Business

Edited Transcript of ATRS profits convention name or presentation 5-Nov-19 1:30pm GMT

EWING Nov 9, 2019 (Thomson StreetEvents) — Edited Transcript of Antares Pharma Inc profits convention name or presentation Tuesday, November 5, 2019 at 1:30:00pm GMT

* Fred M. Powell

Antares Pharma, Inc. – Govt VP & CFO

* John J. Howarth

Antares Pharma, Inc. – VP of Company Affairs

* Robert F. Apple

Antares Pharma, Inc. – CEO, President & Director

* David A. Amsellem

Ladenburg Thalmann & Co. Inc., Analysis Department – MD & Head of Healthcare Fairness Analysis

Girls and gents, welcome to the Antares Pharma 3rd Quarter 2019 Running and Monetary Effects Convention Name.

I can now hand the convention name over to Jack Howarth, Antares Vice President of Company Affairs. Please move forward, sir.

John J. Howarth, Antares Pharma, Inc. – VP of Company Affairs [2]

Thanks, Matt, and excellent morning, everybody. Previous these days we introduced our 3rd quarter 2019 monetary effects and working achievements. A duplicate of the clicking unlock and slide presentation for these days’s convention name are to be had at the Buyers segment of the Antares web site.

Ahead of we start, I might love to remind you that a few of our statements made right through this convention name will comprise forward-looking statements throughout the which means of the protected harbor provisions of the U.S. Personal Securities Litigation Reform Act of 1995. Examples of forward-looking statements come with the ones associated with our long run monetary and working effects, together with 2019 monetary steering and catalysts; long run expansion in marketplace percentage; new product approvals and launches; gross sales and prescription volumes; FDA movements and different regulatory actions; result of ongoing and long run scientific trials; and different product building actions and company building efforts.

Those forward-looking statements are matter to positive dangers and uncertainties, and exact effects may range materially. They’re recognized and described in these days’s press unlock and the accompanying slide presentation and every so often within the corporate’s filings with the SEC on Shape 10-Okay, and is up to date on Antares’ fresh periodic filings on Shape 10-Q and Shape 8-Okay.

Antares is offering this data as of the date of these days’s convention name and does no longer adopt any legal responsibility to replace any forward-looking statements contained on this convention name on account of new knowledge, long run occasions or cases after the date hereof, except for as required through regulation or differently. The corporate cautions buyers to not position undue reliance on those forward-looking statements.

Becoming a member of me at the name these days are Bob Apple, President and Leader Govt Officer; and Fred Powell, Govt Vice President and Leader Monetary Officer.

Let’s evaluate the time table for these days’s name on Slide 3. Bob will start with a high-level evaluate of our exceptional 3rd quarter effects and supply an replace on our industrial trade. Fred will move throughout the detailed financials after which Bob will reply your questions.

I will now flip the decision over to our CEO, Bob Apple. Bob?

Robert F. Apple, Antares Pharma, Inc. – CEO, President & Director [3]

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Thank you, Jack, and excellent morning to everybody on these days’s convention name and webcast. These days we reported a historical quarter of monetary growth pushed largely through gross sales of our flagship product, XYOSTED, in addition to sturdy call for and expansion for Teva’s generic EpiPen. Our numerous mixture of proprietary and partnered merchandise contributed to vital year-over-year earnings expansion for Antares.

These days I am additionally glad to file that the fast expansion in our best line has produced the corporate’s first quarterly source of revenue from operations, in addition to general internet source of revenue. The sturdy execution through our industrial workforce promoting each XYOSTED and OTREXUP, coupled with the similar sturdy execution through our operations workforce supplying our companions with gadgets and merchandise, has us outperforming Boulevard expectancies in all facets of our 2019 trade forecast. In consequence, we’re as soon as once more elevating our complete 12 months 2019 earnings steering.

So let’s discuss one of the most highlights from the quarter and the way our achievements over the last Nine months have helped pave the way in which for why we imagine 2019 is a transformational 12 months for the corporate. Please flip to Slide #4.

This morning we reported $34.Three million in overall earnings, virtually double the $17.Nine million we reported within the 3rd quarter of final 12 months. Overall earnings grew 21% sequentially from the second one quarter. Product earnings grew 113% as opposed to the similar duration final 12 months, and importantly, grew 20% sequentially from the second one quarter. That is very spectacular expansion. It was once pushed through our key proprietary and partnered merchandise similar to XYOSTED, OTREXUP and the generic EpiPen. Importantly, as an immediate results of the expanding earnings reported from our partnered merchandise, royalty earnings grew 126% in comparison to final 12 months and sequentially grew 51% over the new 2d quarter.

I might love to now in short evaluate the two lately introduced merchandise which drove document expansion within the 3rd quarter sooner than turning the decision over to Fred.

XYOSTED, our once-weekly subcutaneous auto-injector of testosterone enanthate for males with testosterone deficiency, was once introduced in January of 2019 through the Antares uniqueness gross sales power of roughly 80 gross sales representatives. Over the 1st Nine months, our release metrics have exceeded Boulevard expectancies. We imagine that could be a vital accomplishment, as new product launches traditionally are tricky, with payer and doctor dynamics developing vital demanding situations on product replace.

Additional highlighting the luck of the release is that our gross sales workforce may be detailing OTREXUP, our legacy RA product, to a wholly other target market of rheumatologists. Now not simplest have they maintained the OTREXUP name plan, they have in truth grown OTREXUP earnings whilst using sturdy expansion of XYOSTED.

As you’ll see on Slide #5, XYOSTED overall prescriptions are increasing well. Extra importantly, new affected person begins are expanding and refills are increasing, an ideal signal of affected person endurance. Robust treatment endurance way excellent charges of fill up, which we can imagine will result in persisted earnings expansion.

