Indivior Share Discussion Threads

[gregmorg] 23/5/2023 07:38

Yup the PDUFA has come thru on score. A very nice additional product and it will be interesting to see the projected build up to the designated $250-300m revenue target that the Co highlighted

[la forge] 23/5/2023 07:26

Jeremy Cutler

07:38 Tue 23 May 2023



Indivior PLC (LSE:INDV) announced that the US Food and Drug Administration (FDA) has approved its Opvee (nalmefene) nasal spray for the emergency treatment of known or suspected opioid overdoses induced by natural or synthetic opioids.

The ruling covers adults and pediatric patients aged 12 years and older.

Opvee is expected to be in the market in the fourth quarter with annual net revenue of $150mln to $250mln expected.

Indivior added Opvee to its portfolio with the acquisition of Opiant Pharmaceuticals which closed in March.

Opvee contains nalmefene, an opioid receptor antagonist that provides fast onset and long-duration reversal of opioid-induced respiratory depression, which is the primary cause of opioid overdose injury and death.

Opvee was designed to address the challenges of what the firm called “today's opioid crisis.”

"Opvee's FDA approval represents a significant achievement in the development of new treatment options to address today's era of opioid overdoses that are driven by powerful synthetic opioids, such as fentanyl," said Mark Crossley, Indivior CEO in a statement.


Proactive

[gregmorg] 19/5/2023 15:10

I see the Indivior share price movement today and have presumed that the PDUFA for OPNT003 with a designated date of 22 May 2023 is somewhat behind it

[casholaa] 27/4/2023 19:06

Sorry, I assumed you were aware of Opiant. And just to confuse you, unless I've got it wrong -as I often do, if you divide the the share price by 5 (remember the 1 for 5?), I think we're effectively at the 300p mark where we were last year and now with less shares, more money and more assets??? dyor + gla etc

[disc0dave45] 27/4/2023 18:40

CashThanks but IMO it's a profit warning despite all the decent Q1 numbers.In Feb in their FY23 guidance they said operating profit was expected to be higher than $212m, they've now said it will be lower.Even their Q1 adj op profit is only above Q1 last year because they reduced some exceptional staff costs etc by $14m - but haven't seen an explanation (or missed it).Will read again as clearly the market liked what they said today and hopefully for holders it will continue upwards now.

[gregmorg] 27/4/2023 13:55

well, I listened to the webcast as well and was pleasantly reassured by the direction. As a long term holder, I guess I would say that anyway!
The Company's comments on the outstanding US litigation was constrained by current talks with the litigants/their lawyers it is having to resolve the issues-- exactly as one would expect. However, as far as UK uptake is concerned, we all know that very few UK institutions are likely to increase their exposure till they see this threat is well behind it. the UK appears to be seriously risk adverse probably explaining why so many growth companies seek other listings.
Nasdaq listing now programmed for June, a month or so later than I had expected but the revenue growth , trading news and projected pipeline looks good to me. We will see.

[adrian j boris] 27/4/2023 13:14

Indivior raises 2023 revenue forecast following Opiant acquisition

Thu, 27th Apr 2023 13:46
Alliance News

(Alliance News) - Indivior PLC on Thursday said net revenue increased by more than 20% in the first quarter, lifting profit, and it updated its guidance for the year following its acquisition of Opiant Pharmaceuticals Inc last month.

Indivior is a pharmaceutical company headquartered in the US state of Virginia that is focused on treatment of addiction.

It said pretax profit increased by 21% to USD58 million in the three months that ended March 31 from USD48 million in the first quarter of 2022. Operating profit rose by 5.6% to USD57 million from USD54 million. Net income increased by 7.3% to USD44 million from USD41 million.

The profit improvement came as net revenue grew by 22% to USD253 million in the first quarter from USD207 million a year before.

Indivior reported a 20% rise in selling, general and administrative expenses to USD131 million from USD109 million. Research and development expenses increased by 20% to USD27 million from USD12 million.

Indivior updated its guidance for 2023 following the completion last month of its acquisition of Opiant, a biopharmaceutical company developing addiction and overdose treatments, for about USD145 million.

