BROOKLINE A Division of CIM Securities Equity Research
CAPITAL MARKETS Member FINRA and SI PC
April 05. 2018
Veru, Inc.
Healthcare Potential to Create More Value Than Meets the Eye,
Initiating Buy $10 TP
VERU
Buy • Conclusions — We are initiating coverage with a Buy rating and $10 TP. In
Initiation of Coverage our view. Tamsulosin DRS. slow release granules, and Tamsulosin XR
capsules have potential to be value drivers for the stock based on their
Current Price differentiated profile including lack of food effect and use in patients with
$1.80 dysphagia. We model substantial revenues in benign prostatic hyperplasia
(BPH) patients with dysphagia. We believe that the stock has significant
Target Price upside potential with modest pipeline success, despite our conservative
$10.00
financial estimates. Our $10 TP is based on probability adjusted sum of
parts valuation of Tamsulosin and 25% premium for rest of the pipeline.
Market Capitalization
96.32M
• Tamsulosin XR and DRS differentiated profile should drive uptake —
Shares Outstanding Tamsulosin XR and DRS would be addressing a well-defined indication with
53.51M an established market and a medical need, and we conservatively model
33% probability of approval and expect launch in 2020. We model peak
Float sales of $886M in 2036.
28.52M
• VERU-944 Phase 2 expected to begin in Q318 - Phase 2 trial to study
Institutional Holdings another 505(b)(2) candidate VERU-944 (cis-clomiphene) to treat hot flashes
4.28%
in advanced prostate cancer patients on hormone therapy is expected to
begin in Q318 with data in O119.
12-month Low/High
$0.90f$3.00
• VERU-111 significant potential in oncology — Veru is also preparing to
Average 90-day Volume start a Phase 1/2 open label trial to study VERU-111, a novel, taxane-like
129,981 oral therapy for metastatic castration resistant prostate cancer (MCRPC)
that targets both alpha and beta tubulin. Investigational New Drug (IND)
Fiscal Year End application for VERU-111 is expected to be filed in O218 and the clinical
September 30 trial, expected to be done in Johns Hopkins as the lead site is anticipated to
have data in early 2019.
Revenues (SM) • Multiple Catalysts in next 12 months — We foresee multiple catalysts in
next twelve months, including NDA filing for Tamsulosin, VERU-944 Phase
Period 2017A 2018E 2019E
O1 2 initiation and data, and VERU-111 IND filing and data. Solifenacin DRG
and TadalafillFinasteride combo capsules NDA filing is expected in 2019.
O2
O3
O4
$13.7 16.1E 25.6E Equity Research
Kmr I' ll' PhD Dir or nior Bi hnology Analyst
EPS ($)
Period 2017A 2018E 2019E
O1 Brookline Capital Markets
O2 Trading: (646) 807-4124 Institutional Sales: (646) 807-4125
O3 www.Brooklinecapitalmarkets.com
O4
($0.25) ($0.271E ($0.261E Refer to Page 25 for Analyst Certification & Disclosures
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Veru, Inc. (VERWI April 05, 2018
Portfolio Manager's Summary
Focus on Developing Urology and Oncology Products Leveraging 505(b)(2)
Veru is a biopharmaceutical company with a focus on developing products in
Urology (including a female sexual health division) and Oncology. It has two
products in the market generating revenues, a female condom and a male penile
desensitizing wipe for premature ejaculation. These products have potentially
large niche markets and would continue to generate revenues. Growth in
established markets and entry into newer geographical markets in South America
and Africa and increasing sales would ensure sustained revenue growth and a
source of capital/expertise for portfolio products under development.
Veru is now focusing on development of differentiated products for urology and
cancer indications and is advancing its efforts to have a pipeline of potential
products that can be approved by 505(b)(2) regulatory pathway for
commercializing successful products.
Figure 1. Pipeline focus on therapeutics targeting urology and oncology
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The most advanced products in its pipeline for 505(b)(2) approval are
Tamsulosin DRS granules (soluble powder) and Tamsulosin XR (extended
release capsules) for benign prostate hyperplasia (BPH) that the company is
planning to file NDAs for in 2018. Solifenacin DRG granules are being developed
for the indication of overactive bladder, and combination TadalafillFinasteride
capsules for enlarged prostate and erectile dysfunction (ED), with NDA being
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Veru, Inc. (VERWI April 05, 2018
planned for these two products in 2019. All these products are well positioned for
approval only after relatively straightforward pivotal bioequivalence (BE) studies.
Veru is also initiating a Phase 2 trial to study another 505(b)(2) candidate VERU-
944 (cis-clomiphene) to treat hot flashes in advanced prostate cancer patients on
hormone therapy with an eye for NDA in 2020.
In addition, Veru is also preparing to start a Phase 1/2 open label trial to study
VERU-111, a novel. taxane-like oral therapy for metastatic castration resistant
prostate cancer (MCRPC) that targets both alpha and beta tubulin. An
Investigational New Drug (IND) application for VERU-111 is expected to be filed
in O218 and the clinical trial - expected to be done in Johns Hopkins as the lead
site - is anticipated to have data in early 2019.
The company has interest in Urology products that can be approved by the 505
(b) (2) regulatory pathway. These drugs are already approved for other
indications, and therefore are overall safe and efficacious with existing clinical
data. These are good candidates for label expansion, with new formulations as
approvals are potentially low risk and lower cost with faster path to pivotal trials.
Tamsulosin DRS formulations to overcome disadvantages of current SOC
for BPI-I
Tamsulosin DRS (XR oral suspension) is 505(b)(2) candidate in an extended
(slow) release soluble powder form for prostate gland enlargement (BPH)
patients who have difficulties in swallowing pills due to dysphagia. BPH is a
common old-age related condition affecting men. Based on census data there
are '-42M men in U.S over that are age 55 and over. Based on a study published
by Guess et. al in The Prostate Journal, the prevalence of histologically
diagnosed BPH is 40 to 50 percent in men aged 51 to 60 and is over 80 percent
in men older than age 80. Branded/generic Tamsulosin is approved (brand name
as FLOMAX; available as Tamsulosin hydrochloride pills) and available for
treatment of BPH. FLOMAX was developed by Astellas Pharma. However, many
elderly patients, or those with neuropsychological disorders or those living with
consequences of stroke often have dysphagia or swallowing difficulties. Up to
50% of more of those afflicted with Parkinson's disease, Alzheimer's disease,
stroke, or those living in long term care centers suffer from dysphagia and cannot
therefore be treated for BPH even when an approved treatment is available.
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Veru, Inc. (VERWI April 05, 2018
Tamsulosin is a selective alpha 1- adrenergic blocker for alpha 1 receptors in
prostate gland. Enlarged prostate may push against the urinary bladder and
affect the musculature around the bladder or urethra that passes urine for
excretion, thus resulting in reduced capacity of the bladder, pinching/constriction
of the urethra and other mechanical issues. Tamsulosin acts by relaxing the
smooth musculature around the bladder/prostate neck area. This helps improving
urine flow and reducing BPH symptoms.
