Mar 9, 2016
Executives
Dolly Vance - EVP, Corporate Affairs and General Counsel Raul Rodriguez - CEO Ryan Maynard - CFO
Analysts
Anupam Rama - JPMorgan Eun Yang - Jefferies
Operator
Good afternoon, and welcome to Rigel Pharmaceutical's Earnings Conference Call for the Fourth Quarter and Year End of 2015. All participants are in a listen-only mode.
We will be facilitating a question-and-answer session at the end of today's conference. [Operator Instructions] I would like to remind you that this call is being recorded for replay purposes from Rigel's website.
[Operator Instructions] And now, I will turn this conference over to our first speaker, Dolly Vance, who is Rigel's Executive Vice President, Corporate Affairs and General Counsel.
Dolly Vance
Hello, and welcome to our quarterly earnings conference call. The financial press release for the fourth quarter and year end of 2015 was issued a short while ago, and can be viewed under 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 to regulatory and clinic development plans. These statements are subject to risk and uncertainties that may cause actual results to differ from those forecasted.
A description of these risks can be found in our most recent report in Form 10-K on file with the SEC. Any forward-looking statements are made only as of today's date, and we undertake no obligation to update these forward-looking statements to reflect subsequent events or circumstances.
At this time, I would like to turn this call over to our CEO, Raul Rodriguez.
Raul Rodriguez
Thank you, Dolly, and hello to everyone for joining us today. 2015 was an excellent year for Rigel.
We made significant progress on our key goals including moving fostamatinib forward in multiple clinical indications, adding new partnerships, and strengthening our balance sheet. We put tremendous effort into increasing the speed and efficiency of enrolling patients in the Phase 3 clinical trials for ITP.
We achieved full enrolment in the first study January and the second study is close to full enrolment. We expect to have results from the first study in the middle of 2016 with results from the second study to follow.
Also in 2015, we made significant headway of preparing the preclinical PK and CMC sections of the NDA to facilitate filing it with the FDA in early 2017. We recently announced that we have initiated a Phase 2 study for fostamatinib autoimmune hemolytic anemia.
We expect to have results from stage one of this study by the end of 2016. So, our Phase 2 study in IgA nephropathy, we have added centers in Asia.
This is due to the prevalence of this disease being about five times higher in Asian countries than in the U.S. or Europe.
Our goal in IgA nephropathy is to demonstrate a directional signal and to identify an agent pharmaceutical partner to help and execute advance studies and this indication in that region. In addition, we continue to support active preclinical development programs to extend our pipeline including our IRAK inhibitor molecules which have potential in oncology and immune indications.
In all, we made excellent progress in 2015 and set the stage -- set the company up well for 2016. I will return to our plans for 2016 later.
At this time, I'm going to ask Ryan Maynard, our Chief Financial Officer to review the fourth quarter and year end 2015 financial results.
Ryan Maynard
Thank you, Raul. For the fourth quarter of 2015, we reported a net loss of $12.7 million or $0.14 per share, compared to a net loss of $22.3 million or $0.25 per share in the fourth quarter of 2014.
Revenue was $8.5 million for the fourth quarter and this year end was primarily related to the continued amortization of the $30 million upfront payment from Bristol-Myers Squibb, as well as the license fee from a third-party executed in October of last year. In the fourth quarter of 2014, we've reported revenues of $8.3 million that was all related to the continued development of R256 with AstraZeneca.
We reported cost and expenses of $21.3 million for the fourth quarter of 2015 compared to $30.6 million for the same quarter of 2014. The cost in the fourth quarter of 2014 included a $9.3 million charge related to our sublease signed in that year.
Development cost related to the Phase 3 ITP program also increased in 2015 as compared to 2014. As of December 31st, 2015, Rigel had cash and investments of $126.3 million compared to $143.2 million at the end of 2014.
This translates into a net burn of only $16.9 million for 2015, which is a key accomplishment for us, driven primarily by our successful out-licensing efforts in 2015. We therefore expect that our current cash on hand should be sufficient to take us into the third quarter of 2017.
