Q4 2020 Catalyst Pharmaceuticals Inc Earnings Call
[music].
Greetings and welcome to the catalyst Pharmaceuticals fourth quarter and fiscal year 2020 financial results Conference call. At this time all participants are on a listen only mode. A question and answer session will follow the formal presentation. If he would like to ask a question on the phone. Please press star one on your telephone keypad.
If anyone should require operator assistance during the conference. Please press star zero on your telephone keypad and.
As a reminder, this conference is being recorded it is now my pleasure to introduce your host Ms Ali Grande.
Chief Financial Officer. Thank you. Please go ahead.
Good morning, everyone and thank you for joining our conference call. Please close catalyst fourth quarter and full year, 2020 for National regional and corporate line.
On today's call, we have Patrick Mcenany, Chairman and Chief Executive Officer, That's just the only other chief operating officer and keep safe.
And you compensate and.
Yes, and they'll Carman Chief commercial officer.
Joining me on the Q&A, we will also have the two Gary Ingenito, Chief medical and regulatory.
Uh huh.
Before we begin I would like to remind him and he's a filing comments and the Q&A session. We will make statements about expected future results, which maybe four and a few statement for purposes of sales case law and.
These statements relate to our current expectations estimates and projections and are not guarantees of future first one day.
Meanwhile from it.
I'm, sorry, the views and assumptions that are difficult to predict and may prove not to yet.
Especially in light on that.
COVID-19 actually.
Larissa, Let's me Barry.
Forward looking statements should be coming from.
And then.
Information contained in our SEC filings.
Clearly there is faster.
In 2020, and our report on form 10-K and.
And then I will turn on this call on wages.
Thank you Alan and thanks, everyone for joining us on this morning for our fourth quarter and year end 2020 results and business update call.
I hope that everyone is staying safe and healthy during these difficult times.
This past year and extremely challenging year from catalyst and especially for our commercial organization.
So with that backdrop we.
We're very pleased with the financial results there were no income.
And our press release.
Despite operating under very difficult conditions, and the COVID-19 environment, we generated net revenue of $119 1 million and net income from operations from $41 3 million, which included a noncash stock based compensation expenses.
$6 3 million, which resulted in almost $46 million from additional cash and investments on the balance sheet at the end of the year compared to the end of 2019.
Additionally, we ended the year with $143 million and cash and investments and no funded debt.
And I will provide you more financial details on a few minutes.
I noticed that I would say, there's often and I just wanted to say once again, how proud I am on the team's ongoing efforts to demonstrate.
Our steadfast commitment to the patients who we serve.
We have shown a remarkable resilience and ability to continue to expand and number of patients and I'm sorry.
Moving from <unk> to treat their condition.
COVID-19 continues to make it somewhat challenging for patients who have left.
Who have not received a definitive diagnosis from our position because of the difficulty and scheduling and in person appointment or their personal concerns about in person visits with their treating physician.
Last year, COVID-19 had a material impact on a number of new patient starts and we had projected for 2020.
And patient starts and Q2 and Q3 of the past year were modest on a relative basis compared to the pre COVID-19 period.
I'm pleased to report we've seen a significant increase and new patient starts from current apps.
And the last few months and.
And we're continuing to see improvement and most of all of our commercial metrics.
We believe and you'll see that we are well positioned the company for future growth.
Jeff will provide you with more details on our commercial operations shortly.
Yeah.
As you May recall late last year, our use pattern for three or four diamond from parity issue.
And this pattern and four additional patents that are pending and the patent and state are expected to provide protection until at least 2034.
This patent protection and addition to our seven year orphan drug exclusivity for <unk>.
Recently, we announced an expansion on the company's strategic focus to include acquiring or in licensing and innovative technology platforms and earlier stage programs.
And other therapeutic categories outside of neuromuscular disease.
To accomplish these priorities catalyst is prepared to invest more heavily and research and development, including acquiring earlier stage opportunities and innovative technology.