Although FLOMAX is the choice alpha-blocker treatment for BPH in the elderly,
there are several issues with the current state of treatment. FLOMAX is only
available as a capsule and must be taken 30 minutes after meals to ensure
optimal absorption. Fasting levels of absorption, or disintegration of the capsule
can result from accident or nonconformance (chewing, crushing, opening of the
capsule cover) in patients who have difficulties with instructions, and this results
in very high absorption in a small amount of time which can have undesirable
side effects. Since this relaxes musculature, reduction of blood flow could
happen resulting in low blood pressure, dizziness, fainting. -15% of patients with
BPH may also suffer from dysphagia (often resulting from neurological damage
in conditions like Parkinson's disease, stroke) as perhaps unrelated but
associated conditions and such patients get precluded and cannot benefit fully
from the standard of care regimen. In these patients that cannot take capsule
form of Tamsulosin, BPH can lead to bladder infection, sepsis and may have to
be treated with more invasive methods like catheterization to empty the bladder
and/or surgery.
Tamsulosin-DRS can address a substantial market for BPH in dysphagic
patients
Veru's Tamsulosin-DRS is its Tamsulosin-XR (extended release formulation) in
an oral suspension form. XR slows the release of Tamsulosin, thus reducing the
chances of overdose related side effects. Tamsulosin XR, made into dry granules
in a powder form that can be suspended in water (DRS formulation) and taken
orally would allow for the medication to be taken as a liquid instead of a capsule.
This can therefore bring in the currently underserved population of BPH +
dysphagia patients into the fold of pharmacological intervention. This leads to
better conformance of the patients, is more comfortable and an affordable
solution. This would be a long-awaited solution and Veru is well positioned to
serve the space and take advantage of this substantial market opportunity.
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Veru, Inc. (VERWI April 05, 2018
Bioequivalence (BE) studies show DRS to be acceptable and safe
The XR version itself is the safer (no food effect) capsule version of Tamsulosin
hydrochloride and should be able to gain traction in the existing BPH market that
is served by FLOMAX capsules. Tamsulosin-DRS would extend the market for
the first time to those who also have dysphagia. Two bioequivalence studies
have been completed to show that the new DRS formulation (extended release
as suspension granules) leads to similar exposure as FLOMAX.
In a stage 1 completed study on 12 patients, single dose FLOMAX (given after
food) was compared with Tamsulosin DRS (after food and in fasting conditions)
and the PK pharmacokinetics analysis showed that the absorbed amounts of
Tamsulosin DRS given without food was equivalent to FLOMAX with food. This
means that the DRS, even when administered as an oral suspension liquid
(which provides with conformance benefits, but also should be slowly released,
and therefore slowly absorbed) is able to achieve a slower, optimal absorption
because of the XR formulation equivalent to FLOMAX with food, essentially
showing that this formulation has no food effect.
Results of a stage 2 BE study on 36 patients for 21 days also reported
bioequivalence between single dose Tamsulosin DRS (fed and fasted) and
FLOMAX (fed) for measures of AUC (area under curve) but not for Cmax
(maximum concentration in blood/plasma). AUC measures total drug exposure
over time and is a function of absorption and elimination. Cmax is the maximum
concentration of a drug in serum and depends on rate and extent of absorption.
The ratio of these two measures gives a measure of absorption. The results here
reiterate that, whereas the body gets the equivalent total amount of exposure to
the Tamsulosin as DRS or capsule (FLOMAX), the maximum absorption (rate,
extent) is lower for DRS suggesting a slower absorption rate or lower sustained
exposure compared to FLOMAX capsules with food.
Another bioequivalence study, the final one, is ongoing now (1Q18) to confirm
that Tamsulosin XR has no food effect with an in vitro dissolution study and
validation of stability of GMP manufactured batches. The Cmax would also be
tested to see if there is equivalence with FLOMAX. These bioequivalence studies
are relatively straightforward and have shown acceptable profiles compared with
FLOMAX. Added with the definite advantages of the XR/DRS formulation
(removal/reduction of food requirement, ease of administration and lack of side
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Veru, Inc. (VERWI April 05, 2018
effects), this should lead to better acceptability and therefore better market
potential than FLOMAX capsules. Veru anticipates filing an NDA application in
2018 based on these results. Veru has recently reported that it has received a
waiver of $2.4M for NDA fees as a small business and it would free up resources
for further development of pipeline programs
Major clinical and market need for BPH patients
FLOMAX and related generics of the alpha-blacker class enjoy a multibillion
dollar market for BPH in US. The initial target for Tamsulosin DRS would be
dysphagic men with BPH in long-term facilities. About 13% of FLOMAX and other
generic markets are represented by long-term facilities. Around 3.6M new
prescriptions are written annually for BPH patients with dysphagia. It is estimated
that about 68% of men placed in long-term care facilities have dysphagia. In the
US, three leading group purchasing organizations (GPOs) that manage FLOMAX
purchasing supply for long-term facilities could be approached for Tamsulosin
DRS to give access to this crucial patient population. Veru also plans to maintain
pricing parity with FLOMAX, the wholesale acquisition cost (WAC) for which is
about $730 (for 100 tablets) to gain acceptance by the medical community,
payers and the patients.
That XR capsule (and therefore DRS powder) has no food effect is an attractive
proposition for urologists to write prescriptions for Tamsulosin XR capsules over
FLOMAX, the target prescriptions for which are over 22 million/year for men who
do not have dysphagia and '-4M prescriptions a year for about -15% patients
who have dysphagia. This represents a market (for FLOMAX and Tamsulosin
generics) of $3.58 in US alone (-$4.18 for all alpha-blockers), besides the ROW
opportunity that could be even bigger. The IP exclusivity could potentially be
enjoyed by Veru up to 2036 from the Tamsulosin franchise that it licensed from
Ariana Therapeutics. Ariana (now Camargo) would receive $10M over three
years after the drug has been in market for one year. Tamsulosin XR and DRS
would be addressing a well-defined indication with an established market and a
medical need, and we conservatively model 33% probability of approval and
expect launch in 2020.
Solifenacin DRG granules for overactive bladder
Veru's urology pipeline for 505(b)(2) pathway includes solifenacin DRG granules
for the treatment of overactive bladder (OAB). Overactive bladder is experienced
by a sixth to a fifth of the adult US population and has a higher prevalence with
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Veru, Inc. (VEAL!) I April 05, 2018
increasing age where the prevalence can be from a third of short-term care
patients to over 70% of population in long-term care facilities. This causes an
increase in the frequency of urination, lack of bladder control and urge
incontinence or involuntary emptying of the bladder. OAB affects both men and
women with a wide variety of causes ranging from medications, infections,
tumors or stones. The musculature around the urinary bladder controls the urine
flow and contracts when the bladder is full, resulting in an urge to urinate which is
aided by the contraction of the muscles and controlled constriction of the bladder.
In OAB, the muscles may be affected resulting in involuntary contraction of the
muscles, thus leading to incontinence.
Solifenacin for treating OAB
Solifenacin succinate (trade name Vesicare) tablets are given for managing OAB
and represent the standard of care for overactive bladder. Vesicare is marketed
by Astellas. Solifenacin is a small molecule urinary antispasmodic that helps by
relaxing the musculature thereby reducing the urge to pass urine. Solifenacin is a
selective M3 muscarinic receptor antagonist. These receptors are important for
muscle contraction and solifenacin competes with acetylcholine to bind these
receptors, thus resulting in reduced muscle tone in the bladder. This allows for
reduction in the urge and better retention of urine in the bladder.
