November 2018 press release, the company experienced increased research and development expenses for the fourth quarter of 2018.

At December 31, 2018, the Company had cash and cash equivalents of $19.3 million.

Targeted Future Milestones

FDA approval for the higher dose naloxone product candidate – target agency action date of October 31, 2019;
Sandoz’s launch of the SYMJEPI 0.3mg and 0.15mg products for the U.S. retail market;
Commercial agreements for the naloxone product candidate and for the SYMJEPI 0.3mg and 0.15mg products outside of the U.S.; and
US Compounding reaching profitability in 2019 (targeted by mid-year).

On March 15, 2019 Diplomat Specialty Pharmacy reported 4th Quarter and 2018 Year End Financial Results (Press release, Diplomat Speciality Pharmacy, MAR 15, 2019, View Source [SID1234534376]).

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4th Quarter Revenue of $1,361 Million, an increase of 18%, Net (Loss) Income Attributable to Diplomat of $(298.0) Million, compared to $6.5 Million, Adjusted EBITDA of $43.5 Million, an increase of 63%
Full Year Revenue of $5,493 Million, an increase of 22%, Net (Loss) Income Attributable to Diplomat of $(302.3) Million, compared to $15.5 Million, Adjusted EBITDA of $167.8 Million, an increase of 65%
FLINT, Mich., March 15, 2019 /PRNewswire/ — Diplomat Pharmacy, Inc. (NYSE: DPLO), the nation’s largest independent provider of specialty pharmacy and infusion services, announced financial results for the quarter and year ended December 31, 2018. All comparisons, unless otherwise noted, are to the quarter or year ended December 31, 2017. The Pharmacy Benefit Management ("PBM") segment comparisons are impacted by the timing of the Company’s acquisitions, which occurred in late 2017. Prior period financials have been recast to include certain direct expenses as part of cost of sales instead of selling, general and administrative ("SG&A") expense for our Specialty segment. This is a reclassification change only and has no impact on overall results.

Diplomat Specialty Pharmacy (PRNewsFoto/Diplomat Pharmacy, Inc.)

Fourth Quarter 2018 Highlights include:

Revenue of $1,361 million, compared to $1,155 million, an increase of 18%
Specialty segment revenue of $1,192 million, compared to $1,143 million
PBM segment revenue of $179 million, compared to $12 million
Specialty segment total prescriptions dispensed of 229,000, compared to 224,000
PBM segment total volume, adjusted to 30-day equivalent, of 1,936,000, compared to 764,000
Gross margin of 6.9% versus 6.3%
Specialty segment gross margin of 5.7% versus 6.0%
PBM segment gross margin of 14.3% versus 32.8%
EPS of $(4.00) per diluted common share versus $0.09 per diluted common share
Adjusted EBITDA of $43.5 million, compared to $26.6 million
Adjusted EBITDA margin of 3.2% versus 2.3%
Net cash provided by operating activities was $1.8 million, compared to $41.6 million
Net Debt; defined as total debt including contingent consideration less cash and equivalents, decreased to $638.2 million, from $646.7 million at September 30, 2018
Full Year 2018 Highlights include:

Revenue of $5,493 million, compared to $4,485 million, an increase of 22%
Specialty segment revenue of $4,791 million, compared to $4,473 million
PBM segment revenue of $729 million, compared to $12 million
Specialty segment total prescriptions dispensed of 918,000, compared to 886,000
PBM segment total volume, adjusted to 30-day equivalent, of 8,171,000, compared to 764,000
Gross margin of 6.8% versus 6.1%
Specialty segment gross margin of 5.9% versus 6.0%
PBM segment gross margin of 13.1% versus 32.8%
EPS of $(4.07) per diluted common share versus $0.23 per diluted common share
Adjusted EBITDA of $167.8 million, compared to $101.8 million
Adjusted EBITDA margin of 3.1% versus 2.3%
Net cash provided by operating activities was $35.0 million, compared to $135.3 million
Brian Griffin, Chairman and CEO of Diplomat, commented "While our 2018 financial results were strong, market conditions in 2019 are significantly more challenging than expected in our specialty and PBM businesses. 2019 is a rebuilding year, and we continue to focus on driving additional volumes to Diplomat by creating partnerships with health plans and hospital systems to meet the demand for better clinical outcomes and management of specialty spend. We are also committed to rebuilding our PBM business."

"The Company’s cost structure is no longer supported by the current business environment and we are accelerating operational efficiency initiatives.

I remain confident that Diplomat is making the right investments and executing the right strategy and operational initiatives to leverage our competitive strengths and position Diplomat for future growth and profitability," said Griffin.

