Indivior Share Discussion Threads

[gregmorg] 02/5/2018 15:30

From webcast I understood the message to be that Sublocade is moving along reasonably faster than the management had estimated . Sales data at the interim figures etc. Plus
management up beat re RBP 7000 to be launched 4th Quarter providing all approvals in place. Somewhat different game with the latter as not previously in that market nevertheless quite upbeat on its prospects . I think I understood the final approvals are anticipated in June.

[sarkasm] 02/5/2018 15:00

KEEP THE FAITH BUT EXPECT A SELL OFF WHICH SHOULD GIVE THE BRAVE ANOTHER BUY IN
OPPORTUNITY


GOOD LUCK

[sarkasm] 02/5/2018 14:57

Indivior chief upbeat on prospects for Suboxone replacement
08:12 02 May 2018
The company provided the update alongside first-quarter financial results
man shooting up
The company has come up with a once-a-month injection for addicts

Indivior PLC (LON:INDV) chief executive Shaun Thaxter believes low-cost copycat competition to its main drug should become “less relevant to our long-term prospects” following the launch of a new, long acting replacement.

The past six months have been taken up with a legal rear-guard against firms hoping to launch a generic version of Suboxone, which is used to treat addiction.

Success for the challengers could wipe out a good proportion of the Indivior’s revenue stream.

Luckily, the company is almost in a position to cede this ground with the introduction of Sublocade, which is a monthly injection for addicts.
Schizophrenia drug too

This, and a treatment schizophrenia, should progressively allow the drug developer to replace the revenues lost to the cheap generics.

“It's still early days in the Sublocade launch and, while we have had to manage some expected logistical complexities, we have been very encouraged by initial patient and physician enthusiasm, as well as by the pace of payor coverage,” said CEO Thaxter.

The update came alongside first-quarter results, which revealed net revenues fell 4% to US$255mln, giving operating profit of US$116mln, down from US$128mln a year ago.

The numbers were in line with expectations, Indivior said, with the top and bottom-line declines reflecting the market “dynamics̶1; for the mainstay product Suboxone Film.

Full-year guidance was “reconfirmed” with net revenue expected in the range of US$1.13bn to US$1.170bn, giving net income of as much as US$320mln.

[steeplejack] 02/5/2018 14:55

Pleasing that Sublocade has got off to a good start.Shares have had a very good run of late.Wouldnt be surprised to see the shares consolidate around this level.

[steeplejack] 02/5/2018 14:30

"Indivior’s shares have taken a beating in recent months after losing a couple of legal cases in its battle to protect the patent of Suboxone Film, which generates 80 percent of its revenues."This geezer must be following a different company from the one I hold.The Indivior I hold has been hitting new all time highs.

[gregmorg] 02/5/2018 09:00

Mm,
Figures give less of a clue than the CEO upbeat comments.

CEO Confident of achieving year's guidance ( at an interesting early stage)and "very encouraged" by Sublocade take up. Will produce sales data at Interim stage so obviously confident on initial reception as stated. Maybe a few punters disappointed that Sublocade sales guidance is not forthcoming yet but it is very early days. Still fighting various patent infringes as vigorously as ever although noted the CEO comment re long term importance.

We will see what extra is said on the webcast call. Much of initial share price move down appears to have been recouped although this story has never been about shorter term share price movements. Admit I have rarely understood those movements anyway!

[waldron] 20/4/2018 09:05

RNS Number : 5738L

Indivior PLC

20 April 2018

Indivior Announces New Drug Submission to Health Canada for SUBLOCADE(TM) (Buprenorphine Extended-Release) Injection for the Treatment of Moderate to Severe Opioid Use Disorder

Health Canada Grants Priority Review Designation for SUBLOCADE(TM)

Slough, UK and Richmond, VA, 20 April 2018 - Indivior PLC (LON: INDV) today announced that it has filed a New Drug Submission (NDS) with Health Canada's Therapeutic Drugs Directorate for SUBLOCADE(TM) (buprenorphine extended-release) injection, for subcutaneous use, for the treatment of moderate to severe opioid use disorder (OUD) as part of a complete treatment plan to include counseling and psychosocial support. Health Canada granted Priority Review status for SUBLOCADE on April 6, 2018(1) . If approved, SUBLOCADE will be marketed by Indivior Canada Ltd.

