Cipher Pharmaceuticals Inc.

Good morning, ladies and gentlemen, thank you for standing by welcome to the cipher pharmaceutical 2nd, quarter 2022 results conference call at this time all participants are in a listen only mode following today's presentation instructions will be given for the question and answer session. If anyone needs assistance at any time during the call, you may press the star followed by the 0 on your push button phone. As a reminder, this conference is being recorded today, Friday, August 12, 2022. On behalf of the speakers that follow, listeners are cautioned that today's presentation and the responses to questions may contain forward-looking statements within the meaning of the safe harbor provisions of the Canadian provincial securities laws. Forward-looking statements involve risks and uncertainties and undue reliance should not be placed on such statements. Certain material factors or assumptions are implied in making forward-looking statements and actual results may differ materially from those expressed or implied in such statements. For additional information about factors that could cause results to vary, please refer to the risks identified in the company's annual information form and other filings with Canadian regulatory authorities. Except as required by Canadian securities laws, the company does not undertake to update any forward-looking statements. Such statements speak only as of the date made. I would now like to turn the call over to Mr. Craig Mull, Interim Chief Executive Officer of the company. Please go ahead, Mr. Mull.

Thank you, Operator, and good morning, everyone. Joining me today is Scott Langell, CIFRS CFO. On today's call, I will make opening remarks before passing the call over to Scott to review the financial results in detail. Following our prepared remarks, we will open the call for questions and note that all amounts are in U.S. dollars unless otherwise stated. We are pleased to report that Cypher delivered another strong quarter, generating positive net income and cash from operating activities. Our results demonstrate the stability of our business and the benefits of our cost reduction strategy. We ended the quarter with $24.2 million in cash or 31 million Canadian on our balance sheet, which provides us with tremendous financial flexibility as we evaluate a number of profitable product and company acquisitions to accelerate and continue to drive shareholder value. In May, the company's partner, Moberg Pharma, began patient enrollment for the North American Phase III study of MOB015 to treat nail fungus. The purpose of the study is to facilitate market approval by the U.S. Food and Drug Administration, or FDA. Cypher holds the exclusive Canadian rights to MOB015. In Canada, according to Acuvia, the total prescription market for onychomycosis was greater than $75 million Canadian per year, with a single product having over 90% market share. In June, the company partner Canfeet Biopharma announced positive topline results from its phase three comfort study in the treatment of moderate to severe psoriasis. Based on the safety and efficacy data revealed in the trial, Canfeet plans to approach the US FDA and the European EMA with a protocol for a pivotal phase three study for drug approval and registration. We are pleased to see the continued progress that Moberg is making to commercialize MOB015. Patient enrollment is another positive step towards commercialization, and we look forward to competing in this large market with an innovative topical product that would provide a new safe and effective treatment option for many Canadians who suffer from this common nail infection. On the canned feet, Phase 3 comfort results, which were positive indication for CF01-01, an estimated 1.5 million Canadians suffer from psoriasis and rheumatoid arthritis, and Cypher holds the Canadian marketing rights to this new and novel product, which we believe holds substantial commercial potential. We continue to perform formulation and stability testing for our tattoo removal product, ETR001. And we expect to move into animal studies in the very near future. The product has a significant market potential, and it is a highlight and focus of the company to move this product forward. Moving on to the financial results, our second quarter results showed relative relatively stable revenue as we continue to transition through the launch of Absaroka AG. Product revenue increased by 0.2 million, or 7%, to 3.5 million for the second quarter of 2022, compared to 3.3 million for the comparable period in 2021. Product revenue for EPURIS was 3.3 million in the second quarter of 2022, up 9%, from 3.1 million in the comparative period. Product revenue continues to be driven by the strength of Epirus, which generated 3.3 million in revenue. Again, a 9% increase from the comparative period. We are incredibly pleased with the performance of Epirus, which continues to be the most prescribed isotretinoin product in the Canadian market. Licensing revenue from Absaroka in the U.S. was 1.3 million for the three months ended June 30th, compared to 2.4 million for the three months ended June 30th, 2021, but relatively unchanged from 1.4 million in the first quarter of 2022. Absaroka's market share was approximately 4.4 compared to 4.2 in Q2 2021, according to Symphony Health. Market share, market share, including Sun's Absaroka LD, was approximately 5.5%. We believe that the market shares for this portfolio have stabilized, and we expect that we will continue to see the same levels of volume throughout the contract with Sun. Currently, in our isotretinoin portfolio, Cypher is receiving royalties from Sun Pharma for the branded product, Absaroka, the authorized generic, as well as Absorica LD. In addition, we recently announced an extension of this partnership from November 30, 2022 through December 31, 2026 for Absorica and Absorica AG, which will extend our revenue cash flow streams for this portfolio. Overall, CIFR has assembled an attractive portfolio of assets beyond our currently marketed products and will continue to move these products towards commercialization. We continue to strengthen our balance sheet. At June 30th, 2022, our balance sheet had 2.4 million in cash and no debt. And again, 24.2 million US in cash. Placing Cypher in an excellent position to continue to buy back shares and to actively pursue product and business acquisitions in a prudent manner with a focus on near-term profitability. We believe that CIFR now has a stable runway for growth. Aligned with our stated strategy, we remain focused on identifying and evaluating profitable product and company acquisitions that will accelerate our growth and drive shareholder value and are continuing to build cash reserves in anticipation of such transactions. Over the past quarter, CIFR's focus has been on M&A. We have reviewed many deals and opportunities and are advancing our review and analysis of several of these interesting possibilities. Yesterday evening, we announced the appointment of Brian Jacobs to the role of CFO effective August 15th. Brian's extensive experience in M&A and strategic leadership will help fortify our management capabilities and drive our next phase of growth. Brian brings a proven track record of senior financial expertise and enterprise success in the companies that he's been involved with. He also has extensive experience in managing growth, risk management, and cost efficiencies. We believe that his expertise will be valuable and will help us focus in pursuing profitable product and business acquisitions. Brian is an accomplished and strategic financial leader and has extensive experience in public company compliance, financing, as well as mergers and acquisitions. I am pleased to report that Scott Langell will remain with CIFR and will be focusing on business development strategic mergers and acquisitions i would like to thank scott for his contributions and look forward to working with him as he evaluates a number of profitable profitable product acquisitions which will help accelerate the growth of cipher and continue to drive shareholder market value i now would like to turn the call over to scott for a financial review

