On May 8, 2017 DelMar Pharmaceuticals (Nasdaq: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on developing new cancer therapies, reported new mechanism of action (MOA) data for its anti-cancer product candidate, VAL-083 (dianhydrogalactitol), a "first-in-class" small-molecule DNA-targeting agent in temozolomide (Temodar)-resistant GBM, at the World Federation of Neuro-Oncology Societies (WFNOS) (Press release, DelMar Pharmaceuticals, MAY 8, 2017, View Source [SID1234518897]). Schedule your 30 min Free 1stOncology Demo! The Company presented two posters at the Quadrennial session of the WFNOS Conference in Zurich, Switzerland.
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The titles and summaries of the posters are as follows:
Abstract 1: Distinct mechanism of action of dianhydrogalactitol (VAL-083) overcomes chemoresistance in glioblastoma. Zhai et al, 2017.
It has been previously demonstrated, both preclinically and in the clinic, that VAL-083 is active in temozolomide-resistant GBM. Glioblastoma cells are known to become refractory to treatment because they are able to repair the DNA damage caused by temozolomide using the MGMT* enzyme and the MMR** family of enzymes. While temozolomide is inactive in GBM cells where MGMT is functional, it has already been demonstrated that the activity of VAL-083 is unaffected by the MGMT status of a cell and hence VAL-083 remains active, even when temozolomide has failed.
The authors now show that VAL-083 is not only able to circumvent the MGMT pathway but is also able to override the secondary temozolomide resistance mechanism seen in GBM—MMR DNA repair. In cancer cell-lines VAL-083 is able to induce DNA damage and resultant cell apoptosis even when MMR enzymes (MLH-1 and MSH-2) are made constitutively active.
Taken together, these data provide preclinical evidence, and support the clinical rationale, that VAL-083 should be studied as a front-line therapy for GBM patients in whom active MGMT and MMR pathways will result in chemoresistance to temozolomide.
These results also add to the growing evidence that temozolomide may only be a viable front-line treatment in the 1/3 of GBM patients for whom biomarker data reveal inactive MGMT and MMR enzymes. VAL-083, whose activity is independent of, and agnostic to, the MGMT and MMR activity, may in fact be a superior alternative.
Abstract 2: Clinical trials of VAL-083 in patients with chemoresistant glioblastoma. Bacha et al, 2017.
In this poster the authors review historic clinical trials of VAL-083 run by the National Cancer Institute and the modern dose-finding trials conducted by DelMar (ASCO 2016) to provide the rationale for the ongoing and new clinical development of VAL-083 in GBM. This topic was also the recent subject of a contributed editorial by CEO Jeff Bacha and CSO Dennis Brown for Life Science Leader, entitled Cancer Breakthroughs: A Look to the Past Can be a Look to the Future.
DelMar has announced plans to investigate VAL-083 in Phase 2 and Phase 3 clinical trials in recurrent and newly diagnosed GBM. A pivotal randomized, controlled Phase 3 Study in Temozolomide-Avastin Recurrent GBM ("STAR-3") will evaluate the overall survival of VAL-083 versus salvage chemotherapy for GBM patients who have previously failed both temozolomide and bevacizumab (Avastin) and for whom there exists no approved treatment option. Should VAL-083 show a survival benefit in this moribund, recalcitrant population, it could revolutionize the GBM treatment landscape. A Phase 2 study of VAL-083 at MD Anderson Cancer Center is currently enrolling second-line GBM patients who have failed front-line temozolomide and test positive for MGMT. Finally, a Phase 2 trial enrolling MGMT-expressing front-line GBM patients to be treated with VAL-083 in lieu of temozolomide has the potential to introduce biomarker testing into the GBM treatment paradigm to determine which patients will receive temozolomide and VAL-083, respectively, based on their MGMT expression status.
