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La Jolla Pharmaceutical Co (LJPC)
Q4Â 2018 Earnings Conference Call
March 04, 2019, 4:30 p.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
See all our earnings call transcripts.
Prepared Remarks:
Operator
Welcome to the La Jolla Pharmaceutical Company Fourth Quarter and Full Year 2018 Financial Results Call. At this time, all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will follow at that time. (Operator Instructions)
On today's call, La Jolla will be making forward-looking statements, as that term is defined in the Private Securities Litigation Reform Act of 1995 including but not limited to statements related to La Jolla's expectations regarding net sales and net cash used in operating activities for the full year 2019, the expectations regarding future clinical and regulatory milestones, such as expected NDA submissions and approvals and expected timing for commencement and completion of clinical studies. These statements relate to expectations regarding future events or La Jolla's future results of operations. These statements are only predictions or statements of current expectations and involve known and unknown risks, uncertainties and other factors that may cause actual results to materially different from those anticipated by forward-looking statements. La Jolla cautions listeners not to place undue reliance on any such forward-looking statements, which speak only as of the date they were made.
Certain of these risks, uncertainties and other factors are described in greater detail in La Jolla's filings with the US Securities and Exchange Commission, SEC, all of which are available free of charge on the SEC's website at www.sec.gov. These risks include, but are not limited to, risks relating to La Jolla's ability to successfully commercialize market and achieve market acceptance of GIAPREZA. La Jolla's ability to grow net sales of GIAPREZA, potential market sizes, including for septic or other distributive shocks. The timing and prospects for approval of GIAPREZA by the European Medicines Agency or other regulatory authorities, the scope of product labels and potential market sizes as well as broader commercial opportunities for GIAPREZA and La Jolla's product candidates; the impact of pharmaceutical industries regulations and healthcare litigation in the US, United States; the success of development activities for LJPC-401, LJPC-0118 and other product candidates; potential indications for which La Jolla's product candidates may be developed; the timing, costs, conduct and outcome of clinical studies; risks relating to the development of drug candidates; the anticipated treatment of future clinical data by the US Food and Drug Administration, EMA and other regulatory authorities, including whether such data will be sufficient for approval; the expected duration over which La Jolla's cash balances will fund its operations; and other risks and uncertainties identified in La Jolla's filings with the SEC. La Jolla expressly disclaims any intent to update any forward-looking statements to reflect the outcome of subsequent events.
I will now turn the call over to Sandra Vedrick, Director of Investor Relations and Human Resources at La Jolla. Please go ahead.
Sandra Vedrick -- Director of Investor Relations and Human Resources
Thank you, operator, and thank you for joining our fourth quarter and full year 2018 conference call.
I would like to introduce the members of La Jolla management team that are present on the call today. Dr. George Tidmarsh, our President and Chief Executive Officer; Dennis Mulroy, our Chief Financial Officer; and Jennifer Carver, our Chief Operating Officer.
Now I will turn the call over to George.
George F. Tidmarsh -- President and Chief Executive Officer
Thank you, Sandra. Good afternoon, and thank you for joining us. In 2018, we made important strides toward fulfilling our mission of developing and commercializing innovative therapies intended to significantly improve outcomes in patients suffering from life threatening diseases. First, we launched our first commercial product GIAPREZA at the end of March 2018. Second, our Marketing Authorization Application or MAA for GIAPREZA was validated by the European regulatory authorities. And finally, we achieved important milestones in our development stage programs that we expect will lead to an NDA filing for LJPC-0118 and a key data readout for LJPC-401 both in the second half of this year.
I'll begin by reviewing GIAPREZA, which was approved by the US Food and Drug Administration as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock. GIAPREZA mimics the body's endogenous regulatory peptide angiotensin II that is central to the renin-angiotensin-aldosterone system to increase blood pressure. Shock occurs when the organs and tissues of the body, do not receive adequate blood flow and it is associated with a mortality rate exceeding most acute conditions requiring hospitalization. Distributive shock is the most common type of shock in the inpatient setting with approximately 800,000 distributive shock cases in the US each year, despite the availability of catecholamines and vasopressins approximately 300,000 patients a year are not able to achieve adequate blood pressure.