Thanks, Greg, and good morning, everyone. We'll provide a financial update for our second quarter results. Total revenue was $5.6 million in the quarter compared to $6.1 million for the comparative period. Licensing revenue was $2 million for the quarter compared to $2.8 million for the prior year. Licensing revenue from Zorica in the US was $1.3 million compared to $2.4 million in the prior year. Zorica and the authorized generic version of Zorica market share for the three months ended June 2022 was approximately 4.4% compared to approximately 4.2% for the prior year, according to Symphony Health. Total market share, including the authorized generic and Sun Pharma's Zorica LD was approximately 5.5% compared to 6.2% in the prior year. Licensing revenue from the extended release Tramadol product concept and authorized generic version of concept in the U.S. was $0.02 million for the three months ended June 30, 2022, compared to $0.05 million for the prior quarter. Lipophen and the authorized generic version of Lipophen was $0.07 million for the quarter compared to $0.04 million in the prior quarter. The increase was due to the change in the distribution partners and related terms of the distribution agreement. Product revenue increased by 0.2 million or 7% to 3.5 million for the second quarter compared to 3.3 million for the comparable period in 2021. Selling general and administrative expenses were 1.1 million for the second quarter, a decrease of 6% compared to 1.2 million for the three months ended June 30th, 2021. Total operating expenses for the second quarter were $2.2 million, a decrease of 5% compared to $2.3 million in the prior period. Net income was $2.1 million or $0.08 per diluted share for the quarter compared to a net income of $2.8 million or $0.10 per diluted share in the comparative period. Adjusted EBITDA for the second quarter was $3.6 million compared to $4.1 million for the prior year. The company had $24.2 million in cash and no debt at June 30, 2022. Cypher generated $5.2 million in cash from operating activities for the six months ended June 30, 2022. With a strong balance sheet, a reduced cost structure, and additional visibility from the four-year extension of our relationship with Sun Pharma, we are focused on identifying and evaluating the right assets to drive our growth. We'll now open the call up to questions. Operator?

