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Depomed, Inc. (NASDAQ:DEPO) Q3 2016 Antithesis Appointment Alarm November 7, 2016 4:30 PM ET
Christopher Keenan – Vice President of Broker Relations
James Schoeneck – President and Chief Executive Officer
August Moretti – Senior Vice President and Chief Banking Officer
Matt Gosling – Senior Vice President and Accepted Counsel
Jack Anders – Vice President of Finance
Jason Gerberry – Leerink Partners
David Risinger – Morgan Stanley
Ami Fadia – UBS
David Amsellem – Piper Jaffray
Irina Koffler – Mizuho
Ken Trbovich – Janney
Good afternoon and able to the Depomed Third Division Budgetary Year 2016 Banking After-effects Appointment Call. Please agenda this accident is actuality recorded.
I would now like to about-face the appointment over to Christopher Keenan, Vice President of Broker Relations. Please go ahead.
Thank you, Teresa. Acceptable afternoon and able to our broker alarm to altercate the company’s third division 2016 banking after-effects appear beforehand today. The columnist absolution accoutrement our antithesis for this aeon is now attainable on the Investors folio of our website at depomed.com. With me today are Jim Schoeneck, President and Chief Executive Officer of Depomed; August Moretti, Senior Vice President and Chief Banking Officer; Matt Gosling, Senior Vice President and Accepted Counsel; and Jack Anders, Vice President of Finance.
I would like to admonish you that the affairs discussed on this alarm accommodate advanced statements that absorb risks and uncertainties, including those accompanying to the commercialization of NUCYNTA, NUCYNTA ER, Gralise, CAMBIA, Lazanda and Zipsor.
The company’s banking angle and antithesis advice for 2016, development affairs and expectations for cebranopadol, and added statements of approaching expectations that are not absolute facts. Absolute after-effects may alter absolute from the after-effects predicted and recorded after-effects should not be advised an adumbration of approaching performance. These and added risks are added absolutely declared in the Accident Factors area and added sections of our Anatomy 10-K for the year concluded December 31, 2015 and our annual abode on Anatomy 10-Q that will be filed with the SEC.
Depomed disclaims any obligation to amend or reclaim any advanced statements fabricated on this alarm as a aftereffect of new advice or approaching developments. Depomed’s activity is to alone accommodate banking advice and advice aloft accumulated goals for the accepted budgetary year and to provide, amend or reconfirm its advice alone by arising columnist absolution or filing adapted advice with the SEC in a about attainable accessible document.
References to accepted cash, banknote equivalents and investments are based on the balances as of September 30, 2016. All guidance, including that – all guidance, including that chronicle to the company’s accepted absolute artefact revenues, operating revenues, adapted non-GAAP antithesis and adapted EBITDA are as of today, November 7, 2016.
Investors can accretion an annual of the alignment for artful non-GAAP antithesis and adapted EBITDA in today’s antithesis release, as able-bodied as adaptation to the agnate GAAP banking measures.
With that, I’ll about-face the alarm over to Jim Schoeneck.
Thank you, Chris, and acknowledge you, all, for abutting us today. I’ll alpha today’s alarm with an overview of our third division results, how we are positioned for the butt of the year and finally, I’ll assay a few contempo events. Augie will afresh altercate our financials afore I accommodate the closing comments and accessible the alarm to questions.
First, let me say that our annual after-effects fell able-bodied abbreviate of our expectations. During the quarter, several factors afflicted the net sales of NUCYNTA and Gralise. The arrears is in three areas, a abstract in the division amid decree abode and shipments, changes in artefact assets accounts affiliated to abatement submissions for above-mentioned periods and added units falling beneath absolute contracts, and decree abode advance for our key articles that did not accommodated our forecast. I’ll abode these areas, afresh Augie will allege to the banking implications in greater detail.
During the quarter, we saw a accepted abstract amid decree accepted shipments, which resulted from a change in our customer’s affairs patterns. As an example, while we saw a 4% access in NUCYNTA ER decree abode from added division 2016 to third quarter, we saw 1% abridgement shipments to our ample customers, as able-bodied as a abridgement in shipments from wholesalers to pharmacies during August and September. Agenda that this was anon afterwards our August bulk access on NUCYNTA and Gralise, the alone one we’ve taken in 2016.
As we apprehend from Augie, the abstracts we’re seeing from October announce that shipments are now added in accompany with decree demand. Affective to the assets accounts in gross to net, bulk aegis accoutrement in assertive managed affliction affairs and adjustments to our acknowledgment affluence accompanying to the bulk increases annual any annual in the division of the August NUCYNTA and Gralise bulk increases. We apprehend to see absolute appulse from these bulk adjustments for the fourth quarter.
We additionally accomplished a cardinal of adjustments to our gross to net for NUCYNTA that about impacted our net sales. Specifically, ancient catch-ups for abatement ancillary to PBM managed affliction and government affairs accoutrement the aboriginal two abode of the year were submitted both through J&J and anon to Depomed afterwards than accepted and were college than forecasted.
Finally the ample managed affliction plan that are not ahead submitted their appliance for rebates appointment claims through PBM consistent an added rebates for the division and added affluence for approaching quarters. This authentic annual will additionally appulse our gross to net in approaching periods. The aberration amid our estimates and the absolute amounts invoiced was recorded in the third division and the accumulative aftereffect of these was significant.
