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Dyax Corp. (NASDAQ:DYAX)

Q4 2009 Earnings Call

February 17, 2010 10:00 am ET

Executives

Nicole Jones - Director of IR

Gustav A. Christensen - President & Chief Executive Officer

George V. Migausky - Executive Vice President & Chief Financial Officer

William E. Pullman – Executive Vice President & Chief Development Officer

Ivana Magovcevic-Liebisch - EVP Corporate Development and General Counsel

Analysts

Mark Monane - Needham & Company

Brian Skorney – ThinkEquity Partners

Phil Nadeau - Cowen & Co

Steven Ostrofsky - Middlegate Securities

Jeff Elliott – UBS Securities

Operator

Good morning and welcome to Dyax Corp's fourth quarter and year end 2009 financial earnings call. At this time I would like to inform you that this conference call is being recorded and that all participants are in a listen only mode. At the request of the company, we will open up the call for a brief question and answer period at the end of the presentation.

Before turning this call over to Gustav Christensen, President and Chief Executive Officer of Dyax, the company will read their Safe Harbor Statement. Please proceed.

Nicole Jones

This morning Dyax issued a press release concerning its fourth quarter and year end 2009 financial results. Dyax would like to remind everyone that statements made today reflect its expectations and future programs, corroborations, strategies and financial performance in our forward looking statement.

These statements including those regarding prospects for the market launch Dyax’s FDA approved product, KALBITOR are based on management’s current assumptions and are subject to risks and uncertainties that could cause actual events (inaudible) to differ materially.

Important information concerning these risks and uncertainties is contained in Dyax’s press release today and is described or referred to its (inaudible) Form 10K, and any periodic reports filed with the SEC. And available on the company’s website at www.dyax.com.

I would now the call over to Gustav Christensen, our President and CEO. Gustav?

Gustav A. Christensen

Thank you, Nicole. Good morning everyone. I would like to welcome you to Dyax’s fourth quarter conference call. Recently we announced a landmark accomplish with Dyax. Namely the market launch of our first product, KALBITOR. Such an achievement could not have been possible without the hard work and unwavering commitment from everyone at Dyax and our network of patients and physicians.

With this achievement, Dyax now joins that small and elite group of biopharmaceutical companies that have discovered, developed, and commercialized a novel product. Our focus now is on ensuring the successful launch of KALBITOR while we continue to advance the other research and development activities that support Dyax as a fully integrated company.

Before discussing this and other accomplishments in detail I’ll EVP and Chief Financial Officer, George Migausky will review our financial highlights. And (inaudible) two other members of the senior management team are joining me today. Bill Pullman, EVP and Chief Development Officer and Ivana Magovcevic-Liebisch, EVP Corporate Development and General Counsel. So with that, I would like to turn the call over to George.

George V. Migausky

Thank you Gustav and good morning all. I refer you to our press release from this morning for a detailed results and will now review certain financial highlights for the fourth quarter and year end 2009. Our revenue for the fourth quarter was $6.3 million in compared to $31.5 million in the same quarter last year.

And for the 12 month period, revenue was $21.6 million from $43.4 million in 2008. The higher 2008 revenue was primarily due to revenue recognized in relation to new licence and collaboration agreements that were entered into during 2008. Most particularly, the $23.2 million recognized under our agreement with Sanofi Aventis in the fourth quarter of 2008 for which there was no corresponding amount this year.

Revenues are expected to fluctuate due to the timing and amount of future milestone payments. The clinical activities of collaborators and licensees and the timing and completion of contractual commitments.

With respect to operating expenses for the quarter, these costs decreased to $8.8 million from $16.4 million in 2008. And for the 12 month period in 2009, operating expenses decreased to $46.6 million from $68.1 million in 2008. It’s important to note that these costs decreases occurred while concurrently incurring costs to build the commercial infrastructure for the launch of KALBITOR.

Within these operating expenses, research and development costs decreased in 2009 despite new and additional costs of $5.8 million associated with the manufacture of DX-88 drug substance. The decrease in research and development expenses was due to the following factors. The work force reduction implemented in late March of 2009 together with other external costs reduction. Reduced clinical trials costs in 2009. Expenses eliminate at Dyax from the out licensing in 2008 of DX-2240 and DX-88 in on pump cardiac surgery. And the closing of our Liege, Belgium research facility in 2008.