*MGMT= O6-Methyl Guanine DNA-Methyl Transferase **MMR=mismatch repair
About VAL-083
VAL-083 is a "first-in-class," small-molecule chemotherapeutic that demonstrated clinical activity against a range of cancers including GBM in historical clinical trials sponsored by the U.S. National Cancer Institutes (NCI). DelMar has demonstrated that VAL-083’s anti-tumor activity against GBM is unaffected by the expression of MGMT and MMR in vitro. Further details can be found at View Source
VAL-083 has received an orphan drug designation in Europe for the treatment of malignant gliomas and the U.S. FDA Office of Orphan Products has granted an orphan designation to VAL-083 for the treatment of glioma, medulloblastoma and ovarian cancer. Based on historic clinical trials run by the NCI, the modern Phase 1/2 dose finding trial run by DelMar in GBM (ASCO 2016), and recent guidance from the FDA, the Company has embarked on Phase 2 or 3 trials for VAL-083 across recurrent and newly diagnosed GBM. DelMar has announced plans to advance VAL-083 into a pivotal randomized multi-center Phase 3 clinical trial for the treatment of bevacizumab-failed GBM, a Phase 2 trial (with MD Anderson Cancer Center) in first recurrence GBM patients prior to bevacizumab therapy, and into a separate international Phase 2 trial for newly diagnosed MGMT-unmethylated GBM. DelMar believes that data from its clinical trials, if successful, will form the basis of a new treatment paradigm for the vast majority of GBM patients whose tumors exhibit features that make them unlikely to respond to currently available therapies.
About Glioblastoma Multiforme (GBM)
GBM is the most common and aggressive primary brain cancer. Current standard of care includes surgery, radiation and treatment with temozolomide (TMZ), however nearly all tumors recur and the prognosis for recurrent GBM is dismal. Most GBM tumors have unmethylated promoter status for MGMT. Second-line treatment with anti-angiogenic agent bevacizumab has not improved overall survival (OS) and 5-year survival is less than 3%. VAL-083 (dianhydrogalactitol) is a first-in-class bi-functional DNA-targeting agent that induces interstrand DNA cross-links at the N7-position of guanine leading to DNA double-strand breaks and cell death in GBM cell lines and GBM cancer stem cells, independent of MGMT or MMR status in vitro. VAL-083 readily crosses the blood-brain barrier and accumulates in brain tumor tissue. Our recent Phase 1/2 clinical trial in recurrent GBM patients failing both TMZ and bevacizumab, suggested that VAL-083 offers clinically meaningful survival benefits for patients with recurrent GBM and pinpointed a new dosing regimen (40 mg/m2/d on days 1,2,3 of a 21-day cycle) which was well-tolerated and was selected for study in subsequent GBM trials. These trials include, i) an ongoing single-arm, biomarker driven, Phase 2 study to determine if VAL-083 treatment of MGMT-unmethylated adult GBM patients at first recurrence/progression, prior to bevacizumab improves overall survival, compared to historical control with lomustine (clinicaltrials.gov identifier: NCT02717962). ii) A pivotal Phase 3 study in recurrent GBM after failing both TMZ and bevacizumab. The control arm will consist of a limited number of salvage chemotherapies currently used in bevacizumab-failed GBM. If successful, this study will serve as the basis for a New Drug Application (NDA) submission for VAL-083. iii) A single arm, biomarker driven, Phase 2 study to confirm the tolerability and efficacy of VAL-083 in combination with radiotherapy in newly diagnosed MGMT-unmethylated GBM patients whose tumors are known to express high MGMT levels. The results of these studies may support a new treatment paradigm in chemotherapeutic regimens for the treatment of GBM.
Year: 2017
OHSU and Aptose Present CG’806 Preclinical Data Demonstrating Potent Activity Against Patient Samples at AACR Hematologic Malignancies Meeting
On May 8, 2017 Oregon Health & Science University (OHSU) and Aptose Biosciences Inc. (NASDAQ:APTO) (TSX:APS) announced the presentation of preclinical data demonstrating that CG’806, a highly potent pan-FLT3/BTK inhibitor, kills malignant cells in samples from patients with various hematologic malignancies (Press release, Aptose Biosciences, MAY 8, 2017, View Source [SID1234518894]). The data were presented in a poster on Sunday, May 7 at the 2017 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Conference Hematologic Malignancies: Translating Discoveries to Novel Therapies, held May 6-9 in Boston, MA. Schedule your 30 min Free 1stOncology Demo! The poster, entitled CG’806, a First-in-Class FLT3/BTK Inhibitor, Exhibits Potent Activity against AML Patient Samples with Mutant or Wild-Type FLT3, as well as Other Hematologic Malignancy Subtypes, demonstrated the broad potency of CG’806 against various hematologic malignancy cell lines and patient primary bone marrow specimens. In addition, data for CG’806 indicated greater potency of CG’806 when compared to other non-proprietary competitive agents in acute myeloid leukemia (AML) and chronic lymphocytic leukemia (CLL), including the bromodomain inhibitors OTX-015 and JQ-1, and the FLT3 inhibitor quizartinib.