I’ll altercate the decree abode results, as I abode anniversary brand. With that as background, let me now about-face to the after-effects from the quarter. Depomed acquaint the third division acquirement of $111 million, an access of 5% compared to $105 actor for the third division aftermost year. We had GAAP annual net accident of $13 actor or $0.21 a share. Our third division non-GAAP adapted antithesis were $21 actor or $0.28 a allotment and our non-GAAP adapted EBITDA was $35 million. Augie will assay our GAAP to non-GAAP alignment afterwards in the call.
In the third quarter, the NUCYNTA allotment generated net sales of $65 actor and has produced $396 actor of acquirement aback its accretion in April of 2015. During the third quarter, NUCYNTA ER accomplished about 20% year-over-year decree accumulated growth, as able-bodied as best almanac highs for both absolute and branded decree bazaar share.
In August, the cast accomplished an best annual aerial of over 30,000 prescriptions, afore the antecedent annual almanac set in June. Third-party abstracts shows that we are accretion altered or new prescribers of NUCYNTA, with new prescribers up 10% for the aboriginal three abode of 2016 adjoin the aforementioned aeon aftermost year.
We connected to see NUCYNTA IR decree assuming signs of growth, with August up 5% adjoin the above-mentioned year and September up 1%. You’ll anamnesis that the cast was crumbling 10% per year above-mentioned to our relaunch, altered or new prescribers for IR are accretion 4% for the aboriginal nine months of 2016 adjoin the aforementioned aeon aftermost year.
We additionally see an access in bifold prescribers, acceptation those who are assigned both NUCYNTA ER and IR. All these are absolute signs for the future, abnormally aback you accede that the all-embracing opioid bazaar is bottomward with the long-acting bazaar assuming a 4% year-over-year abatement and the short-acting opioid bazaar bottomward 6%. We accept that NUCYNTA offers differentiated backdrop that agreeably positioned it admitting these bazaar pressures.
For managed care, we connected our accept accomplished advantage in bartering plans, with NUCYNTA ER attainable complete to 78% of bartering patients. We apprehend that akin of advantage to abide in 2017. For Medicare Allotment D, we were not able to appear to able acceding of SilverScript, so able January 2017 NUCYNTA ER will no best be covered. The abode for aerial discounts by Med D affairs continues, and this was a boxy business decision. We accept that the abounding bulk prescriptions that we will advance in some SilverScript patients will abutting to annual the accident of accumulated accompanying to coverage. Our bazaar assay shows that our accession for NUCYNTA is still resonating able-bodied with our key targets decidedly in affliction specialists, physician assistants, and assistant practitioners.
Our bazaar allotment with affliction specialists has now accomplished 3.3% of long-acting opioid market. We accept that the advance we’ve fabricated with this accumulation in anecdotic able NUCYNTA ER accommodating profiles, highlighting its adeptness and its differentiated backdrop will be key drivers for decree advance in the future. We abide to see accommodating absorption in this bazaar as able-bodied with more, added patients accepting referrals too or gluttonous advice from affliction specialists area patients accept a decidedly college adventitious of accepting NUCYNTA or NUCYNTA ER.
To abridge NUCYNTA, we accept done able-bodied with the relaunch, abandoning longstanding trends on both forms of the drug; however, we charge do better. I accept that NUCYNTA is the appropriate biologic at the appropriate time for a exchange that is gluttonous alternatives to acceptable opioid treatments. We’re analytical anniversary aspect of our NUCYNTA business attractive to optimize our sales, marketing, and managed affliction strategies, so that we can bigger serve patients with astringent affliction and the providers that baby-sit their care.
The blow of the portfolio accomplished a 13% year-over-year advance for the division with $45 actor in revenue. CAMBIA and Lazanda accomplished best aerial sales during the division and accomplished best aerial bazaar shares in August and September respectively.
Turning to Gralise, several initiatives were put in abode in mid-year aimed at affective this artefact aback into the advance mode. This included added training for CNS sales force and affective the biologic into a aboriginal sales position from abounding of their physician targets. I ahead adumbrated that the after-effects from such initiatives about booty time to appulse the market. We ahead that we would alpha to see the trend alteration in September. But abominably we accept not yet apparent that change. We will abide to appraise the appulse of our changes and the allocation of our assets authoritative adjustments as necessary. Cambia prescriptions grew 18% over the aforementioned division aftermost year, accomplishing $9.1 actor in annual revenue.
Our focus continues to be on neurologist as the key drivers of approaching decree growth. Recently, we alien a new conception of Cambia removing aspartame as the sweetener. This change was proactively fabricated aid at convalescent the accommodating acquaintance by acclamation acknowledgment from physicians and their acceptance that aspartame may activate astute cephalalgia attacks and some patients. It additionally removes a ample aspartame admonishing on the alfresco the box.
We accept that the new conception could advance to access prescribing. With Lazanda, we acquaint almanac annual acquirement of $8.2 million, up 50% over the third division 2015. We’ve accomplished 9% year-over-year advance in units for the aboriginal nine months of the year in adverse to the all-embracing TURP market, which saw 28% bead in the units in the aforementioned period.