Available solifenacin formulations suffer from similar disadvantages as
Tamsulosin in that they are available only as capsules or tablets that are to be
taken in whole and cannot be chewed or crushed. Consequently, people who
suffer from dysphagia (inability to swallow) remain underserved for treatment for
OAB. In these patients, compliance is very low, and interventions include
catheterization and wearing diapers, or surgery.
Solifenacin DRG oral solution to treat OAB in dysphagic patients
Veru is developing Solifenacin DRG, as a novel slow release granule formulation
of solifenacin succinate that can be taken as an oral suspension in dysphagic
patients with OAB. This will increase compliance in these patients who will be the
first target population. Although solifenacin is one of the lowest cost drugs to treat
OAB in US with an average cost of $6.8k for one successful treatment,
solifenacin has a $1.1B market worldwide. We expect that Solifenacin-DRG can
capture a substantial portion of the market because of its advantages over the
solifenacin capsules. DRG formulation would not only bring in revenues from
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Veru, Inc. (VEM.I) I April 05, 2018
treating the dysphagic OAB patients, it can be more attractive for urologists and
patients because of improved compliance and ease of administration.
The FDA has already confirmed one bioequivalence study as valid and Veru is
conducting another bioequivalence study in 2018 and will use the results for
making an NDA filing planned for early 2019. We feel that since the safety,
indication in question and the pharmacologic solution are very well defined, and
the market potential is not in question, solifenacin DRG has a great shot at
approval and should lead to successful commercialization in 2020. We also note
that since the initial target population is the same, i.e., the elderly population at
long-term care facilities. Veru can leverage the same salesforce and marketing
infrastructure for both of its Tamsulosin and Solifenacin product lines.
Tadalafil/Finasteride for BPH.
Tadalafil/Finasteride is another asset that Veru is developing for treatment of
BPH and would utilize 505(b)(2) pathway for approval. Tadalafil and Finasteride
are both used for BPH besides several other disease/disorder conditions.
Tadalafil manufactured by Eli Lilly is marketed as Cialis for treatment of erectile
dysfunction (ED) and as Adcirca for pulmonary arterial hypertension (PAH). The
FDA approved Cialis for treating BPH in 2011. Finasteride (brand names:
Proscar. Propecia) marketed by Merck is approved for treatment of enlarged
prostate (>30 cc volume) as well as hair loss. Tadalafil can be used in
combination with Finasteride can be used for BPH as well as to treat symptoms
of UTI, ED in BPH patients. Tadalafil is a small molecule inhibitor for
phosphodiesterase type 5 (PDE5) which blocks degradation of cyclic GMP by the
enzyme. PDE5 is present in smooth muscles and therefore could be targeted for
treating musculature/vasculature disorders. Finasteride is a small molecule
inhibitor of 5 alpha-reductase enzyme and exerts its action by decreasing the
production of dihydrotestosterone (DHT). Reduction of DHT hormone may
discourage prostatic dysplasia.
Tadalafil/finasteride combination approved for treating BPH
Eli Lilly completed a Phase 3 clinical trial in 2013 to study the combination of
Tadalafil and Finasteride in patients with BPH and related clinical symptoms
which showed that 5mg each of Tadalafil and Finasteride (once daily) showed a
reduction in symptoms (scored by total international prostate symptom score.
IPSS) from baseline by >5 units (at 12 weeks) whereas the placebo arm (placebo
with 5mg Finasteride only) gave a IPSS reduction by 3.76 units. Combination
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Veru, Inc. (VEAL!) I April 05, 2018
also showed a greater reduction on IPSS at other time frames (4.12, 26 weeks)
as well as improvement in quality of life (IPSS-QOL) index scores and several
international index of erectile function (IIEF) measures.
Co-administration of Tadalafil and finasteride is approved for treating initial
symptoms of BPH for up to 26 weeks, but compliance is an issue which could
lead to increased urological issues like urine retention, UTI and related toxinoses
and even death. Veru's proposition is to formulate a combination capsule to
target patients with enlarged prostate (>30cc volume) because of BPH to achieve
increased convenience of taking 1 pill instead of two and achieve better
compliance.
As discussed earlier. BPH is a very common condition and affects up to 25% of
men and 1.1B men worldwide would suffer from BPH in 2018. FDA has reviewed
and validated a BE study in 3O17 and a final BE study is in the offing to support
an NDA application that is anticipated for early 2019. Other than men with BPH
(>30cc volume), those who experience partial or suboptimal response to
finasteride alone or tamsulosin (alone or in combination with finasteride) can
benefit from introduction of tadalafil in their treatment in form of a tadalafil +
finasteride combination.
Veru seems well positioned to take advantage of this generic combination and
the barriers to entry are very low or even non-existent. It might help Veru to
establish itself as a leader in generic BPH medication market with this and other
products that it plans to offer. Ensuring better compliance with an approved
combination is an achievable goal and makes good business sense. However,
we also note that this is not a great differentiator and the competitive space could
get busy if this combination capsule achieves better compliance and ease over
co-administration. It would be important on Veru's part to maintain a price parity
with current co-administration standards.
VERU-944 for hot flashes.
Veru is developing VERU-944 or cis-clomiphene for treating hot flashes in men
who are on prostate cancer hormonal therapy. There are no drugs that are
currently approved for this indication but there is a huge number of patients who
suffer nonetheless and represent a market ready for a new solution.
Prostate cancer is one of the most common cancers and androgen deprivation
therapy (ADT) is an established treatment that reduces the increased male
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Veru, Inc. (VERWI April 05, 2018
hormone (testosterone/dihydrotestosterone) levels so that they do not stimulate
growth in prostate cancer cells. These androgens are produced in testicles, and
reduction in their levels involves surgical or chemical/medical castration. Surgical
castration, also called orchiectomy is done to remove testicles, whereas chemical
castration involves administration of female hormone analogs/agonists which
eventually results in reduction in androgens. While the exact cause is unclear,
reduction/fluctuation in hormone levels is associated with hot flashes, or
sensation of sudden intense warmth/heat, flushing and sweating, and '-80% of
ADT patients are affected by episodes of hot flashes (30-40% of them moderate
to severe) that can be uncomfortable and disruptive to normal physical wellbeing.
Hot flashes continue to affect men even years after ADT (48% at 5 years, 40% at
8 years) and as mentioned above, has no approved therapy to manage the
condition.
Medications like Clomid, originally approved for female fertility in 1967 are often
used off-label for hot flashes in men associated with ADT in prostate cancer.
Clomid (cis-clomiphene) is an oral nonsteroidal estrogen agonist and has been
used off label in men post ADT. This can raise testosterone levels and aid in
hormonal imbalance and has been observed to help with hot flashes.