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"The analyses of CG’806 against primary hematologic malignancy patient samples and cultured cell lines show evidence of potent and broad drug activity in AML and other disease subtypes and support further development of this agent for hematologic malignancies," said Stephen E. Kurtz, Ph.D., lead author and Research Assistant Professor at the OHSU Knight Cancer Institute.
"These findings further strengthen our commitment to develop CG’806 as a targeted treatment for AML and other hematologic malignancies," commented William G. Rice, Ph.D., Chairman and Chief Executive Officer of Aptose. "We are actively preparing ’806 for clinical studies and look forward to filing an IND and taking the molecule into patients as soon as possible."
Through the Beat AML Initiative, primary patient mononuclear cells were derived from 82 patients diagnosed with AML. Primary samples were also collected from patients with myelodysplastic syndrome/myeloproliferative neoplasms (MDS/MPN, n=15), acute lymphoblastic leukemia (ALL, n=17), and chronic lymphocytic leukemia (CLL, n=58). Sensitivity to CG’806 was evaluated across a range of concentrations after a 72-hour treatment. IC50 values were calculated as a measure of drug sensitivity and compared to other agents.
Across the four general subtypes of hematologic malignancies in the dataset, there was broad sensitivity to CG’806, with 59% (48/82) of AML, 29% (5/17) of ALL, 53% (8/15) of MDS/MPN, and 40% (23/58) of CLL cases exhibiting an IC50 of less than 100 nM. Primary AML and CLL cells were sensitive to CG’806 with median IC50 values of 70 nM and 220 nM, respectively. Among the 38 tested AML samples with known FLT3 mutational status, the FLT3-ITD+ AML samples tended to have enhanced sensitivity to CG’806 (median IC50 = 20 nM, n=8) relative to the FLT3-WT samples (median IC50 = 120 nM, n=30). CG’806 also exerted potent anti-proliferative activity against human AML, B-ALL, mantle cell lymphoma, Burkitt’s lymphoma, and diffuse large B-cell lymphoma cell lines. In comparison to the FLT3 inhibitor quizartinib, CG’806 completely inhibited phosphorylation of FLT3 and STAT5 in MV4-11 cells, whereas quizartinib only partially inhibited their phosphorylation.
The presentation will be published in the AACR (Free AACR Whitepaper) Hematologic Malignancies Conference Proceedings. The poster can also be accessed here or at the Publications & Presentations section of the Aptose website, www.aptose.com.
About CG’806
CG’806 is a once-daily, oral, first-in-class pan-FLT3/BTK inhibitor. This small molecule demonstrates potent inhibition of mutant forms of FLT3 (including internal tandem duplication, or ITD, and mutations of the receptor tyrosine kinase domain and gatekeeper region), eliminates AML tumors in the absence of toxicity in murine xenograft models, and represents a potential best-in-class therapeutic for patients with FLT3-driven AML. Likewise, CG’806 demonstrates potent, non-covalent inhibition of the Cys481Ser mutant of the BTK enzyme, as well as other oncogenic kinases operative in B cell malignancies, suggesting CG’806 may be developed for CLL and MCL patients that are resistant/refractory/intolerant to covalent BTK inhibitors.
About the Beat AML Initiative
The Leukemia & Lymphoma Society and the Knight Cancer Institute at Oregon Health & Science University (OHSU) — joined by partnering medical institutions and industry collaborators — are performing groundbreaking research to better understand acute myeloid leukemia (AML). Led by researchers at the Knight Cancer Institute, Beat AML collects samples from participating AML patients treated at 11 academic medical centers across the U.S. Knight Cancer Institute researchers conduct deep genomic sequencing analyses on those samples to create a profile of the possible genetic drivers of AML. Researchers also test the sensitivity of patients’ leukemic cells to a diverse panel of targeted therapies and novel combination regimens. The goal is to eventually match patients with treatments that precisely target their leukemia for durable remissions in AML.