Raul Rodriguez
Thank you, Ryan. As Ryan just reported, our cash position gives us about a year's worth of cash beyond our first expected readout in ITP.
The BMS-TGF beta collaboration in immuno-oncology and our Aclaris-JAK collaboration in immuno-dermatology are actively focused on maintaining a lead clinical candidate to further study. We hope to provide you updates on these later in the year.
In addition to the financial press release, earlier today we issued an announcement that Anne-Marie Duliege has become our new Chief Medical Officer. Anne-Marie brings valuable experience in managing the clinical development of new therapeutics, most notably an agent for treating anemia.
She led the NDA filing effort for vast [ph] hematologic agent, manage the advisory committee process, and enable negotiations. She also provided pre and post-launch guidance to the marketing effort.
Clearly, she is well suited to help us with the completion of fostamatinib ITP study reporting those results and managing the NDA filing and process. Her experience will also be instrumental in addressing the other indications for fostamatinib, mainly autoimmune hemolytic anemia and IgA nephropathy.
In addition to all this, she is an incredibly delightful and professional person. And I’m very much looking forward to working with her.
Anne-Marie will step in for Elliott Grossbard who has decided to retire after 14 years at Rigel. We are very grateful for all of Elliott's many contributions to Rigel and our clinical development programs.
We are also very pleased that he will be staying on as a consultant providing continuity to the fostamatinib in ITP program. Now the 2016, 2016 would be an absolutely pivotal year for Rigel.
We will continue managing our resources wisely and plan to end 2016 with sufficient cash reserves to maintain operations into Q3 of 2017. We will continue our efforts to validate the activity of fostamatinib in treating IgA nephropathy to set its stage for Rigel and a new partner to advance into further clinical trials.
By the end of the year, we will have gained insight into fostamatinib's efficacy and autoimmune hemolytic anemia and hope to set the stage for a pivotal clinical program for this indication. Perhaps most significantly by the end of the year, we will have demonstrated fostamatinib's potential in ITP and we hope to be at the door step of our first NDA filing as a company.
This will be a major advance to Rigel and we look forward to it. I’m sure you will agree that these are exciting time for Rigel and this will be our most exciting year.
We appreciate your continued interest in Rigel and look forward to keeping you up-to-date on our progress. Now, let’s open it up to questions.
Operator
We will open up the lines now for Q&A. [Operator Instructions] The first question comes from Anupam Rama of JPMorgan.
Your line is now open.
Anupam Rama
Hey, guys. Thanks very much for taking the question.
Just a couple from me. I guess the first one is we talked a lot about ITP, but you also mentioned IgA nephropathy readout, maybe just setting the stage for that.
As well as what kind of pre-commercial activities are you guys doing? Just trying to understand the size scope of the sales force and when we might hear more definitive strategy there; will be post the first readout in ITP or will you wait for both?
Thanks.
Raul Rodriguez
Thank you, Anupam. Appreciate your questions.
On IgA nephropathy, the first cohort of that trial should complete readout very shortly and we will have those results by the end of the year. It’s a six-month study, so it will probably in Q4 of the year.
And that will be a directional [ph], keep in mind, this is at the 100 milligram bid dose group and from this dose group, we’re looking for a signal that the product is one, safe and two, having some type of benefit. So, as yet, we're not expecting a strong peak value type result for IgA nephropathy at this point.
But I think it’s to be sufficient to engage with the potential partner in Asia, while we have the next dose group, the 150 milligram dose group underway and we hope to have those -- that trial enrolling later this year. On pre-commercial plans, we are working very hard right now in drafting pre-commercial plans for fostamatinib in the U.S.
for ITP and hopefully, subsequent to that, autoimmune hemolytic anemia. And after some continued iterations of those plans, we plan to share those with you later in the year.
The exact timing, I' not exactly set yet on, but we probably will tell you something close to when we release the first clinical trial results.
Anupam Rama
Great. Thanks so much for taking the question.
Raul Rodriguez
My pleasure.
Operator
Thank you. And our next question comes from Eun Yang of Jefferies.