We believe this strategic expansion will better position the company.
Build out a broader and more diversified portfolio of marketed products and your drug candidates and I expect it does from a lot greater shareholder value over the near term and the long term.
To spearhead this investment we have commenced a national search for a senior executive to lead this more progressive strategy.
We're excited and virtual likely be and M. D ph D. With 15 to 20 years on relevant primary experience and innovative drug discovery. This first one will be responsible for leading strategy development.
Folio planning and medication development from early stage through marketing authorization.
And as part of this strategy strategic plan, we will continue to focus on developing our current pipeline, which includes the development of the long acting formulation of <unk> Sanford Inc. Phosphate.
And proof of concept study evaluating <unk> as a treatment for hereditary neuropathy with liability to price from policies for our agent and pp and discussion with the FDA from a potential and path forward with our musk myasthenia Gravis program.
And we'll have more to say about these programs on a few minutes.
On the litigation front and on.
Our appeal on the.
U S District Court decision and our lawsuit challenging the food drug administration and interpretation of <unk> orphan drug exclusivity under the orphan Drug Act.
The briefs have been filed and young and 11th Circuit Court of Appeals and has granted our request for oral arguments, which is currently scheduled for March 2003rd our next Tuesday.
And you can schedule, we anticipate and decision by the court sometime in the second quarter of this year.
Our previously announced patent litigation against Jacobus Pharmaceuticals, and Panther Rx Jacobus has solid specialty pharmacy provider for our reserves and.
And is proceeding as expected.
These type of cases, however, it takes some time to develop register.
Average discovery and other pre trial activities. So no trial date is expected for the near future.
As we've stated previously it is important to note that these these litigation activities and no way impact catalyst pathways, and our patient services programs and market access preferred apps or our ongoing marketing efforts for <unk>, So adult <unk> patients.
Which represents about 99% on <unk> patient population.
Catalyst intends to continue to aggressively take all steps necessary to protect current action and exclusively under the orphan Drug Act.
Which is specifically intended to.
To encourage and ensure the development on <unk>.
Drugs for patients with rare diseases.
At this point I'd like to turn the call over to Jeff Taylor Carman, Our Chief commercial officer to provide you with further details on our commercial operations.
Thanks, Pat and good morning, everyone I will now walk through 2020, <unk> performance and more detail. We are very pleased with the full year U S. Net sales of $118 $7 million, which represents a 16% growth year over year.
Specifically Q4 was a very strong quarter, delivering $38 million and U S. Net sales our best net revenue quarter since Q3 of 2019 and Spice resurgence of COVID-19.
I wanted to take this opportunity to thank the entire catalyst team for their outstanding performance in 2020, a true testament to our ability to be agile, while maintaining our commitment to sell loans community.
Growth in 2020 was driven primarily by recovery and new patient enrollments in Q3, and Q4 continued favorable reimbursement dynamics and a stabilization on compliance and persistence rates.
In October new naive and three four and NAV patient enrollments or higher than any other month since may 2019.
In Q4, new enrollment outpaced Q3 <unk>.
30%.
And 90 day discontinuation rates are less and 15% and discontinuation is to reserve <unk> continues to be minimal and relatively flat and Q1 2020.
We expect continued growth and 2021 versus same quarter as last year and.
As we build upon the momentum generated in Q4, and the COVID-19 vaccination rate continues to increase allowing for more and in person patient visits.
On the combined effort of our rare disease experience team non personal promotion and inside sales and enables efficient coverage closer to 20 and health care professionals.
Essentially treat adult <unk> patients.
More and purchase sales representative visits will lead to an increase and new patient enrollments based.
Based on early observations and new patient enrollments and achieved new highs and the impact of the pandemic subsides and <unk>.
We are proud to say and over 700 patients.
And now received FERC <unk> prescription.
Yes, continuations and January or 65% lower and January of 2020.
Our catalyst pathways patient services and a tremendous channel in 2020, providing personalized support to adult loans patients caregivers and healthcare professionals throughout the pandemic.