Since release, XYOSTED has recorded double-digit month-over-month sequential share expansion in each new and overall prescriptions. Within the 3rd quarter on my own, Symphony Well being Answers reported that roughly 20,00Zero XYOSTED prescriptions had been crammed, which was once a 73% sequential build up over the second one quarter of 2019. Via September, roughly 35,00Zero XYOSTED prescriptions had been crammed for the reason that starting of the 12 months, and that quantity does no longer account for multiple-month refills. You will need to be aware that gross sales of XYOSTED to the wholesale vendors remains to be upper than the choice of prescriptions reported through IQVIA and Symphony. We imagine a lot of this expansion will also be attributed to sturdy rep efficiency, cast messaging and the paintings we now have accomplished to procure further protection for doable XYOSTED sufferers.

From a protection perspective, an important milestone was once reached on October 1 after we gotten smaller with some other huge pharmacy advantages supervisor, expanding our controlled care protection to roughly 70% of all industrial lives. Our competitive purpose for 2019 was once to succeed in 2/Three of all industrial lives coated within the first 12 months of release, and we now have exceeded this purpose.

We proceed to focus on all huge writers of testosterone merchandise; 3,500 other physicians have written prescriptions for greater than 12,00Zero sufferers since release. Urologists and endocrinologists are writing roughly part of all prescriptions, whilst common practitioners, nurse practitioners and all others are writing the stability. It is a excellent, numerous mix of prescribers, and we imagine it bureaucracy a cast basis on which to make bigger. The newest IQVIA information presentations that our prescriptions are being written for various sufferers who’re both new to testosterone treatment or sufferers who’re switching from a gel or generic injectable. We imagine the developments we’re seeing in each the quantity and form of prescriber and the type of sufferers the usage of the product implies that the XYOSTED product options and messaging are resonating with our target market.

Please flip to Slide #6. On our final quarterly name, we disclosed plans for a brand new branded social media marketing campaign which was once designed to teach sufferers and inspire them to invite their docs if XYOSTED is true for them. I am happy to file that for the reason that release of this virtual affected person marketing campaign, we now have noticed new, nontargeted healthcare execs prescribe XYOSTED. Those had been healthcare execs that weren’t in our authentic name plan. We imagine that our virtual marketing campaign is having an immediate have an effect on on using sufferers to their docs to invite for XYOSTED, which is a key efficiency indicator for judging the luck of the social media marketing campaign.

And whilst this marketing campaign has persisted to ramp up, we need to ensure we keep in contact with the physicians who write XYOSTED, so we now have quite a lot of advertising projects deliberate, together with a complete slate of scientific congresses to wait. If truth be told, we simply returned from the 20th Annual Fall Medical Assembly of the Sexual Medication Society of North The us, the place we hosted a consultation of key opinion leaders who mentioned doctor and affected person reviews the usage of XYOSTED to regard testosterone deficiency. I for my part heard from physicians that XYOSTED was once having a significant and certain have an effect on on their sufferers’ lives, they usually had been inspired at how pain-free and simple it’s to manage XYOSTED. This ongoing assembly job and outreach underscores how vital we imagine it’s to stick energetic in instructing sufferers and healthcare execs on some great benefits of treating testosterone-deficient males with XYOSTED.

In abstract, we stay more than happy with the growth made up to now, and we’re off to an ideal get started. XYOSTED stays the fastest-growing branded product within the testosterone substitute marketplace.

Please flip to Slide #7. Transferring now to generic EpiPen, which stays the quickest increasing of our partnered merchandise, Teva introduced the grownup model of generic EpiPen overdue final 12 months and simply this previous August introduced the EpiPen Jr. Whilst you have a look at the entire epinephrine and EpiPen marketplace developments for the 3rd quarter of this 12 months, you’ll see a dramatic build up in prescriptions crammed and an greater marketplace percentage for Teva’s generic EpiPen. Nearly 237,00Zero prescriptions had been full of Teva’s generic EpiPen within the 3rd quarter for a 27% percentage within the EpiPen marketplace.

The timing of the EpiPen Jr release in August was once vital, because the 3rd quarter is back-to-school and hypersensitivity season, which occurs to be the most powerful quarter for the epinephrine marketplace. With Teva now in complete industrial release mode, they’ve crammed virtually 400,00Zero prescriptions of 2-Paks year-to-date, with just below 2/Three of the ones prescriptions crammed within the 3rd quarter on my own.

We proceed to trace Teva’s fast growth towards their said purpose of a 50% percentage of the EpiPen marketplace, with the latest per thirty days Symphony prescription information reporting them proudly owning a 31% marketplace percentage. During the first Nine months of this 12 months, with the 1st 6 months being a restricted industrial release, mixed product and royalty earnings from the gross sales of the generic EpiPen through Teva ended in $23.Four million in earnings for us. We imagine our partnership with Teva at the generic EpiPen continues to growth in an overly certain route.

On Slide #8, you’ll see that this has been some other leap forward quarter for Antares, and while you have a look at our revised earnings steering of $115 million to $120 million for this 12 months, we now have the potential of virtually 90% expansion in our best line as opposed to final 12 months. We imagine that Antares Pharma is likely one of the maximum compelling expansion tales in our sector on account of posting really extensive will increase in earnings, discounts in working losses and the corporate’s first quarterly source of revenue from operations and internet source of revenue. Most significantly, we imagine we now have set a direction of extra expansion in long run quarters.

Now I will move forward and switch the decision over to Fred for the main points on our exceptional 3rd quarter. Fred?

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Fred M. Powell, Antares Pharma, Inc. – Govt VP & CFO [4]

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Thank you, Bob. Please flip to Slide #9. As Bob stated, this was once some other super quarter for Antares, with vital sequential and year-over-year earnings expansion, and the corporate’s first quarterly source of revenue from operations, in addition to general internet source of revenue.

The 3rd quarter was once crucial quarter for the corporate, with our workers targeted at the industrial luck of our proprietary merchandise XYOSTED and OTREXUP, which on a mixed foundation grew 180% as opposed to the 3rd quarter of final 12 months. As well as, our partnered merchandise with Teva grew sequentially 38% right through the 3rd quarter in comparison to the second one quarter of 2019, whilst our earnings from AMAG’s Makena grew 27% right through the similar duration.