"The Priority Review designation is an important acknowledgment by Health Canada of the potential for SUBLOCADE to help address the current unmet needs for patients living with opioid use disorder," said Shaun Thaxter, Chief Executive Officer of Indivior. "Indivior looks forward to working closely with regulatory authorities to ensure SUBLOCADE, if approved, will be available as soon as possible to the Canadian treatment community to help address the current opioid public health crisis(2) ."

In granting the Priority Review status for the SUBLOCADE NDS, Health Canada noted that OUD is a serious, potentially life-threatening disorder and that there is substantial evidence of the clinical efficacy of SUBLOCADE in the treatment of moderate to severe OUD(1) . Health Canada also acknowledged that SUBLOCADE has the potential to yield improved efficacy through enhanced adherence, due to its monthly administration(1) .

A Priority Review designation indicates Health Canada's goal to review the NDS within a shortened target of 180 calendar days(3) . Priority Review designation may be granted to drug submissions intended for the treatment, prevention or diagnosis of serious, life-threatening or severely debilitating diseases or conditions for which there is substantial evidence that the overall benefit/risk profile is improved over existing therapies, preventatives or diagnostic agents for a disease or condition that is not adequately managed by a drug marketed in Canada.

The NDS submission of SUBLOCADE to Health Canada follows approval of the drug by the U.S. Food and Drug Administration (FDA) on November 30, 2017.

About SUBLOCADE(TM)

IN CANADA, SUBLOCADE IS AN INVESTIGATIONAL PRODUCT AND ITS SAFETY AND EFFICACY IS CURRENTLY UNDER REVIEW BY HEALTH CANADA.

In the U.S., SUBLOCADE is indicated for the treatment of moderate to severe OUD in adult patients who have initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustment for a minimum of seven days(4) . It should be administered only by healthcare providers and should be used as part of a complete treatment program that includes counseling and psychosocial support(4) . SUBLOCADE has a BOXED WARNING in the U.S. and is available through restricted distribution under the SUBLOCADE Risk Evaluation and Mitigation Strategy (REMS) Program(4) .

SUBLOCADE uses the ATRIGEL(R) delivery system, which consists of a polymeric solution of a biodegradable poly-(DL-lactide-co-glycolide) co-polymer dissolved in N-methyl pyrrolidone (NMP), a water-miscible biocompatible solvent. After subcutaneous injection, NMP diffuses out of the polymer matrix and the polymer precipitates, trapping the drug inside and forming an amorphous solid depot in situ. The depot releases buprenorphine over a one-month period by diffusion as the polymer biodegrades.

About Indivior

Indivior is a global specialty pharmaceutical company with a 20-year legacy of leadership in patient advocacy and health policy while providing education on evidence-based treatment models that have revolutionized modern addiction treatment. Our vision is for all patients around the world to have access to evidence-based treatment for the chronic conditions and co-occurring disorders of addiction. The name is the fusion of the words individual and endeavor, and the tagline "Focus on you" makes the Company's commitment clear. Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of opioid dependence treatments, Indivior has a strong pipeline of product candidates designed to both expand on its heritage in this category and address other chronic conditions and co-occurring disorders of addiction, including alcohol use disorder and schizophrenia. Headquartered in the United States in Richmond, VA, Indivior employs more than 1,000 individuals globally and its portfolio of products is available in over 40 countries worldwide. Visit www.indivior.com to learn more.

[waldron] 20/4/2018 09:04

Indivior's Opioid Treatment Sublocade Gets Priority Review In Canada
Pharmaceutical company Indivior PLC said Friday that the Canadian healthcare regulator has granted priority review to opioid addiction treatment...

[steeplejack] 06/4/2018 09:56

Telegraph article today concentrating on lawsuits against Dr Reddys.

[sarkasm] 05/4/2018 09:01

Indivior PLC (INDV.LN) said Thursday that its U.S. subsidiary, Indivior Inc, has filed new lawsuits against a number of pharmaceutical companies over patent infringements relating to generic versions of its opioid disorder treatment, Suboxone.

The U.K.-listed pharmaceutical company said that it has brought suits against Dr. Reddy's Laboratories Ltd. (RDY), Actavis, Par Pharmaceutical Cos., Alvogen and Teva Pharmaceutical Industries Ltd. (TEVA.TV).