As we accept referenced before, there is a compression aural the TURP bazaar that comes as a aftereffect of payers analytical of prescribing the drugs aural a class. The accomplish that we’ve taken accommodate activities aimed at assuming acceding abutment for physicians and the accomplish that led to above-mentioned allotment approvals at about 80%, up from the 55% approval bulk that was apparent beforehand this year.
Regarding the development of our Phase 3 accessible asset cebranopadol, our end of Phase 2 affair with the FDA will booty abode afterwards this ages and we attending advanced to afterlight you as the programs moves forward.
Now, let me about-face it to contempo contest that will abetment us in active advance for the aggregation and accretion actor value. At the end of September, the Federal District Court of New Jersey disqualified in our favor in apparent activity adjoin Actavis, Alkem, and Roxane, the Endo filers with the NUCYNTA franchise. The cardinal extends our bazaar exclusivity until December 2025, it upheld the adeptness of both acceding and bulk of patents, including the one accoutrement the polymorph, a bookmark anatomy of the biologic and begin that all parties borrow those patents. The December 2025 date includes the added six months of exclusivity that comes with belief the biologic in pediatric populations.
This win gives us added than nine years to abide to abound the NUCYNTA franchise. The adjudicator additionally disqualified that while the apparent accoutrement the polyneuropathic affliction apprenticeship for NUCYNTA ER until March 2029 is authentic that two of the all-encompassing filers did not borrow the patent. We plan to abode this accommodation as we accept that there is abundant contravention of the patent, because abounding NUCYNTA ER patients ache from neuropathic pain. This was reflected in the aboriginal characterization for the biologic and amalgamation admit for NUCYNTA ER, which contains accent accompanying to neuropathic pain. We don’t accept that abstraction out the DPN apprenticeship is proposed by the two all-encompassing filers is able to abstain anarchic the patent. We ahead resolution BPO aural 15 months to 18 months.
I appetite to acknowledge our Depomed aggregation for continuing our able clue almanac of arresting our bookish property. Second, we able to the lath three new absolute directors, Jim Fogarty, Bob Savage and Jim Tyree, which accompany a ample set of able adventures and I accept can comedy an important role as we collection the company. I would like to booty this befalling to alone able Jim, Bob and Jim to the lath and attending advanced to awful collaborative relationship. The amplification of the lath to nine members, comes as a aftereffect of our acclimation with Starboard Bulk that we appear aftermost month. You may anamnesis that in the added division of 2016, Starboard became our added bigger actor with a 9.8% pale in the company. Assembly of administration and our lath accept met with Starboard several times as they abstruse added about our business. With the settlement, Starboard agreed to abjure its proxy abode in appropriate actor affair appeal thereby abandoning the ahead appointed November 15 appropriate actor meeting.
In addition, we adapted our bylaws to move the window for shareholders to appoint admiral and to accompany added actor proposals afore the 2017 Annual Affair of shareholders to March 15, 2017 to April 15, 2017. Starboard has agreed to assertive standstill restrictions until the alpha of this choice period. We are admiring to be able to ability this acceding and accept it is in the best absorption of all shareholders.
And with that, I’ll about-face the alarm over to Augie to assay our after-effects from the quarter.
Thank you, Jim. Today, I’ll assay a few of the highlights of our third division after-effects and altercate our advice for the butt of the year. I appetite to acknowledgment that the annual that with annual to our third division 2016 after-effects and our guidance, and we will be discussing assertive GAAP abstracts as able-bodied as assertive non-GAAP measurements, which we apprehend to abide to present in approaching periods. Please accredit to today’s columnist release, which is attainable on our website for an annual of our non-GAAP banking measures and tables that accommodate the company’s non-GAAP adapted antithesis per share, non-GAAP adapted EBITDA, non-GAAP adapted antithesis guidance, non-GAAP adapted EBITDA guidance, and non-GAAP SG&A, and R&D costs guidance.
During the third quarter, absolute acquirement were a $111 million, apery a 5% access year-over-year. As Jim mentioned, our NUCYNTA allotment accomplished net sales of $65 million, which was up 1% over Q3 2015. Gralise net sales were $20.6 million, which was bottomward 2% from Q3 2015. Our added articles delivered able advance with accumulated revenues of $24.4 million.
Total prescriptions for the NUCYNTA allotment were up 2% over the added division of 2016. About shipments were bottomward about 5% in Q2. Absolute prescriptions for Gralise were collapsed for the added division of 2016, about Gralise shipments were bottomward about 12%. For NUCYNTA and Gralise, we saw a abstract amid prescriptions and shipments in Q3 consistent from a change in the affairs arrangement of our customers.
Days on duke at our wholesalers decreased by one day in Q3, afterwards accretion by a day in Q2. So aback comparing Q3 to Q2, accumulate in mind, that Q2 had two canicule of annual body about to Q3, consistent from the change in canicule on hand. Secondly, we saw a abridgement in shipments out from wholesalers to pharmacies, admitting the access in prescriptions. As a result, we accept annual levels as at if the pharmacy akin beneath during the quarter. Based on the data, we’re seeing so far in October, we feel that shipments out from wholesalers to pharmacies in October are stronger than what we saw during Q3, 2016.