As a lot of you realize, our spouse AMAG lately gave the impression sooner than an FDA advisory committee to speak about the findings from a post-approval confirmatory trial for Makena referred to as the PROLONG learn about, which didn’t meet its co-primary endpoint. Whilst the committee mentioned a number of questions, at the key query, 7 committee individuals voted to depart the product in the marketplace beneath sped up approval and require a brand new confirmatory trial, and Nine individuals voted to counsel that the FDA pursue withdrawal of acclaim for Makena. It’s a must to understand that the advisory committee’s vote isn’t binding, however the FDA will imagine it in making their determination.

AMAG lately said their trust within the protection and efficacy of Makena and has indicated that they’re dedicated to exploring choices on the way to acquire further information that will likely be maximum informative to physicians and the FDA, and on the similar time paintings to make certain that eligible sufferers proceed to have get admission to to Makena. The timing and the end result of the FDA’s determination in regards to the ongoing availability of Makena is unsure. All the way through the FDA’s determination duration, we can proceed to provide the Makena auto-injector to AMAG for the distribution to physicians and sufferers.

Let me get started my monetary evaluate through offering an in depth breakdown of our revenues and working bills for the 3rd quarter of 2019. Overall earnings was once $34.Three million for the three months ended September 30, 2019, in comparison to $17.Nine million in 2018, a 92% build up. The release of XYOSTED continues to move as deliberate, as earnings from the product grew 52% sequentially as opposed to the second one quarter, whilst our 2d industrial product, OTREXUP, grew 8% within the 3rd quarter over the 3rd quarter of 2018. Overall earnings from Teva’s generic EpiPen was once roughly $11.Five million, representing over 33% of our overall earnings. The mixed earnings from XYOSTED and Epi, whilst nonetheless of their respective launches, contributed $18.Five million, or greater than part of the overall 3rd quarter earnings.

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Gross sales had been $24.7 million for the 3rd quarter, in comparison to $11.6 million within the 3rd quarter of 2018, a 113% build up. Importantly, product earnings as a share of overall earnings continues to develop and accounted for 72% of overall 3rd quarter earnings. Gross sales of our proprietary industrial merchandise XYOSTED and OTREXUP totaled $11.Five million for the three months ended September 30, 2019, in comparison to $4.1 million in 2018. Partnered gross sales totaled $13.2 million within the 3rd quarter of 2019, as in comparison to $7.Five million in 2018. The rise in overall product earnings was once basically pushed through gross sales of Epi gadgets to Teva.

Licensing and building earnings for the 3rd quarter was once $1.2 million, as in comparison to $2.6 million for a similar duration in 2018, and was once basically pushed from Teva’s teriparatide pen and Pfizer rescue pen building methods.

Royalty earnings was once $8.Four million for the 3rd quarter, in comparison to $3.7 million for a similar duration in 2018, a 126% build up. With all the generic EpiPen franchise now to be had in pharmacies following the August release of the generic model of the EpiPen Jr, royalty earnings grew sequentially from the second one quarter through 51%.

Running bills had been $19.2 million for the 3rd quarter of 2019, in comparison to $11.Nine million in 2018. The rise in working bills in 2019 was once basically as a consequence of further gross sales and advertising bills related to the release of XYOSTED.

For the 1st time within the corporate’s historical past, we generated quarterly working source of revenue, which totaled $2 million, which compares favorably to the working lack of $1.Four million for a similar duration in 2018. That source of revenue was once $1 million for the 3rd quarter of 2019, in comparison to a internet lack of $1.Nine million in 2018. Internet profits in line with percentage was once $0.01 for the 3rd quarter, as in comparison to a internet loss in line with percentage of $0.01 for the quarter ended September 30, 2018.

On the finish of the 3rd quarter, money and money equivalents had been $41.Nine million, in comparison to $27.Nine million at December 31, 2018, an build up of $1.7 million from the $40.2 million reported on the finish of the second one quarter of 2019. All the way through the 3rd quarter, we generated $1.7 million in money from operations, as in comparison to a money burn from operations of $80,00Zero for a similar duration in 2018.

In October, we won the general fee of $2.Five million from Ferring in reference to the sale of the needle-free product line. We in the past recorded the achieve at the sale of the needle-free product line within the fourth quarter of 2018. The sale of this legacy product introduced in $15 million in money over the last 2 years, which was once utilized in increasing our industrial trade.

That concludes my ready remarks. I will now flip the decision again to Bob. Bob?

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Robert F. Apple, Antares Pharma, Inc. – CEO, President & Director [5]

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Thank you, Fred. Wrapping up on Slide 10. That is clearly an exhilarating time for Antares and for our shareholders. We had an excellent quarter, and we imagine that our 3rd quarter and year-to-date effects proceed to turn the growth we now have made in focusing our long run expansion on expanding the varied mixture of our overall earnings. We’re outperforming Boulevard expectancies, and as soon as once more revised upward our 2019 earnings steering to what generally is a doable build up of virtually 90% over 2018 complete 12 months earnings. And whilst we’re laser-focused on using industrial luck, we additionally stay dedicated to advancing our inner pipeline and serving to our companions whole building methods, which we imagine will translate into long run product earnings for our corporate through the years. Operationally, we’re making an investment in expanded workplace, laboratory, production and warehouse area with a purpose to reinforce our all of a sudden increasing trade and set the level for long-term expansion.

To this point, 2019 has been a transformational 12 months for Antares, and we’re pleased with the odd efforts and effects from our workers, which must supply an exhilarating long run for our corporate and shareholders.

This concludes my ready remarks for these days.

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Questions and Solutions

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Operator [1]

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(Operator Directions)

Your first query will come from Elliot Wilbur with Raymond James.

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Elliot Henry Wilbur, Raymond James & Mates, Inc., Analysis Department – Senior Analysis Analyst [2]

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Congratulations to the workforce for crossing each the profitability and working money float thresholds, on the subject of achieving certain territory. I do know that is one thing you guys had been striving in opposition to for a very long time, so excellent task.

