Description
Overview
QLT Inc. (QLTI) is an
intriguing small-cap special situation story with 3 main facets: (1) it's
currently trading near its net cash per share of $2.09; (2) a tender offer
outstanding through January 15, 2009 may allow the company to repurchase 27-30%
of its stock at a value-accretive price; and (3) is completing an asset
divestiture program whose final sale should bring in over $2 per share. Three less important sources of value
include: (1) an already marketed drug, Visudyne, undergoing combination therapy
trials to revitalize its market share; (2) three drugs in early-stage clinical
trials and (3) the potential (admittedly unlikely) for a win on appeal of a
patent litigation case that could reverse a $100MM+ patent infringement
judgment.
I lack the expertise to evaluate the future potential of QLTI's
drugs and the outcome of patent litigation, so I will use a simple valuation
methodology: I value the cash and cash flow generative drugs and treat the
investigative studies underway as worthless despite charging the company 3
years worth of costs to develop them. I
still generate a rock-bottom conservative intrinsic value of $4.08 per share,
74% above the current price.
QLT Inc. is a Canadian biotechnology company focused on
developing drugs utilizing unique delivery technologies (manufacturing is
contracted out and marketing is partnered).
The stock trades in Toronto
under QLT but the majority of volume is on NASDAQ under QLTI and the company
reports in U.S. GAAP. QLTI currently has
two commercialized products: Visudyne treats macular degeneration (the leading
cause of blindness in adults over 55) and Eligard treats advanced prostate
cancer.
A combination of declining Visudyne sales, needing to post
an appeal bond on the patent infringement judgment and making a $42mm
acquisition left QLTI with $127MM of cash at
year end 2007. Facing redemption of a
$172.5MM puttable convertible note in September 2008, QLTI needed to raise
$50MM and so it embarked on an asset divestiture program that is now largely
complete. Despite having averted a cash
crunch, received some positive clinical data and signaling its willingness to
downsize, refocus and return excess cash to shareholders, QLTI's stock has
continued to decline throughout 2008.
Visudyne
Visudyne treats the "wet" form of age-related
macular degeneration (AMD), a degenerative
disease of the retina that is the leading cause of blindness in people over 55. It was QLTI’s
first commercialized drug, launched in 2000 with blockbuster potential. Visudyne is protected by several patents; the
key patents expire in 2015. It is
marketed by Novartis and operating profits are shared 50/50; after QLTI
receives certain cost reimbursements from Novartis, QLTI's
net profit share of Visudyne sales (effectively EBIT margin) works out to about
20%. Competing drugs Macugen and
Lucentis have since taken significant market share; Lucentis especially has
superior results to standalone Visudyne.
However, in early clinical studies, combinations of Visudyne with either
drug show better results than any monotherapy.
QLTI believes that if Visudyne combo
trials are successful and lead to a label change, revenues will increase from the
current $150MM to $200-250MM annually (assumes combo therapy achieves 30-40%
market share vs. its current 15% share in off-label combination usage). QLTI is
conducting a phase II study (RADICAL) of Visudyne plus Lucentis. Top-line results are expected in 1H09. Interim RADICAL
results were announced December 16th and were positive. Novartis is also conducting two studies on
combo therapy with data expected in 2009.
After plummeting for several years, sales of Visudyne finally stabilized
in 2008 at a $150MM run-rate with QLTI's run-rate EBIT (at 20%) of $30MM. If combo therapy studies are successful and
sales increase to the low end of QLTI's
range ($200MM), the incremental annual EBIT would be $6.5MM.
Eligard
Eligard treats the symptoms of advanced prostate cancer by
reducing production of testosterone, which shrinks or slows the growth of prostate
cancer tumors. Eligard uses QLTI's
proprietary Atrigel delivery technology to deliver sustained release generic
Lupron for up to six months. Atrigel
allows for the injection of a drug within a bio-degradeable polymer casing that
degrades over time resulting in controlled release. QLTI
receives a net royalty of 21% from Sanfoi-Aventis on Eligard sales; after costs
of production, QLTI's effective EBIT margin
on Eligard is about 15%. Eligard is the
first six-month depot product in this mature market; it offers increased
convenience & has been taking market share in a slow-growth market. Eligard is patent protected through 2018 and
its sales are annualizing at $220MM. Current
rapid growth of ~20% will peter out as the new 6-month depot finishes taking
market share in Europe.