General and administrative costs, which included commercial infrastructure costs for the launch of KALBITOR increased in 2009 to $25.8 million as compared to $22.7 million in 2008. For the fourth quarter of 2009, Dyax reported a net loss of $10.9 million, or $0.14 per share as compared to net income of $6.4 million or $0.10 per share in the same quarter in 2008.

A net income in the fourth quarter last year was due to the timing of recognition of previously differed revenue under our Sanofi Aventis agreements, as I mentioned earlier.

For the 12 month period, Dyax net loss in 2009 was $62.4 million or $0.90 per share as compared to a net loss of $66.2 million or $1.08 per share for the same period in 2008. As of December 31, 2009, Dyax had cash, cash equivalents and short term investments totalling $52.4 million, exclusive of restricted cash.

Now, moving on to guidance. The financial results just reported reflect our commitment to effectively manage operating costs which were 21% lower in 2009 compared to 2008. And more specifically, in 2009 we reduced research and development expenses by over 30% from our cost management initiatives.

And these 2009 R&D costs include the costs of manufacturing KALBITOR prior to FDA approval. And this has provided Dyax with sufficient commercial product for KALBITOR sales well into 2011. We will continue this pattern of prudent cash management throughout 2010.

Where appropriate, we strengthen the balance sheet to make available the resources to carry out our business plan. And at this time we believe we have the cash and other resources to fund operations into 2011.

And now I’ll turn the call back to Gustav.

Gustav A. Christensen

Thank you, George. Throughout 2009 we were focused on bringing our first product, KALBITOR to market. While moving through the final steps for FDA approval we put in place key components of the commercial infrastructure for KALBITOR’s launch. With careful planning and hard work, KALBITOR became commercially available on February 1, only 59 days after approval.

At today’s call, I’ll spend the majority of the time discussing the commercial strategy and lots of KALBITOR, all by (break in audio) elements in our DX-88 partner programs. And finally an update on our phase display licensing program.

Starting with KALBITOR. We ended 2009 with FDA approval of KALBITOR for the treatment of acute attacks of HAE patients 16 years of age and over, regardless of an atomic location. This marked an important milestone, not only for Dyax but also for the HAE community.

KALBITOR is the first (inaudible) therapy available in the US to treat patients facial, abdominal, peripheral and potentially life threatening laryngeal attacks. Leading up to this approval, we finalized a comprehensive US commercial strategy for KALBITOR. This strategy was developed with a key goal in mind, mainly to insure access to KALBITOR for patient and physicians while providing personalized report services and comprehensive product and disease information.

On February 1, we official launched KALBITOR with orders actively being taken, (inaudible) patient and physician support program called KALBITOR Access. Prior to approval, systematically built a commercial infrastructure lead by our group of marketing, reimbursement, compliance and medical affairs professionals. Our commercial efforts culminated in the hiring of a focus field data team on approximately 25 professionals, consisting of commercial sales reps, medical science liaisons and (inaudible) corporate account directors. All seasonal professionals with a breathe of experience in launching specialty biologics.

At the same time, the commercial team has and continues to be engaged in promoting disease awareness, expanding our network of physicians, developing relationships with commercial and public payers. And we have finalized our strategic product distribution model.

This last step included a selection of an exclusive distributor and various (inaudible), speciality group. Also called ABSG, to manage the distribution and inventory of KALBITOR as well as the customer assistant program known as KALBITOR Access.

Using feedback from our network of patients and physicians we created a KALBITOR Access assistance program with features important to the HAE community. These include, comprehensive product and disease information, reimbursement support services, treatment site coordination and financial assistance for qualified patients.

This personalized support program is staffed with dedicated insurance specialists to help patients with insurance coverage and to determine the most affordable way to receive KALBITOR. To each with a first rate product launch is a well planned reimbursement strategy.

Our strategy for success is focused on three initiatives. One, driving prescription stock forms. Two, managing insurance coverage. And three, facilitating patient access. Market analysis has shown that the majority of HAE patients are covered by a private payer and a significant number have either no co-pay or an affordable co-pay. So far the reimbursement team reports that payers have been open to covering an acute therapy. And they have already made headway with some of the large payers.