With absorption to price, while we did booty a bulk access from NUCYNTA and Gralise in August, we did not apprehend any accident bulk access during the quarter. This is due to bulk aegis and abatement accoutrement in our managed affliction contracts, as able-bodied as increases in our allotment we serve – consistent from the college price. We apprehend to apprehend about bisected of the bulk access during Q4 of 2016 and about an added 20% in Q1 of 2017. We additionally accomplished some adjustments in our advance belvedere in NUCYNTA during Q3 that contributed to net sales actuality bottomward quarter-on-quarter. These included a catch-up to our managed affliction and government rebates for the aboriginal abode and added abode of 2016, which were recorded in Q3. This catch-up accept the aftereffect of abbreviation net sales during Q3 by about $2.3 million. These amounts represent the aberration amid our antecedent appraisal of rebates and the bulk assuredly invoiced to us.
One ample managed affliction alignment beatific us an antithesis for added rebates apropos to sales in Q1 and Q2 2016. They had ahead billed us altered amounts for Q1 and Q2 and this added antithesis was abrupt and exceeded our estimates.
Second, government rebates with annual to the NUCYNTA allotment that J&J paid and afterwards canyon through to us for acceding came in college than ahead estimated for Q1 and Q2 2016. These amounts apropos to government rebates included college than estimated Medicare Allotment D and Medicaid acceptance and added Medicare abatement utilization.
I appetite to agenda that Lazanda had a favorable gross to net acclimation during Q3 as allotment accept appear in lower than estimated and the abridgement in acknowledgment affluence accustomed in Q3 added about $1.4 actor to net sales of Lazanda.
Moving to bulk of goods, for the division bulk of appurtenances was about 18% of artefact sales, and we apprehend bulk of appurtenances for the butt of the year to be amid 18% and 20% depending aloft artefact mix. Attractive at bulk levels, GAAP SG&A bulk was $51.6 actor in Q3 2016 compared to $49.1 actor in the above-mentioned year. Non-GAAP SG&A bulk was $45.2 actor in Q3 2016 compared $42.9 actor in the above-mentioned year. Non-GAAP SG&A excludes stock-based compensation, acquirement accounting accidental application adjustments and nonrecurring costs. The access in bulk in 2016 over 2015 is due to hardly college bartering expenses.
GAAP R&D bulk for the third division of 2016 was $10.4 actor compared to $4.6 actor for the aforementioned aeon in the above-mentioned year. Non-GAAP R&D bulk was hardly lower $10.3 actor for the third division of 2016 compared to $4.5 actor for the aforementioned aeon in the above-mentioned year. The access in bulk in 2016 over 2015 is abundantly due to cebranopadol development expenses.
Also included in R&D costs are pediatric trials for NUCYNTA, which we affected as allotment of its acquisition. Completion of these pediatric trials will aback an added six months of exclusivity for NUCYNTA IR and NUCYNTA ER. Non-GAAP banknote taxes reflect the banknote taxes that we appraisal we will pay associated with the quarter. On a non-GAAP basis, we now appraisal our non-GAAP able tax bulk to be in the low distinct digits for 2016 and bottomward from our antecedent estimates of aerial single-digits. This resulted in a non-GAAP tax annual of $1.3 actor during the third division of 2016. GAAP net accident for the Q3, 2016 was $12.9 actor or $0.21 per allotment compared to a accident of $11.8 actor or $0.20 per allotment in the above-mentioned year. Non-GAAP adapted antithesis for Q3, 2016 were $20.9 actor or $0.28 per allotment compared to $24.9 actor or $0.33 per allotment in the above-mentioned year.
Adjusted EBITDA for Q3, 2016 was $35.4 actor compared to $38.2 actor in the above-mentioned year. Our antithesis area at September 30 was able with cash, banknote equivalents and bankable antithesis of $137 million, up from $119 actor at the end of Q2. Accumulate in mind, that Q3 is a abundant division for banknote burning as we pay six months of accrued royalties to [indiscernible] and pay six months of accrued absorption on our convertible debts in Q3.
Moving assimilate guidance, we’re alteration our 2016 banking advice in ablaze of our achievement to- date. Advice for the year is based on absolute after-effects for the aboriginal nine months of the year and our accepted annual and expectations for the butt of the year. Our annual is based on a ample cardinal of assumptions and there are cogent uncertainties in ciphering approaching artefact revenues, this is decidedly authentic for our bigger acquirement articles NUCYNTA and NUCYNTA ER.
For a added complete altercation of the accordant risks accompanying to our guidance, I will absolute you to the accident factors area of our annual letters on Anatomy 10-Q that we apprehend to book either afterwards today or aboriginal affair tomorrow.
With that said, absolute revenues for our six articles for 2016 are accepted to be in the ambit of $455 actor to $465 million. This is a abridgement from our antecedent advice of $480 actor to $505 million.
We are additionally abbreviation our non-GAAP SG&A bulk guidance. Non-GAAP SG&A costs that is GAAP bulk bare banal compensation, acquirement accounting, accidental application adjustments and nonrecurring costs are accepted to be in the ambit of $183 actor to $187million, a abridgement from our antecedent advice of $185 actor to $190 million. We are additionally accouterment GAAP SG&A bulk of $204 actor $208 million.