And prior to the approval of GIAPREZA, there had been no new treatment innovations for these patients over the past 50 years. We launched GIAPREZA in the US in March 2018. To support commercialization, we built sales, marketing, medical affairs and pharmacovigilance capabilities among others. The sales organization includes health systems access, clinical nurse educator, and critical care specialist teams. Together, these groups work in tandem to educate healthcare providers regarding the value that GIAPREZA brings to patients with distributive shock. Since launch, we continue to build a strong reputation with the clinical community that treats distributive shock patients. To date, approximately 380 hospitals have ordered GIAPREZA and we have heard anecdotally from these hospitals that GIAPREZA is performing favorably and consistent with what we expected based on our earlier clinical findings. Our commercial efforts this year are focused on securing formulary approvals at the hospital -- at the hospitals that collectively will give us access to approximately 70% of the patients that are treated for distributive shock.
Turning our attention to the European Union. The marketing authorization application for GIAPREZA was validated by the EMA was for the treatment of hypotension in adults with distributive or vasodilatory shock remaining hypotensive despite fluid and vasopressor therapy. Our MAA is based on data from the ATHOS 3 Phase III study, which establishes the safety and efficacy of GIAPREZA in the proposed indication. In January, we announced that we expect to receive the EMA's decision on the MAA in June of this year. If approved, GIAPREZA could be available for marketing in EU in early 2020.
In the European Union, the annual incidence of sepsis in adults is estimated to be more than 500,000, with more than 170,000 patients progressing to septic shock. Beyond our commercial progress, we had a number of data presentations at the Society of Critical Care Medicine's Congress last month. First in a subset analysis of patients enrolled in ATHOS 3, GIAPREZA was found to improve mean arterial pressure or MAP in patients with post operative vasoplegia and catecholamine resistant shock.
Separately, an independent analysis of time below threshold showed a strong association between the time low blood pressure threshold and morbidity and mortality. These data emphasize the need for rapid improvement in blood pressure, which is a core strength of GIAPREZA. In another presentation, an analysis of data from ATHOS 3 show that patients who experienced a significant reduction in catecholamine dose after treatment suffered fewer adverse events and this was more pronounced in the GIAPREZA treated group compared to placebo.
Finally, in support of a potential pediatric indication for GIAPREZA, data from an animal model was presented showing that GIAPREZA raises MAP levels in juvenile animals and was well tolerated with no treatment related clinical abnormalities or effects on any developmental tissue by microscopic assessment at the end of the 28-day recovery period.
I will now turn the call over to Dennis, who will review our financial results before I conclude the call with a discussion of our investigational product candidates. Dennis?
Dennis M. Mulroy -- Chief Financial Officer
Thank you, George. For the three months ended December 31, 2018, GIAPREZA net product sales were $4.2 million. This compares to $3.5 million for the three months ended September 30, 2018, $1.6 million for the three months ended June 30, 2018 and $0.8 million for the three months ended March 31, 2018. For the 12 months ended December 31, 2018, GIAPREZA net product sales were $10.1 million. As a reminder, in December 2017, GIAPREZA was approved by the FDA as a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock and in March 2018, La Jolla launched GIAPREZA in the US.
La Jolla expects 2019 net product sales of $24 million to $28 million. Our net loss for the three and 12 months ended December 31, 2018, was $45.4 million and $199.5 million or $1.73 per share, and $7.85 per share respectively, compared to $38.5 million and $114.8 million or $1.74 per share and $5.41 per share respectively for the same periods in 2017. As of December 31, 2018, we had $172 million in cash and cash equivalents compared to $90.9 million as of December 31, 2017. The increase in cash and cash equivalents was a result of $109.8 million of net proceeds from our March 2018 common stock offering and $124.3 million of net proceeds from our May 2018 royalty financing, offset primarily by net cash used in operating activities.
Net cash used in operating activities for the three and 12 months ended December 31, 2018, was $32 million and $152.4 million respectively, compared to $25.4 million and $85.1 million respectively for the same period in 2017. La Jolla has no debt as of December 31, 2018 and 2017. In 2019, we expect our net cash used for operating activities to be $89 million to $94 million.
I will now turn the call back over to George.
George F. Tidmarsh -- President and Chief Executive Officer
Thank you, Dennis. Before opening the call for Q&A, I'd like to briefly review our development programs with our other clinical product candidates. LJPC-0118 is our investigational product for the treatment of severe malaria, a serious and sometimes fatal disease caused by a parasite that commonly infects a certain type of mosquito which feeds on humans. Severe malaria is often complicated by central nervous system infections that may lead to delirium, which may progress to coma. The active pharmaceutical ingredient in LJPC-0118 was demonstrated to be superior to quinine in reducing mortality in patients with severe falciparum malaria infection in two randomized controlled clinical studies. We plan to file an NDA with the FDA in the fourth quarter of this year for LJPC-0118 for the treatment of severe malaria.