Of course it’s still too early to give any specific details. We have been very encouraged about the progress at this early stage. To date several patients have already been approved for reimbursement and KALBITOR has been placed at their identified treatment sites ready for when attack occurs and they seek treatment.

Our sales force is reaching out to our trial investigators and almost 300 other HAE treating physicians that represents over 1,800 patients. Of this group, our immediate target is the transition of the more than 140 patients from our continuation trial to commercial drug.

Another key commercial objective is to generate greater disease awareness. In support of this effort, we recently launched HAE Hope, an online resource to help patients and their families better understand and manage HAE. The HAE community has been waiting a long time for a treatment of acute attacks. While the road may have been longer than expected you were committed to pursuing a robust (inaudible) program. A program that treated all acute attack locations, including life threatening laryngeal attacks. And attested a treatment that matched the needs of HAE patient and physicians. Such as subcutaneous (inaudible) and non plasma derived syrup.

We’ll have the opportunity to present more and extensive data collected over the course of the HAE clinical development program at the upcoming American Academy of Allergy Asthma and Immunology meeting in late February. These data will provide further information about the clinical benefit and known risks of KALBITOR treatment.

Moving on, outside the US, KALBITOR’s commercial (inaudible) will be addressed through one or more partnerships. While negotiations are ongoing, we are moving forward ourselves with the required elements for a European filing.

In January we made to (inaudible) with the EMA’s approval of the pediatrics plan. A prerequisite for submission. This critical step successfully accomplished our current plan is to submit the marketing authorization application with the EMA during the first half of 2010.

Though most of our energies were focused on a timely launch of KALBITOR we have also been collaborating with our investigators to put in place the last pieces need to evaluate the DX-88’s potential in inhibitor induced angioedema and an acquired angioedema.

Now moving on to our partner programs and (inaudible) indications and retinal disease. Since licensing DX-88, Cubist has moved to compound into two Phase 2 trials for the reduction of blood lose in on-pump cardiac surgery. While Cubist closed enrolment in both trials early, they believe they’ll have a sufficient number of patients to allow for robust analysis of both safety and efficacy.

Cubist expects to determine the next steps for the program late in the second quarter 2010. Our second DX-88 partner program for the treatment of retinal disease is being evaluated by our partner, Fovea Pharmaceuticals which recently acquired by Sanofi Aventis. The first indication being pursued is for treating retinal vein occlusion or RVO induced macular edema. The HAE is in Phase 1 development in this indication.

We look forward to reporting on the future developments of the ongoing (inaudible) programs for DX-88.

KALBITOR and other clinical and research compounds in our internal pipeline were discovered using our powerful phage display technology. We capitalized in this phage display technology by one, housing product candidate for our internal pursuits. Two, licensing at two other companies through revenue generated collaborations under the Licensing and Funded Research Program, or as we call it LFRP. And three, by leveraging it into strategic transactions for accessing alternative sources for capital for Dyax.

Advancements in our licensees clinical states programs are important when looking at the value potential of the FRP. As a reminder, Dyax stands to received milestones and royalties and products from licensees under the LFRP advance through the clinic and into the marketplace.

Today, the LFRP has 18 clinical stage drug candidates and one approved product. Over the course of 2009 we saw the exciting evolution of this pipeline with numerous candidates progressing into the clinic. Developments included in 2009, three (inaudible) compounds entering Phase 1 development, one product candidate advancing to Phase 2 trials, and one into Phase 3. We also (inaudible) this year saw LFRP licensees (inaudible) advance another Phase display discovered research candidate into Phase 1 in (audible) development.

Utilizing Dyax Phase display libraries, we generated on be (inaudible) the anti by-product candidate known as BIIB-033. Which targets lingo-1, which is an novel treatment for MS, which is now in Phase 1 trials. This represent the second margin LFRP product candidate that has entered the clinic.

Overall LFRP, has had a very impressive year with two candidates in Phase 3, one in Phase 2 and 12 in Phase 1. WE anticipate more exciting development in 2010, as the 70 plus candidates that are in various stages in preclinical developments are moving toward the clinic.

In summary, the past 12 months have been an extraordinary period for Dyax that culminated in tremendous achievement starting with the FDA approval of KALBITOR, its subsequent US market launch and the transition of Dyax into a fully integrated biopharmaceutical company.

