Upload
others
View
2
Download
0
Embed Size (px)
Citation preview
1
Building Canada’s leading specialty pharmaceutical company
Knight Therapeutics Inc.(TSX: GUD)
June 2017
This document contains forward-looking statements for the Company and its subsidiaries.
These forward looking statements, by their nature, necessarily involve risks and uncertainties
that could cause actual results to differ materially from those contemplated by the forward-
looking statements. The Company considers the assumptions on which these forward-looking
statements are based to be reasonable at the time they were prepared, but cautions the
reader that these assumptions regarding future events, many of which are beyond the control
of the Company and its subsidiaries, may ultimately prove to be incorrect. Factors and risks,
which could cause actual results to differ materially from current expectations are discussed in
the Company’s Annual Report and in the Company’s Annual Information Form for the year
ended December 31, 2016. The Company disclaims any intention or obligation to update or
revise any forward-looking statements whether as a result of new information or future
events, except as required by law.
2
Forward Looking Statements
• Better a Gud Knight than a bad one
• We never rest at Knight
• May you always have a Gud-Knight
• A Gud-Knight is Gud Medison
• Knighting wrong with making money
• Gud for Knight
• Fun things happen at Knight
• Knight loves a Gud pun
• Gud Knight sleep tight
• Gud time had by all
• Gudluck Jonathan
3
A Knight is Born
4
A Knight’s History
• Founded by co-founder & CEO of Paladin Labs Inc.– 19 years of consecutive record revenues
– Share price increased from $1.50 to $151 per share
– Market capitalization increased from $6 million to $3.2 billion
• Knight’s first day was on February 28th, 2014– The day Paladin’s sale to Endo closed
– Knight initially owned by Paladin’s shareholders as consideration for Paladin sale
Knight is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products
for the Canadian and select international markets
Since starting operations in 2014 with 2 employees, $1M in cash, a single therapeutic pending FDA approval, Knight:
5
Learning to Walk
1 As at March 31, 2017, includes approximately $9M of foreign exchange gains
• Raised $685M at increasing valuations ($3.50, $5.25, $6.75, $8.00, $10.00 per share)
• Received FDA approval for Impavido® in March 2014 and sold PRV for US$125M
• In-licensed over 20 innovative pipeline products from 14 companies
• Acquired NeurAxon Inc., Orphan Canada assets and Neuragen brand
• Sold or out-licensed rights to Neuragen, Impavido and NeurAxon
• Expanded internationally through strategic partnership with Medison (Israel)
• Lent over $125M to 12 strategic loan partners and generated 15+% return
• Committed ~$125M to nine fund managers as part of long-term licensing strategy
• Generated ~$185M1 of net income to date
Significant Achievements Since Founding
6
Growth Strategies
In-licensing or Acquiring Product Rights
Strategic Fund Investments
Strategic Lending For Product Rights
Near Term Pipeline Long Term Pipeline Near and Long Term Pipeline
• In-license innovative pharmaceuticals
• Acquire mature or under-promoted products from Big Pharma
• Develop near-term, low risk/low expense products for the Canadian and global markets
• Committed ~$125M to various funds
• Nine fund investments closed to date
• Two licensing deals closed
• Secured against revenue and/or tangible assets
• IP not taken as only security
• Structured with returns between 15%-20% including interest, warrants, equity and product rights
Firing on Multiple Cylinders
Building a portfolio of innovative pharmaceuticals
Product Portfolio
7
Expanding Pipeline of Innovative Pharmaceuticals
8
Product Selection Criteria
DiscoveryPre Clinical
ModelsClinical Trials
Regulatory Approval
Sales and Marketing
• Focus on later stage products (Phase II, Phase III or approved in foreign market)
• Structure transaction to meet partner needs while protecting downside risk
