Novartis (NVS)

[flatlander_60048]

NVS typically announces the proposed dividend in Jan. ratifies it at the annual mtg in feb and pay it out in April.

FL

[DewDiligence]

Not to worry—NVS pays only one dividend per calendar year.

[urche]

When is the next dividend?

I see the last ex-dividend date was 3/1/10. Is that a regular annual event? I am considering adding some shares, but don't want to just buy a December dividend in a taxable account.

Urche

[Ecomike]

I agree, but you and I don't count, LOL!

Not a quote, just means that what counts is the strong hands with FED dollars buying enough shares to push it up to $100/share. I don't have that kind of cash, so my opinion is just that, a nearly worthless opinion, LOL. But I am long, and happy about.

[DewDiligence]

Novartis Shares Are Cheap, Says Barron’s:

#msg-56670900

[Ecomike]

Shorts are agressively piling on here. Up 28% yesterday and need 5 days to cover. We might get another new high soon if the market rally continues.

http://shortsqueeze.com/?symbol=nvs&submit=Short+Quote%99http://shortsqueeze.com/?symbol=nvs&submit=Short+Quote%99

[flatlander_60048]

4th quarter looking strong

Barring unforeseen conditions (like the buyout of the minority Alcon stake), the combination of recent drug releases (Gilenia,m-enox), flu vaccine and one time items ($35M MNTA payment, $500M Enablex sale) should make for a strong year end for NVS.

FL

[DewDiligence]

Onbrez (QAB149) non-inferior to Spiriva in COPD:

#msg-56227067

[DewDiligence]

Yes, the withholding applies to ADR’s (eom).

[DewDiligence]

NVS Planned Submissions 2010-2014

[urche]

taxes on foreign stocks.

The 15% tax on dividends certainly applies to numerous foreign stocks I have owned. But I can't recall an example of a dividend producing ADR in my portfolio, other than NVS--which I have not held long enough to get a dividend. So, I just want to be sure that ADRs are treated like foreign tickers such as the Canadian royalty trusts which usually trade on pink sheets with strange US tickers.

If so, it seems worth it to clean up the IRA portfolio by selling some foreign stocks that I am otherwise very happy holding.

Urche

[DewDiligence]

I see what looks like great news today on a brain cancer drug FDA approval for NVS!

The new Afinitor approval is for benign brain tumors, not brain cancer. It’s a very small indication that won’t move the needle for a company as large as NVS. Regards, Dew

p.s. One thing that will move the needle for NVS is generic Lovenox, which had $292M in 3Q10 sales following the launch on July 23 (#msg-55774996).

[DewDiligence]

The 15% withholding for dividends has applied to all of the foreign companies I’ve ever owned, which have included companies from about 20 countries on five continents. I’ve never owned shares of a Greek company, however, so it could be that Greece is an exception.

[Ecomike]

I don't recall having this problem with Greek shipping company stock dividends.

I see what looks like great news today on a brain cancer drug FDA approval for NVS!!!!

[DewDiligence]

It’s best to hold NVS in a taxable account so you can apply the 15% Swiss tax withheld from your dividend against your 2010 US income-tax liability. When the shares are held in a tax-exempt account such as an IRA, you can’t recover the 15% Swiss tax and you are simply out the money. Regards, Dew

p.s. The above applies to any foreign dividend-paying stock, not just NVS.

[Ecomike]

I just noticed that I am getting dinged about 15% with a foreign tax on my quarterly dividends, plus a small fee, in my Fidelity IRA account where I have my NVS shares.

Anybody have any clue WTF that is about? A foreign dividend tax on a tax exempt IRA? First I ever heard of this nonsense!!!!

I am going to need to watch the daily history on my account more closely it seems.

[DewDiligence]

Get lost (eom).

[Ecomike]

Interesting shorts data, they need 6 days to cover. A lot of bets that we topped out here.

http://shortsqueeze.com/?symbol=tteg&submit=Short+Quote%99

I am still long.

[Ecomike]

Looks like real good news here today. New 52 high coming today? Again?

http://ih.advfn.com/p.php?pid=nmona&article=44896359&symbol=NVS

[Tungsten]

no ive never heard that before, ever. Thanks for pointing out the obvious that has escaped me.

[DewDiligence]

I was thinking of entering a position but now im not sure it has my style of volatility.

What the heck does that mean?

Im confused, shouldnt this stock be going up?

Ever heard of sell on news?

You may be interested in #msg-54712817 although, based on your prior post, I rather doubt it. Regards, Dew

[Tungsten]

Im confused, shouldnt this stock be going up? I was thinking of entering a position but now im not sure it has my style of volatility.

[DewDiligence]

FDA approves Gilenya with first-line label: #msg-54677007.

[DewDiligence]

NVS Reports Positive Phase-3 Data for 4CMenB in Infants:

#msg-54312729

[DewDiligence]

NVS, Portola Advance Elinogrel to Phase-3: #msg-53876832.

[DewDiligence]

FDA approves Tasigna in first-line CML: #msg-51437844.