Clomid is a mixture of cis-and trans-isomers of clomiphene, out of which cis-
clomiphene is a better estrogen agonist than trans-clomiphene and may result in
reducing testosterone levels (compared with clomiphene which has trans-
clomiphene in majority which might raise testosterone levels). Since ADT works
by removal of androgens, cis-clomiphene might be better than a trans-
clomiphene heavy mixture at keeping testosterone levels low while still
maintaining hormonal balance (and therefore help in managing hot flashes). An
established drug and one that has proven safety and tolerability. Clomiphene has
seen increase in its off-label use in men with over 88,000 men taking clomiphene
in 2016.
VERU-944 is a cis-clomiphene formulation that would be used to treat hot
flashes. Clomid (Clomiphene) is a mixture of cis- and trans-clomiphene has
already been in use for treating hot flashes in ADT men and VERU-944 should
be better than Clomid because of its high estrogenic (because of cis-clomiphene
content) lower androgenic (low amount of testosterone producing trans-
clomiphene) potential. Besides, cis-clomiphene has a higher potency and slower
clearance. making it the choice isomer for treating hot flashes. Consequently,
10
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Veru, Inc. (VEM.1)1April 05, 2018
when commercially available, we believe that VERU-944 would be favored over
Clomid by clinicians for its favorable properties.
VERU-944 can tap into a substantial market
We note that Clomid is one of the cheapest drugs in the market and is listed in
WHO's List of Essential medicine list (as a female fertility drug) that gives it a
credibility and a purposeful authority. The full treatment (for its intended use) runs
to the tune of a few dollars. We believe that VERU-944 can benefit from the good
name of Clomid and can establish a market in men with ADT from prostate
cancer. On the other hand. we also feel that replacing Clomid, which has already
been in off-label use, to become the new standard would take substantial efforts.
Also, we feel that the differentiation from Clomid based on its isomer composition
has not yet been proven without doubt to be of substantial advantage for the
clinicians to take notice. The pricing would also have to be in line with Clomid to
provide a worthy competition to it. Having said that, we are optimistic that VERU-
944 would find its place in the market for treating hot flashes in men, and that
these hurdles would be dealt with well, with data and good commercialization
efforts.
This would be the first approved therapy for hot flashes in men on prostate
cancer hormonal therapy. An IND is planned in 2018, followed by a Phase 2 trial
dose finding study in 120 men. The planned 4 and 12-week endpoints to study
efficacy should reveal dosing and clinical efficacy. We are hopeful that given the
well-established background. VERU-944 would be successful in this regard. The
market size for men with ADT is about 700.000 in US, and since hot flashes
continue even after ADT for many years, VERU-944 would find chronic use.
Even with a 30% penetration in the hormone-therapy related hot flashes, Veru
estimates that VERU-944 could bring in -$600M annual revenues. The
intellectual property should ensure exclusivity in US up to 2035.
Other than hot flashes in prostate cancer related hormone therapy, VERU-944
can find use for other indications as well. Prostate cancer is associated with high
bone metastases and results in bone loss and bone pain. Addition of estrogen or
estrogen agonists like cis-clomiphene can stem/slow the loss, increase bone
mineral density, and VERU-944 could potentially be used alone or with other
therapies like bisphosphonate or radionuclide therapy. Bone metastases related
bone pain occurs in over 40% of prostate cancer patients and is a significant
market upwards of a billion dollars.
11
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Veru, Inc. (VEAL)) I April 05, 2018
Analyzing conservatively, we expect the first indication to be most meaningful for
Veru and it can possibly extract market value with its new cis-formulation. To be
considered for other indications. Veru would need to conduct clinical trials, and
the timelines could be significantly extended. We do not feel that there are any
useful indicators as of now for the planned entry into the bone pain space. While
bisphosphonate therapy is associated with ONJ (osteonecrosis of the jaw) and
estrogen therapy might avoid causing such extreme side effects, VERU-944 is
not differentiated well enough in terms of data sufficiently to stand alone. Without
more conclusive studies, the hope for it in the bone indication is that it will be an
effective product that would find use in conjunction with other therapies, which
could be a significant market for VERU-944. We will keep a close eye on
developments in this arena but realize that it could be some time before we see
VERU-944 for bone remineralization.
VERU-111 is one of the most valuable assets in the pipeline
VERU-111 is a novel small molecule in preclinical development for treatment of
MCRPC and other taxane resistant cancers. It is an orally available small
molecule inhibitor that can target both alpha- and beta- subunits of tubulin and
thus would be more effective to cytotoxic tubulin inhibiting drugs like colchicine,
vinca alkaloids and taxanes.
Of the cytotoxic drugs used in chemotherapy, tubulin inhibitors differ from DNA-
binding drugs in that they affect microtubule formation, an important step in cell
division. Microtubules are needed for spindle formation that is an essential step
in cell division and are therefore these molecules are also called spindle poisons.
Microtubules are formed by structured organization of tubulin subunits, alpha and
beta (recently discovered gamma subunit associates with MTOC and is not a
microtubule component). While colchicine and vinca alkaloids affect formation or
polymerization of the microtubules, drugs of the taxane family disrupt the
depolymerization causing shortage of soluble tubulin subunits available and
affects the dynamicity of further microtubule formation. Whereas all three families
of tubulin disrupters bind the beta-subunit (colchicine bind alpha: beta interface),
VERU-111 is unique in that it can bind both alpha as well as beta subunits at the
colchicine binding site but more tightly.
Chemotherapy with microtubule disrupters like paclitaxel and taxotere is a major
modality of treatment for prostate cancer and there are a few perceived
advantages of VERU-111 to these other agents. VERU-111 is orally available
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Veru, Inc. (VEAL)) I April 05, 2018
whereas the other microtubule disrupting therapies are available in IV form only.
Secondly, VERU-111 binds to both alpha and beta subunits of tubulin and is
likely to be more effective than the beta-binders. VERU-111 is not a substrate for
multiple drug resistance mechanisms that plague the chemo therapy drugs like
docetaxel (taxotere) which is an important first-line chemotherapy drug for
Prostate cancer. Also. as a novel target, alpha-subunit targeting by this new
class of inhibitors may reverse resistance against existing tubulin inhibitors and
other chemotherapeutic agents in general. This is even more important since the
established second line androgen-targeting drugs in use for Prostate cancer, the
likes of Xtandi (enzalutamide) and Zytiga (abiraterone/prednisone) have a very
high degree of cross resistance and cannot be used in sequence for a long-term
management strategy for Prostate cancer. Xtandi (AstelllaslPfizer), approved for
treatment of metastatic castration-resistant prostate cancer (mCRPC) is a
nonsteroidal antiandrogen and acts as an orally delivered antagonist of androgen
receptor (AR, overexpressed in prostate cancer) and inhibits downstream
signaling. However, resistance to the drug develops rather quickly through a
variety of mechanisms including mutations in androgen receptor. Besides.
Enzalutamide induces cytochrome P450 enzymes (enzymes 34A, 2C9, 2C19
and 1A2; and metabolized by 2C8) leading to reduction of its active
concentrations. Zytiga (abiraterone; Janssen) with prednisone is another
approved orally administered therapy for metastatic Prostate cancer. It is
delivered as a prodrug (abiraterone acetate) that is metabolized into the
abiraterone (the active compound) and inhibits androgen production by inhibiting
Cytochrome P450-17A enzyme. Again, resistance develops almost as a rule, and
unfortunately, most patients who receive one of these therapies do not respond
to the other drug as well.