QLTI's run-rate EBIT (at 15%) is $33MM.
Punctal plugs
In Oct 2007, QLTI
acquired a punctal plug drug delivery technology from privately held ForSight
Labs for $42 million. Punctal plugs can
be inserted into the eye's tear ducts and are capable of providing sustained
release of a drug into the eye. The first
drug tested will be latanoprost, which treats glaucoma and ocular
hypertension. QLTI
believes the punctal plugs can provide 90 days of treatment. Latanoprost is the most prescribed drug for
glaucoma with U.S.
sales of $1.7 billion. Its major problem
is that 50% of patients are non-compliant with their eyedrops within 6 months;
punctal plugs could address this problem.
In a small 90-day proof of concept study completed in May 2008 that
enrolled five patients, two lost the plugs while the other 3 reported positive
results (reduction of intraocular pressure).
QLT initiated a phase II study of punctal plugs for glaucoma called
"CORE". Its interim results were announced in Oct.
2008; showing acceptable efficacy, although 23 of 61 patients discontinued due
to loss of efficacy of loss of punctal plugs.
QLTI will initiate a higher dosage in another Phase II study. They are also working on improving available
plug designs to improve tolerance and reduce plug loss rates. QLTI management is very positive on the
technology and believes that if it is successful in glaucoma, the punctal plugs
could be utilized for several other therapies
Other matters
QLTI has two other
experimental drugs in proof-of-concept / phase I studies. Going forward, QLTI’s annualized operating
costs (SG&A and R&D, but excluding COGS counted in EBIT above) will be
about $40MM. Management has promised not
to make acquisitions with its cash. CAPEX
is minimal as manufacturing is largely outsourced. QLTI’s current financials are difficult to
interpret for several reasons: (1) Eligard is classified as a discontinued
operation and disclosure is scarce; (2) Visudyne royalties don’t cover overhead
so QLTI reports quarterly operating losses; and (3) the asset sales distort
quarterly results.
Litigation
QLTI was sued by the
Massachusetts Eye and Ear Infirmary (MEEI) in federal court in 2000 for patent
infringement on Visudyne. QLTI
succeeded in getting the case thrown out in 2002, but MEEI appealed and won
reinstatement in 2005. In November 2006,
MEEI won the case. In July 2007 MEEI was
awarded a 3% royalty on Visudyne sales, back royalties plus accrued interest
and legal fees. The payment for back
royalties and legal fees was $108MM. QLTI
decided to appeal the judgment and was required to post an appeal bond equal to
110% of the judgment to do so ($118.8MM).
The appeal bond, as well as royalties as they accrue and the interest on
the judgment are all included in restricted cash on QLTI's
balance sheet. I have excluded
restricted cash from my valuation, assuming QLTI loses the appeal and the cash
is paid out to MEEI. Oral arguments were
heard in Sept. 2008 and a ruling is expected at any time in 1H09.
Liquidity crunch /
asset sales
In January 2008, QLTI
initiated a restructuring plan. Key
points were major expense reductions (cut 45% of workforce) and four asset
sales: (1) Eligard; (2) its recently approved acne drug Aczone; (3) the Atrigel
drug delivery technology for uses outside Eligard; and (4) its Vancouver
headquarters.
In the first three quarters of 2008, QLTI
sold its HQ for C$65.5MM of which C$12MM was a seller financing (a two-year
6.5% interest only second mortgage) and C$53.5MM was paid in cash, sold Aczone
to Allergan for $150MM and licensed Atrigel to Reckitt Benckiser for $25MM. These asset sales allowed QLTI
to redeem its $172.5MM of converts in September and left it with net cash of
$156MM. QLTI
is currently in active discussions to divest Eligard.