[kookiekook]

Looks like Wall Street expects a positive vote today infrom the FDA Advisory Comittee. The stock (PM price = 46.83) is up about 4.5% since the release of the comittee reports, etc being presented today.

[Ecomike]

Thanks for the update!

Long NVS.

[DewDiligence]

The list of questions for the advisory panel is in #msg-51021749. Regards, Dew

[kookiekook]

NOVARTIS (NVS)

The adgenda for June 10th FDA advisory committee meeting concerning Gilenia is posted at:

http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PeripheralandCentralNervousSystemDrugsAdvisoryCommittee/ucm204899.htm

The only major concern appears the dosage. I believe it will be recommended for approval by the committee with the stipulation that testing at lower dosage be undertaken.

[flatlander_60048]

Afinitor meets Pancreatic cancer endpoint

With the use as a stent coating, kidney cancer, transplantation and half a dozen ongoing trials, this is begining to look like a pipeline in a single drug.

http://investorshub.advfn.com/boards/read_msg.aspx?message_id=50871739

FL

[kookiekook]

FDA Advisory committe set to meet June 10th to review Novaris's GILENIA NDA

http://www.fda.gov/AdvisoryCommittees/Calendar/ucm207667.htm

June 10, 2010: Peripheral and Central Nervous System Drugs Advisory Committee Meeting Announcement
Center Date Time Location
CDER June 10, 2010
8:00 a.m. - 5:00 p.m.
Hilton Washington DC/Silver Spring
The Ballrooms
8727 Colesville Road
Silver Spring, Maryland

Agenda
The committee will discuss new drug application (NDA) 22-527, with the proposed trade name GILENIA (fingolimod hydrochloride) 0.5 milligram (mg) capsules, by Novartis Pharmaceuticals Corporation. The proposed indication for this new drug product is treatment of relapsing forms of multiple sclerosis.

Meeting Materials
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.

Background Material1
Public Participation Information
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

Written submissions may be made to the contact person on or before May 26, 2010.
Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before May 18, 2010.
Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by May 19, 2010.

Contact Information
Diem-Kieu Ngo
Center for Drug Evaluation and Research (HFD-21)
Food and Drug Administration
5600 Fishers Lane (for express delivery, 5630 Fishers Lane, Rm. 1093)
Rockville, MD 20857
Phone: [phone]
Fax: [phone]
E-mail: [e-mail]
FDA Advisory Committee Information Line
1-800-741-8138
(301-443-0572 in the Washington DC area)
Code: 3014512543
Please call the Information Line for up-to-date information on this meeting
A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Website and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.

Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Diem-Kieu Ngo at [phone] at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings.

Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings2 for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).

- - Links on this page:http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PeripheralandCentralNervousSystemDrugsAdvisoryCommittee/ucm204899.htmhttp://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm
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[DewDiligence]

1Q10 results with a few annotations: #msg-49185209.

[urche]

Good point.

I also appreciate the currency diversifiction and enormity of the company. All in all, this seems to be a good hedge , likely to be a sound, if not stellar investment heading into very uncertain times.

Urche

[flatlander_60048]

The best reason to buy is the tie to emerging markets. They are on a pace to eclipse N Amer. in 5 yrs.

[urche]

Thinking of buying some

Novartis is looking tempting to me for the following reasons that seem flimsy individually, but compelling considered together.

--Not much news or comment here lately, while the overall market has risen, making it look relatively attractive. It has been suggested that the company is reeling/adjusting to Alcon deal.
--Looking for increased safety in diversified large caps in particular, which have not enjoyed as much of the recent gains.
---3.7% dividend
---Impressive pipeline (http://investorshub.advfn.com/boards/read_msg.aspx?message_id=45888821)
---international diversification, dollar devaluation.

Comments or negative views on Novartis?

Urche

[DewDiligence]

Alcon Reports Solid 4Q09 Results: #msg-46581738.

[flatlander_60048]

The Vol on the up days is running significantly higher than on down days. Based on today's results, it looks like NVS should run to 60. Of course overall market and the sector conditions could act as an anchor. If the run to 60 happens it should help silence some of the Alcon minority stakeholder gripping.

The good performance from all units and the recent trend by major pharma to copy NVS' moves (i.e., ABT getting into eye care, pfe & MRK starting generic units etc.) strongly demonstrates the quality of the management at NVS.

NVS would be completely blowing the doors off the competition if the FDA did not render a couple questionable decisions (i.e, Galvus, Prexige, etc.). NVS has taken these shots by FDA in stride and has proceeded to gain approval for these products in the developed and emerging markets in the rest of world. This has resulted in geographic diversification. N. America use to account for 40% of sales about 2 years ago, it is now down to 32%.

Given the demographic trends, and the earnings visibility I see no reason why NVS should not trade at its historic average PE of about 19. I suspect this will occur as vaccines gains traction and the new vision care group is formed later this year (assuming successful completion of the Alcon deal).

FL

[DewDiligence]

Link correction: the 4Q09-results PR is in #msg-45888763.