• Manage return to address associated risks
Knight’s involvement
2 - 10 Years 2 - 4 Years 5 - 7 Years 1 - 3 Years
Taking on Commercialization Risk, NOT Development Risk
9
Movantik®
Background
• Exclusive license agreement with AstraZeneca for Movantik® in Canada and Israel
• First oral once-daily peripherally acting mu-opioid receptor antagonist (PAMORA) to be approved in Canada (launched in Canada in October 2015)
Opportunity
• Opioid induced constipation (OIC) affects between 26%-79% of patients taking an oral opioid1,2
• Strengthens Knight’s opioid supportive care portfolio along with Probuphine
• Knight began commercial launch in March 2017 – calling on over 3,000 physicians - 11% of prescribers who represents >50% of Rx
1. Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-cancer Pain2. Chronic opioid induced constipation in patients with non-malignant pain
Treatment of opioid-induced constipation
Background
• Exclusive in-license agreement with Braeburn for Canada
• Subdermal implant for opioid addiction
• Delivers buprenorphine continuously for six months
• Expected to be submitted for Canadian regulatory approval in Q2-2017
Opportunity
• Small number of prescribers that overlap opioid support portfolio
• Addresses issue of patient adherence/compliance
• Addresses issue of diversion/illicit use
10
Probuphine™Novel implant for opioid addiction
Iluvien®(Implant for diabetic macular edema)
• Exclusive in-license agreement with Alimera Sciences
• Continuous micro-dosing over 3 years for the treatment for vision impairment associated with DME
• Approximately 200 retinal specialists in Canada
• New Drug Submission accepted for review by Health Canada in February 2017
11
Ophthalmology Portfolio Differentiated Therapies for targeted physicians
Netildex™(Combination antibiotic/steroid for eye infection/inflammation)
• Exclusive in-license agreement with SIFI for Netildex™ in Canada
• Introduces a new antibiotic with a known steroid leading to less resistance
• Good fit within growing ophthalmic portfolio
• Submission for regulatory approval with Health Canada expected during the second half of 2017
12
Impavido®
Background
• Acquired global rights from Paladin Labs at founding of Knight
• Approved and licensed in Germany and Israel• Obtained US approval in March 2014 along with a
Priority Review Voucher• Sold Priority Voucher to Gilead for US$125M
Opportunity
• Launched in US through Profounda, Knight’s license partner, in Q1-2016
• Pursuing licensing opportunities for Impavido® in Latin America
• Pursuing acquisition and in-licensing opportunities for other tropical disease products
Treatment for Leishmaniasis (visceral, mucosal and cutaneous)
13
Prescription Pharmaceuticals
Product / Family Licensor Indication Status in Territory Territory Rights1
Pain
Movantik® AstraZeneca Opioid-induced constipation Marketed3 CAN, ISR
Probuphine™ Braeburn Opioid addiction Pre-Registration CAN
NeurAxon family N/A Acute migraine, pain and neurological disorders Pre-Clinical – Phase 3 CAN, ISR, RUS, ZAF
Antibe family Antibe Chronic pain and inflammation Pre-clinical – Phase 2 CAN, ISR, RUS, ZAF
Ophthalmic
AzaSite™ Akorn Bacterial conjunctivitis Approved CAN
Iluvien® Alimera Diabetic macular edema NDS in Review CAN
Netildex™ SIFI Ocular inflammation Pre-Registration CAN
Other
Impavido® N/A Leishmaniasis Marketed Global2
ATryn® LFB Prevention of thromboembolic events Pre-Registration4 CAN
60P family 60P Tropical diseases Phase 1 – Phase 3 CAN, ISR, RUS
Advaxis family Advaxis HPV-associated cancers and others Phase 1 – Phase 2 CAN
1 Legend: CAN: Canada, ISR: Israel, ROM: Romania, RUS: Russia, ZAF: Sub-Saharan Africa2 Approved in Germany, Israel and the U.S. (Distributed by Profounda in the U.S.)3 Currently approved and marketed in Canada only4 Knight received a Notice of Deficiency Withdrawal from Health Canada in March 2017
14
Consumer Health Products
Product / Family Licensor Description Status in Territory Territory Rights1
Neuragen® OwnedPain associated with diabetic and peripheral neuropathy
Marketed2 Global (Ex. U.S.)