The suits maintain that these companies are infringing its U.S. patent No. 9,931,305, which was issued on April 3. This is not the first instance of patent litigation it's brought against these companies, Indivior said.



Write to Carlo Martuscelli at [e-mail]



(END) Dow Jones Newswires

April 05, 2018 02:34 ET (06:34 GMT)

[steeplejack] 23/3/2018 09:27

This is what mesmerises the market going forward.Takeover?I think litigation issues might put off many a boardroom at this time.We remain confident in Indivior's long-term outlook and vision. With the successful launch of SUBLOCADE(R) (buprenorphine extended-release injection for subcutaneous use) earlier this month, we have the first and only once-monthly buprenorphine depot injection delivery system. With this potentially transformational treatment, we expect to extend our market leading position in the addiction disease space, and we remain confident in achieving at least $1 billion in peak SUBLOCADE(R) net revenue.

[ali47fish] 23/3/2018 09:22

could this become a takeover target not necessarily in the light of the fall today but generally as i am minded to sell

[steeplejack] 23/3/2018 08:31

Got stock at 320.Not good news but not unexpected news.

[steeplejack] 23/3/2018 08:06

Here we go again.

[waterloo01] 23/3/2018 07:33

Oh. Don't follow closely enough to realise this court date was happening. Ouch. Was thinking of investing on the back of this below. Will be holding off.



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12. Sublocade (Once-monthly buprenorphine)
Developer: Indivior
Disease: Opioid dependence
2022 projected sales: $1.07 billion

The scoop: Indivior needed this drug approval, badly. With generic rivals about to crowd in on its standard treatment, a monthly injectable of buprenorphine — using a mild opioid — is a welcome addition to the field of easing opioid withdrawal — one of the hottest issues of the day. The FDA indicated that it would help, and with the agency leaning in favor of the industry like never before, that’s money in the bank.

[steeplejack] 02/3/2018 22:39

Well,i think you did well Greg,ever since i mentioned the idea,it's being going south!Nonetheless,keep on watch,i'm still happy to be in HCM and actually bought some more last week.

[gregmorg] 28/2/2018 18:02

At least all the directors listed took up a good proportion of their awards which must give comfort for the future--not that we need it! Steeplejack, I did look at HCM and was very tempted but then reminded myself of my previous experiences with Chinese owned entities so I abandoned the idea!

[steeplejack] 23/2/2018 16:30

Investors Chronicle 23 Feb

“Indiviors shares are trading at 15 times forward earnings,a significant discount to peers such BTG.However given the amount of litigation it is mired in,that looks justified.”

Hold


An unjustified discount to BTG in my book!Have sold out of BTG.(The management of BTG always strike me as rather pleased with themselves and I can no longer understand why.Perhaps,cynically,when people start getting knighthoods,damehoods and the like their best work is possibly behind them).

[steeplejack] 15/2/2018 20:32

Jefferies, RBC Capital Markets and Numis reiterated their positive recommendations on Indivior as the opioid addiction drug maker's shares slipped on the back of final results on Thursday.Sales, mostly from the Suboxone opioid addiction film, grew 3% to £1.09bn in 2017, in line with management's previous guidance, noted Numis, driven by 2% growth in the US, and 7% outside America "as the opioid crisis spreads".Indivior's directors guided to another year of top- and bottom-line growth in 2018, with net revenue of $1.13-1.17bn and net income of $290-320m, excluding exceptional items and at constant FX and assuming no launch of a generic film rival and "modest" expectations for Sublocade in its first year.Consensus had 2018 revenues of $1,08bn and EPS of circa 32 cents, implying upgrades are likely.The guidance for 2018 "looks well ahead of market expectations and could imply >10% upgrades from consensus", wrote the Numis analysts. "We await more details on costs (lower legals?) in FY18, which appear to be slightly lower than we had forecast, but otherwise happy with our top of the range numbers with the company more bullish than we normally expect at this time of the year."RBC Capital Markets, which stayed with its 'outperform' and 540p price target, said the results have missed its EPS expectations 3.8% due to higher costs, but the 2018 guidance was seen a positive, "in line with our estimates and meaningfully ahead of consensus", and while investor sentiment might focus on the higher DoJ provision, "the company can afford this."