Particularly, a pair questions for your self, Bob, round XYOSTED, no longer strangely. I assume simply more or less up entrance, because the fixation on kind of the weekly Rx developments most certainly is simplest going to extend going ahead, and Symphony and IQVIA appear to turn a identical development and development, however one of the vital services and products is reasonably a bit of upper than the opposite, simply questioning if you should perhaps supply just a little little bit of colour observation on kind of the way you guys have a look at the ones metrics internally, in particular eager about issues of distribution or gross sales channels that you realize the product is transferring via that simply don’t seem to be merely captured through both of the ones services and products, and whether or not or no longer the adaptation between the ones two, in accordance with no less than what you spot, would possibly simply be sampling error, or one alternatives up, possibly, a part of the channel that the opposite does not. However simply anything else you’ll make clear with recognize to kind of the way to extra correctly gauge more or less the weekly numbers could be useful.

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Robert F. Apple, Antares Pharma, Inc. – CEO, President & Director [3]

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Sure, thank you. Thank you for your whole feedback previous, too, Elliot. So far as the Symphony and IQVIA weekly numbers, we in point of fact use the ones for trending. What is vital to us is what will get shipped out of our distributor to our distribution companions, similar to ABC, Cardinal, McKesson and so on. And so what we are seeing are certain developments. Like I discussed in my ready remarks, our shipments are exceeding either one of the ones services and products so far as weekly numbers. And I feel it is a aggregate of — we do promote direct to a couple huge practices. We additionally, clearly, have some trade that is going throughout the DOD, the Division of Protection, in addition to the Medicare/Medicaid trade, which in most cases does not get picked up smartly through prescription developments. And I feel additionally, it is nonetheless within the early a part of a release, and each IQVIA and Symphony generally tend to take a bit of extra time to get the developments proper, because the physician base continues to switch, and on smaller merchandise, vis-a-vis the release 12 months, I feel they’ve just a little little bit of a more difficult time monitoring down precisely the place all of the scripts are coming from.

All that being stated, we use them for trending. The developments are very certain each from a prescription perspective in addition to shipments, and it could be a excellent day for us when everybody stops browsing at weekly numbers, as a result of reasonably truthfully, they are no longer very correct. However once more, they’re trending in the appropriate route, and I feel you’ll see that in accordance with the place our earnings is for the quarter for XYOSTED, it a ways exceeded Boulevard expectancies since the developments are higher than what the script information is appearing.

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Elliot Henry Wilbur, Raymond James & Mates, Inc., Analysis Department – Senior Analysis Analyst [4]

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Ok. Simply sought after to invite a follow-up query in regards to the present name development, detailing and supply of prescriptions for XYOSTED. It seems to be about 50% of Rx’s are coming from endocrines and urologists, I assume what we might be expecting with more or less a uniqueness product like this. I suppose, despite the fact that, that you are rather energetic on the subject of detailing numerous the high-prescribing GPs, and I am simply questioning, would it not be affordable to suppose that finally this product more or less strikes to extra of a kind of a category development, the place you have got 60% to 70% of prescriptions coming from GPs and simplest 30% to 40% from the consultants, or is it much more likely that we are going to proceed to peer quite excessive share from the ones 2 specialties? Simply making an attempt to determine principally if the ones are main signs for what we would possibly see ultimately in GPs or if that is simply going to be a product the place we see the next focus of Rx’s a few of the consultants.

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Robert F. Apple, Antares Pharma, Inc. – CEO, President & Director [5]

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Sure. So from our name plan perspective, we name at the high-prescribing testosterone writers whether or not they are endocrinologists, urologists or important care doctors. We name on all of the best decile 7s via 10s, necessarily. I feel what we are seeing is the adoption early on is from the important thing opinion leaders, the urologists who in point of fact are the leaders on this house. They have a tendency to write down first. They are very pleased with the product and transferring ahead with it.

Additionally, I feel what is unexpected is we’re seeing numerous endocrinologists writing, which — a disproportionate percentage relative to the category. And I feel that is in point of fact a serve as of — and once more, it is my opinion — it is a serve as of that the degrees that we accomplished within the scientific research are translating into the sector, as from what we are listening to from physicians, and I feel they prefer — the endocrinologists in point of fact like that secure state. And so do the urologists, however I feel endocrinologists focal point closely on hitting positive ranges and goals.

So we are seeing a in point of fact sturdy uptake, extra so than some other product within the area, from endocrinologists. And that might proceed. I feel going ahead, we will see the combo begin to persist with {the marketplace}, that the massive important care writers will prevent — will begin to persist with the important thing opinion leaders as to what they are writing, and I feel general we will see the fashion changing into extra conventional with the overall practitioners being a big piece of the writing. And once more, we do not name on numerous the ones common practitioners as a result of they are within the decrease deciles, however they’ll ultimately write, probably, in accordance with what they are seeing available on the market and so on.

So early on, it is a little bit other than the vintage product within the testosterone area, however I feel it’s going to ultimately gravitate in opposition to being a heavier important care, common practitioner, sexual-medicine-type physician writing. However once more, that continues to be noticed.

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Elliot Henry Wilbur, Raymond James & Mates, Inc., Analysis Department – Senior Analysis Analyst [6]

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Truthful. Remaining query. With recognize to the pipeline, I feel there may be some trust available in the market that there is reasonably a bit of of price accruing within the pipeline that you are not being credited for, and numerous it’s most certainly in accordance with the truth that title, rank and serial choice of numerous the methods don’t seem to be in point of fact identified. In order we take into consideration 2020, any likelihood that we are going to get element on the subject of explicit molecules with recognize to both 1701, the urology product, or the Pfizer — undisclosed Pfizer product, rescue agent?

After which fast subpart to that query, is that program partnered with the Meridian platform? There was once some disclosure in some fresh filings that Mylan is negotiating to procure that trade, and simply sought after to get some readability on whether or not that asset is tied to some other house inside Pfizer or if in truth it’s tied to the Meridian platform. Thank you, Bob.