Indivior now anticipates net revenue of between USD970 million and USD1.04 billion, a 12% increase from the mid-point of 2022. In February the company had said it expected net revenue of between USD950 million and USD1.02 billion this year.

Indivior said it expects adjusted operating profit for this year to be slightly below last year's adjusted operating income of USD212 million, having in February predicted higher income. Indivior said it incurred USD12 million of exceptional costs related to the Opiant acquisition.

Opiant's late-stage assets include investigational opioid overdose treatment OPNT003. Immediately after the acquisition Indivior said it expected OPNT003 to generate peak net revenue of between USD150 million to USD250 million.

Indivior's Chief Executive Officer Mark Crossley said: "Our first quarter results reflect strong momentum across the business and continued dedication of the entire Indivior team to our patients. Sublocade (buprenorphine extended-release) injection continues to power our growth as we drive greater depth of prescribing across Organized Health Systems in the treatment of moderate-to-severe opioid use disorder.

"Within the quarter, we also completed the acquisition of Opiant Pharmaceuticals Inc This important strategic step strengthens our addiction portfolio through the addition of OPNT003 (nalmefene nasal spray), a new potential option for opioid overdose reversal which we expect to launch in the U.S. in the fourth quarter...Finally, we look forward to the additional US listing of our shares on Nasdaq in June."

Shares in Indivior were up 5.0% at 1,543.00 pence in London on Thursday afternoon.

By Emma Curzon, Alliance News reporter

Comments and questions to [e-mail]

[casholaa] 27/4/2023 13:11

No need to pump as it's likely beyond the reach of many retails investors, but this sounds good to me:

"Indivior now anticipates net revenue of between USD970 million and USD1.04 billion, a 12% increase from the mid-point of 2022. In February the company had said it expected net revenue of between USD950 million and USD1.02 billion this year."

[casholaa] 27/4/2023 12:50

I read it as exceptional outgoings had a negative impact on the bottom line. The adjusted figures look good to me? Have a look at "3. OPERATING EXPENSES AND NET OTHER OPERATING INCOME "

[disc0dave45] 27/4/2023 12:44

Must be missing something, operating profit now to be less than FY22....I'd pencilled in $239m now it's less than $212m.Haven't digested all of the update yet just skimmed through so more informed opinions welcome, thanks.

[casholaa] 27/4/2023 11:29

Stellar results imvho. dyor & gla.

[casholaa] 25/4/2023 20:28

We're going to Las Vegas... get your jumpsuits cleaned.

[casholaa] 19/4/2023 10:16

Thank you W. I suspect it's news about the dual-listing.

[waldron] 19/4/2023 09:56

Calendar


April/27 | 12:00pm Earnings Release


Perhaps they be knowing something

[tommibone] 19/4/2023 09:36

For what though? What's the positive?

[casholaa] 18/4/2023 09:37

I think Blackrock picked up a few too from the rns yesterday

[steeplejack] 18/4/2023 08:11

Roivant Sciences is Two Seas second largest holding and has just received a bid from Merck.Clearly,Two Seas think that there are reasons to believe that Indivior could be in the headlines.

[steeplejack] 18/4/2023 07:37

Two Seas Capital now has an interest of over 10%.Formerly known as Kairos Capital Management,they announced a holding of around 5% back 2020.

Two Seas Capital LP seeks to generate outsized, uncorrelated returns through investments in events with a legal or regulatory catalyst.Looks like this hedge fund hopes to benefit from volatility on the back of impending legal proceedings.

[casholaa] 31/3/2023 13:09

They'd be daft not to start a further buyback at these share price levels, the share price appears to me to be at around the level it was at the start of October 2022.

[steeplejack] 31/3/2023 07:54

That's true and a 3% holding in 'financial instruments' confirms as much.

[dealy] 30/3/2023 19:31

I find these brokers to be only intermediate holders. this is not really investment. same across many UK stocks

[steeplejack] 30/3/2023 15:18

Morgan Stanley continues to sell.Soon be under 3% of the ord equity……but it has financial instruments (CFDs i presume) giving a total holding of a bit over 6%.

[dealy] 30/3/2023 08:40

very low volume last 2 days. most other small / mid caps have bounced. catch up opportunity here

[dealy] 29/3/2023 17:16

fair comment