<unk> patients and confidence that they have access to <unk> without disruption.
Prescription approval rates remained over 90% across all payers and government or private commercial insurers.
Furthermore, 98% of re authorization and been granted thus far which shows the value of <unk> is recognized by payers.
Patients who enrolled in catalyst pathways, including those who are covered by Medicare and and accessing foundation assistance and on average co pay of less than $2 per month.
And 2021, and we remain committed to making fared as affordable and accessible to all adult <unk> patients to the extent allowed by applicable law.
And as I mentioned on the Q3 earnings call, we remain confident and our assessment on the remaining potential adult lens addressable market aside.
Besides the already diagnosed <unk> patients not yet on first apps. There are significant number of patients that are unfortunately, and misdiagnosed or underdiagnosed.
We will continue to invest heavily and robust lens educational resources directed towards both patients and healthcare professionals.
Shortened diagnostic journey and <unk>.
Additionally, approximately 50% of <unk> patients are tumor months patients however, less than 20% on patients currently and catalyst pathways are known to be tumor lung patients.
We are actively conducting market research AD boards and working groups and better understand how we can help identify and serve these adult tumor line stations.
In closing we are very optimistic about the growth potential preferred apps and 2021 and beyond our team is eight and rare disease experience and passionate about serving the <unk> community and.
I'll now turn the call over to Dr. Steven Miller, our Chief operating Officer, and Chief Scientific Officer for an update on R&D activities.
I just from the commercial other Joe I'll now provide and update on our clinical pipeline to develop <unk> for additional indications.
And was previously a mouse and our multicenter phase III trial from a symptomatic treatment of Mus carry myasthenia gravis or and there was carrying on with FERC did not achieve statistical significance from the primary and secondary endpoints and we have concluded our detailed analysis on potential reasons why these trials and took not least in terms of course domestic.
And on Assembly and also on as reported previously March persist from clinical improvement was observed in patients and Brian investigators during the initial dose titration period and during the safety follow up study on this Trump and.
And point in time about half the patients from the trial remain on therapy and a safety follow up study and they have stated that firm apps and provided clinical benefit.
Professionally and moving our clinical improvement was also screens and the previous proof of concept trial.
Our analysis of the clinical trial data revealed that there is a large degree of some from variability during the double blinded withdrawal period further and there was plenty of Mg patients appear to exhibit significant shrink and variability from day to day. These sources of excess on unexpected short duration and variability adversely affect.
And to the power and trial, resulting from lack of statistical significance. We believe these sources of variability to be dealt with and I and redesigned trial, but maybe better demonstrate to observed after COVID-19.
And to present on our policy and a new clinical trial protocol to the FDA and for a discussion during the first half of 2020, one and perfectly we will be we will discuss the differences and the design and the new trial relative to the design of the trial and whether or not the agency would be willing to accept and new patent trial and different designs.
And adequate evidence of efficacy.
We anticipate completing this meeting with the agency from a first half from this year and parallel with this evening, we will evaluate new clinical trial sites and discuss the new trial designed with investigators after completing restart activities, we would determine whether or not to proceed with a new trial and incorporates the new design and report our decision actual risk.
Moving on.
And in months.
Catalyst will be initiating a catalyst sponsors and proof of concept and starting to evaluate and treatment of hereditary neuropathy with liabilities of pressure <unk> referred to App store and the third quarter of 2021.
<unk> is on auto some dominantly inherited demyelinating peripheral nerve disease caused by heterozygous deletion of <unk> 22 June leading to a reduction of <unk> 22 proteins are 35% to 50% of normal level, which results from disruption of the Mylan Skus of motor.
And sensory nerve outcome.
<unk>, often present with focal sensory and motor deficits, including numbness and focal per hours.
The events may be triggered by myeloma current and compression from occupational health and people and additional patients <unk> patients.
Are also appointed by strategic catalyst, we use of HMT and refresh.
