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Indeed. There is strong institutional backing for Clinuvel. And impatient and uneducated retailers keep selling and reducing the float. I'm buying.
BLOG POST FROM STOCKHOUSE:
De-risk and acquire: Acerus Pharma moves to stage II of its business model
There are a lot of investors out there who just can't stomach biotech. Not that it's not profitable – a successful biotech play can roll in billions overnight, as happened two weeks ago when Sprout Pharmaceuticals received a billion-dollar buyout one day after the US FDA approved its 'female Viagra' drug.
And it's not because biotech share prices don't go up – if any industry is prone to a sudden groupthink-inspired jump in share price, biotech is it.
No, the reason investors fear biotech is risk.
Playing biotech is often like gambling on red or black on a roulette wheel. Sometimes you double your money, and sometimes it's gone, and while many are happy to play those odds with educated guesswork, not only is the route to FDA approval hard to understand, but the biotech roulette wheel can sometimes take five, or ten, or more years to stop spinning.
Getting an entirely new drug approved is laborious, bureaucratic, and sometimes an outright mystery even to those who have been working in the industry for decades.
That's a challenge for investors, who rely on information relayed from the company to figure out where they are in the the drug approval process, and what the chances are that the company they've invested in isn't lying through its teeth. It’s also a challenge for even the best executives, who can only guess when -or if- they'll be allowed to do business, and have to sometimes be creative with their news flow to keep their stock from sliding as things trundle along.
If all that sounds miserable, it really is. But the payoff, if a company can successfully run the gauntlet, can be written in the billions.
So when a company makes it through the FDA approval process, that’s a big freaking deal.
Acerus Pharmaceuticals Corporation (TSX:ASP, Forum ), formerly known as Trimel Pharmaceuticals Corp., has worked through the FDA approval slog for the last several years and actually managed to get a nasal gel treatment okayed for those folks with low testosterone levels. It was no mean feat, but they got their thumbs up and then licensed that product for sale in the US with Endo Pharmaceuticals (NASDAQ:ENDP, Forum) in an eight-figure deal.
Canadian approval is hoped for by early 2016.
This is huge. This is legitimizing. This is a group that has barged into a crowd of larger, better funded industry giants and come out the other side covered in the blood of their enemies, roaring at the skies like a raging berserker army of good.
Why? Because few companies make it that far. Even fewer Canadian companies, even fewer small cap Canadian companies.
And because the product is good.
Check it: Testosterone replacement is, just in the last few years, a massively big thing. Men are realizing that, for whatever reason, their testosterone is dropping as they hit their 30's and 40's, leading to erectile dysfunction, fatigue, a lowering of muscle density, osteoporosis, mood swings, lowered sex drive... even something called brain fog (which I'm certain I have because... sorry, lost my train of thought for a second).
This has a few names – hypogonadism being the clinical term, though andropause, the male menopause, Low T, and 'having kids' also sum it up... I know this because I'm right in the middle of it. Be it a result of diabetes, treating my body like an alcohol playground for half my life, or surviving on four hours sleep per night (those video games won't play themselves), I've got some symptoms.
So hypogonadism is, right now, a big deal to me. If I don't have it, I will sometime soon. If you're reading this and you've got balls, you will too. In fact, recent studies show that 36% of males have hypogonadism, with the vast majority having no idea.
'The change' isn't just for women anymore and, as I write this, I'm awaiting test results to see if I'm in or standing at the velvet rope.
Currently, the accepted treatment is a testosterone injection you get every week or so, or a gel you smear on your shoulders or thighs, which becomes a lot of fun when you end up smearing it all over your clothes, couch, apartment, kids... Additionally, because so little of the T gets to where it needs to be, you need to take a fat dose to make any difference at all. Frankly, it's a pain in the arse, and I don't want it.
But Acerus’ product, NATESTO, is different because it has a unique delivery system. It's a nasal gel, so you schmear a little inside your schnoz, and your mucosal glands take the good stuff right into the blood where it starts working quickly. Unless your kid has a habit of picking your nose, they're unlikely to be endangered.
It works, it's easy, it has hugely more efficient bioavailability so you don't need an overdose to see a difference, and the delivery system that it uses is Acerus’ tech that, they say, can be moved into other drugs. Did I mention it's FDA approved?
