Indivior Share Discussion Threads

[steeplejack] 28/10/2022 06:10

Its more than likely that the Stock Exchange finds the RNS sitting in their “in tray” and decides to release the figures there and then with no regard to the planned time of release.Once the ADRs have been issued,maybe the Stock Exchange will grasp that there is logic behind the company’s desire to release information when the US is up and about.

[waldron] 27/10/2022 10:47

TOP NEWS: Indivior ups annual guidance on "strong momentum"

Thu, 27th Oct 2022 11:05
Alliance News

(Alliance News) - Indivior PLC on Thursday reported a double-digit rise in both quarterly net revenue and profit, as it raises its full-year guidance.

For the third quarter of 2022, the Richmond, Virginia-based pharmaceutical

firm reported net revenue of USD232 million, up 24% from USD187 million a year ago. It said net revenue growth was primarily driven by Sublocade.

Pretax profit increased by 74% to USD54 million from USD31 million. Operating income went up by 47% to USD56 million from USD38 million a year earlier.

Chief Executive Officer Mark Crossley said: "I am pleased to report another strong quarter of top-and bottom-line performance, led by our long-acting injectable medicines, Sublocade and Perseris, which are benefiting from the strategic investments we have made over the past year."

Sublocade is a prescription medicine used to treat adults with opioid drugs addiction, while Perseris reduces symptoms of schizophrenia in adults.

Indivior said Sublocade exceeded the USD100 million milestone in quarterly net revenue "for the first time from continued strong execution against [its] Organized Health Systems strategy".

Its net revenue for 2022 is expected to be in the range of USD405 million to USD420 million, up 69% from USD390 million to USD420 million in 2021 at mid-point.

For the nine months that ended on September 30, total net revenue increased by 16% to USD659 million from USD568 million a year ago.

Looking ahead, Indivior lifted its 2022 net revenue guidance to a range of USD890 million to USD915 million, up 14% from USD840 million to USD900 million at the midpoint a year ago, based on "continued strong momentum of the business

".

It also expects adjusted operating income to be broadly similar to 2021's adjusted operating income of USD187 million, driven by the continued strong Sublocade growth.

Shares were up 1.8% at 1,636.00 pence each on Thursday morning in London.

In July, Indivior posted a 11% slip in pretax profit to USD106 million for the six months ended June 30, from USD119 million the same period a year earlier, even as net revenue rose 12% to USD428 million from USD381 million.

By Xindi Wei; [e-mail]

[youngers] 27/10/2022 10:39

Great results and my only gripe is again they said being released at 7am US time but then released 7am U.K. time. Someone needs to explain time zones to them

[casholaa] 27/10/2022 10:21

Yeah, Truss + Kwatang went and gave all them barristers a pay rise.

[the grumpy old men] 27/10/2022 10:03

Michele Maatouk
Sharecast News
27 Oct, 2022 10:35
Indivior ups FY guidance after solid third quarter

In the three months to 30 September, net income jumped 52% to $41m, while adjusted operating profit was 53% higher at $58m. Net revenue grew 24% to $232m, driven mainly by injectable opioid treatment Sublocade.

Chief executive Mark Crossley said: "I am pleased to report another strong quarter of top- and bottom-line performance, led by our long-acting injectable medicines (LAIs), Sublocade (buprenorphine extended-release) and Perseris (risperidone), which are benefiting from the strategic investments we have made over the past year.

"Sublocade, our paradigm shift in the treatment of opioid use disorder (OUD), exceeded the $100m milestone in quarterly net revenue for the first time from continued strong execution against our Organized Health Systems (OHS) strategy. Additionally in the quarter, we took an important strategic step to elevate the group's profile in its highest value market and attract a broader group of biopharma-focused investors with shareholder approval of an additional listing, which will be in the US."

Based on its overall performance to date and a strong outlook for Sublocade, the group lifted its total net revenue and adjusted operating profit guidance. It now expects FY 2022 net revenue of between $890m and $915m, up from previous guidance of $840m to $900m. Meanwhile, adjusted operating profit is expected to be to be "modestly higher" than 2021.