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Robert F. Apple, Antares Pharma, Inc. – CEO, President & Director [7]

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Sure. So I believe the entirety you stated, that our pipeline is undervalued, and I feel numerous it has to do with the truth that we do not divulge each proprietary and our partnered merchandise. And it will depend on the partnership. Clearly, with Teva, we now have the Forteo product beneath an annual evaluate, which is a considerable product. We are looking ahead to the FDA approval together with Teva. Teva drives that procedure; they dangle the record. And so we are hoping that that will get licensed quickly and we will be able to release an overly giant, vital product within the osteoporosis area.

So far as the Pfizer program, that may — from what we perceive and from the entirety we are listening to from Pfizer, that isn’t a part of the Meridian transaction or the Upjohn transaction. This is a product this is inside Pfizer’s branded department, and that’s going to stick there. There is not any indication in any way that that is going with the merger or the spinout. And so so far as after we would possibly see or when that can get disclosed, once more, it is in point of fact a serve as of Pfizer’s timing and need to divulge that product into {the marketplace}. It might grow to be obvious once they get started doing a little paintings, so far as sped up paintings with the FDA and so on, however till then, Pfizer’s an overly huge group, they usually most certainly are in the midst of doing 100 methods, so whether they decide to divulge that one is in point of fact as much as them.

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And in our personal inner program, our rescue pen within the neurology area, I totally be expecting that may grow to be very obvious within the — in 2020 as we transfer that product into scientific trials. We are doing numerous in point of fact excellent paintings presently at the software, in addition to components, and we think to transport that into an IND-type surroundings in 2020. In order that’ll grow to be obvious.

And once more, at the different pipeline merchandise that we are operating on, as we growth in opposition to an IND is in point of fact when we will divulge what the ones merchandise are. So we do have an ideal pipeline; we even have some other product with Teva, Exenatide; no longer an enormous product, however nonetheless a significant one for other people with diabetes, crucial person who we are hoping to have licensed quickly with the FDA, once more, as an ANDA. In order that’s our present pipeline, in addition to, we glance to proceed to usher in different alliance offers within the close to time period to proceed to reinforce that pipeline. So with a bit of luck there will be some further information in that house sooner or later, and we will be capable of get the pipeline additional reinforced.

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Operator [8]

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And your subsequent query will come from Anthony Petrone with Jefferies.

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Anthony Charles Petrone, Jefferies LLC, Analysis Department – Fairness Analyst [9]

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Perhaps simply 2 from me and I will be able to hop again in queue. There may be only one on XYOSTED, simply looking to get a way of kind of penetration inside doctor accounts which can be prescribing. What number of sufferers are those physicians prescribing XYOSTED in lieu of a topical or an intramuscular injection? In order that will be the first query.

After which anything else you’ll supply simply on the subject of the AMAG FDA panel that you simply discussed for your ready remarks, simply kind of how we must be eager about that because it pertains to auto-injector purchases going ahead. Thank you.

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Robert F. Apple, Antares Pharma, Inc. – CEO, President & Director [10]

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Positive. So thank you, Anthony. So far as your first query on prescribing behavior of our writers, clearly it is blended. We’ve some giant writers that experience followed XYOSTED and it is most certainly their first-line treatment for many sufferers. What we see is that clearly they are providing it to new sufferers and we are seeing a in point of fact great choice of sufferers which can be new to treatment. About 50% of our scripts are sufferers who’ve by no means been on some other testosterone treatment. In order that presentations that the docs view it as a robust first-line treatment, in addition to when a affected person’s given the choice between gels, IM injections or XYOSTED, they are selecting XYOSTED. So we are seeing a excellent mixture of sufferers.

After which different docs are switching their IM sufferers. Once more, what we now have discovered is that the majority docs will say, hi there, if the affected person does not whinge, they are no longer going to provide it, but when they are complaining, they provide XYOSTED, and in the event that they transfer, they have a tendency to be glad.

However numerous it has to additionally do with protection. We are in point of fact now at a pleasant share of lives coated for XYOSTED, nevertheless it took via October to get there, and with any product release it takes any place from 6 months to a 12 months to get quite excellent protection, should you get it in any respect, and we were given 70% of all lives coated. So I feel we will begin to see the affected person demographics in point of fact converting in accordance with their protection. In the event that they were not coated, it was once a pricey proposition to switch from a generic IM or a generic gel to XYOSTED.

So we are seeing a wide variety of docs. We name them internally, like, dabblers, adopters and one thing else. I will be able to’t recall precisely what it’s. However I feel it is commonplace in that you’ve got docs who’re competitive in browsing at new treatments and undertake them, and it turns into a large a part of their apply, after which others who take time they usually need to pay attention from different docs, they need to pay attention from sufferers and so on.

So I will be able to’t say that we’ve got one explicit physician — form of physician that writes closely and ones that do not. I feel we are seeing a in point of fact great mixture of docs. Like I stated in my ready script, 3,500 physicians have written XYOSTED. We name on about 12,000, most certainly 10,00Zero frequently. And in order that’s a gorgeous excellent combine on an overly early — an overly quick time frame to get that choice of docs writing, after which additionally the choice of sufferers which can be the usage of XYOSTED.

I feel what is vital is as we proceed to get new sufferers, the endurance has been in point of fact sturdy, and so the refills grow to be increasingly more vital, and once more, I feel we are seeing higher endurance than what you in most cases see in testosterone merchandise, and if that development continues, we predict we will proceed to peer in point of fact great expansion with the product.

Your 2d query — sure, thank you. Your 2d query on AMAG. So I am not in point of fact going to touch upon AMAG’s regulatory plan or procedure. What I will be able to let you know is that it is November, so obviously in 2019, I do not believe there will be any have an effect on in any way of the AdCom vote. In chatting with Invoice Heiden, the docs are nonetheless writing Makena auto-injector. Our shipments are nonetheless sturdy. And so for 2019, I in point of fact do not see any have an effect on.