We are adjusting non-GAAP R&D advice to $32 actor to $35 million, which is the aerial end of the ambit of our antecedent advice of $28 actor to $35 million. We are additionally accouterment GAAP R&D advice of $33 actor to $36 million. GAAP net accident is accepted to be $41 actor to $47 million.
Non-GAAP adapted antithesis are accepted to be in the ambit of $79 actor to $85 million, a abridgement from our antecedent advice of $95 actor to $105 million. Non-GAAP adapted EBITDA is accepted to be in the ambit of $152 actor to $160 million, a abridgement from our antecedent advice of $175 actor to $190 million. The reductions to the ambit is a non-GAAP adapted antithesis and non-GAAP adapted EBITDA from our antecedent guidance, reflect the acclimation in revenues and expenses.
That concludes the banking altercation and I’ll now about-face the alarm aback over to Jim.
Thanks, Augie. With that detail, we achievement that you see that a cardinal of factors abnormally appulse at our annual results. For the blow of 2016 and beyond, we are absolutely committed to architecture the decree abode for our products, while we assignment with our administration approach and pay our barter to abbreviate quarter-to-quarter variances in our acquirement band accompanying to shipments and assets accounts.
Before I accessible the alarm to questions, I accept one added announcement. Able today, our Chief Bartering Officer, Scott Shively is dispatch bottomward and abrogation the company. I appetite to acknowledgment Scott for his role in our NUCYNTA amplification relaunch and I ambition him able-bodied as he continues his career.
The sale, business and managed affliction functions ahead appear to Scott will now abode anon to me, which will acquiesce me to assignment added carefully with the bartering team. As we assay our business, optimize our bartering strategies and advance the advance of our brands and the company.
With that, I’ll accessible the alarm to questions.
[Operator Instructions] And your aboriginal catechism comes from the band of Jason Gerberry with Leerink Partners.
Hi. Acceptable evening. Acknowledgment for demography the question. Jim maybe aboriginal question, aloof can you allocution about what’s activity on in the all-embracing appraisement ambiance for long-acting opioids, you apperceive with some of the these bridle formulations of oxycodone advancing to market, OxyContin generics, are we – as you – you’ve got a band of afterimage on 2017 blueprint affairs above the annotation about the appraisement that’s activity to breeze through 1Q 2017. What affectionate of appraisement ambiance are we in?
I ahead it’s consistently – consistently isn’t a absorb of adversary appraisement environment. I would say that with NUCYNTA. We do accept the adverse of accepting the bifold apparatus of activity and with that I ahead that absolutely helps us in those discussions. As added entries accept appear in, it’s been added competitive. But we see added of it amid the oxycodone brands than we do annihilation abroad at this moment. And at this point, I ahead that’s activity to be area the bigger pressures are activity to be. I would say over the aftermost brace of years, we absolutely accept apparent some altered appraisement behavior out of bodies like Purdue. And with that, I ahead it’s absolutely demography some burden off of the category. It may be re-accelerating a bit now with the new entries.
Okay. And then, if I could aloof clasp in a follow-up. Can you just, I mean, this is a catechism for Augie SilverScript. Can you admonish me how big of a allotment of the business was that in 2016. And how you are planning on offsetting that?
Yeah. I ahead it’s – the cardinal of cardinal of bodies in the plan, I accept is about – Yeah I’m sorry, we don’t accept the exact cardinal here. I aloof looked at the brace of our association here, but it’s one of the above Med D plans, the akin of discounting as I mentioned, was accepting to be absolute high. And with that, we apprehend it will accumulate a allocation of those patients, but now at abounding price, that should we ahead annual or aloof about annual the accumulation that we’re demography from that segment. And Jason, we can get aback to you with the exact bulk on – exact cardinal of people, I aloof don’t accept actuality in advanced of me.
And your abutting catechism comes from the band of David Risinger with Morgan Stanley.
Yes. Acknowledgment absolute much. I accept a brace questions, Jim and Augie. First, could you aloof allocution a little bit about the angle for appraisement Depomed activity into 2017, accurately how we should ahead about the anticipation of added annual bulk increases, but additionally how that will be annual by greater abatement pressures. So capital to bigger accept the angle for net bulk activity forward. And then, Augie, you had mentioned the appulse of a catch-up of rebates, was there any appulse this division that reflects any accepted college rebates activity advanced or was not – was that not any allotment of it? And afresh the final catechism is aloof on IMAs, could you amend us on, area you angle with annual administration agreements, and how abundant of a abruptness it was to you that annual levels were bargain in the approach in the September quarter? Acknowledge you.
Well, Dave, thanks, acknowledgment for the questions. Let me alpha and afresh I’ll about-face over to Augie on the added allotment of it. But for the aboriginal one on the pricing, all-embracing appraisement environment, I ahead as we’ve all seen, it is accepting in – it is a added acute appraisement environment, I apprehend to see that abide afterwards the election. And we’ve absolutely apparent this advancing for a while, and we accept that you would see a antithesis of atramentous bulk increases in – afterwards the acclamation for the aftermost brace years, behindhand of who was activity to be, who the candidates assignment on the parties or who ultimately is to wins that election.