Next LJPC-401 is our proprietary formulation of synthetic human hepcidin. Hepcidin, an endogenous peptide hormone, is the body's naturally occurring regulator of iron absorption and distribution. In healthy individuals, hepcidin prevents excessive iron accumulation in vital organs, such as the liver and heart, where it can cause significant damage and even result in death. We are advancing LJPC-401 for the potential treatment of iron overload which occurs as a result of primary overload diseases such as hereditary hemochromatosis or secondary iron overload diseases such as beta thalassemia, sickle cell disease, myelodysplastic syndrome and polycythemia vera.
The EMA has designated LJPC-401 as an orphan medicinal product for the treatment of beta thalassemia intermediate and major and sickle cell disease. LJPC-401 is currently being evaluated in two Phase II studies. The first ongoing study is a pivotal multinational multi-center randomized controlled study in patients with beta thalassemia, who, despite chelation therapy have cardiac iron levels above normal. Beta thalassemia is a disease characterized by the underproduction of hemoglobin due to a genetic mutation.
Due to the underlying anemia, these patients accumulate excessive iron in major organs independent of blood transfusions. This iron overload causes organ damage, which may lead to death. In addition, patients with this disease are often dependent on frequent blood transfusions, which adds to the excess of iron accumulation. The primary efficacy endpoint of this study is the change in iron content in the heart after six months treatment. We expect to report top line results from this study in mid-2020 and if successful, we expect to file an MAA in the European Union.
The second ongoing study of LJPC-401 is a multinational multi-center randomized Phase II study in patients with hereditary hemochromatosis, a genetic deficiency in the production of hepcidin that leads to excessive iron accumulation. There are no FDA approved therapies for hereditary hemochromatosis and the current standard-of-care is phlebotomy procedures that typically involve the removal of a pint of blood on a regular basis, and is associated with significant adverse effects.
The primary efficacy endpoint of the study is the change in transparent saturation, a standard measurement of iron levels in the body and one of the two key measurements used to detect and treat iron overload. We are studying the change from the baseline to the end of treatment. We expect to report top line results from this study in the second half of this year.
In summary, over the course of the last year, we transformed our Company into a fully integrated organization with active clinical development programs and late stage; and the launch of GIAPREZA, a therapy that we believe has the potential to change the treatment landscape for patients with septic or other distributive shock. This year, we expect to file an NDA for LJPC-0118 for the treatment of severe malaria and to report top line results for our Phase II Study of LJPC-401 for the treatment of hereditary hemochromatosis.
We are also excited about the potential for LJPC-401 in treating iron overload in patients with beta thalassemia; and MAA, designated orphan drug indication for which we expect to report top line results from our pivotal study in mid-2020.
We will now open the call up to questions. Operator?
Questions and Answers:
Operator
Thank you. (Operator Instructions) Our first question comes from the line of Joon Lee with SunTrust. Your line is now open.
Joon Lee -- SunTrust Robinson Humphrey -- Analyst
Hi, guys, thanks for the question. For the hepcidin asset, what amount of IO reduction in the heart would you need to see in order for the drug to be commercially viable? And can you remind us what the magnitude of IO reduction you see with -- is with the chelators? Thank you.
George F. Tidmarsh -- President and Chief Executive Officer
Sure. So, to the second half of that question. It's highly dependent upon the chelator used and how it's used. Some chelators really are very poor at removing iron from the heart to much better from removing irons from the liver. And so none of them have an indication for removal of iron from the heart. And oftentimes it actually requires two chelators used simultaneously to kind of shadow from the heart to the circulation to be excreted out of the body. So there's no current optimal chelation therapy for iron overload in the heart. And also just remember for the design of this trial, these patients are already on chelation therapy and failing as evidenced by abnormal levels of iron in the heart.
So in terms of the -- significance of this trial, if we reach the primary endpoint with only a 100 patients in the trial, then it will be clinically meaningful. The clinically meaningful is really, highly intrinsically associated with the size of the trial you need to meet a statistical significance on the primary endpoint. And as you know, many studies are hundreds of patients large to have the power to reach statistical significance. So again, we expect that should we reach statistical significance on the -- our endpoint, and this is all agreed upon with EMA, then we will have a clinically meaningful improvement in cardiac iron.
Joon Lee -- SunTrust Robinson Humphrey -- Analyst
Thank you. And I have a one quick follow-up. In your previous study, I think you had a mix of hemochromatosis and beta thalassemia patients where you showed that you have reduction in iron, serum irons for a week. Have you ever disclosed the data based on stratified by the disease type? Thank you.