Several advantages of VERU-111, potential for market and indication
expansion
Preclinical studies presented by Veru, showed a few advantages compared to
Docetaxel. Oral administration of VERU-111 shows comparable tumor inhibition
with IV administered Docetaxel in PC3 prostate cancer cell xenograft model. In a
xenograft model with Taxol-resistant PC3 cells, more than 6x inhibition was seen
with VERU-111 with better safety profile in animals. While in vitro inhibition was
in PC3 cells was seen at 5.2 nM of VERU-111. comparable inhibition with
Docetaxel was better at 1.2 nM, however, much better in vitro tumor inhibition
was seen when taxol-resistant PC3 cells were tested with comparable inhibition
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Veru, Inc. (VERWI April 05, 2018
seen at 2.1 nM of VERU-111 and 18 nM of Docetaxel. This suggests that VERU-
111 could potentially be used for tumors resistant to other chemotherapy
interventions, and its binding to alpha-tubulin in addition to beta could be the key
to breakdown resistance. Adding to its value proposition are its high oral
bioavailability, availability across the blood brain barrier (can potentially be used
for primary tumors or metastases in brain), a good safety profile and that it is not
a substrate for CYP34A (metabolizes docetaxel/paclitaxel) or MDR (multiple drug
resistance) proteins, factors that would drive VERU-111's entry and success in
the huge Prostate cancer-treatment chemotherapy market where Docetaxel
alone earned -$2.2B in 2012.with generics market growing ever since. It can
potentially be used with or in lieu of vinca alkaloids as well, and in different
indications, and Veru would seek these indication expansions in time. Xtandi and
Zytiga both have multibillion dollar markets.
We believe that VERU-111 could easily achieve indication expansion and can be
used in other indications and can possibly be used singly and/or in combination.
While it is still in preclinical studies. VERU-111, in our view has a very promising
path ahead if it shows safety and efficacy in the Phase 1/2 trials that are in the
offing. IND submission is planned for mid-2018. We assume the application
would be successful in leading the company to the Phase 1/2 studies later in
2H18 where the company plans to enroll MCRPC patients who have progressed
on Xtandi or Zytiga with or without taxane, as well as patients with taxane-
resistant cancers of breast, endometrium and ovaries.
Several events in 2018 to raise interest
In the near term, we see several events in the near horizon that could boost
Veru's profile and make a good case for early entry into sharing its business to
reap benefits. For Tamsulosin DRS/XR, we could see completion of the final
bioequivalence study, followed by an NDA for US and a Marketing Authorizing
Application (for UK) submission, with launches planned for 2019.For Solifenacin
DRG and Tadalafil-Finasteride, the bioequivalence studies could be completed
giving supportive data for their respective NDAs and MAAs in 2019. We note that
while we are enthusiastic about the success of the BE studies, and share the
optimism with the company that FDA would accept and act on the BE data for
approval, it is not outside of realm of possibility that FDA may require more data
or ask Veru to conduct full-scale clinical studies which could push timelines for
approval and commercialization. For VERU-944, we anticipate an IND approval
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Veru, Inc. (VEM.I) I April 05, 2018
making way for a Phase 2 trial. For VERU-111, the road is a little longer, but we
can see a start with an IND followed by initiation of Phase 1/2 trials in 2018.
Figure 2: Multiple catalysts in 2018 and 2019
2018 2019
• Grow US business • Explore sttalegic alternative.
FC2 • Grow restlic sector• secure new Brat)
and S. Atrcan tenders 01 d 02
• Compete BE study 01 • Launch n US 1N
• Frie NON 02 • Launch n Eu 2fri
Tarroulosb ORS BXR
• Cornplete Nanny on manufactured • Continue Seeking aarawship dealt
capsules- RPM
batches 0203 months)
• PartnerUS and ROW
• Meet EMA 02 and Ale ANA 04
• BE study 03 • PreNDA meearq 01 and NDA 03
• Partner US and ROW • Catlett stabaly on manufactured
ScifinwinDRO batches QS months)
pantiles -0AB
• Meet EMA 0 I and MM 02
• Continue partnetehipdeab
• BE study 02 • PreNDA meeting 01 and NDA 02
• Partner US and ROW • Comp** stabary on manufactured
ladalafffInasterlde comto•prostate batches (ansaren)
eolamemem and ED
• Meet Earn Ol and MM 02
• Continue partnership cleats
• IND 01 • Comte* Flian2 0 i
• Initiate Nava oinical trial 02 • inflate Phase 302
VERU-944- hex flashes In men on ADT
• Seek Pannenteps
• INO 02 • Complete Phase1/2
VERu-111 • Inmate Phase 1/2- prostate and other • Innate Phase203
cancers 02/3 at Hopkins • See large puma pat tner
Source: Veru
Other pipeline programs
We note here that the other programs at Veru for VERU-722 [a 505(b)(2)
candidate) for male infertility and VERU-112 for gout could see acceleration of
their development with cash injunctions that could see decline in company value.
PREBOOST for premature ejaculation in market
On the other hand, female and male sexual health products have been bringing
in valuable revenues for Veru and would continue to do so in the foreseeable
future. Its product PREBOOST is a wipe with 4% benzocaine for topical
application to prevent premature ejaculation by providing temporary
desensitization of penis. While there are several pharmacological interventions
available that address PE and associated problems like ED, PREBOOST has a
couple of advantages in that it does not have to be taken orally and is available
as a targeted topical application thus avoiding the potential side effects of the
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BROOKLINE A Division of CIM Securities
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Veru, Inc. (VEIV.1)1 April 05, 2018
oral drugs. This just causes a temporary desensitization given its anesthetic
effects and acts closer to the problem without affecting the sensation of pleasure
or the ability to attain orgasm, compared to other applications that are systemic
and may have inhibitory effects on sex drive and libido besides other unpleasant
side effects.
In a Phase 4 study in 21 men, PREBOOST has shown to significantly improve
the control over ejaculation over placebo, with an over four-minute mean
increase in duration in two months. 80% of men were considered treated for
premature ejaculation and it met both primary (improvement in intravaginal
ejaculatory latency time) as well as secondary (assessed by questionnaires on
global rating of distress, medication assessment and index of premature
ejaculation, IPE) outcomes.
Launched in 2017, this is an OTC product and should not be compared with
other drugs in the space but drives revenues nonetheless. Veru shares
distribution and promotion rights for PREBOOST in US with its partner, Timm's
Medical Technologies.
FC2 is the only FDA approved female condom. Strong revenues globally
and rising.
Its subsidiary the Female Health Company markets the FC2, a female condom
for prevention of pregnancy and STDs in US and 144 other countries. This is a
very successful product that made -$14M in revenues in 2017, with -90% of
coming from public sector buyers who are stakeholders in public and global
healthcare like UNFPA. USAID and Governments of Brazil and South Africa.