Immunocore identifies second novel ImmTAC® in the GSK collaboration
On May 8, 2017 Immunocore Limited, the world’s leading TCR company developing biological drugs to treat cancer, infectious diseases and autoimmune diseases, reported that it has identified a lead compound in its second discovery programme with GSK (Press release, Immunocore, MAY 8, 2017, View Source [SID1234518893]). This novel ImmTAC lead molecule is relevant in a number of cancers including triple negative breast cancers, oesophageal, gastric and ovarian cancers. The identification of this new ImmTAC has triggered an undisclosed milestone payment to Immunocore. Schedule your 30 min Free 1stOncology Demo! Immunocore is now working on two ImmTAC programmes under the discovery collaboration agreement with GSK. The first ImmTAC programme under Immunocore’s GSK collaboration is on track to be submitted as an IND this year and will enter Phase I clinical studies during early 2018, with potential application in Non-Small Cell Lung Cancer (NSCLC), bladder cancer, synovial sarcoma, melanoma and ovarian cancer.
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Immunocore and GSK announced their collaboration in 2013, and Immunocore will receive up to a total of £142 million in pre-clinical milestone payments. In addition, for each product that reaches the market, up to £200 million is due to Immunocore in development and commercial milestone payments, plus up to double digit royalties. Immunocore will be responsible for all pre-clinical development and for the initial clinical trial in patients for the first two programmes. GSK will be responsible for the remaining development and commercialisation of the products.
Dr Bent Jakobsen, Chief Scientific Officer at Immunocore, commented: "Our discovery collaboration with GSK is generating novel ImmTAC molecules which are relevant across multiple solid tumours and the disease targets are all intracellularly located, which are hard for other biologic platforms to reach. Our ImmTAC technology is continuing to demonstrate its versatility across a wide range of cancer types showing an ability to tackle solid ‘cold’, low mutation rate tumours – the majority of tumours and across other diseases. We are growing increasingly confident about our opportunity to help patients with some of the most intractable cancers and major diseases."
Dr Axel Hoos, Senior Vice President Therapeutic Area Head, Oncology R&D Head, at GSK, added: "Our collaboration with Immunocore is progressing extremely well and we have identified novel and promising ImmTAC molecules with potential utility across a broad range of cancer types. We look forward to continued progress in both programmes."
Epizyme Reports First Quarter 2017 Results and Provides Corporate Update
On May 8, 2017 Epizyme, Inc. (NASDAQ:EPZM), a clinical-stage biopharmaceutical company creating novel epigenetic therapies, reported operating results for the first quarter 2017 and reiterated timelines for its upcoming data presentations (Press release, Epizyme, MAY 8, 2017, View Source [SID1234518890]). Schedule your 30 min Free 1stOncology Demo! Upcoming Tazemetostat Clinical Data Presentations
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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
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Phase 2 in Molecularly Defined Solid Tumors: Interim efficacy and safety data from study cohorts in Epizyme’s ongoing Phase 2 clinical trial of tazemetostat in adult patients with molecularly defined solid tumors that have reached futility assessment by the Independent Data Monitoring Committee will be reported in two poster presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 2-6, 2017 in Chicago. The Company will host a conference call to discuss the data on Thursday, May 18 at 8:30 a.m. ET, after ASCO (Free ASCO Whitepaper) abstracts have been released.
To participate in the conference call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 12186629. The webcast, and accompanying slides for the call, will be accessible under "Events and Presentations" in the Investor Relations section of the Company’s website at www.epizyme.com.
Phase 2 in Non-Hodgkin Lymphoma: Interim efficacy and safety data from all five monotherapy study cohorts in Epizyme’s ongoing Phase 2 study of tazemetostat in patients with relapsed or refractory follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) has been selected for a plenary session on Wednesday, June 14, 2017 at 2:00 p.m. CET (8:00 a.m. ET) at the International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland. Data from a 62-gene panel biomarker study of tazemetostat in patients with NHL will also be presented in a poster session during ICML. The Company plans to hold a conference call to discuss these clinical findings on Wednesday, June 14 at 10:30 a.m. ET.
To participate in the conference call, please dial (877) 844-6886 (domestic) or (970) 315-0315 (international) and refer to conference ID 15855261. The webcast, and accompanying slides for the call, will be accessible under "Events and Presentations" in the Investor Relations section of the Company’s website at www.epizyme.com.