I mentioned that, right? Pretty sure I did.
That approval process drew in a fat licensing fee from the giant Endo (which is a $74 NASDAQ stock with $15 billion in market cap) and, if sales are strong, more cash will follow.
Success. They've done it. They can sit back now.
This, by itself, would make for a successful small cap specialty pharma play, but that's far from all there is to this company. In fact, having got through the FDA approval process once, it'd be fairly easy for Acerus to go at it again with a promise of greatness and play golf for five years on your dime.
But the Acerus executive team aren't punching a clock here. Let's talk female Viagra.
You saw the news reports (and the late night host comedy routines) – there's an approved female Viagra pill. Sprout Pharmaceuticals, its manufacturer, got bought out by Valeant the very next day following FDA approval. Everyone got rich and the ladies can now get their own TV ads where nobody explicitly mentions what the product actually does but everyone has knowing smiles and is late for the opera and making the cab driver uncomfortable.
How does Acerus fit into this?
Well, the need for 'female sexual dysfunction' medication comes in several forms. There's the 'I don't want to have sex' form, which is what all the 'female Viagra' fuss was about. But there's also the 'I want to have sex, but I can't have an orgasm' form, which hits about 30 million women in the US that the Valeant product does nothing to help.
Enter TEFINA, an Acerus product that uses that nasal gel we were talking about earlier to allow women to more easily achieve orgasm. TEFINA completed a Phase II study showing positive efficacy results, and the company is currently talking to the FDA about their next step in the clinical development program.
The key to Acerus is that delivery system. It's just better than oral delivery, which can sometimes lead to liver and stomach issues, and takes longer to take effect. On the men’s health side, it’s better than gels which can prevent you from innocently roughhousing with your kids before you’re ‘dry’. It’s quicker to administer, quicker to take effect, and reduces the secondary transference risk.
Imagine, if you will, what happens when that delivery system is applied to pain relievers, or allergy medication, or nutritional supplements, or cancer meds or birth control or hormone replacement or fertility drugs or... well, anything.
The Acerus execs have considered this, and that's where the soft creamy filling comes into play, for Acerus doesn't want to endlessly ride the FDA carousel. It's done the work getting one drug with its nasal delivery system approved, now it's moving quickly on to the second, and in the meantime they plan on acquiring drugs that are already out there in the marketplace, earning revenues but maybe not getting the marketing push that Acerus can deliver.
And they're already started; Acerus recently acquired ESTRACE, an estrogen replacement drug that's been around for a while, precisely because A) they feel it has been under-marketed and could easily be turbo charged in the current market, and B) because it gets their foot in the door in the women’s health space.
So where's the risk? Well, they could run out of money. That sometimes happens in this business, only they just took over $25 million in licensing fees in so they're kind of flush for a long time. In fact, flush enough to go get some more acquisitions, maybe...
They could see NATESTO rejected by Health Canada for use up here, but that seems unlikely considering the FDA is generally considered a harder path to run, and the FDA has thumbed up the drug already. They could see TEFINA stopped at the Phase II stage, but this is a risk worth taking considering the multi-billion dollar potential the drug has.
That Phase 3 portion of the study will cost money – some $50-$60 million to get it through to the end approval stage, which would likely see Acerus need to JV, borrow money, or do a raise. For me, that's the only real 'meh' aspect of the Acerus story and, frankly, they don't even need to do it. They could bring in a partner to lead the last phase of the clinical development process and simply take milestone payments and a licensing fee at the end, all the while putting together a roster of next steps.
image: http://www.stockhouse.com/getmedia/a1c97f4b-85d7-45e2-86a1-b7b4cdf57c85/Tom-Rossi?width=150&height=149
Click to enlargeI talked to Tom Rossi, who is CEO and President of Acerus Pharmaceuticals, last week to see exactly what's next, and was surprised at the answer; no more big budget FDA runs in the near future, more asset purchases and, ultimately, “We want to be Canada's premier pharmaceutical company, with demonstrated expertise in all stages of the product lifecycle from development to commercialization.”
Rossi's plan is to acquire drugs that would fit with the company’s focus in men’s and women’s health, spend pennies on the dollar buying underappreciated products, and bring them to life by leveraging the Acerus expertise.