"A key component of this increase is driven by the continued strong Sublocade growth in the OHS channel leading to narrower guidance of $405m-$420m representing the upper half of updated guidance provided at the half year," it said.

[casholaa] 27/10/2022 07:32

Stellar imho. dyor. gla.

[steeplejack] 27/10/2022 07:25

These are very good results.I suspect the MMs would like to have given the shares a good tonking after recent strength but these figures undermine their bad intentions.Guidance raised,share buyback programme still has around $33m to go,being some two thirds completed.

[adrian j boris] 25/10/2022 10:53

Calendar
10/27 | 12:00pm Earnings Release

[youngers] 25/10/2022 10:46

Some good momentum here ahead of the results on Thursday. Hopefully not just a case of buy the rumour sell the news

[steeplejack] 17/10/2022 06:14

Amongst my portfolio,Indivior shows exemplary resilience!Actually,its the only stock that does.

[the grumpy old men] 16/10/2022 07:55

fwiW just4interest

[steeplejack] 10/10/2022 14:32

Yes both my UK brokers are now correctly presenting my holdings.

[gregmorg] 10/10/2022 13:06

Following on from your comment Steeplejack, I just checked and both Interactive Investor and Hargreaves have adjusted correctly. Fortunately I had ensured that the holdings were all divisible by five so I suppose I got that bit of my arithmetic correct!

[babbler] 10/10/2022 12:04

quick. sell! lol

[steeplejack] 10/10/2022 10:43

Thing is,the broker nominee sites are always behind the curve with consolidations.My holding hasn't been reduced fivefold as yet (it remains the same quantity)but the value has increased fivefold to reflect the post consolidation price.

[gregmorg] 10/10/2022 09:43

You are absolutely correct I have to admit. I had taken note of the change ie around the 1100p mark as the price rather than the quoted price. So for once, it's rather nice to have my mistake pointed out! Thanks

[youngers] 10/10/2022 09:24

Dividing by 5 gets us back to Friday close. No disaster just bad maths ;)

[gregmorg] 10/10/2022 09:07

Ha, ha! Note the qualification " on broker sites" Steeplejack. So dividing by five back to the underlying price and we have a disaster! hopefully a very short term one but the consolidation is rather lumpy.

[steeplejack] 10/10/2022 07:53

Its gratifying to see my Indivior holding valuation has rocketed on broker sites.Never had it so good.

[youngers] 10/10/2022 07:39

Anyone else get excited for 0.25 seconds this morning 😂

[maywillow] 03/10/2022 07:17

FWIW


12. LEGAL PROCEEDINGS

There are certain ongoing legal proceedings or threats of legal proceedings in which the Group is a party, but in which Group believes the possibility of an adverse impact is remote and they are not discussed in this Note 12.

False Claims Act Allegations

-- In August 2018, the United States District Court for the Western District of Virginia unsealed a declined qui tam complaint alleging causes of action under the Federal and state False Claims Acts against certain entities within the Group predicated on best price issues and claims of retaliation. See United States ex rel. Miller v. Reckitt Benckiser Group PLC et al., Case No. 1:15-cv-00017 (W.D. Va.). The suit also seeks reasonable attorneys' fees and costs. The Group was served with the complaint in January 2021. The Group filed a Motion to Dismiss in June 2021. The case was stayed for mediation in September 2021, but the parties did not reach agreement. In March 2022, Relator submitted a request for oral argument on the Motion to Dismiss. On July 21, 2022, the Court entered an order staying the action and reserving a decision on the Group's Motion to Dismiss pending rehearing en banc by the U.S. Court of Appeals for the Fourth Circuit in U.S. ex rel. Sheldon v. Allergan Sales, LLC, which rehearing is currently not scheduled until September 2022.

-- In May 2018, Indivior Inc. received an informal request from the United States Attorney's Office ("USAO") for the Southern District of New York, seeking records relating to the SUBOXONE Film manufacturing process. The Group is discussing with the USAO certain information and allegations that the government received regarding SUBOXONE Film.

