Clearside BioMedical Inc (CLSD)

[finesand]

Compilation: Financials & Drugs (3)

Financials

4Q18 PR https://www.sec.gov/Archives/edgar/data/1539029/000156459019007356/clsd-ex991_14.htm

Cash, cash equivalents and short-term investments totaled $40.9 million as of December 31, 2018. Since then, Clearside has augmented its year-end 2018 cash balance with $5.6 million of net proceeds from sales of common stock under its at-the-market facility.
..
We are prudently allocating funds to our near-term priorities and have reduced research & development (R&D) expenses by closing down the two large Phase 3 studies in retinal vein occlusion (RVO).
Based on our current plans for commercializing XIPERE, R&D activities, and anticipated available funding facilities, we believe we will have sufficient resources to fund our planned operations into the first quarter of 2020, including the potential launch of XIPERE for the treatment of macular edema associated with uveitis.

2018 10-K https://www.sec.gov/Archives/edgar/data/1539029/000156459019007887/clsd-10k_20181231.htm

10-K Page 69

Based on our current research and development plans, including the discontinuation of clinical development of XIPERE together with an anti-VEGF agent for the treatment of RVO, our plans to reduce certain administrative expenses and our timing expectations related to the approval of our NDA submission, we expect that our existing cash, cash equivalents and short-term investments will enable us to fund our operating expenses and capital expenditure requirements into the first quarter of 2020. Accordingly, we have plans to mitigate this going concern risk, which primarily consist of raising additional capital, potentially in a combination of equity or debt financings, or entering into potential collaborations, partnerships and other strategic arrangements. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our capital resources sooner than we expect. These conditions raise substantial doubt about our ability to continue as a going concern within one year after the date the financial statements are issued.

- 2019-03-11 OS 36.04M
- 4Q18 Cash ~ $46.5M ($40.9M + $5.6M shares sold; Down from $65M QoQ)
- 4Q18 Burn ~ $24M (R&D Costs)
- 4Q18 Debt ~ $10M
- 4Q18 Total Liabilities $20.5M
- 4Q18 Equity $23.63M (Down from $44M QoQ)

- Going concern risk
- Cash until 1Q20

- ~$10M debt: 2019 to 4Q22: $0.6M, $3.3M, $3.3M, $2.8M

Today, they should have at least ~$22M cash left being in end of 1Q19.
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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Offerings

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.

2019-03-15 $18.54M ATM ongoing https://www.sec.gov/Archives/edgar/data/1539029/000156459019007893/clsd-424b5.htm

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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.