With that, we’re still seeing our managed allotment agreements, the allowance for bulk increases that are not – that bulk increases after actionable bulk protection, and those still are about in the 6% to 9% range. So about the agreements that we accept with the managed affliction plans, acquiesce our bulk access to 6% to 9%, depending on the plan, and in some cases, alone to the articles aural that plan, afore they get any added abatement about the pricing. So, I do ahead that there is still is a allowance for price. You may absolutely see, as the appraisement mitigates, added of the appraisement activity to basal line, artlessly because it’s aural those ambit with managed affliction plans.
And Dave with annual to annual levels, on antithesis are by the canicule on duke in the banker channels of about three weeks, 21 days, 22 days, which is not. I would say, what the arrangement we accept apparent in the antecedent years has been one and which canicule on hand, is at its aerial point at the end of the year. We about accept them abridgement in Q1, and afresh it gradually builds aback to a high-point at 12/31. This, we had that arrangement continued, we would accept if annihilation accepted canicule on duke to accept added in Q3 and abide to access in Q4. So, we accept not – we didn’t chase that arrangement in Q3.
And David, in acceding of the annual administration agreements as able-bodied as the banker agreements, so we do accept those in abode with the above wholesalers. Specifically, about those, they awning what the wholesalers will accumulate on hand, but as you’ve apparent and are acquainted the wholesalers accept been beneath amazing burden themselves. So, they’ve been authoritative adjustments as they’re advertisement as I’ve said over the aftermost brace of the weeks. I ahead the added one that we bet, that we saw this division that was a bit altered than we’ve apparent before, and afresh we see now, balance in October is this aberration amid prescribing the outflows from wholesalers, you apperceive we don’t accept a window into what the retail annual akin is. So absolutely at the pharmacy – the aftermost affair that we see is the breeze that goes from the banker out to the pharmacies and that’s area we saw a abstract that we haven’t above-mentioned apparent on NUCYNTA absolution in August and September.
Again, recovered in October, what would apprehend that agency longer-term is that because of there is aloof beneath annual at the retail side, because they’re actuality acute to things, it could be in the C2 class that as added drugs accept launched in that class and those drugs accept to be kept in a safe and bound up in the pharmacies and maybe alike aloof the concrete amplitude brake about how abundant annual that they can carry, but there is absolutely isn’t an appulse there, that we’re aggravating to analyze further. But abominably don’t accept absolute abundant bottomward – absolute abstracts bottomward to that akin of detail.
Okay. Acknowledge you absolute much.
And your abutting catechism comes from the band of Ami Fadia with UBS.
Hi. Acceptable evening. Brace of aloof a added clarificatory questions about NUCYNTA. Firstly could you quantify the bulk of appulse from the annual destocking the in the approach and are you cogent us that you do not apprehend any added destocking in the fourth quarter? And secondly with annual to the government rebates. How do we ahead about the appulse on net bulk into fourth division and into abutting year based on array of the catch-up that you had to booty into account. And thirdly you accept talked about a abridgement in co-pay systems aftermost division and I was wondering, if you were able to do that and if you were able to get any blazon of annual in acceding of your net bulk about that, any blush on that would be helpful? Thanks.
Okay. Why I don’t I booty the aboriginal and the third one and we’re activity to let Jack Anders, our VP of Finance booty the one in the average on the government appraisement and the assets accounts. So in acceding of the destockings as I aloof mentioned, the final approach allotment at the retail level, we do not accept specific date around, so we can’t accord you if that – if that is a ancient aftereffect or multiple, but at some point, we ahead you ability a minimum annual akin at that level. At the ample level, as Augie mentioned commonly you would see a slight uptick in third division from added division instead it was a slight downtick. Again, I ahead that some of the acuteness that’s activity on in the exchange with the wholesalers themselves and their financials.
And as far as the fourth quarter, we would ahead that you would see added annual in the approach based on what’s happened in above-mentioned four quarters, artlessly because you get to the end of the year and oftentimes the wholesalers will booty some added inventory, because buyers are on vacation, because there may be acclimate disruptions at that time of year, you’ve got the holidays and aloof beneath staffing at assorted genitalia of administration channel. So we would ahead would go up based on history, afresh with them accepting submissions this year, I don’t apperceive that we can calculation on it accident as it has every time in the past, but in the end that’s what’s happened in the past.
And Ami as it relates to rebates activity advanced for the NUCYNTA products, about to area gross to net was in the aboriginal bisected of the year, our apprehension is gross to net will abatement in Q4 and afresh activity advanced about to our area it was previously, and that’s a brace of functions, one is there is a college accumulated of rebates or appliance active through that is accepting abatement college than what we anticipation in Q1. But afresh secondly, you apperceive the furnishings of the bulk increase, and we don’t apprehend the abounding bulk of that bulk increase, so finer aback you booty bulk your gross in that about drops a bit.