QLTI has largely offset
capital gains from the sales with its capital loss carryforwards.
On the 3Q08 conference call, QLTI disclosed that QLT USA
(the subsidiary holding Eligard) has a $70MM net operating loss that can be
used to either shelter future operating income by an acquirer or shelter
capital gains tax on the sale, depending on the form of the transaction. I assume that QLTI
will either sell Eligard in a tax-free transaction or keep it rather than
accept a low bid or permit substantial tax leakage.
Tender offer
QLTI announced a $50MM
tender offer on 12/01/08 to
return cash to shareholders. The stock
had been trading at 52-week lows of $1.80 - $2.00 for the two prior weeks. It's a modified dutch auction to repurchase
$50MM of stock at a price within a range of $2.20 and $2.50 per share. After receiving bids, QLTI
will select the lowest price at which it can repurchase $50MM of stock and all
tendering shareholders will receive that price (subject to pro-ration if
necessary). So size will vary between 20MM and 22.7MM shares if the tender is
fully subscribed. The tender offer
commenced on December 4th and expires on January 15, 2009.
It's uncertain the tender offer will be successful since the stock has recently
rallied to $2.35 and only a total of 18.8MM shares have traded since the offer
was announced. Anyone who tenders
(besides any small-scale arbs who bought in recently) will take a loss so it's
unclear how many shares will be tendered.
So I value QLTI below both with and without a successful tender offer.
Valuation
My first step in valuing QLTI
is updating the 9/30/08
cash balance of $155.9MM.
QLTI's 4Q08 EBIT (from Eligard
+ Visudyne) at current run rates should be $12.7MM.
4Q overhead (SG&A & R&D) is estimated at $11MM. QLTI also expects to make a $16.5MM cash tax
payment owed on the asset sales. These
items will result in a 4Q cash burn of $14.8MM, leading to an estimated
year-end cash balance of $141MM (also note QLTI
doesn’t have any debt).
I value Visudyne using a simple DCF through patent expiry in
2015 assuming no growth of current EBIT of $30MM, a 35% tax rate (even though
cash flow from Visudyne is less than overhead and QLTI
isn't paying taxes) and a 10% discount rate.
My DCF value of Visudyne is $99.6MM.
I value Eligard with a similar DCF but assume 5% annual EBIT
growth from the current $33MM through patent expiry in 2018. My DCF value for Eligard is $175.7MM.
The Vancouver
two-year mortgage note is for US$9.9MM; discounting this back two years at 10%
yields a present value of $8.2MM.
Adding up the cash, Visudyne, Eligard and the mortgage
yields $424.6MM. Next I assume QLTI
spends current annualized overhead of $40MM for three years as it completes its
current clinical trials, with no positive results. So I subtract $120MM cash burn from my asset
value, leading to intrinsic value of $304.6MM.
I realize this is a bit unorthodox, but three years will be enough time
to complete current drug development projects and I simply don’t see QLTI
spending $40MM every year into the future with no positive results. Based on 74.62MM shares out, the intrinsic
value is $4.08 per share, 74% above the current price. This is my rock-bottom conservative valuation. If the tender offer is successful at the
maximum price of $2.50, QLTI will spend
$50MM to retire 20MM shares. The
post-tender intrinsic value rises to $4.66, 98% above the current price.
Adding in more speculative sources of value, the Visudyne
combo therapy upside of $6.5MM annually boosts its DCF value by $27MM, and I
value the punctal plugs platform at $50MM ($42MM purchase price plus some value
appreciation from positive trials).
These increase per-share intrinsic value to $5.11 pre-tender and $6.07
post-tender. Additional (though even
more speculative) value could come from early stage pipeline drugs and QLTI's
appeal being successful, which could return $120MM cash to the company.
Catalyst
Completion of accretive tender offer.
Tax-efficient sale of Eligard near intrinsic value of $175MM.
Additional cash return to shareholders.
Positive clinical trial results on Visudyne combination therapy and/or the punctal plugs.
Potential ruling in the company’s favor in the MEEI patent litigation.