Thank you. And if you would like to ask a question, please signal by pressing star 1 on your telephone keypad. If using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment. Once again, everyone, to ask a question, simply press star 1 on your telephone keypad. All right. And we will take our first question from Andre Uden with Research Capital. Please go ahead.

Hi, Craig and Scott. Some of this, I guess, was in your filings, but just wondering if you could just discuss a little bit further in terms of the Absorica competition, and also if you expect Sun to add any promotional efforts to your LTE formulation. That would be great. Thanks.

Andre, it's Craig here. Thanks for the question. From a competitive standpoint on the iso-threatening market in the U.S., obviously, we've seen the launch of RIG, of our authorized generic, which was followed by ACADIS's generic launch. And then subsequent to that, Upshur Smith also launched. We have found that over since the launch that The market shares for these products have stabilized. And that again, AG holds the largest share of all of the isotretinoin products. And we're not seeing much movement in that share over the last few quarters. The pricing has stabilized as well. We're not seeing, you know, much in the way of increasing growth in that adjustments. And so we believe that This portfolio is stable going forward for Cypher. And Andre, I think that you had a second part of that question that you don't mind repeating it for me.

Sure. Just in terms of Sun, do you expect them to add any additional promotional efforts to the LD formulation?

The LD formulation that is manufactured by Sun and of which Cypher continues to earn a royalty from, has not gained the market share that had been expected by Sun. I think that they may be considering additional commercial activity around that product, but we're not privy to it, even though that we've been part of the launch of that product. I believe that because it's a genericized market segment that you're not likely to see a lot of additional commercial activity for that product.

That's fair. And just on the business development front, I've been asking a number, especially pharma companies, is what are the trends that you're seeing in terms of prices of product acquisitions? Is it stabilized? Is it dropped? Is it going up? Like, what sort of trends are you seeing?

Well, we're seeing a lot more deals being presented to us, and there seems to be quite a bit of movement in the Canadian specialty pharma market. Some of the players have been highly leveraged, and I think that that might be catching up to them now. But what we're finding is that we're getting a lot more calls, a lot more interest of doing deals. from the Canadian specialty pharma area, but also in product acquisitions that we've been looking at. I think that higher interest rates have meant that those that are leveraged are concerned about their cash flows and profitability going forward. And that creates a real opportunity for Cypher. We have no debt. We've got about 30 million Canadian on our balance sheet. And we've been looking at a lot more deals than we have in previous quarters. Now, this quarter in particular, this past quarter hasn't been overly productive just because of the amount of holidays, particularly European holidays.

We expect that's going to pick up again in September. Great. Thank you.

All right, and moving on, we'll hear from Doug Lowe with Lee Jones Gable.

Please go ahead.

Yeah, thanks, operator, and good morning, gentlemen. Just sticking with the isotretinine theme that Andre kick-started here. I've always been interested in Apuris' historic revenue ramp, which nine years post-launch, I mean, he continues to establish record quarterly revenue levels, and that's quite unusual for most branded therapies that we've ever tracked. So, Just kind of wondering if you have any interesting comments about how your marketing strategy in Canada sort of continues to capture market share from Accutane and Claris, and whether or not you see any possibility that that trend line could continue for what is clearly a fairly mature brand in the Canadian dermatology market. And then I have a follow-up.

