Re: Farmas USA
GALE
Resumen de la conferencia
We've made the decision to relocate our headquarters from Portland Oregon to the San Francisco Bay Area over the course of 2015, home to numerous biotechnology and pharmaceutical companies
Reached a major milestone with the completion of enrolment in our pivotal Phase 3 Present Trial last month.
Second best quarter of net revenue in the best to back months since Abstral's product launch. Most importantly we continued our increased penetration within the oncology space as we head in the launch of our second commercial oncology support of care product Zuplenz.
-PRESENT trial: lymph node positive breast cancer patients with HER2, 1+, 2+, tumors in the adjuvant setting. interim analysis at 70 events by the end of this year or the first quarter of 2016 and we project to arrive at the primary endpoint in 2018.
-Phase IIb combination trial with trastuzumab :300 patients , clinical trial treating women who are no positive high risk no negative including triple negative and who are HER2 1+ and 2+ expressers. we have expanded the eligibility criteria to include patients who are HLA-A24 and A26 positive. This addition broadens the utilization of NeuVax in this trial particularly amongst women of Asian descent where these HLA Alleles are prevalent. completion of enrolment in this trial in the first half of 2016 with a primary endpoint of disease free survival at two years.
-Phase II trial in breast cancer patients who are with higher HER2 3+ expressers. primary endpoint: time to invasive local, regional, or distance recurrence, a new primary tumor or death due to any cause. The trial is enrolling and we look forward to the emerging data in 2016
- our second immunotherapy asset GALE-301 is a peptide vaccine derived from folate-binding protein and is targeting the event prevention of recurrence in ovarian and endometrial cancers. Diseases where the recurrences are high and the outcomes are often quite far. The early data was presented last year at the Society of Immunotherapy of Cancer and our abstract was accepted for publication at ASCO. We expect to present a more robust dataset at a Scientific Congress in the fall.
- hematology asset, GALE-401. controlled-release formulation of Anagrelide in development to reduce elevated platelet count in patients with thrombocythemia secondary to myeloproliferative neoplasms. Our Phase II top line data has been accepted for a poster presentation at the European Society for Hematology Meeting next month and we will refer to preliminary safety, efficacy, and pharmacokinetic results at that time.
We reported actual net revenue of $2.8 million for the first quarter of 2015, our second highest quarter of net revenue since our relaunch of Abstral in 2013.
Regarding Abstral reimbursement and coverage, our managed markets group had a significant advance this quarter securing exclusive or co-preferred status for Abstral as of April 1 with Caremark.
Looking back to the year end March 2014, the average units of Abstral per pay transaction or prescription was roughly 50 tablets while in March of this year the average number increased 41% to 72 tablets per transaction. The profitability of our overall business is best valuated by calculating the actual revenue derived from each billed or paid transaction.
Our long-term strategies that develop lasting relationships with medical oncologists, radiation oncologists, and palliative care specialists since we believe this represents the most stable market, the best potential for Abstral. Percentage of our oncology business grew significantly quarter-over-quarter and we now have 34% of our business coming from oncology focused specialists. We expect that our promotion of Zuplenz will further increase the penetration of Abstral into the oncology space.
Zuplenz: MonoSol Rx is manufacturing the product. We expect this final product to be ready for sale in July. We have increased our Medicare Part D coverage from 1% at the acquisition of Zuplenz to approximately 40% at launch. We expect to be at or near parity with the branded competition in 2016. We expect that piece of our commercial business to begin contributing to our net revenue by the end of the year.
The year-over-year increase in SG&A cost was driven by the expansion of our management team and infrastructure needed to support our growing commercial programs and development pipeline as well as non-recurring legal and other professional services incurred during the period.
The decrease in R&D cost year-over-year and from last quarter is a result of completing the enrollment period for our NeuVax Phase 3 PRESENT trial.
$52.9 million in cash and cash equivalents
$30 million increase in cash during the quarter represents the $42.2 million raised in follow on equity financing offset by a $11.6 million in cash used in operations, $900,000 in principal payments on long-term debt and $500,000 in additional payments on the Zuplenz asset.
Also during Q1, we raised $6.6 million under the Lincoln Park and ATM agreements. These financings contributed $42 million cash during the first quarter of 2015. In addition in April the underwriter exercise their option to purchase the over allotment of shares for additional net proceeds of $5.4 million which is not included on our Q1 balance sheet.
Revenues: $2.8M (+27.3%); COGS: $0.4M (+33.3%); R&D Expense: $5.9M (-13.2%); SG&A: $7.4M (+8.8%); Operating Loss: ($11.1M) (+5.9%); Net Loss: ($10.5M) (-320.0%); Loss Per Share: ($0.08) (-300.0%); Quick Assets: $52.9M (+123.2%).
