Eagle Pharmaceuticals inc (EGRX)

[Disquisition]

DELISTING DUMPING

[Renee]

EGRX: delisted from the Nasdaq to the OTC:

https://otce.finra.org/otce/dailyList?viewType=Additions

[Lime Time]

Delist 10/3

OTC

[mcsharkey]

Fairly positive investor analysis for EGRX found at THIS LINKFor what it's worth, an excerpt:

Does Eagle Pharmaceuticals Have A Relatively High Or Low P/E For Its Industry?
We can tell from its P/E ratio of 35.99 that there is some investor optimism about Eagle Pharmaceuticals. You can see in the image below that the average P/E (18.6) for companies in the biotechs industry is lower than Eagle Pharmaceuticals's P/E

And includes this graphic

Eagle Pharma has two 8-Ks almost back-to-back, that cause some pondering. Some data here:

Common Stock (EGRX) Institutional Holdings | Nasdaq.
...
Ownership Summary.
Label Value
Institutional Ownership 95.67 %
Total Shares Outstanding (millions) 14
Total Value of Holdings (millions) $751

Link to FORM 8-K March 13, 2020 - On March 13, 2020, the U.S. Court of Appeals for the District of Columbia Circuit affirmed the decision originally issued by the U.S. District Court for the District of Columbia on June 8, 2018 requiring the U.S. Food and Drug Administration to grant Eagle Pharmaceuticals, Inc., or the Company, seven years of orphan drug exclusivity in the U.S. for BENDEKA (bendamustine hydrochloride injection, or bendamustine HCI), a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine hydrochloride.


Link to Form 8-K March 17th filed yesterday 2020 Eagle Pharmaceuticals, Inc., or the Company, announced that the Company’s Board of Directors, or the Board, approved a new share repurchase program, or the Share Repurchase Program, providing for the repurchase of up to an aggregate of $160 million of the Company’s outstanding common stock.

I realize this has been a tough year.

GLTUA

[mcsharkey]

Eagle Pharmaceuticals to Discuss Fourth Quarter and Full Year 2019 Financial Results on March 2, 2020
WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Eagle Pharmaceuticals, Inc. ("Eagle" or the “Company”) (Nasdaq: EGRX) today announced that the Company will release its 2019 fourth quarter and full year financial results on Monday, March 2, 2020, before the market opens.

GLTA

[mcsharkey]

Good Day Sprycel,
Coming over from the TYME board now. Hoping you're doing well. I'm pretty pleased with EGLX & THYME's basic partnership now. Thinking your brand has saved mine (and others).

Wishing for the best for ALL OF US.

Any insight you have is appreciated. Of course, this is true for any board member here.

You tell me yours, I'll tell you mine.

Damn, that's out of 6th grade:)

GLTUA

[mcsharkey]

Good Day. Any hope here? With TYME board on this site.
Wishing all well.

[Sprycel]

Well after 2 years they got the FDA to back them up.

[Sprycel]

They finally did it after 2 years:

https://seekingalpha.com/news/3435579-fda-backs-exclusivity-eagle-pharmas-bendeka-late-2022

[Denairo]

What is going on with this stock? Just keeps slipping, can’t hold ground.

[Bickema]

Scott Tariff on Biologics acquisition

Yes. So, we will report Randall on how we are dealing with the biologics business regularly. You will see news flow coming out of Eagle over the course of this year about what we are doing. This technology – there is two very important aspects to this acquisition. First, the technology in viscosity reduction of biologics can be used in so many ways that will benefit patients and our shareholders. We have the ability with this technology to help branded companies with first time biologics lower their viscosity. What does that do for them? We are seeing situations where we are having discussions about reducing the number of injections. We are having discussions about how to take subcu IV drugs turning them into subcu drugs. And we also have the opportunities we discussed in the past at great length is going to the biosimilar market and taking some biosimilars in giving those individuals a chance to have a leg up on their competition and take these IV biosimilars to a subcu route. We can also go to biosimilars that have multiple injections and reduced a number of injections as a way to improve the products in the biosimilar space. We continue to work on molecules in-house on our own for a proof-of-concept and to have animal data and tox data and then take it forward to biosimilar companies and branded companies. So far, we are very pleased with the progress we are making and the reason that we decided to bide down those milestone obligations now and we believe that this technology and this capability will be a significant leg of Eagle’s growth as we start to get to the later stages of the current products that we spoke about today in the pipeline. And so these are products that will come to the market 4 or 5 years from now, but hopefully starting this year and going forward, we will start to sign deals we see milestone payments and so forth as a way to bring value into the company in the near-term. Very, very excited about this acquisition, couldn’t be more pleased since we made it. And then second to that, what we now have is what I will refer is taking the ground in Cambridge, which is just for our industry, just a remarkable place to do business. We have some very talented PhDs and we have access to some very talented people at MIT. And quite frankly, they are helping us with our entire pipeline and our portfolio. They have helped us with fulvestrant, they are helping us with the IM version of Ryanodex, Drs. Langer and Klibanov are about the most brilliant minds in our industry and having them helping us and consulting with us regularly has been just wonderful. And so we are thrilled with this acquisition. And as we sit here today, I am very confident that we will see significant value coming out of this acquisition in the years to come. And you will start to hear more about it as the year progresses as well.