"Already in 2017, we have made progress in our novel epigenetic pipeline, led by tazemetostat," stated Robert Bazemore, president and chief executive officer. "We have continued to advance tazemetostat in multiple clinical trials in a range of solid tumors and hematological malignancies, and as both a monotherapy and in combination with other anti-cancer agents. We look forward to reporting interim data from our Phase 2 study in molecularly defined solid tumors in our conference call next week and from our Phase 2 study in relapsed or refractory FL and DLBCL in June."
Recent Achievements
In May 2017, the Company earned a $10 million milestone payment from GlaxoSmithKline (GSK). The milestone payment follows GSK’s initiation of GLP toxicology studies for a first-in-class methyltransferase inhibitor discovered by Epizyme and licensed to GSK.
In April 2017, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to tazemetostat for the treatment of patients with relapsed or refractory FL, including patients whose tumors have wild type EZH2 or EZH2 activating mutations. Fast Track designation is intended to provide expedited processes for the development and FDA review of drugs that may reduce development time and costs associated with bringing a drug to market.
In March 2017, Epizyme initiated clinical investigation of tazemetostat in combination with prednisolone in relapsed or refractory patients with DLBCL, based on observed preclinical synergy of the agents. This combination regimen is being conducted as the sixth cohort in the ongoing Phase 2 NHL study.
In January 2017, Epizyme completed enrollment of all wild type EZH2 cohorts in its ongoing Phase 2 study of tazemetostat in patients with relapsed or refractory FL and DLBCL.
First Quarter 2017 Financial Results
Cash Position: Cash, cash equivalents and marketable securities were $211.2 million as of March 31, 2017, as compared to $242.2 million as of December 31, 2016.
Revenue: No revenue was recognized in the first quarter of 2017, compared to $0.5 million for the first quarter of 2016.
R&D Expenses: Research and development (R&D) expenses were $24.7 million for the first quarter of 2017, compared to $17.7 million for the first quarter of 2016. The increase is primarily due to the expansion of the tazemetostat clinical program and advancement of our proprietary research pipeline.
G&A Expenses: General and administrative (G&A) expenses were $8.3 million for the first quarter of 2017, compared to $5.8 million for the first quarter of 2016. The increase is primarily due to higher pre-commercial, intellectual property, business development and product planning expenses.
Net Loss: Net loss was $32.5 million for the first quarter of 2017, compared to $22.9 million for the first quarter of 2016.
2017 Guidance
Epizyme believes, based on its current operating plan, that its cash, cash equivalents and marketable securities of $211.2 million as of March 31, 2017 will be sufficient to fund the Company’s planned operations into at least the third quarter of 2018.
About the Tazemetostat Clinical Trial Program
Tazemetostat, a first-in-class EZH2 inhibitor, is currently being studied in ongoing Phase 2 programs in both follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL) forms of non-Hodgkin lymphoma; certain molecularly defined solid tumors, including epithelioid sarcoma and other INI1-negative tumors; and mesothelioma, as well as in combination studies in DLBCL. Tazemetostat has been granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of patients with relapsed or refractory FL, either wild type EZH2 or with EZH2 activating mutations, and for relapsed or refractory DLBCL with EZH2 activating mutations, as well as Orphan Drug designation for malignant rhabdoid tumors.
Eagle Pharmaceuticals, Inc. Reports First Quarter 2017 Results
On May 5, 2017 Eagle Pharmaceuticals, Inc. ("Eagle" or "the Company") (Nasdaq:EGRX) reported its financial results for the three months ended March 31, 2017(Press release, Eagle Pharmaceuticals, MAY 8, 2017, View Source [SID1234518888]). Highlights of and subsequent to the first quarter of 2017 include: Schedule your 30 min Free 1stOncology Demo! Business Highlights:
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Bendeka total market share rose to 95%, as of March 31, 2017;
Received a $25 million sales milestone payment from Teva related to cumulative Bendeka sales reaching $500 million;
Eight new patents allowed by the U.S. Patent and Trademark Office for Eagle’s Bendeka portfolio bringing the total to 14 issued or allowed, with 13 listed in the Orange Book;
Ryanodex sales increased to $4.4 million during the first quarter;
Granted Priority Review by the U.S. Food and Drug Administration (FDA) for the Company’s NDA for Ryanodex for Exertional Heat Stroke (EHS) with a PDUFA target date of July 23, 2017;
Appointed Richard A. Edlin to the Company’s Board of Directors, and as a member of the Board’s Nominating and Corporate Governance Committee;
NDA for Pemetrexed Injection for non-small cell lung cancer and mesothelioma accepted for filing; PDUFA target date of October 30, 2017; and,
By the end of the quarter, Eagle had purchased $51 million in Eagle common stock as part of its $75 million Share Repurchase Program. Since commencing this program approved by the Board in August 2016, Eagle has purchased 756,000 shares.