About 3000 patients in the United States and then.
On the functional and Jim Island, and <unk> and <unk> patients and their success.
Outward current from intermodal voltage share repurchasing chubb's application of it Hitachi channel blocker Montgomery Sanford and you expect it to improve actually potentially propagation and Nathan PPA, thereby alleviating sensory deficits motor deficits and strategic and Asian country. This hypothesis and support for our research and we can compete.
Animal model with <unk> and 'twenty two matters items solution.
Moving on to other markets and research opportunities. We previously reported that we have reached agreement with the job and <unk> on a regulatory pathway to seek approval from FERC and Japan. Initially for the treatment of maps product would be a new chemical entity for that market and as such would be granted 10 years of market exclusivity as a reminder.
Under Japanese market is about 40 per cent of the size of the U S margin from about 200 <unk> hundred patients. There are also no therapies image anthonys market for <unk> future.
Regarding our <unk> AOI product under development, we have developed and first group of Canada and long argued before and it was and I'm also completed a pharmacokinetic or PK study of those cash.
And the formulation.
And results will inform on the design and future formulations from the ultimate goal of providing patients with an effective medications and they need to take only once in the morning, and once you resume and.
We are also on energy numerous physicians and most patients to get input into the design and comparable product because they feel would be superior to the card for <unk> product offering and <unk>.
And what is the basis for our design goals from Ford.
On a product.
Carlos has also made significant progress on developing and intellectual property as states and protect preferred on franchise last October we reported the issuance of U S. Patent number turns 70 93 893 Masters are imbalanced grain free for time, and a parity expiring and therefore, some 2034 catalyst has also begun to.
Total preferred on franchises and it's filed suit and federal court against Jacobus Pharmaceuticals, and Panther, our ex for induced infringement of ownership.
And remember of the documents related to this case on publicly available for anyone interested in learning more about the case and <unk>.
And tablets and for other pending patents related and some of the use of firm absolutely were recently published all four of these patents are being prosecuted under triangle and status of the U S patent and trademark office and we are hopeful that most if not all of them and the issue in 2021 and assuming the issuance of these patents catalyst also anticipate taking appropriate legal action to protect this new.
Patented intellectual property and I will now turn the call over to Ali Grande Chief Financial Officer to review our financial results.
And Steve.
Scott mentioned.
EPS without 2020, your reseller and.
And it's difficult and some of the COVID-19 pandemic remains steady and our front line.
And revenue growth and prudent expense management allowed us to be cash flow positive every quarter in 2020, we lead and our cash position sufficient to achieve.
And obviously without the need for any future day.
And lease financing.
Yesterday, we filed on May 2020, and form 10-K, with the SEC and we reported detailed fourth quarter and full year and financial results press release.
Let me highlight a few of those based on snap on 2020, we achieved total revenue of $119 1 million from here.
$102 3 million.
And on 19, each represented in the and.
And 16% year over year increase.
Reported GAAP net income.
75 million from 'twenty, and 'twenty with 72 cents per basic and 71 per day in the next year.
GAAP net income from $81 9 million weighted.
And maybe one maybe.
And great day of and it Shannon and 88000 net.
Net income for 'twenty, and 'twenty influence and easy by $1 million.
And maybe.
<unk> been able this year next day.
And is it from the lagged and he's great. Thanks Anthony.
<unk> day.
And I'll ask the third quarter of 'twenty.
For 2020, and non-GAAP net income, excluding $6 $3 million of expenses related to a non cash based compensation was $81 2 million or seven 8%.
<unk>, Inc.
And that he six cents per day, and this year and come back.
And 2019, non-GAAP net income, excluding the $8 million and expenses related to noncash stock based compensation.
And $35 seven.
And 35 and free.
Visa Inc.
And that relationship.
Income from sales of $17 million on the year 'twenty one.
And $14 eight millions with EMEA and 2019 remained consistent at 8% and anticipated.