Past 2019, what we stated within the ready script, it is in point of fact — it is most likely going to be an extracted or a longer time frame because the FDA gathers all their knowledge that they want. AMAG’s operating with them, as they disclosed of their profits simply final week. They are operating with the FDA to take a look at to get a hold of some other learn about to behavior whilst the product remains in the marketplace. However the time that it takes and the end result is in point of fact one thing I will be able to’t expect at this level, and we are going to proceed to provide the Makena auto-injector product to AMAG, and prefer I stated, it’s going to — on a go-forward foundation, we will simply stay doing what we now have been doing previously, which is supplying them a really nice product that they have got been distributing to their physicians and sufferers.

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Operator [11]

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Subsequent, we can pay attention from Stacy Ku with Cowen and Corporate.

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Stacy Ku, Cowen and Corporate, LLC, Analysis Department – Fairness Analysis Affiliate [12]

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First on XYOSTED, are you able to remind us of plans for copay reinforce for XYOSTED going into the following 12 months? Perhaps lend a hand us perceive what may well be the pushes and pulls shall we be expecting for quantity dynamics and gross to nets in 2020. And I’ve 2 follow-ups.

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Robert F. Apple, Antares Pharma, Inc. – CEO, President & Director [13]

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Sure, so I will let Fred reply the gross to internet, however at the copay reinforce, presently, our program is copay reinforce of as much as $125, I feel, for sufferers who’ve industrial insurance coverage. And we get in point of fact excellent usage with the copay reinforce. About 65% of our sufferers make the most of a copay reinforce. And as our protection continues to develop, our copay techniques will most likely keep growing.

Taking a look into 2020, we are browsing at quite a lot of adjustments which may be made. Most likely the reinforce will keep the similar, however we are browsing at if there may be anything else we will be able to do in Q1, the place with high-deductible plans taking dangle in Q1 for all merchandise, is there some way that we will be able to decrease the impact of the ones high-deductible plans at the prescriptions in Q1? We’ve not come to a conclusion on that, however obviously copay help is a kind of spaces that you’ll lend a hand a affected person as they are going via that transition to hide their drugs in that first couple months the place it is numerous out-of-pocket price for them as a person.

So far as the gross to internet, I will flip that over to Fred.

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Fred M. Powell, Antares Pharma, Inc. – Govt VP & CFO [14]

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Positive. Thank you, Bob. Just right morning, Stacy. In regards to the gross to internet, that share has been making improvements to right through the 12 months. Firstly of the 12 months, we now have mentioned our first-fill-free program previous to us gaining the numerous protection that we’ve got available in the market now, and that in truth introduced down our gross-to-net share beneath the place it’s presently. After we check out the 3rd quarter, we are within the mid- to higher 50% that is still in internet, so due to this fact, about — just a little over — between 40% and 45% deductions that we’ve got, and the most important ones being the copay, in addition to the everyday for vendors, in addition to we now have stored the first-fill-free program in position, after which the rebates. We think that share to stick secure, in addition to somewhat build up as we move into the top of the 12 months. After which as Bob stated, we are these days browsing on the methods for the 1st quarter of subsequent 12 months, in addition to all of subsequent 12 months, as to the copay help methods. However as of now, we are browsing within the mid- to higher 50% that is still in internet within the gross-to-net calculation.

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Stacy Ku, Cowen and Corporate, LLC, Analysis Department – Fairness Analysis Affiliate [15]

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That is in point of fact useful. And likewise, so how must we take into consideration the cadence of EpiPen-related earnings? Particularly, how it will relate to Teva’s marketplace percentage objectives and doable stock development.

After which, how has your fresh quarterly efficiency modified how you are looking on the finish of 2019 and 2020 on the subject of doable profits steering and doable persisted profitability?

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Robert F. Apple, Antares Pharma, Inc. – CEO, President & Director [16]

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Smartly, I imply, obviously, our expanding steering, a large piece of this is across the EpiPen. I imply, we had an excellent quarter in Q3, which is traditionally the most efficient quarter for — within the epinephrine marketplace on account of again to university and allergic reactions and so on. So we see Teva’s marketplace percentage being within the — any place from 31% to 34% or upper relying at the week. We think to peer that development proceed to make stronger as they are attempting to achieve their said purpose of 50% marketplace percentage of the entire EpiPen marketplace. So I feel going ahead, we are being conservative in This autumn, and as the Q3 is the most powerful quarter for EpiPen, we do not know what will occur in This autumn. It is unpredictable for us. We all know our shipments are sturdy to Teva, however what is going on out to the industry is in point of fact — we do not know till the top of the quarter.

So we think EpiPen to keep growing. We think it to be a significant a part of our trade going ahead. And we now have been more than pleased with how Teva’s been generating or appearing. To have over, I feel I stated, 400,00Zero prescriptions crammed since release — to place it in viewpoint, we do — we promote — we make — or in a pack, it is Three auto-injectors. It is 2 with drug and 1 with — 1 teacher. And so it is hundreds of thousands of pens that we produced, and we are in point of fact pleased with that during that we proceed to send Teva, and we all know that they are no longer development stock. We all know that they’re supplying the marketplace and that they’re aggressively gaining marketplace percentage and proceed to promote virtually the entirety that we send. So we are in point of fact pleased with that, the place that program’s going.

In 2020, I in point of fact can not expect at this level. It is too early to decide how temporarily or in the event that they hit their 50% marketplace percentage purpose. It is a purpose, and presently the developments are sturdy, and we are in point of fact pleased with the place Epi goes. And we see that being a long-term significant product for each organizations.

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Operator [17]

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Your subsequent query will come from David Amsellem with Piper Jaffray.

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David A. Amsellem, Piper Jaffray Corporations, Analysis Department – MD and Senior Analysis Analyst [18]

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So had a couple of, first on XYOSTED, and express regret if I overlooked this, however I sought after to get a way of the combo — the affected person combine between those that had been on topicals as opposed to those that had been on intramuscular injections as opposed to those that are testosterone-naive, and the way you are seeing that evolving. That is primary.