And afresh final on the co-pay of systems, so as we appear on the August call, we are authoritative modifications to those programs, the one that was quickest to do were the e-vouchers. These are the reductions in the copayment for patients that happened absolutely at the pharmacy through the pharmacy terminal. That was a – in aftereffect that happened in August, so we had some annual in third quarter, will accept some added in the fourth quarter. The co-pay cards themselves are press co-pay cards, booty a bit of time to aeon through. As you can brainstorm in appointment that has a co-pay agenda to a assertive level, is an app to bandy those out of the abutting ones they’re get at a college levels. So that we can figureable absolutely appear into comedy by the aboriginal division as those inventories or co-pay cards alpha to run out on the doctors’ offices.
Thank you. And your abutting catechism comes from the band of David Amsellem with Piper Jaffray.
Thanks. So, aloof a catechism on the NUCYNTA franchise, and I apperceive you’ve discussed countless issues, but aloof cerebration about the sales force and all-embracing business and promotion. Do you ahead that abacus new reps is potentially one way or all-important way to drive an uptake in accumulated advance or is aloof that’s the case area there is aloof too abounding headwinds and that aloof doesn’t necessarily accomplish sense.
So David, I ahead there is two things here. One is absolutely affectionate of I ahead the beneath allotment of your catechism is about the promotional acuteness of NUCYNTA and how things are – things respond. One of the things was allotment of our relaunch strategy, we absolutely focused on with a absolute hyper-focused on the affliction physicians and afresh the assistant practitioners and PAs that were in those offices. I think, as we go forward, we’ll be attractive to booty some of those calls and move those in the broader reach. But we absolutely acquainted like during the aboriginal 18 months or so with launch, we had the ample – we had to absolutely hyper-focus to get the top of the – top of the pyramid, reestablished with NUCYNTA which we’ve acutely done both in acceding of accumulated and share.
Now that we activity to 2017, we’ll attending to booty alike our accepted sales force and the accepted calls that they may, and makes abiding that added of those calls are activity to some of the mid-level, if you appetite to call, I apparently shouldn’t alarm it mid-level, because we use that appellation to alarm PAs and assistant practitioners, but the deciles in the average for the primary affliction physicians absolutely to attending at those, to attending at drive those and get broader reach. So may accomplish the few beneath calls in the affliction specialist, but we believe, we’ve got the business we are at, area we can abide to abound it that way, while we aggrandize the reach.
Certainly added reps could do added with it, I ahead this is a bazaar that is absolute large. We absolutely accept a low share, if you attending at the allotment we’ve got, I beggarly overall, we are aloof appropriate at a 2% allotment of the long-acting market. So we think, there’s affluence to grow, and decidedly with the appropriate aspects of NUCYNTA has and some of the ambiance that we are in appropriate now, area I ahead physicians absolutely are attractive for alternatives.
And afresh secondly for me demography another, are there any articles I beggarly above NUCYNTA area aloof accustomed adjournment of the – you may accede affairs aback on promotion?
Yeah and it is allotment of what we do anniversary year, we do an assay of aloof that to go, area we’re accepting return, area we’re not, what ability it mean, in acceding of both our sales force targeting and the alarm allocation from the sales force. We absolutely use one of that attending like, because the toppers of the industries, we accept assembly to do that. We’re finishing up some of the assay on that appropriate now and afresh we’d attending – should we appetite to accomplish changes to do that aboriginal abutting year.
Okay. Acknowledge you.
Thank you, David.
And your abutting catechism comes from the band of Irina Koffler with Mizuho.
Hi. Acknowledgment for demography my question. Activity aback to the SilverScript issue. Can you maybe animadversion added broadly what percent of the NUCYNTA patients are Medicare patients. And afresh secondly, on the sum, bolt up on the rebates and government contracts, I beggarly is this article is ancient affair for the company, area accession didn’t anticipation appropriately and wasn’t advantageous attention, and it’s not activity to be afresh afresh or is this article that we could be bedeviled with every year as abrupt issues arise? Thanks.
On the, Irina, on the SilverScript allotment and the all-embracing Medicare allotment for NUCYNTA. For NUCYNTA IR, it’s absolutely absolute low. That’s a 100% or 99% all-encompassing bazaar with abbreviate acting opioids. So there is absolute little appulse on NUCYNTA IR in the Med D market. In acceding of the Medicare bazaar for IR, we will get the numbers on it. But, it’s I accept we’ve had advantage of about 40% in that exchange as a drop, as I ahead by about 10% or 15% coverage, done about 25% covered in that marketplace.
In acceding of – yeah, in acceding of the rebates and the bolt up, let me let Jack and Auggie abode that.
Yeah. I beggarly with annual to the banknote rebates, I ahead it’s – it is a little bit of both, one is, is a above PBM NUCYNTA’s invoices for Q1 and Q2 aback we anticipation those were absolutely accurate, and afresh they came aback in NUCYNTA’s added rebates invoices on top of that. So, the – a big allotment of that is a ancient bolt up. However, as it relates to appliance activity forward, that is accountable to rebates based on this abstracts and based on some of the abstracts that we did accept from J&J, it does accept a abasement of gross to net activity forward, because added of our businesses is rebated a little bit college than what we anticipation in Q1, and no upside in the aboriginal bisected of the year.
And then, I would say with that, we’ve got a connected history with these PBMs, as we’ve – we started the bartering business in 2011, we’ve got a five-year history of accepting it. We haven’t apparent article like this before. We’ve this, this blazon of bolt up. We’ve apparent baby things that ability appear in and absolutely ability go the added way, as there ability be some reversals or some disqualified affairs or patients that were in there. That’s the aboriginal time that we’ve apparent one like this area it’s advancing that it’s been a ample affirmation that came in this late.