As a reminder, and Costco from.
And 2020 and play and 19 benefited from inventory and Brian <unk>.
Yes.
Research and development expenses were 16 5 million for 'twenty, and 'twenty down from 18, 8 million, which way and IP.
And then just 1% decrease in research and development expenses year over year and really Didnt.
And the increases and expenses and a medical and Venezuela and plenty of issues and.
And the interest expenses from our ongoing.
And for trials and studies and we closed out the ambulance AMG and SME and <unk> China.
We think that we sit from them and us will continue to be substantial in 2020. One as we began and proof of concept study with <unk> and PPE.
And with Axis and expanded access programs.
And as diesel emulation program from a fair enough and.
And our regulatory path.
Seek approval for it and finance payments and the lands and Japan and begin to evaluate for items essentially of input on it and those go.
And I mean these pieces.
SG&A expenses for 2020 total police $1 2 million from currency.
And <unk> explain $9 million in 2019, and 20% increase year over year is primarily attributable to the expansion of our sales force and the first quarter of 2020 and constant contrasting with IV Andi sees ex and <unk> sales sales agency increases increased costs from illegal.
On the litigation and the stimulation and additionally, any dnas weighted personnel.
And our expanding operations.
Net SG&A expenses will continue to be substantial in 2020 one.
And we competing on our efforts to increase revenues from fair enough and thanks.
And Amit.
And this is the 31st 2020, and I've had cash and investments.
And $2 million and no.
More detailed.
Information on and how it may be found in the company's annually.
And on form 10-K, which was filed with the Securities and Exchange Commission yesterday March 15th and.
And can be found.
Nations page on our website www <unk> catalyst.
And with that I'll turn the call over from that.
Thanks Kelly.
Like to close our prepared remarks today by providing you with an overview of our corporate objectives for 2021.
First and foremost emphasize continues on a strong commercial launch of preferred apps for loans patients, which represents the cornerstone of our business.
As we are beginning to move back to more normalized times per.
And this pandemic.
We anticipate a more accelerated rate of growth and revenue as the year progresses.
We believe that our work has just begun as we believe there are many more <unk> patients who have not yet been diagnosed or had been misdiagnosed and it could be effectively treated and referred apps.
Next.
And aggressive initiatives to build through acquisition or in licensing a portfolio of additional protection therapies to treat rare unmet medical needs.
This will include bringing on board, a chief product development officer to lead and strategy and development portfolio management and execution of a plan, yes exactly executive search is currently underway.
And third continue to protect and prosecute our pattern and statutory exclusivity for current apps and any other assets that we may acquire we will.
Continue to file additional patent applications as we develop new intellectual property surrounding our assets.
Next we are continuing our development efforts for <unk> by commencing soon a proof of concept study for <unk> TP and meeting with the FDA and the second quarter to discuss our findings from the Musk Mg trial.
And determining if there is a reasonable regulatory path forward for this life threatening disorder.
Also we will continue to work and a good pace for developing a long acting formulation of <unk>.
Lastly, we will manage our company for growth and new build shareholder value, while continuing to operate with fiscal discipline.
I just wanted to say once more how pleased we are with the operational results that our team delivered during 2020.
And we look forward to continue on our efforts to assist the adult <unk> patients and their trading positions find ways to gain access to and FDA approved therapy for this disease.
We believe that 2020, one will be a transformative year for the company with multiple ongoing development programs and our strategy to build our clinical and commercial portfolio.
And this expansion plan along with the continued global commercial execution and preferred apps means catalyst is well positioned for a strong success in 2021 and beyond.
I'll now turn the call over to the operator that we make sure that we may now take your questions.
Thank you the floor is now open for questions participants connected CFO on May Press star one on their telephone keypad at this time to register a question.
Formation total indicate your line is from the question queue.
You May press start to try and move your question from the queue.
Once again Thats Star one to register a question at this time.
Our first question is coming from Joe <unk> of Piper Sandler. Please go ahead.