[Bickema]

http://investor.eagleus.com/press-release/eagle-pharmaceuticals-inc-reports-fourth-quarter-and-full-year-2017-results

[Bickema]

WIth a market cap of 880 million and cash on hand at 170 million, per last quarter earnings, Eagle has an EV of 710 million. Which I think looks pretty cheap.

Bendeka is now bringing in roughly 40 million in royalty revenue per quarter. However Treanda generics can launch in November of 2019.

So at the very least Eagle has another 8 quarters of 40 million royalty revenue coming there way. So at the very least, that leaves an EV of (710-320) of 390 million for the entire pipeline including Bendeka post 2019. Again this implies 0 dollars for Bendeka post generics which obviously will not happen.

So I personally think 390 million for the entire pipeline and Bendeka post 2019 generics if awfully cheap, however nothing comes easy for Eagle, most of their products require litigation against the novel drug's developer and Ryanodex expansion has been rough.

Eagle and the FDA are not seeing eye to eye on EHS expansion, Ecstasy and Meth trial recruitments are going slower than expected.

Sorry my post is a bit of rambling, I currently do not own any Eagle shares but will look to add when I have dry powder.

They are currently in litigation with Elly Lilly in regards to their pemetrexed generic so follow that case as it very likely will be the next newsworthy event for Eagle.

[Denairo]

Have not been here in quite a while, not sure who’s the moderator or DD guru. Can you save me some up front time and give me the skinny on current position and pending developments, and should I dig deeper or just move on? Any help is greatly appreciated!!!!!

[Bickema]

Dew how much of the 700 EV for Eagle would you ascribe to Bendeka?

Treanda generics hit the market in Nov 2019, so Eagle has approx 8 full quarters of 97% market share at roughly 40 million in Revenue per quarter.

I think its fair to say Bendeka is worth $400 million on the low side so that would leave $300 million to account Eagle's entire pipeline - Ryanodex, Pemetrexed, Falseodex.

If Lilly licenses Eagle's pemtrexed than Eagle is severely undervalued. I would model a partnership similar to that with TEVA, Pemetrexed generics won't hit until May 2022.

[make it happen]

big news Only 40 mil market cap cash till 2020

[Bickema]

Eagle Pharmaceuticals Announces Positive Results of Study Conducted to Evaluate Neuroprotective Effects of RYANODEX Secondary to Nerve Agent Exposure

http://investor.eagleus.com/press-release/eagle-pharmaceuticals-announces-positive-results-study-conducted-evaluate-neuroprotect

Eagle is going for a full on blockbuster drug with Ryanodex, just going to take some time.

Long term Eagle is undervalued here IMO, pemetrexed overhang currently keeping me out.

[GD]

Suing the FDA for Bendeka's Orphan application was a huge mistake,
now FDA gets their revenge, they make the rules and change them
any way and time they want, it is better to get on with good side
of FDA, IMO.

[stugwins]

Classic Scott Tarriff.... A typical salesman without situational awareness. Just empty fluff..

Remember when he sued the FDA for Bendeka's Orphan application?

He should feel lucky he stumbled on bendamustine.. All else is BS (Arsia, Ryanodex, Agniomax, etc, etc...)

[DewDiligence]

EGRX receives CRL for Ryanodex in heatstroke: #msg-133316969.

[Bickema]

Too hot to handle: Study shows Earth's killer heat worsens

https://www.yahoo.com/news/too-hot-handle-study-shows-150320127.html

[bio_fan]

Class action lawsuit update

Judge tosses Eagle Pharmaceuticals investors' case over rejected drug

Eagle Pharmaceuticals Inc has won the dismissal of a lawsuit accusing it of misleading investors about the likelihood of the company's gaining Food and Drug Administration approval to market a ready-to-use version of the blood thinner Angiomax.