“There are so many products that, for whatever reason, just don't get the big pharma push anymore,” says Rossi. “They don't always have the facility to bother, so these products languish, make a few million a year without much effort. We want those drugs because we have the team, the people and the networks to maximize their potential. We will also work on expanding our product portfolio by repurposing older drugs and make them, safer and easier to use, via our novel, nasal delivery platform.”
Rossi is no Venture exchange carpetbagger, nor is he a snake oil seller. In fact, he came to Acerus after a run as CEO of Novartis’s Belgian and Canadian affiliates, and before that was with Merck, and before that was at Johnson and Johnson, so this is a business he is intimately familiar with, successful in, and equipped to dominate.
“We're building a great pharmaceutical company,” says Rossi, adding, “and we hope to generate a lot of news going forward as we play out on that promise.”
Let's be clear on this; I want Acerus to win. Not just because it'd be nice for another Canadian spec pharma company to get some runs on the board but because, if those test results come back positive for low T next week, I need their product to exist in the Canadian marketplace, like, today.
Gentlemen, time to invest in your balls, and in your lady's lady parts. What cause could be more important?
--Chris Parry
http://www.twitter.com/chrisparry
FULL DISCLOSURE: Acerus Pharmaceuticals Corporation is a Stockhouse Publishing marketing client.
New substantial holder: Lagoda Investment Management.
http://ow.ly/SyrRd
http://www.nasdaq.com/quotes/institutional-portfolio/lagoda-investment-management
With reference to prior posts I believe this is a $10 stock today. At least.
There is huge activity on Share Scene and in Google Groups. My mission here is to build awareness and prepare for the influx of new US investors when folks wake up.
The EMA PRAC has approved the RMP and Scenesse is now released for EU distribution.
A non event because everyone knew it was bound to happen but a crucial step in the right direction.
Now we just need to know how much the company will charge for the implant and which countries they will target first.
Good times are ahead for the investor who can see the significance in this.
http://www.asx.com.au/asxpdf/20150921/pdf/431g5v7r6s3bsy.pdf
We're waiting for the PRAC decision on the RMP. I consider it a fact that they approved but we need to hear it from the company. Any day. Also, we will get an update on the roll out of Scenesse and pricing. Then we will learn about the Vitiligo ph2b from Singapore. I expect that before the Type C meeting with the FDA which is later this month. So lots of significant news coming up and I expect it all to be good.
Probably one of the best decisions you've ever made. Hope so. GL
Bring in Erin Brockovich
Great news. And wise of Leo to bring Dr. Jorgensen into the spotlight and let him do some talking in the PR.
Why don't we as shareholders find an attorney who will take on a class action against Rosen ? That seems warranted in this situation.
It might even be advantageous for CTIX to finally set the record straight in court. Imagine Dr. Shapiro et al as witnesses against James Devries. I don't think we will ever see a SA hit piece again after such a humiliating yet entertaining event.
Rosen just sues in bulk. CTIX is just one of many companies they got in the net when trawling the net. Depressing.
What happened to the expect fantastic news tomorrow never ending story ?
But please tell me why you think it will be difficult to stay above $2 at year end without a reverse split ?
EMA PRAC meeting now concluded. PR about Scenesse roll out in Europe expected anytime now.
Thank you for your continuous insight. Please elaborate on why you see the pps close to $1 at year end if there is no reverse split. Do you recommend that I open a short position ?
Maybe. But take a look at the Facebook page. The good doctor is young. Lots of friends at the Uni. of C Dept of Emergency - could very well be him.
It looks like Mako Research is run by a Dr. at the University of Cincinnati - Department of Emergency Medicine.
http://www.zoominfo.com/p/James-DeVries/1981535423
Trimel changes name to Acerus Pharma as of today
I'm not worried about shorts at all. I think the overall short interest in Clinuvel is minuscule and I'm of the belief that the science will be the the determining factor not games played.
I'm still adding at these levels.
You might be right that it wasn't B but another derivative of the platform. Nonetheless, I don't see any of the compounds being ready for the olympics. My point was, though, that I have compete confidence that the K ph2 will materialize.