I ntellectual Property Related Matters

ANDA Litigation

-- The Group filed actions against DRL in the United States District Court for the District of New Jersey ("NJ District Court") alleging that DRL's generic buprenorphine/naloxone film product infringes US Patent Nos. 9,687,454 and 9,931,305 ("the '454 and '305 Patents") in 2017 and 2018, respectively. The cases were consolidated in May 2018. In July 2018, the NJ District Court granted the Group a Preliminary Injunction (PI) pending the outcome of a trial on the merits of the '305 Patent and required the Group to post a surety bond for $72m in connection with the PI. In November 2018, the Court of Appeals for the Federal Circuit (CAFC) issued a decision vacating the PI against DRL. Separately, DRL filed an amended answer alleging various antitrust counterclaims. The parties reached a settlement following mediation in June 2022, and the case accordingly was dismissed on June 27, 2022. See Note 10 for further discussion regarding settlement payments and timing of those payments.

-- The Group filed actions against Alvogen Pine Brook LLC and Alvogen Inc. (together, "Alvogen") in the NJ District Court alleging that Alvogen's generic buprenorphine/naloxone film product infringes the '454 and '305 Patents in 2017 and 2018, respectively. The cases were consolidated in May 2018. In January 2019, the NJ District Court granted Indivior a temporary restraining order ("TRO") to restrain the launch of Alvogen's generic buprenorphine/naloxone film product pending a trial on the merits of the '305 Patent and Indivior was required to post a surety bond of $36m. Indivior and Alvogen entered into an agreement whereby Alvogen was enjoined from selling in the US its generic buprenorphine/naloxone film product unless and until the CAFC issued a mandate vacating Indivior's separate PI against DRL. The CAFC's mandate vacating Indivior's PI as to DRL issued in February 2019 and Alvogen launched its generic product. Any sales in the US by Alvogen are on an "at-risk" basis, subject to the ongoing litigation against Alvogen in the NJ District Court. In November 2019, Alvogen filed an amended answer alleging various antitrust counterclaims. In January 2020, Indivior and Alvogen stipulated to noninfringement of the '305 Patent under the court's claim construction, but Indivior retained its rights to appeal the construction and pursue its infringement claims pending appeal. Indivior's infringement claims concerning the '454 patent and Alvogen's antitrust counterclaims remain pending in the NJ District Court. Summary judgment motions have been fully briefed, but the NJ District Court has not ruled on those motions. No trial date has been set. In June 2022, the parties participated in court-ordered mediation. The parties did not reach settlement. The court has scheduled oral arguments on the parties' summary motions for August 29, 2022.

Antitrust Litigation and Consumer Protection

Antitrust Class and State Claims

-- Civil antitrust claims have been filed by (a) a class of direct purchasers, (b) a class of end payor plaintiffs, and (c) a group of states, now numbering 41, and the District of Columbia. The various plaintiffs generally allege, among other things, that Indivior violated US federal and/or state antitrust and consumer protection laws in attempting to delay generic entry of alternatives to SUBOXONE Tablets. Plaintiffs further allege that Indivior unlawfully acted to lower the market share of these products. These antitrust cases are pending in federal court in the Eastern District of Pennsylvania. The court has not set a trial date. Summary judgment motions related to the Direct Purchaser, End Payor, and States actions were fully briefed and were argued in December 2021. The deadline for the class exclusion or "opt out" was June 5, 2022.

-- In 2013, Reckitt Benckiser Pharmaceuticals, Inc. (now known as Indivior Inc.) received notice that it and other companies were defendants in a lawsuit initiated by writ in the Philadelphia County (Pennsylvania) Court of Common Pleas. See Carefirst of Maryland, Inc. et al. v. Reckitt Benckiser Inc., et al., Case. No. 2875, December Term 2013. The plaintiffs include approximately 79 entities, most of which appear to be insurance companies or other providers of health benefits plans. The Carefirst Plaintiffs have not served a complaint, but they have indicated that their claims are related to those asserted by the plaintiffs in In re SUBOXONE, MDL No. 2445 (E.D. Pa.). The Carefirst case remains pending.