U.S. District Judge Jose Linares in Newark, New Jersey, ruled the plaintiffs in the proposed class action lawsuit had not sufficiently alleged facts supporting their claim that Eagle's statements about the drug's characteristics were false.

[W4]

Replacing a CFO is one of the biggest red flag's there is. No explanation from management makes it look even worse.

The president bought 200 shares? Are you kidding? Such a huge vote of confidence. lol

[GD]

What about at the beginning CEO said more news on Monday
with earnings reports, but where is the news bedsides the
earnings report? My guess is what ever is the news, the deal
did not get done before Monday, hence the stock tanked from
95 to 86, some one knows what it is and coming up soon,
than we had the two days back up and holding today, feel
like HS approval any day, shouldn't take FDA that long to make
a decision since the data set is very small and Ryanodex
is already approved drug. we may see what ever the news
any day now, IMO.

[bio_fan]

Interesting comment from the Deutsche Bank conference about hopefully announcing "new licensing agreements over the course of the next month" for the biologics division.

33 mins into the webcast.

[GD]

EGRX is acting strange(strong), is buyout from TEVA finally
happening or Ryanodex approval any day now leaked?

[Bickema]

FDA Grants Priority Review for Eagle Pharmaceuticals’ Ryanodex NDA for the Treatment of Exertional Heat Stroke

http://investor.eagleus.com/press-release/fda-grants-priority-review-eagle-pharmaceuticals-ryanodex-nda-treatment-exertional-hea

Under the Prescription Drug User Fee Act (PDUFA), the FDA will aim to complete its review within six months of the NDA submission; the PDUFA date for the NDA has been set for July 23, 2017.

[Bickema]

EGRX Financial Update as of 12/31/16 from JP Morgan webcast

50 million - Cash
37 million - Accounts Receivable
25 million - Bendeka Milestone Payment anticipated in Q117


Tariff said they have bought 37 million worth of stock are are continuing to buy back their shares

also, said Eagle could benefit greatly from changes to corporate tax rates

[Bickema]

Eli Lilly's Alimta escapes early generics—and a sales hit—with patent win over Teva

http://www.fiercepharma.com/pharma/eli-lilly-prevails-teva-s-alimta-patent-challenge

Chalk up a win for Eli Lilly in a much-watched patent tussle over the blockbuster cancer med Alimta. A federal appeals court said generic versions from Teva and others would step on a key Lilly patent, a decision that could shield the company's big seller until 2022.

Lilly’s “vitamin regimen patent” has been “confirmed in every validity challenge to date,” Michael J. Harrington, the company's SVP and general counsel, said in a statement. The decision by the U.S. Court of Appeals for the Federal Circuit follows two earlier wins at the appellate level.

If the company survives all remaining challenges, it’ll have exclusivity on the drug until May 2022. Lilly has a compound patent on Alimta through next January.

Used to treat advanced non-small cell lung cancer and mesothelioma, Alimta is a top seller for the drugmaker, pulling in nearly $2.5 billion in 2015 sales. Through the first 9 months of 2016, it delivered $1.74 billion in sales.

In the past Tariff has said they think they have a way around this but I am not up to date or a current shareholder. I will listen to the JPMorgan webcast to get the latest.

[DewDiligence]

This was the first 2017 guidance for Bendeka/Treanda, so it wasn't actually lowered, but it was lower than investors expected. TEVA didn't give a reason for the low guidance, and no one on the hour-long CC last week asked about it.

My assumption is that the NHL/CLL arena is becoming more competitive with several newly approved drugs, which is reducing Bendeka/Treanda's market share.

[jsmith77]

But why did TEVA lower their sales guidance? Another drug on the market?

[DewDiligence]

Low 2017 sales guidance for Bendeks/Treanda.

[jsmith77]

What was the reasoning for the drop?

[DewDiligence]

EGRX -7% on TEVA’s 2017 guidance: #msg-127680719.

[DewDiligence]

[OT]—MNTA's first NVS partnership deal (for generic Lovenox) was badly negotiated from MNTA's standpoint, and that gives me a somewhat negative opinion of Alan Crane. I don't feel strongly about it, however.