I think there is one very important observation to make regarding the PR this AM and other statements made by Leo regarding clinical trials: He has never ever said something in a PR regarding the science or the progression of trials that hasn't been absolutely true. Unfortunate, he has been a little over enthusiastic in other PR's e.g. talking about how B might be ready for the Rio olympics, uplisting and how Obama should pay attention to CTIX but when it comes to info about the clinical trials he has always been very accurate and to the point. Therefore, when Leo says they are planning for a Ph2 in ovarian cancer I give it a close to 100 % chance that we will see a ph2. History shows that. Good times ahead.
EMA PRAC meeting begins today. Clinuvel's RMP is up for final review and approval.
Expect news later this week regarding roll out of Scenesse in Europe.
http://www.clinuvel.com/index.php?option=com_k2&Itemid=8&id=484_4e1673bfec99ec412c3110dec5760c2e&lang=en&task=download&view=item
2014 AGM:
http://clinuvel.com/resources/pdf/20141128AGMSlides.pdf
2015 AGM coming up soon.
NEW INVESTORS CAN BEGIN HERE
Welcome to the Clinuvel iHub. There are some very active forums out there with valuable information about this company, but awarenes about both the stock and the products is very limited in the US so my goal is to provide a comprehensive walk through of the company, the products and the investment opportunity it represents so new investors have a place to start their DD.
In my view this is one of the most interesting and undervalued biotech companies right now. The fact that the lead drug already obtained EMA approval late last year for the absolute light intollerance disorder, EPP de-risks the stock tremendously. The company is also peforming mid to late stage trials in the depigmentation disorder, Vitiligo and resluts seem very good.
The clever investor with a little patience will see, that the historic approval of the World’s first tanning agent holds an extreme upside when the first medical indications are rolled out and broader use can commence. Think Botox and you know what I mean. Add Scenesse as a general preventative for skin cancer due to the protective tan it provides and the numbers get very big.
CLINUVEL:
Clinuvel is an Australian biotech company with headquarters in Melbourne, Australia and an operating office in Baar, Switzerland. The company was formely know as EpiTan but changed it’s name to Clinuvel in 2006 following a change in management.
http://www.lifescientist.com.au/content/biotechnology/news/epitan-opts-for-name-change-854737925
EpiTan tried to promote EPT1647 (later known under the trade name, Scenesse) as a cosmetic drug which wasn’t very popular with the FDA or the EMA. No regulator wants to approve a drug solely for cosmetic use, and Epitan almost went bankrupt.
A new CEO was brought in, Philippe Wolgen, and under his guidance the company has performed er very successfull and well managed turnaround. Off label is now an absolute no-go if you ask the CEO and the strategy is to devellop Scenesse for patients with legit conditions. Last year this strategy resulted in a historic marketing approval of Scenesse following the longest review process in the EMA’s history. It too several years and heavy involvement by patients, patients advocates and scientists who spoke in favor of the drug in person in front of the CHMP – the council that desides whether a drug gets approval or not.
http://www.clinuvel.com/en/investors/news-publications/announcements/2014-announcements/clinuvel-invited-to-emas-chmp-plenary-session-for-an-oral-explanation-on-scenesse%C2%AE-maa
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002548/smops/Positive/human_smop_000747.jsp&mid=WC0b01ac058001d127
http://www.clinuvel.com/en/news/company-news/new-england-journal-of-medicine-publishes-pivotal-phase-iii-scenesse%C2%AE-studies
http://www.nejm.org/doi/full/10.1056/NEJMoa1411481?af=R&rss=currentIssue&
It appears that the EMA was and still is worried that Scenesse will be used by people who just want a nice glow through sunless tanning. Therefore, the scutiny reached the absurd, but finally, the CHMP approved Scenesse as a profylactic treatment for people suffering from the extreme light intollerance disorder, EPP in all European countries.
http://www.clinuvel.com/en/scenesse/epp
Investors were thrilled. For more than a decade many had witnessed the PPS decline or stay at depressing levels. But many, my self included, didn’t want to sell because of the potential of Scenesse. In my view, this is truely a drug that can change the world. Now, the historic approval paved the way for some exictement, and the stock went up quite a bit following approval. But the EMA had more hurdles in store for Clinuvel. They wanted a comprehensive post-marketing risk plan in place to avoid off label use of the tanning agent. They seems to be afraid that people will stop using the dangerous tanning beds and turn to the safe and protective alternative: Scenesse. It seems stupid but that’s the way the regulative system works. For almost a year, Clinuvel has been working on such a safety program involving monitoring of all the patients who recieve Scenesse and a post marketing study as well. That has led to the declining share price but I expect that to change very soon when the PRAC approves Clinuvel’s safety program within the next week or two.