Manufactured in Kuala Lumpur, Malaysia with a capacity of 100M units/year, FC2
already has and anticipates large orders that would bring in revenues in the
coming years. FC2 is the only FDA-approved female condom as of now was
launched in US in April 2017 and is already experiencing stronger revenues in
US in FY18 ($1.5M in first 4 months) and plans to keep up with demands and
selling by hiring salesforce and medical representatives this year. This is a strong
area of growth that Veru has already established leadership in, and we expect
the demand and commercialization to trend higher in the near future. Currently
classified as a Type 3 medical device by FDA with more stringent review
requirements that discourages other brands/companies to enter this space, FC2
currently enjoys a unique place of being the only approved product in the market,
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BROOKLINE A Division of CIM Securities
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Veru, Inc. (VERWI April 05, 2018
and one that is available only by prescription. Most insurance companies cover
the use of FC2.
While this is beneficial for Veru at present as the exclusivity drives higher prices,
it could change in future as there have been calls for reclassification to Type 2 as
well as making this an OTC product. We feel that in the time to come, the FDA
would come to reclassify the product category to Type 2, and broaden its use as
an internal, rather than a female condom, thus rightfully acknowledging its use for
anal sex and for sex between male partners. This would bring in more
competition, but Veru would be well placed as an already established and
recognized product. As a prescription-required object, it is enjoying exclusivity,
premium pricing and insurance coverage, and even it FC2 is made into an OTC
again because of market pressures, it could still benefit as a well-established
product and bring revenues from serving a higher volume of demand.
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BROOKLINE A Division of CIM Securities
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Veru, Inc. (VEAL!) I April 05, 2018
Company Description
Veru (VERU) is a biopharmaceutical company with a focus on developing
products in Urology (including a female sexual health division) and Oncology. It
has two products in the market generating revenues, a female condom and a
male penile desensitizing gel for premature ejaculation. Veru is now focusing on
development of differentiated products for urology and cancer indications and is
advancing its efforts to have a pipeline of potential products that can be approved
by 505(b)(2) regulatory pathway for commercializing successful products. The
most advanced products in its pipeline for 505(b)(2) approval are Tamsulosin
DRS granules (soluble powder) and Tamsulosin XR (extended release capsules)
for benign prostate hyperplasia (BPH) that the company is planning to file NDAs
for in 2018. Solifenacin DRG granules are being developed for the indication of
overactive bladder, and combination Tadalafil/Finasteride capsules for enlarged
prostate and erectile dysfunction (ED), with NDA being planned for these two
products in 2019. Veru is also initiating a Phase 2 trial to study another 505(b)(2)
candidate VERU-944 (cis-clomiphene) to treat hot flashes in advanced prostate
cancer patients on hormone therapy with an eye for NDA in 2020. In addition,
Veru is also preparing to start a Phase 1/2 open label trial to study VERU-111, a
novel, taxane-like oral therapy for metastatic castration resistant prostate cancer
(MCRPC) that targets both alpha and beta tubulin. An Investigational New Drug
(IND) application for VERU-111 is expected to be filed in O218 and the clinical
trial is anticipated to have data in early 2019.
We Value Veru Using a Sum of Parts Valuation
We value Veru based on a sum of parts valuation of the commercial potential of
Tamsulosin DRS granules (soluble powder) and Tamsulosin XR in benign
prostatic hyperplasia (BPH). We estimate revenues, COGS, R&D expenses and
SG&A for the indication and calculate profit after tax until 2036 when Tamsulosin
patents are expected to expire. We calculate NPV based on the profit after tax.
We assume 33% probability of success for Tamsulosin in BPH. We assume 10%
peak penetration and conservatively assume a price of $2,200 per year in 2020
when we expect Tamsulosin to be launched for BPH.
We apply a discount rate of 10% to our net present value calculations on top of
the probability adjustments we apply to account for the development risks
associated with these programs. We include a valuation of $107M based on 25%
pipeline premium for the rest of the pipeline to reach our $10.00 target price.
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Veru, Inc. (VEAL)) / April 05, 2018
Figure 3: Veru BioPharma Sum of Parts Valuation
Expected Probability of Peak Market Peak Sales Probability
Launch Success Share (SM) adjusted NPV
TAMSULOSIN DRS(XR 2020E 33% 10% S886 5429
Pipeline premium 25% $107
Sum of Parts Value (SM) 5536
NPV per share 510
Source: Brookline Capital Markets Estimate
Risks
Veru is facing clinical, regulatory and reimbursement risks that are common in
drug development. If these risks are greater than our expectations then the share
price may not meet our target price.
Developmental Risk
Veru must complete bioequivalence and stability studies for some of the drugs
being developed under the 505(b)(2) regulatory pathway. Some of these studies
may not be successful or may be delayed. There is a possibility that some of the
drugs under development may fail to meet efficacy and safety requirements in
clinical trials. There is a lot of variability in patients being treated for various
indications and, therefore predicting the outcome of clinical trials is inherently
difficult.
Regulatory Risk
Veru is utilizing the 505(b)(2) regulatory pathway for getting its products
approved by the FDA. While this pathway is comparatively shorter for approval
as these drugs are already approved for other indications and therefore are
overall safe and efficacious with existing clinical data, several risks remain
including the inability to show bioequivalence. lack of long term stability of the
drug product etc. These new formulations are potentially low risk and lower cost
with a faster path to pivotal trials, but there is a possibility for regulatory
authorities to require additional trials.
Commercial Risk
Veru shares distribution and promotion rights for PREBOOST in US with its
partner, Timm's Medical Technologies. It is also marketing FC2 female condoms.
It must participate in tender process and be successful to generate revenues
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BROOKLINE A Division of CIM Securities
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Veru, Inc. (VEM.I) I April 05, 2018
incremental for its FC2 female condoms. Veru will need to obtain pricing and
reimbursement approvals following regulatory approval of it new products.
Intellectual Property Risk
Veru has filed patent applications covering Tamsulosin. Once granted, the patent
protections are expected to last from the priority date to 2036. Veru does not
have any issued patent for Tamsulosin. There are risks involved with patent
prosecution and some of the patent applications may be rejected or limited
claims may be allowed.
