Aug 4, 2015
Executives
Dolly Vance - EVP, Corporate Affairs and General Counsel Raul Rodriguez - CEO Ryan Maynard - EVP & CFO
Analysts
Eun Yang - Jefferies Anupam Rama - JP Morgan
Operator
Good afternoon and welcome to the Rigel Pharmaceutical Second Quarter 2015 earnings conference call. All participants are in a listen-only mode.
[Operator Instructions] I would like to remind you that this call is being recorded for replaying purposes on Rigel's website. And now I will turn the call over to our first speaker, Dolly Vance, Rigel’s Executive Vice President, Corporate Affairs and General Counsel.
Dolly Vance
Hello and welcome to our quarterly earnings conference call. The second quarter 2015 financial press release which you saw a short while ago and can be viewed on the news section of our website www.rigel.com.
As a reminder during today's call we may make forward-looking statements regarding our financial outlook as well as regulatory and product development plans. These statements are subject to risk and uncertainties that may cause actual results to differ from those forecasted.
The description of these risks can be found in our most recent quarterly form – in form 10- Q on file with the SEC. Any forward looking statements are made only as of today's date and we undertake no obligations update these forward-looking statements to reflect the sequence events or circumstances.
At this time I would like to turn the call over to our CEO, Raul Rodriguez.
Raul Rodriguez
Thank you Dolly and thank you everyone for joining us today. In addition to Dolly, Ryan Maynard, our Executive Vice President and CFO is joining me on this call.
We have had a good quarter and have made good progress on our goals. As we discussed in our last call, Rigel is making a transition from R&D stage company to a commercial stage company.
While doing this we are continuing to advance our R&D pipeline in the immunology and oncology therapeutic areas. Keeping this transition is fostamatinib in ITP and new indications.
We continue to expect that the [redox] from the fostamatinib of phase 3 program in ITP will be available in the middle of 2016. We will also have a complete NDA package for fostamatinib in ITP ready to file in the U.S.
by the end of 2016. At this time studies have enrolled more than half of the expected number of patients and we are continuing to open new clinical centers to ensure that we meet our time lines.
In addition there are teams at Rigel already compiling sections of the NDA applications, once the results of the two phase 3 studies are available the data will be compiled and probably included in this application. I will now ask Ryan to give you an update on the financial results from this past quarter.
I will then return to share some additional information on our business including one of the new clinical programs we are excited about.
Ryan Maynard
Thank you Raul, and good afternoon everyone. For the second quarter of 2015, we reported a net loss of $14.0 million or $0.16 per share compared to a net loss of $25.5 million or $0.29 per share in the second quarter of 2014.
Contract revenues from collaborations this quarter were $5.2 million which was all related to our collaboration with Bristol-Myers Squibb, it was comprised of $4.8 million of amortization of the $30 million upfront payment and $350,000 of research reimbursement. We did not record any revenue in the same quarter in 2014.
We reported expenses in the second quarter of 2015 of $19.2 million compared to $25.5 million in the same quarter of 2014. This decrease was primarily due to savings in our facilities cost achieved by sublease and a portion of our space and a reduction in fostamatinib development cost.
The reduction in fostamatinib development cost was due to certain start up costs we incurred for the phase two ITP trials in the second quarter of 2014. As of June 30, 2015 we had cash, cash equivalence and short term investments of $143.9 million compared to $143.2 million for December of 2014.
We continue to expect to end this year with cash and investments in excess of $100 million which should be sufficient to take us into the second quarter of 2017. Now I will turn the call back over to Raul.
Raul Rodriguez
Thank you for the update Ryan. During the last call we introduced a number of possible new indications for fostamatinib.
Today I would like to give you an update on those plans for few of these. One of these we are pursuing is autoimmune hemolytic anemia.
Hemolytic anemia effects an estimated 40,000 adult patients in the U.S. It is a condition that results when the body's own antibodies bind to red blood cells which subsequently results in their destruction.
This is a similar disease processes at ITP but here it is directed at red blood cells rather than platelets. There is a significant need for new therapeutics in this indication since there are no currently approved treatments.
Patients are treated with steroids, some with Rituxan and then unfortunately a splenectomy. This disease is also a good complement to Rigel’s ITP program since the same physician audience treat both types of patients.
We are currently designing a phase two study in hemolytic anemia to start early next year. Starting first with the limited number of patients in part 1 to verify a benefit, we will then roll into a more robust phase two, part two that we hope will show a clear benefit in this orphan disease.
We will share more of our plans for this clinical program for fostamatinib in future announcements and calls. In addition we are pursuing several indications for fostamatinib utilizing outside collaborators and major academic centers.