Another reason for the declining shareprice and the current low level is that the New York Based company, Retrophin (RTRX) tried but didn’t succeed with an unsolicited take over of Clinuvel.
http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0CB4QFjAAahUKEwihwr39x93HAhXFaT4KHdJmBjs&url=http%3A%2F%2Fwww.clinuvel.com%2Fen%2Finvestors%2Fnews-publications%2Fannouncements%2F2014-announcements%2Fclinuvel-declines-unsolicited-proposal-from-retrophin&usg=AFQjCNHJzsB_oq-_PKPuSSnpCWqugPlx7Q
Prior to the takeover proposal Retrophin, under the supervision of the former CEO Martin Shkreli, had been accumulating millions of shares in Clinuvel, and when Clinuvel declined the offer and Shkreli was ousted from Retrophin, the new management decided to sell all shares in Clinuvel.
http://biz.yahoo.com/e/150511/rtrx10-q.html
This has caused a huge selling pressure and most likely caused the share price to depreciate along with investor fatigue because of the new safety requirements following the long awaited EMA approval.
But now we seem to approach crunch time. Scenesse will be sold in the first European countries before year end and a type C meeting has already been scheduled in September to discuss an NDA with the FDA. Furthermore, trial results from the Company’s Phase IIb in Vitiligo performed in Singapore are due anytime. If the results are positive, investors will probably begin to see how extremely undervalued this company is. Former trial results bode well:
http://www.medscape.com/viewarticle/832214
Now, lets play with some numbers.
Shares out: App. 45 m.
Market Cap: $82 m. (USD)
EPP:
Prevalence is said to be 1:75.000 to 1:200.000.
Many patients are know by the specialized porphyria centers in Europe and the US but due to general unawareness of the conditions many patients are believed to be undiagnosed. Roll out of Scenesse will most likely change that.
Europe: App. 4500 patients.
Price per implant (still not official but probably) $7000. Patients will get 2-3 implants per year to be protected from UV and visible light throughout the months with the most sun.
That’s app. $63 m. for Europe alone. PACME (profits after cost and marketing expences) will probably be high because Clinuvel is distributing Scenesse directly to the porphyria centers who have already been working closely with the company throughout the past decade. Lets take a round number: $50 m. That’s an $1.11 EPS and if you use a P/S ratio of 10 that’s a share price of $11.10.
Add the US EPP sufferers and that number will probably double.
Also, the company is develloping a melanocortin analog for topcal use through their 82 % stake in the Singapore joint venture, Vallaurix. It’s meant as a pediatric version for of the implant in the treament of EPP and as a follow up for Vitiligo. But imagine when the word gets out that the already approved tanning implant is about to be released as a cream. Future on an off label use is not prices in the EPP numbers at all.
VITILIGO:
http://www.ncbi.nlm.nih.gov/pubmed/19608058
http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=4&ved=0CDkQFjADahUKEwj7tMC0z93HAhXKNj4KHcHVAPE&url=http%3A%2F%2Fwww.clinuvel.com%2Fen%2Finvestors%2Fnews-publications%2Fannouncements%2F2014-announcements%2Fscenesse%25C2%25AE-vitiligo-study-results-published-in-jama-dermatology&usg=AFQjCNGIu_G_tcUZDDLMDrZ1quPpQbKxKA
Prevalence is app. 50 m. world wide. Let’s assume that the price per implant drops significantly when such a broad patient population will have access. But even with a very low price per implant of let’s say $500 and 5-10 required implants in the combination therapy that’s $2500 – 5000 per patient.
With app. 3.200.000 Vitiligo sufferers in the US (Michael Jackson was one of them) let’s say that 5 % will use what I believe will become the new standard of care: Scenesse in combination with narrowband UVB.
That’s 160.000 patients yearly and between $400 – 800 m. Clinuvel will most likely require a partner to perform the last Phase III trail and to bring Scenesse to market to treat Vitiligo, so let’s assume that Clinuvel can keep 40 % (on top of up fronts and milestones that I leave out just to be conservative.)