-- The Group has evaluated the antitrust class and state claims in light of the DOJ settlement under which a Group subsidiary pled guilty to one count of making a false statement relating to health care matters in one state in 2012 (as discussed above under DOJ Resolution). The Group continues to believe its defenses and continues to vigorously defend itself. Select plaintiffs in these matters previously made settlement demands, which were not accepted and are not current offers, totaling approximately $290m, which was used for contingency planning only to model possible downside financial effects. The final aggregate cost of these matters, whether resolved by litigation or by settlement, may be materially different. If the Group were to entertain further settlement discussions, we make no representations as to what amounts, if any, it may agree to pay, nor regarding what amounts the plaintiffs will demand.

Other Antitrust and Consumer Protection Claims

-- In 2020, the Group was served with lawsuits filed by several insurance companies, some of whom are proceeding both on their own claims and through the assignment of claims from affiliated companies. Cases filed by (1) Humana Inc. and (2) Centene Corporation, Wellcare Healthcare Plans, Inc., New York Quality Healthcare Corp. (d/b/a Fidelis Care), and Health Net, LLC were pending in the Eastern District of Pennsylvania. The complaints were dismissed in July 2021. Plaintiffs filed Notices of Appeal in August 2021 to the United States Court of Appeals for the Third Circuit ("Third Circuit"). The Third Circuit heard oral arguments on this appeal on March 31, 2022. Humana also filed a Complaint in state court in Kentucky with substantially the same claims as were raised in the Federal Court case. That case has been stayed pending a decision in the Third Circuit appeal. Cases filed by (1) Blue Cross and Blue Shield of Massachusetts, Inc., Blue Cross and Blue Shield of Massachusetts HMO Blue, Inc., (2) Health Care Service Corp., (3) Blue Cross and Blue Shield of Florida, Inc., Health Options, Inc., (4) BCBSM, Inc. (d/b/a Blue Cross and Blue Shield of Minnesota) and HMO Minnesota (d/b/a Blue Plus), (5) Molina Healthcare, Inc., and (6) Aetna Inc. (collectively, the "Roanoke Plaintiffs") are pending in the Circuit Court for the County of Roanoke, Virginia. These plaintiffs have asserted claims under federal and state RICO statutes, state antitrust statutes, state statutes prohibiting unfair and deceptive practices, state statutes prohibiting insurance fraud, and common law fraud, negligent misrepresentation, and unjust enrichment. In June 2021, defendants' motion to stay was denied and certain claims were dismissed without prejudice. The Roanoke Plaintiffs have filed amended complaints, and the Group has filed demurrers, seeking dismissal of some of the asserted claims. Oral arguments on the demurrers are scheduled to occur on September 1, 2022.

-- The Group has begun its evaluation of the claims, believes in its defenses, and intends to vigorously defend itself. Engagement with the claimants has been minimal. Accordingly, no estimate of the range of potential loss can be made at this time.

Civil Opioid Litigation

-- The Group has been named as a defendant in more than 400 civil lawsuits brought by state and local governments, public health agencies against manufacturers, distributors, and retailers of opioids alleging that they engaged in a longstanding practice to market opioids as safe and effective for the treatment of long-term chronic pain to increase the market for opioids and their own market share, as well as individuals alleging personal injury claims . Most of these cases have been consolidated and are pending in a federal multi-district litigation (MDL) in US District Court for the Northern District of Ohio. Litigation against the Group in the MDL is stayed. Motions to remand are currently being considered by the court in over 50 cases to which the Group is a party (among numerous other defendants).

-- The Court in the MDL held a status conference on June 22, 2022, with county and municipality plaintiffs and certain manufacturer defendants (including the Group) and distributor defendants to discuss what information the parties needed to proceed, whether the parties would entertain settlement and whether there should be any bellwether trials from this subset of plaintiffs and defendants. The court agreed no additional bellwether trials are needed, provided that all of the parties were progressing on a settlement track. Additionally, the court ordered a status conference with this same group of plaintiff and defendants for September 23, 2022.

-- Separately, the Group's response to five individual complaints filed in West Virginia state court that have not been transferred to the MDL is due by August 5, 2022.

-- Given the status and preliminary stage of litigation in both the MDL and state courts, no estimate of possible loss in the opioid litigation can be made at this time.