Clearside BioMedical Inc (CLSD)

[finesand]

Compilation: Financials & Drugs (2)

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Financials

3Q18 10-Q https://www.sec.gov/Archives/edgar/data/1539029/000156459018028565/clsd-10q_20180930.htm

- No going concern
- Cash until 1Q20
- Quarterly burn ~ $19M

- 3Q18 Cash $65M
- 3Q18 Debt $10M
- 3Q18 Accounts Payable $11.9M
- 3Q18 Total Liabilities $25M
- 3Q18 Equity $44M

- ~$10M debt becomes due in 1Q20 (as well), final 4Q22

- Next 10-K filing March 4- 18

- 3Q18 ER CC

Based on the estimated reduction in R&D expenses that we expect to come with the previously discussed discontinuation of our combination therapy development and including our anticipated available borrowing capacity under our debt facility, we believe that we will have sufficient resources to fund our planned operations into the first quarter of 2020.

Today, they should have at least ~$33M or $1.04/sh cash left being in the 5th month after 3Q18 ($31.67M burned).
However, based on the ER CC, they expect to reduce the burn rate.

No (debt) concerns IF they get the Uveitis indication approved this year.

Need to read a little about the debt covenants etc,
so far all assets are pledged and lender is the SVB bank and others. Interest 7%+LIBOR.

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Last Offering

Last raise in March, $79M while stock is running up - no dip back then due to strong PEACHTREE Phase 3 Data https://www.sec.gov/Archives/edgar/data/1539029/000119312518075391/d453044d424b5.htm

Days earlier they filed a template 424b5 as an ATM, then as definite share offering.

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Failure Nov'18: Phase-3 XIPERE used together with the EYLEA® .. for the treatment of retinal vein occlusion (‘RVO”)

http://ir.clearsidebio.com/news-releases/news-release-details/clearside-biomedical-announces-sapphire-phase-3-study

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Next: NDA for XIPERE™ for the Treatment of Macular Edema Associated with Uveitis, filed Dec '18
- http://ir.clearsidebio.com/news-releases/news-release-details/clearside-biomedical-submits-new-drug-application-xiperetm

- XIPERE/UVEITIS http://www.clearsidebio.com/programs.htm#UVEITIS

- PEACHTREE Phase 3 Data http://ir.clearsidebio.com/news-releases/news-release-details/clearside-biomedical-announces-positive-topline-results-pivotal

- MAGNOLIA (ext) Data https://globenewswire.com/news-release/2019/01/20/1702660/0/en/Presentation-of-Clearside-Biomedical-s-Extension-Study-of-PEACHTREE-for-XIPERE-Exhibits-Durability-Following-Second-Dose.html

- NDA acceptance by FDA within next 7-10 days?

- NDA approval expected to be within 6 month? Fast track?

- US Launch expected in 2019

- First therapy with this indication

January slides http://ir.clearsidebio.com/static-files/7edc337d-df24-4e66-b1f8-97ff01b3c9a0

Question: Is XIPERE + EYLEA Combo failure for RVO reducing any chance for XIPERE mono (?) success for Uveitis?
Answer: Probably unrelated, more insight would be welcome.

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Napkin Valuation for XIPERE for Uveitis

US Market Size 210k eyes or $466M in 2020 (slides)

We expect the same additional market size of the EU and then probably China - but it would be fair to say double market size world wide!

Let's use conservative multiples now:

$460M US market size -> $23M revenue @ 10% market penetration
$23M gross profits or EBITDA @ 50% margin
$18.4M MCAP or $0.575/sh P/E 1 @ 20% discount late stage phase

P/E 15 is conservative, which we will use here.

P/E 15: $276M MCAP or $8.62/sh for the US only.

Current PT of $5+ can be reached by using P/E around 10, while excluding ex-US licensing income.

Company is not a one drug wonder play, but has several other in their pipeline - do your DD.