Our direct discovery and clinical development can be challenging. Its ultimate reward is the translation of these efforts into a drug that’s made available to patients and physicians. The commercial availability of KALBITOR we have reached this goal and are delivering on our commitments to the HAE community, namely a treatment to the acute ACE attacks.

We are excited about the commercial prospects of KALBITOR. And we have built upon that momentum of this past year to advance the other key components of our business model. A DX-88 franchise, our internal pipeline and our Phase display licensing program.

I’ll now turn the line back over to the operator to begin the question and answer portion of the call.

Question and Answer Session

Operator

Thank you. (Operator’s instructions) And your first question comes from the line of Mark Monane with Needham & Company. Please proceed.

Mark Monane - Needham & Company

Thank you, good morning. And thanks for the review and congratulations on the recent market launch. My question is that could you please go over how you see the competitive space now for HAE? Just a little while ago there were very few treatment options in the US. Now there’s more. Maybe you could talk about how KALBITOR might fit in? And as Rodney King might say, how we can get along, all the products might be able to get along in the HAE sandbox?

Gustav A. Christensen

I think what you’re really asking is, if Dyax can sell KALBITOR as a small company? So, let me first start by saying that we have a difference of product profile, which characteristics that are important to patient and physicians. Meaning, the treatment for all anatomic effect locations. Sub-Q (inaudible) and a non plasma derived serum. And I think we showed our ability to commercialize the product by bringing the product to market on only 59 days after approval it was available in the channel to be prescribed by doctor.

We have built a specialized sales organization of 25 people. A sales force of 16 that comes from the leading biopharmaceutical companies in the country, GeneTex, Engine (ph) Giliate (ph), Centocore, Biogen and so on. And a group of MSL specialists that come from the same type of firms. So we believe that we are very, very well persistent to, in fact, execute all plan.

We should also just remember that this is a concentrated and focused patient population. Meaning and it’s easy to target. So our goal is actually quite simple, it is to make KALBITOR the treatment of choice for acute HAE attacks.

And just one more point, you asked the other product. We have had a year where the prophylactic treatment have run through 160 payers that have accepted a treatment costing $400,000 per year. And I think that background puts in perspective why we have seen a very positive reception with these payers in covering acute attack treatment with price we’re given, a much lower cost annual treatment.

Mark Monane - Needham & Company

That was very helpful. Building on that question, can you give us an update about the payers and any status you can concerning formulary? And then are sales being sold to Bergen and then Bergen’s distributing it? How exactly does that work?

Gustav A. Christensen

Let me do that in actually two. It’s too early to give you statistics on how fast people are moving through. But the fact that we, already now at this call, having launched the product February 1, have patients through approval with (inaudible) product would indicate that some of the payers can move very quickly. We have our own planning purposes, not assuming that we move any faster than the prophylactic treatment did. But we are seeing some very early quick movements on the payer side, which is very encouraging.

And our sales (inaudible), maybe George you will comment on how we recognize the sale.

George V. Migausky

All of our shipments, and therefore sales, are done through AmerisourceBergen or one of the entities of AmerisourceBergen. So all product and all sales go through them as our exclusive distributor.

Mark Monane - Needham & Company

Okay. That’s helpful. And then I was looking, George, on the balance in the income statement about inventory. Maybe you could comment about inventory that’s currently available and how you’re recognizing inventory at this point?

George V. Migausky

Right. So, all of the drug substance product that we manufactured was expensed prior to FDA approval. So those costs have already – they’re not on the balance sheet. They float through the P&L already. Subsequent to approval, those costs will be – as any kind of inventory, will be on the balance sheet. So that’s the cost side of the equation. But on the supply side of the equation, we did manufacture DX-88 drug substance in the early part of 2009. And that’s why we had said earlier we will have drug substance and drug product available to supply all of our KALBITOR sales well into 2011.

Mark Monane - Needham & Company

Thank you very much for the added information.

Operator

Your next question comes from the line of Brian Skorney with ThinkEquity Partners. Please proceed.