Thanks for the question, Doug. Craig here. Yeah, ePURES continues to grow. We continue to promote the product, and we've taken different methods to do the promotion just because COVID restricted us from getting into the doctor's office in any meaningful way. We've had a number of different seminars and lectures by key opinion leaders on the product. and they've been exceptionally well attended, not only by dermatologists, but we're finding that family doctors are also interested in prescribing, you know, isotretinoin products, and ePuris is often at the top of their selection process. The product is absolutely valued amongst the dermatology segment. We continue to speak with them on a regular basis, not only about Epirus, but also other pipeline products that we're working on as well. And it's a resounding response that we get about Epirus. They think it's the gold standard. And I expect that we'll continue to increase our volumes and our market share. The family doctor area is obviously a very, very large market. And they often look to the key dermatologists in their regions. for advice on what to prescribe. And the product that's being prescribed is Epuris. We expect that, you know, come September, that we will be engaging our contract sales organization to go out and physically promote the product as well. And we expect that we'll continue to take market share. And if we are able to get some public reimbursement in Quebec, And in BC, the market share increases could be quite substantial.

That's great context. Thanks, Greg. And then a boring tax question to the chaser. Just wondering what your strategy would be to being able to realize the considerable tax losses that you acquired in the Crevio acquisition several years ago, seeming your tax expense continues to be at, you know, constitutive Ontario tax rates. And just wondering if there's some sort of a strategy through your tax policy in order to realize those tax losses. I'll leave it there. Thanks.

We are indeed realizing those tax losses. We are accruing provision for taxes, but in our tax filings, we are utilizing the cardium losses for 2021. So we have begun utilizing those tax losses on a filing basis. And we are also actively promoting the hospital products to run the business as it should be and so we've hired a promotional organization to run that business and we are actively looking for products to enhance that business so it's It's actively being pursued both with the current products and looking for future products to grow that business.

Great. Good stuff. Thanks, Doug.

All right. And our next question will come from Mike Schimmick, a private investor.

Please go ahead.

Yeah. Hi. I have several questions. The first one would be with regards to the NCIB project. It appears to have been completed by the end of July and I was wondering if you expect to renew it.

Yes, we expect to renew it. I think it expires in September and our intention is to renew it.

In September? Yes. Okay. Okay, great. My second question was related to MOB 15. The release date appears to be at the end of 2023, hopefully in Europe. And I don't have a vast familiarity with the Canadian pharma industry. So I was wondering how we could expect to see, what we could expect to see in Canada for release date in Canada if Europe is accurate in terms of end of 2023.

And Mike, when you say release date, the date that it can be commercialized, is that the date that you're referring to?

Yeah, product launch, when they actually start doing sales.

Okay. So our game plan with MOB is that we will, you know, wait for the results to come in and, you know, we'll get updated results as well. We're in close contact with MOLBRG. It's a very exciting product for them, and they're wanting as much assistance as they can get, and we're providing that for them where we can. I expect that the results for this phase three study that they're doing in the U.S. will be completed within the year. It'll probably take three months to do the reporting and statistical work before they're in a position to submit to the FDA. If the results are what we hope and expect, CIFR can, in parallel, apply to Health Canada with a complete submission file. Once that complete submission file is submitted, We believe that will take approximately nine months to a year to get full approval by Health Canada and at which point we can commercialize the product.

Okay, great. Thank you very much for the clarity on that. My two last questions. With regards to one of the prior callers asked a question regarding this as well, and I was wondering if you can offer any additional clarity. Sorry for asking for that. Income tax payable at the end of 2020 was $2.6 million, and now income tax payable is ramped to $7.9 million. As I mentioned, that has something to do with the filing. I was wondering why, if you can offer any additional clarity on why that keeps on going up.

Sure. We had a discussion with our auditors and for the financial statements, the decision was made to accrue taxes. However, in our actual filings with Revenue Canada on tax returns, we are utilizing the cardium losses. So we're applying those cardium losses to the tax returns, but with our discussions with the auditors, we decided to accrue taxes on the financial statements, and that's a conservative approach, obviously.