[DewDiligence]

Updates

4Q09 results: #msg-45888552.

Senior management changes: #msg-45887968, #msg-45888143.

[flatlander_60048]

It definately has been a sore point. Especially since I'm increasingly hearing reports of adverse events for Januvia. I think NVS decided not to resubmit Galvus in the US do to an apparent bias on the part of FDA.

FL

[DewDiligence]

[Deleted]

[DewDiligence]

The Galvus/Equa approval in Japan is not hugely consequential per se, but the newswire I posted on the other board includes the Japanese approvals of two other big-selling drugs: Afinitor and Exforge. So, all told, it’s a non-trivial development, IMO.

I singled out the Galvus approval because the non-approval of Galvus in the US has been a sore spot from longstanding NVS longs. Regards, Dew

[DewDiligence]

I think NVS and MNTA are poised to get approval for M-enoxaparin (generic lovenox). I believe Sanofi had about $3B in sales of this drug last year. So if NVS MNTA gets the only generic approval, this could be a huge generic launch worth at least an estimated $1B to the NVS/MNTA team.

The NVS/MNTA application for generic Lovenox is in the US only, where annualized sales of branded Lovenox are running at about $2.6B (#msg-43119870). If the FDA approves the generic application from NVS/MNTA and does not approve the applications from other applicants, Lovenox will easily become the largest-selling generic drug of all time from any company. Regards, Dew

p.s. The latest version of the MNTA ReadMeFirst primer is at: #msg-45756105.

[Ecomike]

Thanks for the post. I see a lot of NVS news lately, but no discussion or posts about them here. I am long NVS. Do you think this news is significant, share price wise?

[DewDiligence]

Japan approves Galvus (a/k/a Equa): #msg-45763551.

[Ecomike]

Nice post, and details, Thanks! Some of your post, helps explain in part why NVS has been so free and aggressive with spending money in the acquisitions and expansion (recent China move) areas, other than just grabbing low hanging fruit at distressed prices. Guess I will take a second look at buying more. I am also long.

[flatlander_60048]

Possible 2010 NVS news flow

I think NVS is in the sweet spot for the next two years (i.e., until the Diovan expiration). The positive news flow will be lead by pharma. NVS has had more launcnes in the past 3 years than any other pharma company. The costs of these launches were realized in 2008 and 2009 and now the the sales ramp should help grow the top and bottom line. Look for this to become evident in the 4th qtr 2009 conf call on January 26.

In addition, I'm optimistic for the new drugs in COPD and MS (FTY 720 filed in December). While the FDA contiues to be difficult for NVS and just about anyone in pharma, the rest of world sales are ramping nicely. The EU approval of Onbrez, NVS' COPD is significant since the smoking rates are much higer in some areas of the EU than in N. America. This could also represent a tremendous play on emerging markets. COPD drugs should help emerging market sales since the smoking rates are quite high in the developing and emerging markets.

FTY720 could be a home run by hitting the market in 2010. I believe NVS filed for FDA approval in December 2009. Since Merk Serono got shot down, NVS could have the firs oral MS drug on the market a year or more ahead of the competition.

The over the counter business should benefit greatly by the sales of Prevacid which launched in Mid Nov. I read an independent piece that suggested that it could be poised to be the best selling OTC drug on the market.

Finally, I think NVS and MNTA are poised to get approval for M-enoxaparin (generic lovenox). I believe Sanofi had about $3B in sales of this drug last year. So if NVS MNTA gets the only generic approval, this could be a huge generic launch worth at least an estimated $1B to the NVS/MNTA team.

In terms of the NVS valuation, I have little fear and added more on the recent pullback. NVS is still trading at historically low PE and they are growing the E with a very diversified pipeline (geographically diversified, product offerings are diversified etc.). Even the Alcon accuisition serves to diversify the sources of sales and earnings. The combination of Ciba and Alcon will control about 1/3 of the vision care market and will be the largest player in this area at a time when the baby boom demographic bulge will create peak demand for vision care products (think cataracs, mac. degeneration, etc). While I think NVS paid full value for Alcon, time will prove this to be a tremendous purchase.

The analyst following NVS are pretty limited, so NVS could stand to benefit from additional coverage. This should happen as the sales growth of the new products makes it apparent that NVS will grow its way out of the upcoming Diovan expiration.

Obviously, I'm long NVS. Best wishes for 2010.

FL

[RUSTYJ]

A new plant opens today in North Carolina adds about 300 new jobs sounds good to me

[Zilla]

YES! I love NVS partnerships. :P My TTNP is doing quite well.
I had CHBO when it rocketed up on the news, but that was a mistaken ID. I bought some HTDS today on the pull back and will collect even more because it works with the REAL company bought out 85% by NVS in China... I actually almost bought it earlier in the week and liked it at .01 so the pull back today SCREAMED BUY BUY BUY. So I did. :)
NVS is a long term BEAST. The 3 month line is a rocket. It's too rich for my blood...unless we get a double dip :-O