Hey, guys. Thanks, so much for taking my questions here on your <unk> call. You mentioned that you know on October and November the new patient enrollment starts were the highest <unk> seen since July of 2019, but weren't quite ready to call. It a trend. It seems like based on your comments now that maybe that was in fact, the trend and I'm.
If you could speak a little bit more to that and.
And whether you have any expectations to issue guidance at some point in 2021.
Joe.
Thanks for the question.
Let me first address guidance.
We'd like to see another quarter or two as the.
And as the country starts to open again and physicians are are actually seeing patients and person before we give guidance. So we're not prepared today, I think and another quarter or two.
Should be prepared to provide guidance at that time.
The first part of your question and I'll, let Jeff address in terms of trends and we are now seeing versus.
Forecast back in Q3 share. Thanks for the question, Joe and you're right.
In Q3, Q4, specifically October November and very strong new enrollments.
And as you know there is a little bit of a range a resurgence of the pandemic and.
November and December, which kind of slowed that at trend little bit, but thankfully, we're seeing the other countries open up a little bit and in Q1. So far we are tracking to have our best new enrollment order since Q2 of 2019, so and that's for new naive.
Patients, which is very significant so the team is doing.
Fantastic job the other thing I wanted to add in there is Ali mentioned it too we have and expansion and 80% expansion of our sales force that happened right before the pandemic, we have yet to fully realize that expansion and see that the true potential. We know we will see that and patients will be able to see their physician. So.
All of those things combined we expect significant growth and new enrollments in 2021.
Great. Thanks, and if I could just ex one one follow up.
So it sounds like your 90 day discontinuation rates have held largely steady I'm wondering if you've seen any impact from the pandemic to those numbers and if you expect that number to potentially maybe also improve and as things open up and patients begin to start seeing their physicians and person.
Yeah.
And it's a good question Joe.
And response to that.
And as the 90 day discontinuation rate is very strong at this point less than 15%.
We don't see the pandemic.
And we could we see that continuing to be stable may be decreasing a little then right now in Q1, I can say that our discontinuation and are also tracking to be the best quarter that we've had since the second quarter of launch. So we are seeing some positive upside there too.
Okay perfect. Thanks, so much for taking my questions.
Thanks, Joe.
Thank you. Our next question is coming from Charles Duncan of Cantor Fitzgerald. Please go ahead.
Yes.
Yeah, Good morning patent team.
Thanks for taking our question and congrats on a nice quarter.
I had one commercial question and then maybe a couple of pipeline questions with regard to the commercial question and I think Jeff mentioned tumor lens patients being relatively under represented.
And your.
Patient population. If you will that are taking first apps and so I guess are there any specific endeavors or initiatives that you are pursuing to identify and more tumor lens patients. It would seem to me in some ways to be and easier put too to accomplish with that and could we see more.
Our tumor lemons patients, taking the drug going forward.
Charles Good morning, Thanks for the question I'll turn that over to Jeff to address so Charles Youre, absolutely right significant opportunity with tumor loans patients.
And from from data that we've seen up to 50, and 50% to 60% of lens patients had tumor lamps. So what we want to do it's underrepresented right now those patients are underrepresented and our current patient population and moving.
Out of our catalyst pathways. So we are doing AD boards working groups market research to better understand the needs. There. How we can identify those patients. We can use claims data to identify those patients and we are doing so per.
And just the claims data and we will continue to do so on a quarterly basis. So that will help provide us leads now the number one key here is we want to provide information to all focused on.
Oncologists that are trading for instance for example, and small cell lung cancer small cell lung cancer has the highest has the highest rate of tumor loves our small cell lung cancer patients.
So we will focus on those traders and provide educational materials to those oncologist and then we'll direct those physicians to either re.
<unk> out to neurologists, and neuromuscular or give those physicians and opportunity to diagnose on their own and also prescribe. So that's our approach and then we will also expand that out to other tumor types that are associated with lens.