Quantity two is, I do know you have got commented at the gross to internet, however I sought after to get a way from you as to the place you assume that is going to move in 2020 and even longer-term.

After which finally I had a query on capital deployment. I imply, you might be successful, and you are development your money place, so I sought after to get a way from you as to how you are eager about the addition of property the place you’ll leverage your industrial infrastructure. Thank you.

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Robert F. Apple, Antares Pharma, Inc. – CEO, President & Director [19]

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Positive. So David, for your first query in regards to the mixture of XYOSTED sufferers, about 50% or extra of our sufferers are new to treatment, which I feel, once more, is an excellent share of our sufferers being naive to testosterone substitute treatment. It presentations that the docs are pleased with XYOSTED being a first-line treatment. So 50% are new.

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At the different aspect of it, I might say that nearly all of the stability is from IM injections. It is exhausting for me to decide whether or not — how a lot was once gel as opposed to IM, however obviously, I feel, the overwhelming majority are IM injection sufferers who need a greater injection, need to do away with the ones — probably do away with the ones peaks and valleys that they see with IM injections. And in order that’s the second one largest part of our affected person base. After which some on gels.

I feel longer-term, we will see extra expansion within the IM aspect of the trade as a result of I feel as docs transfer clear of that, smartly, if the affected person’s no longer complaining I am not going to provide anything else, to in the event that they see that XYOSTED is in point of fact operating smartly for his or her different sufferers that probably they will begin to be offering it to their sufferers which can be on IM and begin to get them extra — get extra switches going.

However once more, our focal point in point of fact is solely giving — having XYOSTED as a call for sufferers, and to this point it is been a gorgeous excellent mixture of sufferers opting for to move with XYOSTED as opposed to the generic choices which can be available in the market. So general, we are pleased with the affected person response to XYOSTED.

So far as the gross to internet, I will flip that over to Fred once more.

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Fred M. Powell, Antares Pharma, Inc. – Govt VP & CFO [20]

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Positive. Thank you, Bob. Sure, with the gross to internet, as I used to be simply citing, we had been browsing on the growth of the share right through the 12 months. 3rd quarter and, we imagine, fourth quarter, we must be within the mid- to higher 50% closing at the nets, so browsing at a gross-to-net cut price within the 40% to 45%. We see that rather solid within the 3rd and fourth quarter. Going ahead, we wish to spice up that quantity up as we get into 2020 and past, however it is but to be decided what methods we are going to be putting in for the copay help, in addition to the have an effect on of overall rebates for all of 2020. However I might say presently we are relaxed within the mid-50% to 55% to 60% closing on the internet line or a 40% to 45% deduction.

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Robert F. Apple, Antares Pharma, Inc. – CEO, President & Director [21]

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So far as your deployment of capital, I imply, it’s kind of early to be discussing capital deployment when it is our first quarter of producing money, however I might say that in most cases, as a result of we now have an overly productive gross sales workforce of roughly 100 other people general, while you have a look at 80-some reps plus 10 district managers and so on, sure, we’re browsing at different merchandise to probably achieve, however there may be no longer many available in the market. However we’re browsing at property as a result of that is one house the place we might undoubtedly deploy our capital to reinforce our earnings with what we predict is an overly efficient useful resource with our gross sales power. They have got accomplished a in point of fact nice task of XYOSTED and OTREXUP and we need to probably give them some other product.

And in order that’s the place — that is the house that we are in point of fact browsing at from our capital perspective. The whole lot else is in point of fact being funded through operations. Our inner R&D is being funded through operations. Our exterior R&D with our companions is being funded through them, which brings in more earnings and benefit for us. And so our money and expansion, with a bit of luck, going ahead, will likely be used to usher in different property.

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Operator [22]

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(Operator Directions)

Subsequent, we can move to Matt Kaplan with Ladenburg Thalmann.

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Matthew Lee Kaplan, Ladenburg Thalmann & Co. Inc., Analysis Department – MD & Head of Healthcare Fairness Analysis [23]

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Simply sought after to dig in just a little bit extra into the XYOSTED. A pair issues — it sort of feels to me your endurance charge must be beautiful excessive given the extent of nRx and refills relatively. Are you able to communicate just a little bit about what your endurance charge is? I assume traditionally, given traditionally, endurance on TRT treatments has been beautiful low previous 6 months. And what is your — or 12 months particularly. What is your sense now, given, I assume, even if it is early within the release?

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Robert F. Apple, Antares Pharma, Inc. – CEO, President & Director [24]

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Sure, I imply, I feel that is — it is obviously nonetheless early. The majority of our sufferers in point of fact get started — did not get started coming onto treatment till, like, March, April, after we began to peer the developments transferring up. However I can say the endurance seems to be beautiful darn excellent at this level. We are seeing endurance 6, 7 months of the sufferers who began. The one person who won’t — one of the most sufferers that we are not seeing endurance in is that if they had been first-fill-free and they do not have insurance policy. They usually, a few of them do not, clearly, pay for it out of pocket. And so that is the one house the place we see much less endurance on account of a monetary determination, no longer on account of a drug determination, for probably the most section.

So general, I feel we are forward of the place we concept we might be from a endurance perspective. Obviously, such as you discussed previous, this treatment is one in most cases that is wrought with low endurance, however we appear to be bucking that development early on. However once more, it is very early, however presently, issues are browsing beautiful sturdy in that house.

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Matthew Lee Kaplan, Ladenburg Thalmann & Co. Inc., Analysis Department – MD & Head of Healthcare Fairness Analysis [25]

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Ok, excellent. And on the subject of your present payer protection, you stated you are 70% forward of time table with recognize to the protection. The place do you assume you should pressure that? Is that the place you more or less plateau now, or do you spot that proceeding to develop going ahead?