Fourth Quarter Financial Summary:

Revenue for the fourth quarter of 2018 was $1,361 million, compared to $1,155 million in the fourth quarter of 2017, an increase of $206 million or 18%. Our Specialty segment revenue amounted to $1,192 million, compared to $1,143 million in the prior year quarter, while revenue from our PBM segment amounted to $179 million, compared to $12 million in the prior year quarter. The increase in our Specialty segment was driven by manufacturer price increases and an increase in our oncology and infusion volumes, partially offset by reimbursement compression to maintain contractual relationships with certain payers and a volume decrease in certain therapy classes, including immunology and multiple sclerosis. The increase in our PBM segment is due to timing of our PBM acquisitions late in the fourth quarter of 2017 versus a full quarter impact in the fourth quarter of 2018.

Gross profit in the fourth quarter of 2018 was $93.9 million and generated a 6.9% gross margin, compared to $72.6 million gross profit and a 6.3% gross margin in the fourth quarter of 2017. Gross profit from our Specialty segment was $68.2 million, compared to $68.5 million in the prior year quarter, while gross profit from our PBM segment was $25.6 million, compared to $4.1 million in the prior year quarter. The gross margin increase in the quarter was due to the impact of our PBM acquisitions, partially offset by reimbursement compression in our Specialty segment.

SG&A expenses for the fourth quarter of 2018 were $79.9 million, an increase of $10.2 million, compared to $69.7 million in the fourth quarter of 2017. This increase is primarily driven by a $4.6 million increase in employee cost, including employee cost for our acquired entities, and a $0.6 million increase in share-based compensation. Also contributing to the SG&A expense increase was a $5.9 million increase in amortization expense from definite-lived intangible assets, inclusive of capitalized software for internal use, associated with our acquired entities. We also experienced increases in other SG&A expenses; including, rent due to the addition of our Chandler, Arizona facility, Information Technology ("IT") expense due to the implementation of a new operating system, travel, consulting and professional fees, as well as other miscellaneous expenses. These increases were partially offset by a $2.2 million decrease in acquisition related expenses.

Net (loss) income attributable to Diplomat for the fourth quarter of 2018 was $(298.0) million compared to $6.5 million in the fourth quarter of 2017. This decrease was primarily driven by a $262 million non-cash impairment charge related to goodwill and definite-lived intangible assets associated with our PBM segment due to the effects of client losses and a reduced financial forecast, on our annual impairment analysis, as well as a $46 million non-cash goodwill impairment charge related to our Specialty segment due to the effects of a reduced financial forecast, on our annual impairment analysis. Income from operations for the fourth quarter of 2018, excluding the non-cash impairment charges, was $13.9 million, compared to $2.9 million in the fourth quarter of 2017. We experienced a $6.0 million increase in interest expense due to the outstanding debt required to fund our PBM acquisitions in the fourth quarter of 2017. Our income tax benefit decreased $2.4 million due primarily to a $64.5 million increased tax benefit at statutory rates offset by a $9.8 million impact due to the impairment of our non-deductible goodwill relating to our prior stock acquisitions and a $48.7 million valuation allowance made in the fourth quarter of 2018 on deferred tax assets due to a cumulative loss position driven by the impairment charges. Income taxes were also impacted in the prior year by the passage of the Tax Cuts and Job’s act which, after taking into account the provisions of the Tax Cuts and Jobs Act, caused our net deferred tax liabilities to be re-remeasured for a one-time benefit of approximately $7.9 million. Adjusted EBITDA for the fourth quarter of 2018 was $43.5 million compared to $26.6 million in the fourth quarter of 2017, an increase of $16.9 million.

Earnings per share for the fourth quarter of 2018 was $(4.00) per basic/diluted common share, compared to $0.09 per basic/diluted common share for the fourth quarter of 2017.

Full Year 2018 Financial Summary:

Revenue for 2018 was $5,493 million, compared to $4,485 million in 2017, an increase of $1,007 million or 22%. Specialty segment revenue amounted to $4,791 million, compared to $4,473 million in 2017, while revenue from our PBM segment amounted to $729 million compared to $12 million in 2017. The consolidated revenue increase was principally driven by the full year impact of our 2017 acquisitions, including our PBM acquisitions, and the impact of manufacturer price increases in our Specialty segment. These increases were partially offset by reimbursement compression and by a volume decrease in our immunology, hepatitis C, and multiple sclerosis business categories, as well as other lower margin business categories, including human immunodeficiency virus and osteoporosis, compared to the prior year.