Over the course of the third and fourth quarter of this year and then also into 2022.
Okay. That's helpful. Appreciate day additional color on that now turning to the pipeline.
I guess question for Steve with regard to Musk MG has has the FDA meeting actually then schedule or is that a hope to hope to see and have in the second quarter and.
And then with regard to the observations that you made appreciate all the color on this I would have expect to randomize withdraw protocol that you had with musk mg to be relatively high power and so can you provide us any color on the symptom variability that you alluded to and and what drives.
Said is that is that something that you can identify upfront.
And perhaps deal with with a longer screening period or what can you do to reduce the impact that potentially compounding variable on the on the outcome of this study going forward.
Okay, well, that's a whole bunch of questions Charles let me try to answer and hopefully I'll remember them all.
With regard to the.
Moving.
And we can't provide any more details and we have already proven to provide in July and I can assure you we will have and mishaps and.
And.
Second with regard to the variability contribution be.
Exposure period during the randomization phase and the trial was emerging short period of time and.
Sure.
It involves the collection of just one data point at the beginning and what they reported to you on.
The answer to resolving the variability is really do subsequent simple and she's collect more data and just average out the effects of the Whistler and patient variability that we observed and so that's essentially what the plan is and we'll collect blogs and paid on through telemedicine.
Okay. So you are not anticipating an additional trial I thought you referred to.
And additional trials or are you seeing more observations within a new trial.
Correct.
We're going to three and presenting to the FDA, a new trial design and part of that design and includes the collection of more data.
Got it Okay, and then with regard to H M. P. P.
And I appreciate the outline on that opportunity can you tell us anything about the design of the trial that you would like to run and is a proof of concept trial within H M. P. P and would you be starting that in the second half and base year.
Yeah as I said, we anticipate starting in the third quarter I cant provide any details on the trial design at this time because we're still.
Completing the design would be.
Investigator and expert emotion and Cooper.
Okay last question for Alley with regard to.
Cash flow positive you know congrats on that great stuff, but when you think about the current cash do you believe that it is sufficient to fund not only the commercial efforts, but also.
Perhaps two additional trials one in musk Mg one on an H M. P. P. At the second half of this year is is cash good there or would you perhaps raising additional funds.
Fund the pipeline.
Charles This is Pat I'll take that question.
We entered your salary and pointed out last year was $140 million and cash.
And we're generating somewhere between $10 million to $15 million per quarter, right now and I expect that will increase as the year goes on so I think that we're well positioned our balance sheet is solid.
On the cash on hand.
Dr. <unk> studies, and we've talked about today and and actually we believe and we have enough cash to to entertain looking at.
Other opportunities, which we're currently doing.
And with the balance sheet and we currently have and the cash there were generating on a quarterly basis as well as debt debt.
And as has been available to us for quite some time debt.
We've not had to to avail ourselves of thank God.
But for the right asset and the right opportunity, we would certainly take on.
From debt so.
And.
I hope I've answered your question, but I think we're in good shape with the with the balance sheet and our.
And on our corporate objectives for this year.
Yep that addresses it thanks for the added information Pat and team congrats on a good quarter.
Thank you Charles.
Thank you. Our next question is coming from Joon Lee of Truth Securities. Please go ahead.
Yes. Good morning. This is actually less on for June. Thank you for taking my questions.
First on the.
Just wanted to get an update on the partnership's search and Japan, and also and update on debt commercialization efforts and Canada, and what would you be expecting on the near term and revenue contribution there. Thank you.
Sure.
As we said on.
On a run and our press release and.
And our 10-K.
We're in discussions with a partner.
For Japan.
These discussions have been ongoing for quite some time and as we negotiate terms and we hope to have something to say.
With regard to a partnership next quarter and Q2.
And we're optimistic that.
And once that definitive agreement is signed and that our partner will be moving quickly to get the drug registered and Japan.
With regard to to Canada.
And.
We view that opportunity.
As is representing about 10% on the U S market.