Brian Skorney – ThinkEquity Partners

Good morning and congratulations on the commercial launch. Couple of quick questions, maybe you could help me out with. When we’re looking at the initial launch and modeling that out, is there an expectation that they’ll be an initial stocking (inaudible)? And I know it’s early, but is there any indication as to the average number of doses a patient might stock up on or the clinic that a patient will visit might stock on, since I would image this would be very hard to do it just in time type sale process. And also on the open label expansion, can you just give us details on how many patients currently remain in that extension? How many attacks have been treated, how many have hypersensitivity reactions, if any? And also are those patients going to be the first to actually go on as payers?

Gustav A. Christensen

Well, there was many questions. Brian, thank you, but we had over 140 patients in the open label study. I don’t have right at hand, but I think there was given over 650 doses or thereabouts. So those patients are of course some of the early ones moving through. But actually the first couple of patients move for reimbursements I believe were not coming out of the open label study. But they, of course, will be among the goals of patient growing through early.

In terms of giving guidance on the early sales, we tried to work with ABSG so they have a maximum one month inventory. So go right into pipeline bowl situations. And so that’s, there really is no filling of the pipeline in that sense.

Brian Skorney – ThinkEquity Partners

I mean, when you saw one month of inventory, I’m just trying to gauge, what’s your expectation as to what one month of inventory is? I think we have estimates anywhere from 8-15 packs per year for these patients. So, I mean, when you say one month inventory is that one dose or would that be two doses?

Gustav A. Christensen

I think what we would work with them on is, since they are in the patient access program they have a sense too of the patients moving through. So each patient would typically pick two sites for treatment. And each site will have two doses. So as a patient set up you would normally have access to four doses of KALBITOR. So that would be the typical patient.

There may be a patient that only picks the ER or a doctor’s office that will be available to him, 24/7. In that case he may only have two. But that would be – and since they know – I think we are focusing on patients that come through with scripts and how they move through validation of insurance coverage and then approval and approval of the script and then the set up of the site. And that gives us time to have a pretty good feel for the set up of the patients. The actual use of treatments, people just simply learn over the first several quarters as we see how often they go in to treatment. And as you know there will be some variability quarter by quarter.

Brian Skorney – ThinkEquity Partners

Right. That’s very helpful. And just really quick housekeeping wise, what was the stock based comp line for the quarter?

George V. Migausky

The stock based comp is under a million dollars in the course of a quarter, well under a million.

Brian Skorney – ThinkEquity Partners

Okay. Thank you.

Operator

Your next question comes from the line of Phil Nadeau with Cowen & Co. Please proceed.

Phil Nadeau - Cowen & Co

Good morning, thanks for taking my questions. Now first, just a couple of follow up questions on earlier questions. On the inventory issue, if put together kind of the two halves of your comments, it sounds like you’re not going to have any cost of goods for KALBITOR that’s sold well into 2011? Is that a fair statement or is there – am I missing a subtly?

Gustav A. Christensen

No. Essentially you’re correct. Virtually all those costs have been written off as they were incurred. And the only thing close to cost to goods sold will be nominal amounts associated with the Phil finished process of the drug substance. But that’s nominal compared to the overall costs of manufacturing the product.

Phil Nadeau - Cowen & Co

Okay. And then on booking sales. My understanding is that you have inventory sitting – you or AmerisourceBergen have inventory sitting at the hospital that is only billed to the hospital when the vial is actually used by the hospital. Do you book the sale when it’s shipped to AmerisourceBergen or do you book the sale when the vial’s actually opened at the hospital?

Gustav A. Christensen

Yeah. It’s the former. We will book the sale at the time we both ship it to AmerisourceBergen and they take title.

Phil Nadeau - Cowen & Co

Okay, great. So it’s really their inventory that’s sitting in the hospital, not yours.

Gustav A. Christensen

That’s correct.

Phil Nadeau - Cowen & Co

Okay, great. And then on the open label 140 patients, do you have an estimate of how long it’ll take to convert them all to clinic to (inaudible) paying patients?

Gustav A. Christensen

Phil, it depends on the doctor and the patients getting the paperwork put together and so on moving forward. We believe that as the open (inaudible) will finish, there will be an incentive for them to start moving the paperwork.

Phil Nadeau - Cowen & Co

And what’s the date of the completion of the open label study?

Gustav A. Christensen

I don’t think we have given the date. But it’s in a couple of months.

Phil Nadeau - Cowen & Co

Okay, great. And then just last question, is on the payers themselves. How long has it taken on average for patients to be approved for reimbursements so far? Could you give us any idea of how many patients you have applied for reimbursement?