George F. Tidmarsh -- President and Chief Executive Officer
I believe that in our post -- one of our posters or presentations at EHA we had individual patient data, but I could go back and look at that. What I can tell you is that there was in that cohort of patients, which wasn't large. We didn't see any difference in the disease type in terms of the effect of LJPC-401, that is, it was equally effective for iron reduction in all of the different disease types that were studied.
Joon Lee -- SunTrust Robinson Humphrey -- Analyst
Great. And one last question, can you remind me what the cash runway is?
George F. Tidmarsh -- President and Chief Executive Officer
Currently, based on our cash balance and our expected net burn, we have cash into the second half of 2020.
Joon Lee -- SunTrust Robinson Humphrey -- Analyst
Thank you.
George F. Tidmarsh -- President and Chief Executive Officer
Thank you.
Operator
Thank you. Our next question comes from the line of Phil Nadeau with Cowen and Company. Your line is now open.
Phil Nadeau -- Cowen and Company -- Analyst
Good afternoon and thanks for taking my questions. I guess first on the GIAPREZA launch, could you give us an update on what proportion of patients who have distributive shock today have access to GIAPREZA? I think you said the goal was 70% this year or over the next couple of years, so where are you today?
George F. Tidmarsh -- President and Chief Executive Officer
I'm sorry, could you repeat the question?
Phil Nadeau -- Cowen and Company -- Analyst
Yes, what percent of patients having distributive shock have access to GIAPREZA today?
George F. Tidmarsh -- President and Chief Executive Officer
So we are aiming to have access to 70% of the patients that in the US that have distributive shock this year, where that's our goal this year. That's always been our stated goal. With 380 ordering institutions out of the little over at 1,000, we're probably in the 40% range, 35%- 40% range, but I could follow-up with that exact calculation.
Phil Nadeau -- Cowen and Company -- Analyst
That's helpful.
George F. Tidmarsh -- President and Chief Executive Officer
That represent, if you say we are in a institution it's ordering, it's not to say that we've fully penetrated that institution, but in terms of the ordering it's well into that 70%, which we've targeted.
Phil Nadeau -- Cowen and Company -- Analyst
And back in January, I think you said that one of the other goals for 2019 was to increase the penetration of those hospitals that are ordering already? Can you talk a little bit about what we expect to do to increase their penetration?
George F. Tidmarsh -- President and Chief Executive Officer
Yes, so what our main objective for this year is to present contracting opportunities to hospitals that have utilized GIAPREZA and want to increase that utilization but are understandably cost sensitive. Our contracting efforts typically involves a volume discount tier, which is fairly standard in the industry, so that as the volume of a given institution goes up then -- they get a increasing percent discount over that increased volume. So, we are presenting those contracting opportunities to the major health systems and institutions, and typically it's those institutions that already have experience with GIAPREZA.
For those institutions that don't have experience with GIAPREZA yet, we hear that cost is a barrier to entry. We have other contracting opportunities for those institutions, they tend to be short term discounts and it really take its design to take cost off the table to drive volume and we're very confident that as these institutions get experience with GIAPREZA that they will see the full value of -- they use GIAPREZA in the treatment of septic or other distributive shock.
Phil Nadeau -- Cowen and Company -- Analyst
Okay, that's very helpful. Same questions on 401. What are your plans for beta thalassemia in the US? Is there any update on the ability to take that pivotal data to the US regulators?
George F. Tidmarsh -- President and Chief Executive Officer
No update from what we've said before, the FDA is aware of our protocol and has signed off on it. We have not engaged in any special protocol assessment or other approval discussions with FDA. We do believe that our endpoint is a clinically meaningful endpoint that the FDA is very comfortable with and should we reach statistical significance. I have a confidence that we will have a good chance at approval in the US as well.
Phil Nadeau -- Cowen and Company -- Analyst
Great. And one last question on the finances. The cash burn guidance seems to imply a pretty big cut in quarterly operating expenses. One is, is that a fair assessment? And two, if so, can you give us some sense, where that expense is coming from? Is it coming from R&D or SG&A?
Dennis M. Mulroy -- Chief Financial Officer
Yes, there is going to be a significant change in our spending in 2019 versus 2018. And we took those -- made those changes in the fourth quarter and they are pretty evenly spread throughout the company to reduce spending in the various areas and yet still maintain our focus and the efficiency of generating the GIAPREZA sales.