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Robert F. Apple, Antares Pharma, Inc. – CEO, President & Director [26]

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Sure, I feel that we are at a really nice point. I feel 70% for any branded product is a gorgeous sturdy protection share. And we are going to have fine details. We are going to have some plans that come to a decision to not quilt, others that’ll upload on in accordance with their — what their consumers are announcing. And so I might say that I do not see an important build up from this level on, however we will see fine details, and with a bit of luck, we will get just a little bit extra regional protection. Numerous the PBMs, we are on their nationwide formulary, however while you move — while you peel that onion again, there may be some plans which can be in there that do not quilt, that we would possibly win through the years. That’ll build up that quantity. And once more, there will be plans that say, hi there, I am simply no longer overlaying any testosterone merchandise, they usually drop out of the universe. However general, I feel that is — it is a beautiful a hit excessive quantity so far as protection is worried, and we will proceed to paintings on making improvements to that, however I would not be expecting a big build up of protection from this level on.

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Matthew Lee Kaplan, Ladenburg Thalmann & Co. Inc., Analysis Department – MD & Head of Healthcare Fairness Analysis [27]

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Ok, that is useful. After which on the subject of the EpiPen, you talked just a little bit in regards to the seasonality, which is de facto anticipated, more or less again to university within the 3rd quarter. Are you able to give us just a little bit extra element on the subject of the extent of that seasonality as opposed to 2d quarter and primary quarter?

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Robert F. Apple, Antares Pharma, Inc. – CEO, President & Director [28]

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Sure, I wouldn’t have any of the ones numbers in entrance of me. And once more, with it in point of fact being a release 12 months for us and Teva, and extra so for Teva, I will be able to’t even expect what This autumn will likely be relative to their marketplace penetration at this level. We all know that the weekly developments had been excellent, however should you have a look at the entire marketplace in This autumn, it is been down relative to Q3. Now not dramatically, however it is been down. And Teva may dollar that development just a little bit through simply getting extra marketplace percentage, however I feel general the marketplace goes to peer a This autumn marketplace, which is traditionally less than Q3. I do not know the precise numbers off the highest of my head so far as what share of — what number of scripts had been written in Q1 via This autumn general, however obviously we did have a look at Q3, and it’s the most powerful quarter for the epinephrine marketplace. And with a bit of luck Teva will keep growing their marketplace percentage and we will see persisted expansion with the EpiPen product.

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Matthew Lee Kaplan, Ladenburg Thalmann & Co. Inc., Analysis Department – MD & Head of Healthcare Fairness Analysis [29]

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Ok, excellent. After which final query, more or less just a little little bit of a follow-up to Elliot’s on the subject of your pipeline, you do not divulge what the goods are, however perhaps something which may be useful for us is that if you should lend a hand us perceive the other merchandise and the present marketplace sizes that you are going after, and I assume in particular, on your inner product, for Pfizer, after which extra in particular, we find out about teriparatide, however what — lend a hand us perceive what the teriparatide alternative is for Antares in particular.

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Robert F. Apple, Antares Pharma, Inc. – CEO, President & Director [30]

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Smartly, so, that is a in point of fact tricky query to reply to. It is numerous other merchandise, and so we are not ready at this level to provide you with a marketplace estimation at the general — all of the different merchandise, particularly Pfizer, when it is an undisclosed product. I feel you would be capable of slender it down beautiful temporarily as to what the product is, and that may more or less defeat the aim of what Pfizer’s looking to do. Similar factor with our different inner program. Once more, I stated previous that we will be most certainly disclosing that product in 2020 as we transfer into an IND and the scientific trials. So it isn’t like we are asking — we are not — it isn’t going to be that for much longer sooner than it is disclosed on a few the methods.

On the person who is disclosed, Forteo, I feel final 12 months Lilly’s product did about $750 million within the U.S., in regards to the identical quantity globally. So for Teva, it is a huge marketplace alternative. It is clearly larger than epinephrine. And with a bit of luck once they get the approval, the product’s substitutable, and if it is substitutable, I feel shall we see probably the similar substitution charge that we are seeing with EpiPen.

So it is a significant product as a result of we get — we promote them the gadgets. It is obviously no longer the quantity of gadgets like epinephrine; it is a a lot lower-volume product however a far upper buck price. I feel the — do not quote me in this, however I feel the Forteo pen’s about $3,500 a pen. And so the buck price could be very excessive, and we get a royalty on that buck price. We get a excessive royalty relative to Epi on account of that more or less exchange or combine, the exchange in dynamics between value and quantity. So we get a — we commence out at a high-single-digit royalty to a mid-teen royalty on Forteo, which clearly might be very significant for us as a company relying at the penetration that Teva will get.

And so once more, I feel — and globally, the remainder of the marketplace, we get the similar economics for Teva with Forteo on the remainder of the arena, however the remainder of the arena, pricing is way less than within the U.S. However general it is nonetheless a significant quantity of doable alternative for Teva and for us.

So I might say that that is the simplest different one I may symbolize. Exenatide, which may be disclosed, that is a smaller product. I feel general the emblem’s doing round $100 million. It is not a large alternative, however for us and Teva, it is crucial as a result of it could be one of the vital first generic merchandise to be had for other people with diabetes. And so it is nonetheless a viable and vital product for either one of us, so with a bit of luck that may get licensed. And that’s the reason the very same economics, from our perspective, as Forteo — high-single-digit royalties to the mid-teens, and we promote the gadgets. Once more, no longer a ton of gadgets being bought in that marketplace, so it is extra at the buck price.

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Operator [31]

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And girls and gents, that does conclude the question-and-answer consultation for these days. I might now like to show the decision again over to Jack Howarth for any further or ultimate remarks.

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John J. Howarth, Antares Pharma, Inc. – VP of Company Affairs [32]

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Thank you, Matt, and thank you once more for becoming a member of us on these days’s convention name. In case you have any follow-up questions you’ll achieve me at 609-359-3016. That concludes these days’s name.

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Operator [33]

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As soon as once more, that does conclude the decision for these days. Thanks on your participation; you could now disconnect.


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