Financial Highlights:
First Quarter
Total revenue for the first quarter of 2017 grew 160% to $76.8 million compared to $29.6 million in the first quarter of 2016;
Product sales increased to $15.3 million compared to $14.1 million in Q1 2016;
Royalty revenue increased to $36.5 million compared to $9.5 million in Q1 2016;
License and other revenue increased to $25.0 million compared to $6.0 million in Q1 2016;
Sales of Ryanodex grew 132% to $4.4 million during the first quarter of 2017 compared to $1.9 million in Q1 2016;
Q1 2017 income before income tax provision was $32.7 million;
Q1 2017 net income was $22.9 million, or $1.50 per basic and $1.42 per diluted share, compared to a net loss of $0.9 million, or $0.06 per basic and $0.06 per diluted share in Q1 2016; and,
Cash and cash equivalents were $27.7 million and accounts receivable were $84.7 million as of March 31, 2017.
"This was another strong quarter for Eagle, driven by Bendeka and Ryanodex, with sequential and year-over-year growth in revenue and profitability. We are executing our strategy and remain confident that it will be another transformative year for Eagle with ongoing progress," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.
"With Priority Review granted by the FDA for our Ryanodex NDA for Exertional Heat Stroke and a PDUFA date of July 23, 2017, we are preparing for launch and are scaling our commercial organization accordingly. With multiple opportunities in place including our Pemetrexed PDUFA date in October, continued progress on fulvestrant and a potential third indication for Ryanodex for Ecstasy and methamphetamine intoxication, we expect the momentum to continue. We are also investing in our product pipeline, with up to four clinical trials anticipated this year and look forward to reporting on our progress," added Tarriff.
First Quarter 2017 Financial Results
Total revenue for the three months ended March 31, 2017 was $76.8 million, as compared to $29.6 million for the three months ended March 31, 2016. A summary of total revenue is outlined below:
Three Months Ended March 31,
2017 2016
Revenue:
Product sales $ 15,286 $
14,122
Royalty revenue 36,507 9,469
License and other revenue 25,000 6,000
Total revenue 76,793 29,591
Product sales increased to $15.3 million on net product sales in Bendeka, Ryanodex, docetaxel injection non-alcohol formulation, and Argatroban. Royalty revenue increased to $36.5 million, as a result of the increased sales of Bendeka. License and other revenue increased to $25.0 million due to the milestone payment from Teva triggered by cumulative sales of Bendeka of $500 million.
Research and development expenses increased to $7.5 million in the three months ended March 31, 2017, compared to $5.5 million in the prior year quarter. The increase was largely due to continued spending on our R&D pipeline.
SG&A expenses increased to $18.6 million in the first quarter of 2017 compared to $12.1 million in the three months ended March 31, 2016. Sales and marketing pre-launch related expenses accounted for the bulk of the increase as the Company prepares for the commercial launch of Ryanodex for EHS, if approved.
An income tax provision of $9.7 million was recorded during the first quarter.
Net income for the first quarter of 2017 was $22.9 million, or $1.50 per basic share and $1.42 per diluted share, compared to net loss of $896,000, or $0.06 per basic and $0.06 per diluted share in the three months ended March 31, 2016, due to the factors discussed above.