Phil Nadeau -- Cowen and Company -- Analyst
Perfect. Thanks for taking my questions.
George F. Tidmarsh -- President and Chief Executive Officer
Yeah, just to -- sure and I'll just expand on that a bit. We have done fairly sophisticated analysis on the team needed to commercialize GIAPREZA and we are very confident that our organization currently and with some changes, additions and sort of some changes in terms of the direction of the organization, we are very confident that we have sufficient commercial effort behind GIAPREZA to maximize sales.
Phil Nadeau -- Cowen and Company -- Analyst
Got it. Thanks for taking my questions. Very helpful.
Operator
Thank you. Our next question comes from the line of Eun Yang with Jefferies. Your line is now open.
Eun Kyung Yang -- Jefferies -- Analyst
Thank you. I have a question on 401 for hereditary hemochromatosis. So, now we are expecting data in the second half of this year. What do you think you would need to show in order to capture market share or replace current standard-of-care phlebotomy? From talking to physicians, it seems to me that, although the genetic mutation is relatively common, the disease penetrance is low and our phlebotomy is quite effective, we do once monthly or bimonthly dosing on maintenance. So, kind of wondering what would you need to show to compete in the marketplace, if approved?
George F. Tidmarsh -- President and Chief Executive Officer
So the -- so, of course, first of all, Eun, thank you for the question. And to reiterate, there are no approved therapies currently for the treatment of hereditary hemochromatosis. So, in terms of FDA approval, there really is nothing out there to compare to. Phlebotomy is used and there is a general perception among physicians that it can adequately control the iron levels in patients. I think, unfortunately, that perception is not routinely shared with the patient -- among the patient population and we've done a significant amount of work there.
If you speak with the patients, they are looking for an alternative to phlebotomy, because phlebotomy not only is it inconvenient, you have to travel to a infusion or blood donation center, you have to take several hours out of your day. It is associated with significant adverse effects, including the insertion of a large bore needle. And interestingly enough, there are many publications showing that phlebotomy actually worsen some of the symptoms of hereditary hemochromatosis, more specifically the joint pain and the joint discomfort.
And so, I think that, with our once-weekly subcutaneous injection without the need to leave your place of work, to be inconvenienced, to suffer some of those adverse effects, we think that LJPC-401 has a potential to displace phlebotomy significantly for the treatment of hereditary hemochromatosis. And to our knowledge, there really is nothing else in development for HH. And so if successful, we would likely be the first approved therapy.
So, I think that we will significantly improve the outcome for these patients. Now, to your point about the penetrants, we -- so we estimate -- well, the data suggests there is over 1 million patients in the US affected genetically with the mutation that causes low hepcidin. But to your point there, we estimate that only about a quarter of a million of these patients are recognized and undergo treatment. So, it's not unusual actually that a patient will get diagnosed somewhat accidently by either presentation of a -- an incurred adverse effects, such as organ failure or on a routine blood test. So, we will certainly launch a significant effort to more broadly educate and diagnose patients with HH. So that, they can potentially be treated with LJPC-401 before they incur the organ damage that necessitates very frequent phlebotomy that again is attendant with significant adverse effects. So, that I -- fully answer your question?
Eun Kyung Yang -- Jefferies -- Analyst
Sure. Thank you. Thank you, that's helpful. And 401, what's the sub Q (ph) weekly dosing volume?
George F. Tidmarsh -- President and Chief Executive Officer
The current volume is 1 ml.
Eun Kyung Yang -- Jefferies -- Analyst
Okay. And the last question is on GIAPREZA. So, are you expecting European approval in June this year? So, upon approval, when do we expect European partnership or would you go alone and now started doing kind of a pricing negotiation with the various governments in Europe?
George F. Tidmarsh -- President and Chief Executive Officer
So, yes, the decision on the MAA is expected in June of this year and we have begun to undertake all of the necessary groundwork in Europe, such as meeting with some of the individual country pricing authorities. And we will assess as we go along about the value of any potential partnership, if we were to do that. We have been approached by multiple entities and we will assess those as they come, but we don't have any stated timeline for any potential partnership.
Eun Kyung Yang -- Jefferies -- Analyst
Okay, thank you.
Operator
Thank you. Our next question comes from the line of Ed White with HC Wainwright. Your line is now open.
Ed White -- HC Wainwright -- Analyst
Hi, thanks for taking my question. So, just on 0118, can you tell us a bit more about the data that you've seen there and that you're using for the potential NDA filing? And then, also just looking -- thinking of our priority review voucher, what steps have to be taken to undergo an application for a priority review voucher and the chances for attaining that? Thank you.