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BROOKLINE A Division of CIM Securities
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Veru. Inc. (VERU)I April 05, 2018
Financials
Figure 4: Veru Annual P&L ($)
Fiscal Year entities September 30
■ 2017 MU 20198 10201 20211 20221 20231 20211
Revenues: ■
TaUSQ1.0541 ORS .ore0.14477 acIP4414 ) SO $21.301.450 132,591219 144.324.05E 556,513,174 569.172124
Revenues from The Fern8e Hear, Company 513.656592 516.119.772 525.551.596 526.829.178 19.170837 529.579.168 531.058,127 532,611.033
Tots revenues 113466492 116.119272 525.561.596 149.139421 144.761.866 573.903.226 117.571401 S101.713.158
Operating doneness:
Cost of pats soli 56.636.060 57.497,827 $11313,735 513,406.494 114.158,054 115.822,620 517712397 $18.459,682
Researe1, a-4 et.tiovnere 53504482 18.787423 510,544,907 512,653.615 115.167666 $18221599 $21,865,919 526.239,103
Acivert669 554270 12.947697 $3,006.651 13,1166.764 13.128.120 53.190,682 13,254,496 $3.319,586
Stang. genera: 501 63—carathe 511,019.091 116,223,901 $17846.291 536,130.920 139.744.012 $43.718.413 548,090,255 $52.899,280
flusr.els aceuseon $935.781
Total operating expenses 122.149.794 $36466.848 143.151.584 14546RM 172.644.862 510,963.315 $90,323,067 1100.917,650
Operating (loss) income (19.494.112) ($19.337.471) 017499.946) (117,12741591(111.582.9%) dr.eso.oes) 152.751,766) sass,sor
Other income (expense'
Merest and other (excense. more. not ($46,543) (154277) ($55.363) ($56.470) ($57.600) (558.752 , (150.927) ($461.125)
Foreir curre-cy tansecton roes. peal (161.1n6) ($220,321) 6224.7271 (1229222) 45233606) 15238,4821 1$243,2521 (5248,117)
loth alter expenses ($106.378) ($274,598) 11280.0901 ($285,692) ($291,406) ($297.234) 15303,1781 (5309242)
Matto's/Income (18442499) (119.611474) 017490.076) (SI/413.16H (512.174.402) 157.347.323) 113454.946) 5566,266
Income tax (benefn) expense (11.910.44.1) (13.246.963)
Net income (loss) (16412.447) (116.365.621) 017.800.076) (517.413.1911 (112.174492) 117.347,323) 113.564.946) 1561266
Net k.ss per share 0025/ (SO 27) 11 261 ($0241 (50 16) (10 09) (10.041 SO 01
Share% autstamang. bssc and darted 34.640.306 61,515,637 67,472,723 71.846.359 75438677 79,210,611 83171,141 87,329,896
Source: Company reports, Brookline Capital Markets Estimate
Figure 5: Veru Quarterly P&L ($)
Fiscal Year ending September 30 Dec 31 Mar 31 June 30 Sep 30
2017 Ct1:18E 02:18E 0118E 04:18E 2018E
Revenues:
TANSel.059 DRS (Orobabirty adjusted)
Revenues from The Female Health Company $13,655,592 52.588,613 $3,103,938 $4,345,510 $6,083,714 516, 119.772
Total revenues $13,666,592 $2,586,613 $3,103,936 $4,346,510 $6,083,714 $16,119,772
Operating expenses:
Cost or coos sold 56,636.080 $1,272,574 61,427,810 51.998.935 52,798,508 57,497,827
Research and development 53,504,482 52,038,786 $2,140,725 S2,247,762 12.360.150 $8,787,423
Advertising $54270 62,947,697 $2,947,697
Selina. general and administrative $11,019,091 53,764,137 $3,952,344 64.149.961 64.357.459 616,223.901
Business acouston 3935,781
Total operating expenses $22,149,704 $10,023,194 $7,620,880 58.396,667 59416,117 535,466,848
Operating (loss) income ($8,494,112) ($7,436,681) ($4,416,944) ($4,061,147) (S3f0 /103) (519,337,076)
Other income (expense)
Interest and other (expense) income, net ($46,543) (613,189) ($13,432) ($13,701) (513.975) (554277)
Foreign currency transaction (loss) Rain (56t.835) (553,455) (354,524) (555,615) (556.727) (3220,321)
Total other expenses ($108.378) (566.624) (567,956) (369.316) (370.702) (5274.598)
Net Lossfincome (58,602,490) (57,603,206) ($4,484,900) ($4,120,463) ($3,603,106) ($19,611,874)
Income tax (benefit) expense (51,990,443) ($3,246,663) ($3,246,063)
Net income (loss) ($6,612,047) (54257,152) ($4,484,900) ($4,120,463) ($3,503,105) ($16,365,621)
Net loss per share (5025) (50.08) (50.08) (50.07) (50.06) (50.27)
Shares outstanding, basic and dieted 34,640,308 53,154,076 56,343,321 59,723,920 63,307,355 61,515,837
Source: Company reports, Brookline Capital Markets Estimate
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BROOKLINE A Division of CIM Securities
CAPITAL MARKETS
Veru, Inc. (VEAL)) l April 05, 2018
Figure 6: Tamsulosin Market Model
5$13E 34456 1wE 26211 SOX 312E 3164 MME MME UM Xs* 263E 11132 034 M3M 34331 24345 10310 SOW
5 non •44 tt. &NS:Hi Men) , 41 43 4) 44 46 46 47 44 40 SO 51 52 53 54 S5 56 17 SI 03
lg. Pr. ..once 4144 0% 0% 0% 0% 0% 43% 0% 0% 13% 41% 0% 0% 0% 0% 45% 0% 0% 0%
00 PrOtittf • Ira0, 4 , 19 It 20 20 20 21 21 22 22 22 23 23 24 24 25 25 26 26 27
% of cowl/ owl 004442 in 13% FS% 0% IS% in 0% 45% 9% IS% IS% in 0% IS% IA 15% IS% in In
("Avis Warta f:r Tale-M.0,A DRS 1)004 1100 2677 2134 2.110 SASS 3314 300 SIM 124 1370 342 3107 3.5/7 364 1721 3766 3171 Shil 4.02
lAttrit CA" CRS Premix., 0T 10% I3% 20% 13% 30% 33% 4* 40% :EX it 0% 90% 100% 100% 10 0% 103 100% 100%
isorNACSh DC/See...4 oaten 0 3121 4400 61.052 77142 952711 03311 12211 2022 21642 20120 321107 )4.64 1/2 03 379.5$6 747.140 *IAN 402.797
ia✓y,LO5a. COS strut( ow 12.201 12.201 12203 52210 1220) 52210 52,240 12200 1220) 5210) 12200 52200 42210 52210 12200 5220) 52.200 12200 12200
ruasoL094 MS revenue* 112 KI 10 546 5443 501 5171 1210 5249 5327 1415 lea %I, roe MI 190 SUS 122 WS 5666
COG311M1 2 SO 2 115 17 14 SIO 111 516 122 126 13! 636 140 14, 542 SO SO 144
SILO CiMP SS SS 2 15 2 SS SS 15 15 2 SS SS SS SS SS 2 IS SS 56
166.4(1111 14 2 144 551 ISS /44 NI 104 VP PS 174 VS I* 114 VA WI 199 004 5109
tow tip/49es (12 16 SS I* 562 567 171 579 SU SOS RI4 MS III) SIX 51)1 512 1141 24 51St SISI)
ma Pro* Mil 16) (5S) SS 636 SP SOO 1433 SW Me 1347 342 5604 SS* 5672 5643 Si VMS 1116 3327
Opeastwq *wpm 10% 37% 50% 56% Si% V% 73% 16% 40% 12% OM Si% SI% 63% 63% 42% 62%
PION IPA) I* 06) * DI SO 1106 542 121 RA SUP 1434 1604 SUS 1617 242 NW 2204 RS star
Taw Rare 30% X% X% X% X% X% X% X% 32 X% )0% 30% X% X% 30% 1011 X% 30% 430%
19.44 (111 010% (5202) 02991 0406) 06641 07161 (51042) (512721 015111 IMMO 029161 020491 112012) 021151 021491 1121601
ROM Ow. W IVA% 11641 062 963 936.4 WI MO KU $1172 $147.2 1243.1 MU Ma USA 500.4 WU MU UNA SIMS 1641.7
SPY*. 1.W140211W) Het clistowd
IX*
$1
• a%I
1/14 0.011RY CA sun.** 33%
Pr Obitateocipened SPY 141
WM Del Owe 111
Source: Company reports, Brookline Capital Markets Estimate
22
EFTA00810597
BROOKLINE A Division of CIM Securities
CAPITAL MARKETS
Veru. Inc. (VERU) I April 05, 2018
Figure 7: Veru Balance Sheet ($)
2017 2018E 2019E 2020E 2021E 2022E 2023E 2024E
Currenssssstar