Liquidity
As of March 31, 2017, the Company had $27.7 million in cash and cash equivalents and $84.7 million in net accounts receivable, $71 million of which was due from Teva. This represents an increase of $17.4 million in cash and cash equivalents and net accounts receivable compared to December 31, 2016. The Company had no outstanding debt.Eagle Pharmaceuticals, Inc. ("Eagle" or "the Company") (Nasdaq:EGRX) reported its financial results for the three months ended March 31, 2017. Highlights of and subsequent to the first quarter of 2017 include:
Business Highlights:
Bendeka total market share rose to 95%, as of March 31, 2017;
Received a $25 million sales milestone payment from Teva related to cumulative Bendeka sales reaching $500 million;
Eight new patents allowed by the U.S. Patent and Trademark Office for Eagle’s Bendeka portfolio bringing the total to 14 issued or allowed, with 13 listed in the Orange Book;
Ryanodex sales increased to $4.4 million during the first quarter;
Granted Priority Review by the U.S. Food and Drug Administration (FDA) for the Company’s NDA for Ryanodex for Exertional Heat Stroke (EHS) with a PDUFA target date of July 23, 2017;
Appointed Richard A. Edlin to the Company’s Board of Directors, and as a member of the Board’s Nominating and Corporate Governance Committee;
NDA for Pemetrexed Injection for non-small cell lung cancer and mesothelioma accepted for filing; PDUFA target date of October 30, 2017; and,
By the end of the quarter, Eagle had purchased $51 million in Eagle common stock as part of its $75 million Share Repurchase Program. Since commencing this program approved by the Board in August 2016, Eagle has purchased 756,000 shares.
Financial Highlights:
First Quarter
Total revenue for the first quarter of 2017 grew 160% to $76.8 million compared to $29.6 million in the first quarter of 2016;
Product sales increased to $15.3 million compared to $14.1 million in Q1 2016;
Royalty revenue increased to $36.5 million compared to $9.5 million in Q1 2016;
License and other revenue increased to $25.0 million compared to $6.0 million in Q1 2016;
Sales of Ryanodex grew 132% to $4.4 million during the first quarter of 2017 compared to $1.9 million in Q1 2016;
Q1 2017 income before income tax provision was $32.7 million;
Q1 2017 net income was $22.9 million, or $1.50 per basic and $1.42 per diluted share, compared to a net loss of $0.9 million, or $0.06 per basic and $0.06 per diluted share in Q1 2016; and,
Cash and cash equivalents were $27.7 million and accounts receivable were $84.7 million as of March 31, 2017.
"This was another strong quarter for Eagle, driven by Bendeka and Ryanodex, with sequential and year-over-year growth in revenue and profitability. We are executing our strategy and remain confident that it will be another transformative year for Eagle with ongoing progress," stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.
"With Priority Review granted by the FDA for our Ryanodex NDA for Exertional Heat Stroke and a PDUFA date of July 23, 2017, we are preparing for launch and are scaling our commercial organization accordingly. With multiple opportunities in place including our Pemetrexed PDUFA date in October, continued progress on fulvestrant and a potential third indication for Ryanodex for Ecstasy and methamphetamine intoxication, we expect the momentum to continue. We are also investing in our product pipeline, with up to four clinical trials anticipated this year and look forward to reporting on our progress," added Tarriff.
First Quarter 2017 Financial Results
Total revenue for the three months ended March 31, 2017 was $76.8 million, as compared to $29.6 million for the three months ended March 31, 2016. A summary of total revenue is outlined below:
Three Months Ended March 31,
2017 2016
Revenue:
Product sales $ 15,286 $
14,122
Royalty revenue 36,507 9,469
License and other revenue 25,000 6,000
Total revenue 76,793 29,591
Product sales increased to $15.3 million on net product sales in Bendeka, Ryanodex, docetaxel injection non-alcohol formulation, and Argatroban. Royalty revenue increased to $36.5 million, as a result of the increased sales of Bendeka. License and other revenue increased to $25.0 million due to the milestone payment from Teva triggered by cumulative sales of Bendeka of $500 million.
Research and development expenses increased to $7.5 million in the three months ended March 31, 2017, compared to $5.5 million in the prior year quarter. The increase was largely due to continued spending on our R&D pipeline.
SG&A expenses increased to $18.6 million in the first quarter of 2017 compared to $12.1 million in the three months ended March 31, 2016. Sales and marketing pre-launch related expenses accounted for the bulk of the increase as the Company prepares for the commercial launch of Ryanodex for EHS, if approved.
An income tax provision of $9.7 million was recorded during the first quarter.
Net income for the first quarter of 2017 was $22.9 million, or $1.50 per basic share and $1.42 per diluted share, compared to net loss of $896,000, or $0.06 per basic and $0.06 per diluted share in the three months ended March 31, 2016, due to the factors discussed above.
Liquidity
As of March 31, 2017, the Company had $27.7 million in cash and cash equivalents and $84.7 million in net accounts receivable, $71 million of which was due from Teva. This represents an increase of $17.4 million in cash and cash equivalents and net accounts receivable compared to December 31, 2016. The Company had no outstanding debt.