Your line is now open.
Eun Yang
Thank you. Can you hear me?
Raul Rodriguez
Yes Eun. How are you?
Eun Yang
Good. Thank you.
So now that we are expecting Phase 3 data in ITP in the second half of this year, can you talk about what level of placebo response rate would you like to see? Also what response rate you think would be necessary in order to be competitive in the marketplace?
Raul Rodriguez
Okay. Well, we're hoping to see explicitly significant difference over placebo, most importantly.
I think that would give us an opportunity to move forward and show to the FDA that the product is an attractive product and we will seek approval with that. I think the positioning of the product is a very interesting one.
The current agents on the markets are TIPO [ph], MiMedx and others and they have a very different mechanism of actions than fostamatinib provides. fostamatinib may be very attractive and most likely will be used in patients who have tried TIPO agents that is not necessarily TIPO failures but TIPO-experienced patients.
And that's an attractive positioning for the product because in that segment, there are no products that are used that are effective and nothing is a proof for that fraction of the market. And that’s a very attractive positioning because there's quite a number of patients out there that have tried a TIPO agents and not had good success so weren’t remaining on those agents.
So, I think we have a very good opportunity with that positioning of the product.
Eun Yang
Patients can actually recycle TIPO MiMedx. So, I don’t know what’s the kind of response rate when they try second time.
So, in order to competition as TIPO MiMedx experience that setup a -- do you think you need to show the response rate closer to 50%, 50%, 60% that TIPO MiMedx have shown.
Raul Rodriguez
No, I don’t think we need to show anything like that. I think what we need to show is that we have a benefit in patients overall and that we have a benefit in TIPO-experienced patients in particular and I think we’ll show that.
Eun Yang
So, do you know what portion enrolled patients have TIPO MiMedx experience in those Phase 3 trial?
Raul Rodriguez
I don’t know the exact answer for that other than we know that many do. I don’t have a specific percentage of the current patients that have experience.
We know quite a number do.
Eun Yang
Okay. And then my second question is the -- in Europe, you previously mentioned that you need to run hepatitis study against the TIPO MiMedx in order to get approval and you may be looking for a partner who can run Phase 3 trial as well as a commercialization.
When do you think you will start to such a discussion?
Raul Rodriguez
We're hoping to start those discussions towards the middle of this year in advance of having data so that when we get the data, we already at least have identified partners and have some initial thoughts on paper with some parties. So, we can very quickly move after that to finalize a deal for Europe.
And I think there they may have to do a subsequent trial comparing fostamatinib to unactive agent. It not need to be a very big trial, but that's something that we'd like to get further guidance on in the next six months or so.
Eun Yang
Okay. And my last question is on hemolytic anemia, [indiscernible] approved a drug further indication, when you move into pivotal study, you would be able to file for approval post in the U.S.
and EU, correct?
Raul Rodriguez
I know in the U.S. once we will have discussions with the FDA in terms of what a pivotal program would look like.
And we hope to have those discussions with them soon after we receive the results from -- towards the end of this year with this first part of the study and that will allow us then to develop with the scope in protocol for that pivotal program would look like that -- hopefully we could launch next year. In Europe, I think the answer would be the same, but we haven’t had any interaction at all with agencies there to do that.
So, we would have to do that as well.
Eun Yang
Okay. Thank you very much.
Raul Rodriguez
The trials would be -- in all likely a global trial, not just U.S. at that point.
Eun Yang
Great. Thank you.
Raul Rodriguez
You’re welcome.
Operator
Thank you. I will now turn the call over to Mr.
Rodriguez.
Raul Rodriguez
Well, thank you very much. I appreciate it.
And I appreciate your questions. 2015 was a good year.
I think 2016 will be an even better year and a more exciting year, pivotal year for the company. I think we’ve made very good progress and we have a very strong direction where we want to go with this company with fostamatinib in particular, in ITP and non-immune hemolytic anemia, other indications, and then other products follow to that.
So, thank you for your support and we look forward to meeting with you and answering any more questions you may have.