That’s a share price of <$71 for Vitligo in the US using very very conservative numbers. I believe that Vitiligo could cause the share price to go above $200 but I don’t want to be ridiculed as a dreamer.
LABEL EXTENSIONS:
Clinuvel has stated that they will seek label extensions for some of the many other conditions that involves intollerance to light. They have performed numerous phase II and III trials and I see many obvious label extensions down the road.
http://www.clinuvel.com/en/scenesse/clinical-results
http://www.clinuvel.com/en/scenesse/ongoing-clinical-trials
Disclaimer: I am long Clinuvel with a significant number of shares and I am still accumulating. I have been in this stock for + 10 years and I have never sold a share.
I believe that Scenesse will revolutionize the way humans protect themselves against the sun and UV. I also believe that off label use will be the norm sooner rather than later when the FDA approves Scenesse for EPP and / or Vitiligo.
Please refer to the CLVLY board
I've been in this stock for +10 years. Feel free to ask. Happy to help you in your DD.
In a week we will know the outcome of the European PRAC meeting. The result is pretty much given: EMA will aprove the post marketing commitments and Clinuvel will begin roll out of Scenesse in Europe within a month. Type C meeting with the FDA already scheduled later this month and Vitiligo results coming up. This is a perfect time to accumulate. If you trusted your dd a year or two ago it's insane not to load up now at these prices. Biotech is notoriously risky business but investing in a tanning agent which has already obtained EMA approval knowing the potential makes Clinuvel a safer bet than most others. I am accumulating.
EPP is extremely undervalued IMO.
Take Germany: 80 m. inhabitants. France: 60 m. inhabitants. Event with the most concervative 1:200.000 rate for EPP that's 400 and 300 patients in these
two countires alone. And since Clinuvel expects to be present in "key" European states within few months I believe we could easily be seeing
+1000 patients on Scenesse Q4 2015 or Q1 2016. Germany and France alone - with only two implant per patient per year - should
result in $24 m. pre PACME. And this is very very concervative. $24 m. equals $0.53 EPS and with a x 10 ratio that's a PPS of $5.33 for
Germany and France alone using a prevalence rate of 1:200.000. Add some of the other "key" European states and the PPS should hit
$10 easily and very quickly.
Please elaborate. Extremely interesting.
Not that I don't believe that you could be correct but who is the source ?
Yes. That was Leo's mail to me. Posted it when I was sure it was ok.
Leo should get rid of the confidentiality disclaimer in his signature.
I appreciate that you're eager to see results. I am too. But, really, biotech investments are notoriously very long plays. Can easily take 10 years before you get to a good exit point. Some might be lucky and catch a good company right before it takes off but I'd consider that to be very rare and more like winning the lottery. I've held one of my other companies for 12 years now and I've never been happier. Still buying that one too. That's why biotechs can be so painful to invest in if your timeframe is only a year or maybe two. I'd say that the very minimum is 3-5 years unless you're a gambler who are looking for 20-50 % ROI which is not why I am here. Furthermore, CTIX is not a slow company. Most companies spend 10-12 years advancing a drug from pre-clinical through and NDA and 9/10 fail. B is advancing very fast and K might seem slow but oncology is a slow game. But the reward is high.
I'm fairly young so I don't mind waiting some more years. Most of the money is intended for my children anyway. Never walk away from a winner. Either you or someone you love will profit from your investment when the day comes. GL.
I believe that BH mentions three years as a possible exit, right BH ? Personally, I'm counting on 3-5 years.
Fast forward to 2018: One morning I'd like to wake up and see that were past the $200 mark. Getting a little impatient here.
Wasn't this also what Yossuf reported after his visit ? Correct me if I'm wrong
I did know that such a voucher can be extremely valuable but I find it somehow unnecessary to include the trade value of it in the pr. Leo would never sell it anyway. We're developing drugs not trading options. So including that information in the PR might provide some with 'nice to know' info but IMO it can backfire and make the CEO sound a little desperate which none of us want. I'd like Leo to stay the course and be even more concise when communicating. That will build trust IMO. Again, I applaud Leo for keeping us informed.