Cash 53,277,602 524.518.939 534,927.895 $45,852,782 542,657.195 548,581248 559,977.307 576664,144
Accounts receivable 53.555.350
hvenlory, net 52.767.924
Prepaid expenses 5897.097 $731952 $788,549 $808,977 5847 326 5889.692 $934.177 $980885
TOW current assets 510.297.973 $26248891 535.696.444 546.659.769 $43.704.520 549.470.940 560.911.484 577.638029
Rant and equebent net $555.539 4583.316 5612.482 $643.106 5675.261 $709.024 $744,475 $781,699
Other trade receivables 57.837,600 08229375 58644644 59,072.888 59,524530 $10,002,857 510,503.000 511,028150
Other assets $156.431 5184253 $172,465 $161,088 5190.143 5199.650 5209.633 $220.114
Deterred neon/ taxes 58.827.000
hungbie assets. net $20,752,991 521.790.841 022.880,173 524.024.181 325225.390 528.488.860 027.810.993 029.201.542
Goodwal 56.878.932 57222,879 $7,584,023 57,963.224 56.361.385 58,779.454 $9218,427 59.879.348
TOW assets $55,306,366 $63239.363 575.586,430 188.544.244 187,683,230 $95,648,585 5109,396,011 5124545683
Current liabilities:
Accounts payable $2,685,718 52.820,004 52.961.004 $3,109,054 53264,507 $3.427.732 $3,599,119 53,779.075
Unearned revenue $1,014,517 $1,065,243 $1,118,505 51.174.430 51233.152 51294.809 51.359.560 $1.427.527
ACCTUal expenses end other current bates 51.441.359 51.513.427 51.589,098 51.668,553 $1.751.981 $1939.580 $1,931.559 52.028137
Accrued ceepernaton $345.987 $383286 5341.451 5400.523 5420.549 5441.577 5464656 5486.838
TOW current liabilities 15487.681 $5,761.960 $6.050.058 $6.352.661 56,670.189 57.003,696 $7141)101 57.721.678
Ober isbanes 51.233.750 51.295.438 51,360209 51.428.220 51.494631 51.574.612 51.653.343 $1,736.010
Deferred rent $131830 5134422 $145,343 $152.610 5160.240 5163.252 $176,865 $185.498
TOW liabilities 16.863.161 57.195.819 57.656.610 57.933.391 $8,330.060 58.746,563 59.183.891 59,643.086
Stockholders' e0uity
Comron snares $554922 $809,314 5870248 $737,270 5810,997 $892,097 $981.307 51,079437
AdditiOnalpaid-6 rumen 590.550.669 5107.577.558 5136,917,063 $161.604.474 $167.820.386 $178.143.083 $190.809.706 5206.088245
Accumulated Ws* consirehensive kiss (581.519)
Acoemulated *fief (534,263262) (552.143,338) (549.558.489) (581.730.891) t589,078,213) ($92133.158) (591,576.892) (584.264.888)
Treasury stock. al cost '57.808.6051 (57.806.605) (57.806.605) (57.806.605) (57 806.665) (57,806,605) (57.805805) (57.806605)
TC4Ill stroCkhotlert eouly 548.453205 556.013.534 568,030.820 580.610.854 579.353.170 586.902.022 $100.214.120 $118.902.797
Total liabilities and stockholders' equity 555,306,36 $63,239.353 $75,584.430 $88444244 187,683230 $95.648.685 5109.396,011 1128645983
Source: Company reports, Brookline Capital Markets Estimate
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BROOKLINE A Division of CIM Securities
CAPITAL MARKETS
Veru, Inc. (VERWI April 05, 2018
References:
1. httpslAvww.statista.comistatistics/2414881population-of-the-us-by-sex-and-age/
2. Guess HA, Arrighi HM, Metter EJ. Fozard JL. Cumulative prevalence of prostatism matches the autopsy
prevalence of benign prostatic hyperplasia. Prostate. 1990:17(3):241-6.
Public Companies Mentioned in this Report:
Astellas Pharma (ALPMY — NR - $15.00)
Eli Lilly (LLY — NR - $78.60)
Merck & Co (MRK -NR-$54.54)
Pfizer Inc. (PFE -NR-$36.13)
Johnson & Johnson. (JNJ -NR-$130.41)
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EFTA00810599
BROOKLINE A Division of CIM Securities
CAPITAL MARKETS
Veru, Inc. (VEIV.1)1 April 05, 2018
Important Disclosures and Disclaimers
Distribution:
This report and all information contained within is intended for qualified institutional or professional clients
of Brookline Capital Markets and qualified prospective institutional clients and is not meant for
redistribution. The contents of this report represent the views, opinions, and analyses of its author. The
information contained herein does not constitute financial, legal, tax or any other advice. All third party
data presented herein were obtained from publicly available sources which are believed to be reliable:
however, Brookline makes no warranty, express of implied, concerning the accuracy or completeness of
such information. In no event shall Brookline be responsible or liable for the correctness of, or update to,
any such material or for any damage or lost opportunities resulting from use of this data.
Analyst Certification:
I, Kumaraguru Raja, hereby certify that the views expressed in the foregoing research report accurately
reflect my personal views about the subject securities and issuer(s) as of the date of this report. I further
certify that my compensation is not directly, or indirectly, related to the specific recommendations or views
contained in this report.
Financial Interests:
The analyst, Kumaraguru Raja, has no financial interest in the debt or equity securities of the subject
company of this report. Further, no member of his household has any financial interest in the securities of
the subject company. Neither the analyst, nor any member of his household is an officer, director, or
advisory board member of the issuer(s) or has another significant affiliation with the issuer(s) that is the
subject of this research report. The analyst has not received compensation from the subject company. At
the time of this research report, the analyst does not know or have reason to know of any other material
conflict of interest.
Brookline Capital Markets
Brookline Capital Markets is a division of CIM Securities, LLC. Brookline Capital Markets is a member of
FINRA and SIPC. Brookline does not make a market in the securities mentioned in this report, and does
not have an ownership interest in the securities. Brookline intends to solicit investment banking business
from the subject company in the next three months. Brookline has not managed or co-managed a public
offering for the subject company, nor received compensation for investment banking activity from the
subject company in the 12 months prior to publication.
Definitions of ratings:
Buy: Potential returns of more than 15% above current market price
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BROOKLINE A Division of CIM Securities
CAPITAL MARKETS
Veru, Inc. (VEM.1)1April 05, 2018
Hold: Potential for the securities to decline or appreciate less than 15%
Sell: Potential for the securities to decline more than 15% from current market price
Total companies covered: 9. % of Buy recommendations: 100. % of Hold recommendations: 0. % of Sell
recommendations: 0.
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