We are currently working with various investigators who have acquired or are acquiring grants to conduct patient trials with fostamatinib [indiscernible] disease and some ovarian cancers. In addition Rigel is also exploring the utility of fostamatinib as a treatment for other cancers.
In closing a few comments on our partnerships activities. Earlier this year we entered into significant collaboration with Bristol-Myers Squibb for the research and development of Rigel’s TGF beta receptor inhibitors as potential therapeutics in cancers using an immuno-oncology approach.
We are pleased with the pace at which this collaboration has been proceeding. We also are in discussions with potential new partners to move more of Rigel’s preclinical assets forward.
And we look forward to partnership related announcements in the near future. And finally I would like to welcome Keith Katkin to Rigel's Board of Directors.
Keith is the CEO and President of Avanir Pharmaceutical and brings a tremendous background in commercialization which will be very helpful to Rigel as we make the transition from R&D stage company to a commercial stage company. Now let's open up the call for questions.
Operator
[Operator Instructions] Okay. We will take our first question from Eun Yang from Jefferies, your line is now open.
Eun Yang
Thank you. Raul, if I heard you correctly did you say that in the ITP trials more than a 50% of the target patients have been enrolled to-date.?
Raul Rodriguez
That's correct Eun.
Eun Yang
Okay. So as of last update I think that you mentioned that about 60% of the clinical sites were open at the time in the two trials, can you give us an update on that?
Raul Rodriguez
Sure. We have added new centers in the trial.
We have a bit over 70 centers now opened and we are planning, we have also added new countries as well since the last call so we are planning an opening an additional 30 to 40 centers in the next several months. So, in total we will have over 100 centers open for the trial.
Eun Yang
Okay and then, are we still expecting the patient enrollment completion for at least one trial by end of this year?
Raul Rodriguez
We are about, that's about right and that means the results by some, we are in the middle of next year.
Eun Yang
Okay. And then, one quick question on immune therapy with Bristol-Myers Squibb, can you give us an update to when and the partner who nominate high ended candidates and may go into clinic?
Raul Rodriguez
I can't really give us specifics on that since it is partnered and is at BMS’s discretion when that happens. But, I assure you that we will be able to announce that will be announced in our filings when that does happen.
To-date we have made very good progress in the collaboration. There were teams, sizable teams at the BMS and a team here at Rigel working very closely to meet that milestone.
Eun Yang
Okay. Thanks.
Operator
Thank you. [Operator Instructions] I am just showing one further question queue at the moment Anupam Rama from JP Morgan.
Please go ahead.
Anupam Rama
Hi guys. Thanks so much for taking the question.
So, for ITP you guys have talked about potentially filing for orphan drug designation. I am wondering where you are in that process and if you talked to regulators about potential orphan drug filing as well as for the NDA filing expected by year end 2016 if you would expect that to be a rolling filing if you get orphan drug status?
Thanks.
Raul Rodriguez
Thank you, Anupam. We have filed for orphan indication in the U.S.
for fostamatinib, I don't have a good sense on the timing on that application yet but we have done so. And that obviously will have bearing on how we do the filing towards the end of next year, but we will meet our goal.
Right now we are preparing all the sections that we can in advance to meet the goal of filing the NDA by the end of next year in the U.S. So, I think we are confident that that we will be able to complete these filings by the end of next year.
Anupam Rama
Great. Thanks so much for taking the question.
Raul Rodriguez
Sure.
Operator
Okay. I am showing no further questions in the queue.
I would like to turn the call back to Raul Rodriguez for final remarks. One moment we actually did have one more question from Eun Yang from Jefferies, please open that line now.
Eun Yang
Well, thank you. So the follow-up question on cancer immune therapy with the Bristol-Myers Squibb, I think you guys previously mentioned that potential leading candidate nomination by the end of this year and although you cannot really comment specifically is that kind of on track based on the progress that you mentioned earlier?
Raul Rodriguez
Yes, it's really within, as I said within BMS’s discretion that is the next milestone. But I think we will have to wait until we get there in terms of that announcement and so I hate to preempt fair announcement giving you the specific time frame but suffice to say we are very pleased with the progress that the collaboration is making and I think both sides are working very hard to meet that next goal and we are confident that we will meet it in a reasonable time frame.
But I can't give you a specific time frame I am afraid.
Eun Yang
Okay. Thank you.
Raul Rodriguez
With that I would like to thank you for your interest at Rigel and in your questions. We look forward to keeping you informed on our progress both in the clinic on partnerships and other areas as well.
And thank you very much.
Operator
Okay ladies and gentlemen this does conclude your conference. You may now disconnect and have a great day.