George F. Tidmarsh -- President and Chief Executive Officer
Sure. So, we are in the process of wrapping up the clinical study that was requested by FDA for our NDA submission and we'll update as we gain further clarity about the timing on the filing that we expect later this year. We have gained additional data from two large randomized controlled trials in the treatment of severe malaria that showed a survival benefit of the active ingredient of LJPC-0118 and so we're confident as we stand today that we have sufficient data based on our communications with FDA and remain on track for that filing timeline. So, yeah, that -- and I'm sorry, what was the second part of your question?
Ed White -- HC Wainwright -- Analyst
The second part was just about the priority --.
George F. Tidmarsh -- President and Chief Executive Officer
Priority review of ours . Yes. So, typically what happens is, part of the NDA submission is a separate part of the application for the priority review voucher. And we strongly believe that we meet all of the statutory requirements for the issuance of PRV, malaria itself, we know is a neglected tropical disease that's on the stated list of diseases that are eligible for priority review voucher. Secondly, the active ingredient as to not have been improved previously and we believe based on all our analysis that, that is in fact the case and then the clinical data has to show a significant benefit and we are very confident that the data does show a significant benefit.
So, while we can't always be certain until it actually happens, we believe by a very thorough and exhaustive analysis of the statutory requirements for issuance of a PRV that we will be eligible where that process takes place in parallel with the NDA review.
Ed White -- HC Wainwright -- Analyst
Okay, thanks, George. And then as far as marketing, is this something that you would market on your own or would you look for a partner?
George F. Tidmarsh -- President and Chief Executive Officer
Well, this, it's since there is about 1,700 malaria patients in the US every year, almost 300 will be will progress to severe malaria and that sits there will really be no other treatment. We do not believe that this will require much effort in terms of marketing. So there --- we do have the infrastructure currently, that would support this. We're working with distributors to get the drug -- for GIAPREZA, we have the relationships with distributors to have approved products on the hospital shelves. So if 0118 is approved, we have that infrastructure. We have the infrastructure with our pharmacovigilance to support it, medical affairs and so forth, but we do not believe that it would require significant sales and marketing efforts, simply because it would be a essential therapy for a very rare condition that is severely life-threatening.
Ed White -- HC Wainwright -- Analyst
Okay. Thanks for taking my question.
George F. Tidmarsh -- President and Chief Executive Officer
Thank you.
Operator
Thank you. Our next question comes from the line of Anupam Rama with JPMorgan. Your line is now open.
Tessa Romero -- JPMorgan -- Analyst
Hi guys. Thank you for taking my questions. This is Tessa on for Anupam this evening. I believe you have mentioned that a clinical trial needed for the NDA for LJPC-0118 and malaria is under way and fully recruited. Can you orient us to the trial design, what would be considered a win here? And then maybe related, piggybacking on the last question, if there are publishing strategy on the earlier clinical trial data? Thanks very much guys.
George F. Tidmarsh -- President and Chief Executive Officer
Yes, I think, for sure the data that we are collecting currently is a trial that really looks at the Pharmacokinetics and the distribution of our version, our LJPC-0118, our version of the active ingredient which has previously been shown to improve outcomes. And yes that trial is fully enrolled and we are finalizing the collection of the last bits of data and we'll update everyone at the time that we are completed with that trial and update on our timing, expected timing for the NDA. I think we will absolutely publish the data, and I think we will, we do have certainly plan in place to update the public in the medical community about the data and the availability of 0118 should get approved. So yes, we do have a coherent publication strategy.
Tessa Romero -- JPMorgan -- Analyst
Okay, thank you.
Operator
Thank you. And we have no further questions at this time.
George F. Tidmarsh -- President and Chief Executive Officer
Thank you all for attending our conference call today. I appreciate your support of LJPC.
Operator
Ladies and gentlemen, thank you for participating in today's conference. This does conclude today's program. You may all disconnect. Everyone have a great day.
Duration: 40 minutes
Call participants:
Sandra Vedrick -- Director of Investor Relations and Human Resources
George F. Tidmarsh -- President and Chief Executive Officer
Dennis M. Mulroy -- Chief Financial Officer
Joon Lee -- SunTrust Robinson Humphrey -- Analyst
Phil Nadeau -- Cowen and Company -- Analyst
Eun Kyung Yang -- Jefferies -- Analyst
Ed White -- HC Wainwright -- Analyst
Tessa Romero -- JPMorgan -- Analyst
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