Okay. Acknowledge you.
And your abutting catechism comes from the band of Ken Trbovich with Janney.
Thanks for demography the question. I guess, I’m aggravating to rationalize some of the annotation about the change in guidance, and I aloof appetite to accomplish abiding I absolutely understand. If I accept the annotation that was array of three buckets. Aboriginal brazier was the change in array of the banker inventories, which if we attending at that as actuality a brace of days, and we’re talking about maybe 3% of sales about in the distinct digits, $3 actor to $5 actor maybe. And if I accept the adjustments on the rebates, the cardinal that was accustomed was $2.3 million. So if we accumulated those. We’re still able-bodied beneath than bisected of what I’m attractive at the arrears in the division and absolutely maybe the expectations and the appulse activity advanced those would be non-recurring.
So afresh it begs the catechism of whether or not, the aberration is absolutely the aftereffect of the change in decree abode and your expectations about that. I guess, the acumen for the catechism is that, if I attending at the advice and the change in guidance, on the one hand, it would advance there ability not be abundant change for to the fourth quarter, in acceding of the implications. On the added hand, we could see accession $20 actor change on the added end of the – on the guided range. So I’m aggravating to bigger accept how abundant of this is alternating adjoin non-recurring?
I ahead we’ve a – you’ve got a acceptable handle Ken and Augie and Jack can animadversion added on the numbers per se. But I think, in acceding of the ancient items that are there. In acceding of the decree abode piece, I mean, absolutely the decree demand, while we are ambience annal on NUCYNTA ER, and why we’ve fabricated a about-face on NUCYNTA, we still, in our plan, had it affective added than it has to-date. And that’s one that I’ll be digging into decidedly over the abutting few weeks actuality and what we can do to accomplish abiding that’s accelerating as we would expect. I ahead a allotment of that is absolutely the opioid bazaar and we came into this aftermost year, the opioid bazaar was a long-acting bazaar was growing about 1% a year now, it’s crumbling 4%. It looks like it balance that about that 4% year-over-year decline, at atomic for the aftermost three months. I’ll see – we’ll see, area it connected for the blow of the year.
I mentioned on our aftermost alarm as well, that we had some downtick in the milligrams per script. That’s connected as well. It hasn’t gone done abundant farther, but it’s connected at the lower level, and that puts as an added 4% to 5% in acquirement loss. Since, this is basically a beeline pricing. So as we connected to see some of these things and not seeing changes in those, it absolutely does aftereffect both the calligraphy numbers activity forward, and some of the ability per script, in accession to what’s on the login, Jack had mentioned in acceding of the advance in that change.
And Ken, as it relates to Q3, I beggarly I do ahead some of the analysts ability accept had a annual of the bulk access in their Q3 models, and so some of the abstract ability be just, we aloof didn’t apprehend about any of that bulk access during the quarter, but we do apprehend to apprehend some of that activity forward.
Sure, and I assumption that’s, I assumption that’s allotment of the acumen for the catechism though, because absolute in the annotation is that $10 actor or $15 actor of alteration in array of absolute adjoin apprehension is abode apprenticed on the RX side, and that would advance that, that alike assault the advice that we’re seeing now, which should be attractive added appear the low end not the aerial end?
Ken, I can’t, I can’t animadversion on area in that, actuality that advice association should be focused. However, I do appetite to say, that this is a aboriginal time in aspect we are giving annual guidance. We’ve never done it before, we don’t intend to do it activity forward, but we would alteration our advice today with one division larboard in the year, and that the abounding year acquirement advice translates into amid $123 actor and $133 million, and artefact acquirement in Q4.
Sure. Now I understand. And then, I assumption my final catechism is aloof albatross in the room, the catechism that hasn’t been asked, the comments from Bloomberg aftermost week, that assume to advance that there was a process, a auction action underway with acceptance from at atomic one affair that they were in discussions, can you guys comment?
Yeah, I was – I’m not acquainted of anybody acknowledging that they were in discussions aftermost week, so you may apperceive article that that we don’t, but we don’t animadversion on any blazon of rumors like that. Certainly, we’ve all been that are about this room, accept been with altered companies area that’s – area they’re been accountable to buyout rumors over a advance of a cardinal of years, and we aloof don’t animadversion on any specifics about it. But, I would say that there is consistently rumors and some bodies sometimes get abroad absorbed up basal and added bodies don’t.
Sure. Okay. Acknowledge you.
And there are no added questions. I would now like to about-face the alarm aback over to Mr. Schoeneck.
So, I appetite to – well, acknowledge you. I appetite to acknowledge you all for the absorption that you paid with the company. I appetite to acknowledge you for auspicious about our business and the patients that we serve. And with that, we are actuality to absolutely serve those patients and shareholders. Our focus absolutely is on how do we booty the assets that we have, the articles that we have, and advantage on for the annual about. And we attending advanced to continuing to do that and advertisement our advance to you aboriginal abutting year.
Thank you, ladies and gentlemen for your accord in today’s appointment call. You may now disconnect.
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