Gustav A. Christensen

It’s too early to say. I think when we will move here over time is to target our patients that have been approved and have had product shipped. Because that’s sort of the absolute numbers. As you can see on the timeline, there has been a few that moved through with very, very nice speed. And it’s just too early to say whether that’s a complete indicator for how everyone will move through.

Phil Nadeau - Cowen & Co

Okay. And sorry, one last question for George. George, can you give me some idea of how much the SG&A run rate is going to increase now with the launch of KALBITOR? It sounds like you recently hired some sales reps. I’m sure there’s some marketing and promotional materials. And I’m trying to just get a better understanding of what that’s going to do to the run rate?

George V. Migausky

Yeah. So we haven’t really given guidance. And we really can’t give guidance until we’re a little further down the road, in terms of specific quantitative type guidance. But that being said, obviously there’ll be a little bit of a bump now with the commercialization costs, whether it’s sales force or other marketing related costs associated with the launch of KALBITOR. So there will be a little bit of a bump. But it’s not going to double our costs or make a dramatic change in our fundamental G&L.

Phil Nadeau - Cowen & Co

Okay. That’s helpful. Thank you.

Operator

(Operator’s instructions) And your next question comes from the line of Steven Ostrofsky with Middlegate Securities. Please proceed.

Steven Ostrofsky - Middlegate Securities

Good morning. I’d like to offer my congratulations as well on the commercialization of KALBITOR. I have a question, if you could possible shed any additional light on the review that’s going on at Cubist on the cardiac indication. Cubist had indicated earlier that they might have a decision by the end of the first quarter. And you indicated that it looks like that decision may spill into the late second quarter. Is there any additional information you can give us on what’s happening with that?

Gustav A. Christensen

No. That’s very much consistent with Cubist’s plan. They’re responsible for all of the development decisions. They’re very much in the active wrap up mode for, come serve one, come serve two, so they can get to database log. And they expect decision making late in that second quarter.

William E. Pullman

I’d say this is in line with their own statements actually on the last part of the call.

Operator

Your next question comes from the line of Jeff Elliot with UBS Securities. Please proceed.

Jeff Elliott – UBS Securities

I just have a couple of quick questions. Most of them covered. Can you give us any indication on directionality on spend? I know you said you were going to keep costs under control. But in terms of (inaudible) we’re looking at run rate from where we are? Also can you remind us of the timing of your – in terms of when you think you could get approval given that your pushing that forward through potentially on your own and that direction.

George V. Migausky

First, on the first part of your question, Jeff, it’s hard to be quantitative if we’re not really giving guidance until we have more data on how the launch goes. We had spent during the middle and latter part of 2009 somewhere in the order of $15 million per quarter. It’s actually a little less than that in Q4. And we will see the bump, as I mentioned earlier from some of the commercial costs that will show up going forward. It’s not going to dramatically change our cost structure. And I know that’s more general than qualitative. But I think maybe it’s the best framework we can provide for you at this time.

Jeff Elliott – UBS Securities

Okay.

Gustav A. Christensen

And maybe, Jeff repeat the questions you had –

Jeff Elliott – UBS Securities

I just was curious on when you think you could get to a European market launch. If you could remind us of the timing?

William E. Pullman

I think the first step is the filing. And already we’ve got in place one of the critical elements, namely the pediatric infantation (ph) plans that’s approved. So we can now proceed with the filing. We plan to do that in the first half of 2010. And beyond that I think as we’ve always said, cycle times with regulatory view are beyond our control. There are estimates, benchmark estimates, of how long it takes. But I can’t answer that question specifically given what will move downstream with the process.

Gustav A. Christensen

Well, maybe I’ll just add that we do not plan to market ourselves in Europe. But we plan to commercialize with a partner in Europe.

Jeff Elliott – UBS Securities

Okay.

Operator

There’s no further questions in the queue. I would now like to turn the call back over to Mr. Gustav, CEO for closing remarks.

Gustav A. Christensen

Well, I want to thank you all for dialing in. And we’ll keep you informed of our progress as we move forward. Thank you very much.

Operator

Ladies and gentlemen, thank you for your participation in today’s conference. This concludes the presentation. You may disconnect and have a wonderful day.

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