Gross profit in 2018 was $376.0 million and generated a 6.8% gross margin, compared to $274.1 million and a 6.1% gross margin in 2017. Gross profit improved $101.9 million, or 37%, compared to the prior year period. Gross profit from our Specialty segment was $280.6 million, compared to $270.1 million in the prior year, while gross profit from our PBM segment was $95.4 million, compared to $4.1 million in the prior year. The gross margin increase was primarily due to the impact of our PBM acquisitions, partially offset by reimbursement compression in our Specialty segment.

SG&A expenses for 2018 were $335.7 million, an increase of $80.1 million, compared to $255.6 million in 2017. Of this increase, $40.4 million related to employee cost, including employee cost for our acquired entities, a $10.9 million increase in share-based compensation, and a $1.7 million increase in severance and related expenses. Also contributing to the SG&A expense increase was a $27.5 million increase in amortization expense from definite-lived intangible assets, inclusive of capitalized software for internal use, associated with our acquired entities. We further experienced increases in other SG&A expenses including consulting and professional fees; rent due to the addition of our Chandler, Arizona facility; IT expense due to the implementation of a new operating system; recruiting primarily related to our CEO search; travel; as well as other miscellaneous expenses.

Net (loss) income attributable to Diplomat for 2018 was $(302.3) million compared to $15.5 million for 2017. This decrease was primarily driven by a $262 million non-cash impairment charge related to goodwill and definite-lived intangible assets associated with our PBM segment due to the effects of client losses and a reduced financial forecast, on our annual impairment analysis, as well as a $46 million non-cash goodwill impairment charge related to our Specialty segment due to the effects of a reduced financial forecast, on our impairment analysis. Our 2018 income from operations excluding the non-cash impairment charges, was $40.4 million, compared to $18.6 million in 2017. We also experienced a $30.9 million increase in interest expense due to a significant increase in outstanding debt to fund our PBM acquisitions, and a $2.1 million decrease in income tax benefit due to the same factors impacting the fourth quarter 2018. Adjusted EBITDA for 2018 was $167.8 million versus $101.8 million for 2017.

Earnings per share for 2018 was $(4.07) per basic/diluted common share, compared to $0.23 per basic/diluted common share for 2017.

Revised 2019 Financial Outlook

For the full-year 2019, we provide financial guidance as follows:

Revenue between $4.7 and $5.0 billion, versus the previous range of $5.6 to $5.8 billion
Specialty segment revenue between $4.4 and $4.6 billion, versus the previous range of $5.1 to $5.3 billion
PBM segment revenue between $0.3 and $0.4 billion, versus the previous range of $0.45 to $0.5 billion
Net (loss) income attributable to Diplomat between $(37) and $(26) million
Adjusted EBITDA between $110 and $116 million, versus the previous communication of "flat to low single digit percent year over year growth"
Diluted EPS between $(0.50) and $(0.34)
Our EPS expectations for 2019 assume approximately 75,300,000 weighted average common shares outstanding on a diluted basis and a tax rate of (21)% and (18)%, for the low- and high-end of the range, respectively, for the full year 2019, each of 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 this morning, March 15, 2019, 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 2672528 approximately 15 minutes prior to the call. A live webcast of the conference call and associated slide presentation will be available on the investor relations section of the Company’s website for approximately 30 days at ir.diplomat.is.

On March 15, 2019 Oragenics, Inc. (NYSE American: OGEN), a leader in the development of new antibiotics against infectious diseases and effective treatments for oral mucositis, reported the enrollment of the 60th patient in its Phase 2 double blind, placebo controlled clinical trial of AG013 (NCT03234465) (Press release, Oragenics, MAR 15, 2019, View Source [SID1234534401]).

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AG013 is an oral mouth rinse composed of a recombinant Lactococcus lactis bacteria strain that contains the coding sequence for human trefoil family factor 1 (hTFF1), which is continually secreted by the bacteria. The trefoil factor family (TFF) is a family of three different peptides secreted by epithelial cells of the gastrointestinal tract in response to injury (Hoffman, 2004). Their presence has been implicated in reducing chemotherapy- and radiation-induced injury, both in preclinical studies (Beck et al., 2004) and in clinical trials (Peterson et al., 2009).

"We are encouraged and pleased to have made this important intermediate progress. The number of patients interested in participating in the clinical trial highlights the need for new treatment options for prevention of severe oral mucositis in this patient population," said Alan Joslyn, CEO of Oragenics, Inc. "While we are confident in the measures we have taken to potentially expedite the pace of patient enrollment in future periods and we remain optimistic about such enrollment rates, given the pace of patient enrollment to date, we now anticipate that the top-line data readout of the AG013 study will likely occur in early 2020."