Just based on population the most part.
And we're hoping that debt can wind up being.
A meaningful contributor to to our P&L going forward.
We had a bit of a roadblock there as you know.
Net.
Health Canada's decision to approve <unk>.
10 days after our approval, which is currently in litigation and that cash was litigated and their early December and we are hoping for a decision any day now so the outcome of that trial could certainly make a big difference and the Canadian market.
That is helpful. Can you also discuss pricing strategy against and.
And Japan, and Canada versus the U S market.
Yeah, we're not prepared to talk about pricing yet for cash.
Canada and Japan.
And both of those markets as you know.
Their pricing is different and typically based on international and baskets and so we.
We expect debt the price and Canada will be will be lower.
And the U S price and certainly the price and Japan will be lower.
Great. Thank you.
Thank you.
Thank you. Our next question is coming from Scott Henry of Roth Capital. Please go ahead.
And <unk>.
Thank you good morning and.
Congratulations on the positive momentum.
You have.
And I have a couple of questions first which is on.
A little different I came across and international patent, which.
Was 434 DAP.
And to treat sexual dysfunction.
Can you talk about <unk>.
You know what you may have seen to motivate that patent filings.
Sure Scott Thanks for the question and I'll turn that over to Steve.
Well Scott ransom.
Our interest in question and there are only a few things I can say about it right now.
Deferred us was launched our pharmacovigilance programs with character and a few unexpected cases of improvement from resolution of sexual dysfunction issues, primarily female patients.
Based on these reports we filed a patent for the treatment of sexual dysfunction with <unk> and <unk>.
And our fabrication was published on February 11th from this year, it's obviously deposits and ground across recently Tao.
Catalyst is consulting with experts and evaluating the potential value and probability of clinical and commercial success for them.
And possible development pathways for this as a potential new indications preferred ups.
And as we've described to our export and potential indication further on.
And the investment community event on.
Okay, great. Thanks for the color on that Steve.
And I did have a couple of other questions first.
From a modeling standpoint.
How has pricing been.
On a sequential basis should we assume stability as far as revenue per patient or just curious severity changes and with that.
Scott.
And your price is and stable.
And we had a.
And our price increase and it is.
Basically in line with.
Where there are peers that are selling and rare diseases rare disease drugs.
And and <unk>.
Certainly in line right in line with inflation.
Okay.
Speaking of inflation on.
Obviously, you're generating a lot of cash and you have a lot of cash on the balance sheet.
Which some would say is a depreciating asset or or at least the purchasing power is would you consider taking you know as you look at other companies would you consider investing in your own company, perhaps through a share buyback.
At least with a small portion of that.
Scott.
Same day.
Everything is on the table as we look around to make investments and to acquire potential therapies or <unk> companies.
We are we do believe that and our stock price and our market cap is <unk>.
Extremely low based on our financial results and the opportunities that are in front of us.
So I would.
I would say, we wouldn't take that off the table and is a consideration at this point.
Okay, Great patent final question just.
The collaboration revenue line and showed up and third quarter and fourth quarter.
How should we think about that number going forward at least.
Prior to Canada, and Japan coming in.
Scott and I'll, let and Ali and so and then.
Oh absolutely.
Collaboration from our revenue from collaborations and different way on the fourth quarter is related to cash.
Okay. So we should expect that to continue then at similar levels I don't know if theres any.
And some timing related there, perhaps initial shipments or any color on that.
I would say.
And the resolution of the court case, we'll have a lot to do with that number going towards.
Okay, great. Thank you for taking the questions.
Great. Thank you.
Ladies and gentlemen that concludes today's question and answer session I would like to turn the floor back over to management for closing comments.
Yeah.
Thank you for joining us today, and and I look forward to future calls have a great day.
Ladies and gentlemen, thank you for your participation and interest and catalyst Pharmaceuticals, you may log off the webcast or disconnect. Your phone lines at this time and have a wonderful day.
Okay.
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