Okay, great. That's what I thought it was. Okay, my final question relates to the answer that you gave to our caller as well, which I found interesting. You talked of Quebec and BC public reimbursement with regards to Everest. Is it currently the situation that some of your competitors do have public reimbursement and you do not? And if that situation changes, then we can expect a substantial increase to market share from those markets. Is that what you're saying there effectively?

That's correct.

Oh, that's interesting. Okay, great. Well, thank you very much for answering all my questions.

Thank you.

And our next question will come from Peter Raytek with Raytek Consulting.

Please go ahead.

Good morning. Craig, I was wondering if you have any updates on efforts to sell IsoTrenin in South America and in particular in the large Brazilian market. I think we talked about this probably about six months ago. And while I do appreciate some of the difficulties in getting into those markets politically and otherwise, well, the question is, Are there any updates, and in particular with regards to Brazil, given the size of that market and the nature of the product, et cetera, and then presumably the wide appeal it would have in that market?

Hi, Peter. Thanks for the question. Yes, we are making progress in Latin America in particular. We continue to have issues with the Brazilian regulatory authority. And it really stems from the fact that they want all products that they allow onto their formularies to be manufactured in Brazil. And that really becomes a non-starter for us. We've looked at other ways to do it. We're working with Sun in Brazil, who is our commercialized partner, commercialization partner at the moment for Brazil. And they are telling us that they're having extreme difficulties on getting the authorities there to. To accept our submissions, they continue to work at it. And they've got, I believe some meetings in the not too distant future to. To try to address some of the. Some of the difficulties were some of the limitations that we're having with the regulatory people on a positive note. The EPIRUS has now been approved in Mexico, and our partner there, our commercialization partner, Italimex, is in the final stages of having a plan set for commercialization, which we expect in the next few months the product will be on the market and being sold. We have a royalty arrangement on that product. that we will collect a royalty on revenues, products sold in Mexico. The same company, Telemax, also has branches in other Latin American and South American countries, including Chile, Peru, and a number of other ones. And we're working with them and Gallifar to see if we can get approvals in the more lucrative markets.

Okay, very good.

Any other questions on that, Peter?

I was just wondering if you had any update on the tattoo removal cream that's in the pipeline.

Yes. I mentioned earlier in my speech here, but we are at the stage where we're working with contractors to stabilize the formulation. And we need to be able to stabilize the formulation in order to move to the next phase, which would be animal studies. And that's where we're at. I believe that that work is nearly complete. The results are good. We have a stable formulation. And the next step will be putting the product into animals to do animal trials. We've gotten a great deal of interest from other groups on this product. And we're looking at some possible partnerships on the development of the product itself. We have great hopes for this product.

Okay, terrific. And if I could, just one last question. This is, I guess, really for Scott. With respect to the tax losses that we've talked about, it's my understanding that none of them are close to expiry in terms of, when I say close, within the next couple of years so that from a utilization or potential utilization standpoint, none are at risk of falling off the table without being utilized. Is my understanding correct in that regard, Scott?

Yeah. Are you talking about the cardium losses? Is that correct?

Yes. Yes. Sorry. Sorry.

No, no. We're fine there. We would have plenty to utilize on our filing sub-tax accounts.

Okay. And again, none are near-term expiry.

I don't believe so. Dave, is that your understanding as well? I think the first year of losses is 2026, or expiry of losses is 2026. Okay.

And in the order of magnitude, just roughly on that one, do you have that offhand?

I don't, no.

Okay. All right. I mean... Hopefully, the profitability of Cypher is going to well exceed whatever that number is in any event between now and then, and therefore, it will be fully utilized. That's hopefully the expectation. Okay, very good. Thank you, Greg, Scott, and Brian. I appreciate it.

Thank you. Thank you, Peter.

And we have no additional questions. I'll turn the call back over to Craig Mull for closing remarks.

Thanks for joining the meeting today. We look forward to keeping you updated on our progress and for the balance of 2022 as we execute on our priorities. We expect that the coming quarters will be very exciting for CIFR. Again, thanks for your time and look forward to talk to you again next quarter.

And this concludes today's call. We thank you again for your participation. You may now disconnect.