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Akebia Therapeutics (AKBA)- Vadadustat FDA Approved AT LAST!!

Posted on 2/1/21 at 12:56 pm
Posted by bayoubengals88
LA
Member since Sep 2007
19075 posts
Posted on 2/1/21 at 12:56 pm
While I realize that it's nice to throw a few hundred or a few grand at the next 200% gainer, that's not really my thing. As some of you know, I've been accumulating shares of AUPH for right at four years now. It's main drug (voclosporin), now marketed as Lupkynis, has shown stellar data from Phase I all the way to a nod from the FDA (22 Jan). Though I'm up more than 300% on my original shares, the stock price is still relatively low, and value is just starting to be realized as sales have just begun.
Inevitably, I will cash out of my Aurinia position at some point, and I think that identifying the next "AUPH" could be the likeliest road to wealth accumulation for me. For whatever reason, I don't mind a good wait, and I've learned a lot from the "games" and manipulation that accompanies the world of clinical trials and small pharmas.

While AUPH is taking a few years to reach full potential, you should be happy to know that AKBA seems to be much further ahead, yet currently one hell of a bargain. Without further delay, here's the DD:

MISSION
To address complications related to chronic kidney disease (CKD), specifically anemia. Approximately 5.7 million Americans alone are affected by anemia as a result of CKD.

DRUGS
Auryxia - This drus is available now, and has two indications.
1. control serum phosphorus levels in patients with CKD that are ON dialysis.
2. treat anemia in patients with CKD who are NOT on dialysis.

Auryxia competes against the injectable SoC from the early 1990s. Auryxia is an oral treatment.
Sales have been modest, but increasing. 55.5 million in 2017, 96 million in 2018, roughly 35 million per quarter in 2020

Vadadustat
While Auryxia is making money, it seems like the company is much more excited about Vadadustat. Two separate clinical trails concluded in 2020--one for treating anemia due to CKD for people ON dialysis (Innovate) and the other for those NOT on dialysis (Protect).

"Protect" failed on safety.
The measure was MACE (Major Adverse Cardiovascular Events). This failure sent the stock from over $20 to $3 immediately.

And here's where the uncertainty lies... Akebia is expecting to file a singular NDA for both studies at any moment now.
They are confident that the stellar efficacy from Innovate (for dialysis), which met its safety endpoint plus the efficacy of Protect (no dialysis) will be enough...


These graphics are helpful:

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Failed safety withstanding, I think this company is worth a look for three reasons.

1. Auryxia alone is producing 1/4 of the company's current market cap in revenue, and continues to show consistent growth since 2017. Vadadustat would be complimentary to Auryxia as the two drugs treat different aspects of anemia due to CKD.

2. Vadadustat is already approved in Japan and has begun earning royalties thanks to a partnership with Mitsubishi Tanabe. Akebia also has a working relationship with Otsuka, which has paid up front cash, reimbursements for R&D, and future royalties (Otsuka has a similar deal with AUPH in Europe and Asia).

The following quote is from 2017: "Akebia has established three significant collaborations for vadadustat in a little over a year, which together total more than $2.2 billion in potential value and include $573 million or more in upfront payments and committed development funding. In addition to this agreement and the U.S. collaboration with Otsuka, Akebia has established a collaboration with Mitsubishi Tanabe Pharma Corporation for the development and commercialization of vadadustat in Japan, Taiwan, South Korea, Indonesia, India and select other countries in Asia."

3. The potential renal caused anemia market represents a 2B dollar in the US alone. 3.5 billion globally. Therefore, with a market cap of less than 500 million, Akebia is severely undervalued. The company has 269 million in cash equivalents and 143 million shares outstanding.

As a bonus, take a look at institutional ownership. It's above 80% with Wellington and Blackrock owning 12 and 8 percent respectively. Buyout???

$3.17 at time of posting.
This post was edited on 3/27/24 at 8:15 pm
Posted by jrodLSUke
Premium
Member since Jan 2011
22294 posts
Posted on 2/1/21 at 1:11 pm to
What happened in September to cause that plunge in stock value?
Posted by Paul Allen
Montauk, NY
Member since Nov 2007
75292 posts
Posted on 2/1/21 at 4:51 pm to
I do like the low entry point. It’s similar to AUPH in February of 2017.
Posted by oklahogjr
Gold Membership
Member since Jan 2010
36772 posts
Posted on 2/1/21 at 5:12 pm to
Just what I needed another auph style play
Posted by castorinho
13623 posts
Member since Nov 2010
82078 posts
Posted on 2/1/21 at 8:12 pm to
Posted by Powerman
Member since Jan 2004
162266 posts
Posted on 2/1/21 at 8:38 pm to
I like it. Putting 1k into it to start and will probably put in for a recurring weekly buy of 100.
Posted by rintintin
Life is Life
Member since Nov 2008
16203 posts
Posted on 2/1/21 at 10:36 pm to
Nice DD. What kind of timeframe are you looking at? Multi-year type of play?
Posted by LSU in Frisco TX
In the Green
Member since Oct 2006
752 posts
Posted on 2/1/21 at 11:10 pm to
quote:

bayoubengals88


Thanks for the detailed and thoughtful post.
Posted by oklahogjr
Gold Membership
Member since Jan 2010
36772 posts
Posted on 2/2/21 at 1:28 am to
Did some dd. Analyst have a $10 price target? That's like 5x.
Posted by cuyahoga tiger
NE Ohio via Tangipahoa
Member since Nov 2011
5853 posts
Posted on 2/2/21 at 1:18 pm to
As usual great stuff BB. By chance do have any info , like what you have isn’t enough, the institutional put/call ratio?

TIA... I think I’m gonna ride with you again
Posted by WDE24
Member since Oct 2010
54184 posts
Posted on 2/4/21 at 8:58 pm to
For everyone missing AT this evening, here is a pick for you from BB88. Akebia could take off on NDA news.
Posted by rintintin
Life is Life
Member since Nov 2008
16203 posts
Posted on 2/5/21 at 1:39 pm to
Glad I jumped on this yesterday, thanks for the tip.

That huge gap from Septemeber was so tempting.
Posted by PhiTiger1764
Lurker since Aug 2003
Member since Oct 2009
13936 posts
Posted on 2/5/21 at 2:57 pm to
Enjoyed your write up.

This is not something I have ever really done before the GME saga, but I decided to check out the short interest. According to yahoo finance data from January 15, short interest is 23% of float. From my understanding that is pretty high.

Not sure if that has anything to do with the run today, but I decided to buy some cheap OTM calls for 2/19. $5.50 strike price..
Posted by Powerman
Member since Jan 2004
162266 posts
Posted on 2/8/21 at 1:10 pm to
Got in at 3.99

Bought in more today
Posted by BZ504
Texas
Member since Oct 2005
9638 posts
Posted on 2/8/21 at 3:18 pm to
Thank you for this bayoubengals88!
Posted by MrLSU
Yellowstone, Val d'isere
Member since Jan 2004
26062 posts
Posted on 2/26/21 at 2:49 pm to
Looks like a good stock to invest in!
Posted by GeneralLee
Member since Aug 2004
13111 posts
Posted on 3/1/21 at 7:40 pm to
What do you see as the upside potential here if the NDA is filed? Flipped this from $3.5 to $4.3 a few weeks ago and bought back in at $3.35 but concerned that we might be nowhere near the bottom if the NDA is months away, given their earnings disaster on the recent call.
Posted by DawgCountry
Great State of GA
Member since Sep 2012
30591 posts
Posted on 2/21/23 at 3:37 pm to
any news driving this down today?
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