[Bickema]

Dew are you aware that MNTA's former CEO Alan Crane is a Arsia Therapeutics co-founder?

Do you have an opinion on him?

[Bickema]

Something to note here is that Eagle's largest shareholder, Proquest, who had been very active selling shares recently and who acquired their original stake of 4.8 million shares in the IPO, hasn't sold a share since the day after Eagle announced the acquisition.

Maybe they have sold and haven't had to file yet? I am not sure on all the legalities on 13D's

Proquest Claims to have over $900 million in management, this would make their share in Eagle approx. 1/3 of their entire portfolio. I would expect them to continue selling shares at returns of over 500%.

Maybe I am looking to far into this...

[stugwins]

Instead of me trying to articulate why this doesn't make sense why don't we ask EGRX to articulate why it does and we can then collectively have a good laugh...(notice the market dropped 10% on the news of the agreement?)

All I'd like to say here is that many many "technology" companies tried to do what you suggest but realized that it ain't working.

[bio_fan]

msg was duplicated. Wouldn't let me delete this one.

[bio_fan]

"Who knows what Biogen and the other companies have in mind! They may have a great product that only needs the resolution of a viscosity problem but the core of their product is covered by some other IP. Does this even matter to EGRX? "

That's exactly what Eagles plans are.
Work with partners and license their technology to them to resolve the viscosity problem.
The partners will pay for all clinical trials.
Eagle would receive upfront, milestone and royalty payments.

[jsmith77]

Ryanodex is looking like its going to bring in a lot of profit once/if approved. I listened to the whole investment day recording and think that they greatly underestimated it themselves. $2300 a vial, likely $250M+ per year if approved for EHS. I'm liking where this company is going.

[stugwins]

That's the problem with intellectual lightweights (Tarriff is just an example..). They pay more attention to what other people say and do rather than having knowledge and conviction themselves. Aware of their shortcomings, they easily get bedazzled by academic stars like Langer without understanding the fit to their business plan.

Who knows what Biogen and the other companies have in mind! They may have a great product that only needs the resolution of a viscosity problem but the core of their product is covered by some other IP. Does this even matter to EGRX?

What is the fit of ARSIA to EGRX? Can somebody articulate a scientifically sound rationale? Does EGRX have any scientists, patents, know-how that gets complemented by ARSIA? Does EGRX even understand what biologics and biosimilars are?

For all I know, Langer&Co found a bunch of bumpkins loaded with money (just by serendipity...) and they sold them a waaaay overvalued asset..

[bio_fan]

I guess Biogen and 11 other companies that Arsia has deals with do not believe its a bluff.
Biogen's deal is worth 100Mil

[DewDiligence]

Agreed (eom).

[stugwins]

Dew, I fully understand your disappointment.
I voiced concerns about Tarriff in the past (ethics at Par, understanding technology, etc) and today he just proved me right. As somebody with low self-confidence would do, he was bedazzled by academic titles, ignored the fundamentals and ventured into something he (and his organization) doesn't understand and don't have the horsepower to compete in..Arsia seems more like an academic bluff rather than a real company.

To put it simply, creating solid IP around viscosity modification is next to impossible. Somebody will always find something better (or close enough..).

Pity...

[DewDiligence]

I cashed out today (#msg-126485051), so I'm resigning as board moderator.

EGRX still has a lot of potential, of course, but the risk/reward tradeoff just became less favorable, IMO.

GLTA

[DewDiligence]

I wasn't expecting this move (see bottom of #msg-126484009), but the company being acquired has some high-profile principals.

[Bickema]

Eagle Pharmaceuticals Initiates Rolling Submission of NDA for Ryanodex in Exertional Heat Stroke

http://investor.eagleus.com/press-release/eagle-pharmaceuticals-initiates-rolling-submission-nda-ryanodex-exertional-heat-stroke

[Bickema]

Eagle Pharmaceuticals Signs Definitive Agreement to Acquire Arsia Therapeutics Marking Entry into Biosimilar Market

http://investor.eagleus.com/press-release/eagle-pharmaceuticals-signs-definitive-agreement-acquire-arsia-therapeutics-marking-en

Under the terms of the stock purchase agreement, Eagle will pay approximately $30 million at closing, $27.3 million of which will be paid in cash and $2.7 million of which will be paid in Eagle common stock. Eagle has also agreed to pay up to $48 million in additional payments upon the completion of certain milestones, for aggregate potential payments of $78 million.

[DewDiligence]

Very nice!