Flat Tummy Tea™ Synergy Herbal detox tea Marketed CAN, ISR, ROM, RUS, ZAF
FOCUSfactor™ Synergy Dietary supplement Marketed3 CAN, ISR, ROM, RUS, ZAF
FLEXISEQ™ Pro Bono BioPain and joint stiffness associated with osteoarthritis
Not Yet Marketed QUE, ISR
Hand MD™ Synergy Line of anti-aging hand skincare products Not Yet Marketed CAN, ISR, ROM, RUS, ZAF
Crescita family Crescita Dermo-cosmetic products lines Not Yet Marketed CAR, ISR, ROM, RUS, ZAF
1 Legend: CAN: Canada, CAR: the Caribbean, ISR: Israel, QUE: Quebec, ROM: Romania, RUS: Russia, ZAF: Sub-Saharan Africa2 Approved and marketed by Knight in Canada only3 Approved and marketed in Canada only
15
Medical Devices / Diagnostics
Product / Family Licensor Indication / Description Status in Territory Territory Rights1
TULSA-PRO® Profound Prostate ablation Pre-Registration CAN
3D Signatures family 3D SignaturesDiagnostic and prognostic tools to improve treatment outcomes
In Development CAN, CAR, ISR, ROM, RUS, ZAF
1 Legend: CAN: Canada, CAR: the Caribbean, ISR: Israel, ROM: Romania, RUS: Russia, ZAF: Sub-Saharan Africa
Strategic Fund Strategy
16
Long-term Path for Product Rights
• Strategy: Knight invests in life sciences venture capital funds in order to obtain preferential access to innovative pharmaceutical products and earn LP returns
• Investment: ~C$125M invested in nine funds in Canada, Europe and US with proven track record of positive returns
• Results: Fund strategy led to license of Iluvien® from Alimeraand license agreement with Advaxis for their portfolio of products for Canada
17
Fund Strategy OverviewDiversifying Access to Products
18
Strategic Fund Portfolio
Fund Amount Healthcare AUM Development Stage Geography
Teralys C$30M C$450M VCAP Fund of Funds Canada
Domain US$25M US$2.4B Early stage North America
Forbion €19.5M EUR€400M All clinical stages Europe
Sectoral US$13M US$3.6B Late stage to small cap Global
Sanderling US$10M US$900M Early stage North America
HarbourVest C$10M US$2.3B VCAP Fund of Funds Canada
TVM US$1.6M EUR€1.3B All clinical stages Global
Bloom Burton2 C$1.5M C$50M Commercial stage Canada
Genesys C$1M C$200M Early stage North America
Total1 ~C$125M All stages Worldwide
1 Total in CAD is converted at the Bank of Canada noon exchange rates as of the commitment dates. Using the March 31, 2017 exchange rates, total fund commitments are C$135M with C$99M remaining to be funded.
2 Bloom Burton healthcare lending trusts are managed by Stratigis Capital AdvisorsSource: Fund information provided by fund managers
Commitments to Date
19
A GUD Track RecordNotable Investments by Knight’s Partner Funds
Strategic LendingAnother Source of Products and Return on Investment
20
• Strategy: Enter into secured loans with life-sciences companies in exchange for product rights for Canada and select international markets
• Investment: Over C$125M loaned to 12 strategic loan partners generating 15+% annual return on invested capital
• Results: 15+ innovative products in Knight’s portfolio have been sourced via secured lending strategy
21
Strategic Lending OverviewLeveraging Knight’s Balance Sheet for Products
22
Strategic Lending Portfolio
CompanyPrincipal Loaned5
Interest Rate1 Maturity2
ProductRights
Medimetriks US$23.0M 13% 2019
Synergy US$11.5M 15% 2017
Crescita3 C$6.8M 9% 2022
Profound C$4.0M 15% 2019
60P Pharma US$4.1M 15% 2020
Pediapharm4 C$1.25M 12% 2019
Ember US$1.0M 12.5% 2016
Antibe C$0.5M 10% 2018
1 Interest rate may be reduced by up to 2% should certain fundraising targets be met2 Some loans may be extended provided certain sales and profitability milestones are met3 Crescita acquired INTEGA Skin Sciences Inc.4 Pediapharm debenture is held indirectly through the Bloom Burton Healthcare Lending Trust5 As at March 31, 2017, Knight has loans receivable of C$54M
23
Strategic Lending Benefits All
CRH Knight
• CRH stock price increased by more than 3x within 4 months following loan
• Raised C$27M of equity at $3.40 per share and prepaid ~25% of Knight loan
• Prepaid balance of Knight loan in and replaced it with bank debt at 3.5%
• Increased market cap from ~$30M pre-Knight to over $500M two years later
• Sold CRH shares received as part of loan for proceeds of ~C$9.9M
• Successfully exited CRH loan following early repayment
• Earned an all-in IRR of 40+% in less than 12 months
CRH Medical – US$30 Million Secured Loan
24
Security Provides Greater Value
• Following default, Knight acquired
global rights to Neuragen®
• Sold the US rights to Synergy CHC
for proceeds of US$1.2M within 4
days of acquiring global rights
• Knight markets Neuragen® in
Canada – generating over $250K of
annual sales
• Pursuing out-licensing
opportunities for Rest of World
Origin Biomed – C$850K Secured Loan
Rest of World Pharma
25
Finding Other Knights
26
Rest of World Strategy
Vision Target Geographies
• Rest of World (outside US, Europe, Japan) specialty pharma will continue to experience growth
• Knight will be partner of choice for 2nd / 3rd tier markets
• Leverage GUD financial strength and business development capabilities to accelerate growth in each of these markets
• Knight has licensed rights to 15+ products for select international markets
• High growth countries with expanding access and funding for medicines
• Stable legal and regulatory systems, including IP protection
• Non-core geographies for other companies
• Knight acquired 28.3% of Medison Biotech (1995) Ltd., an Israeli specialty pharma company
Small Markets – Single Partner
• In September 2015, Knight acquired 28.3% ($80 million) of Medison Biotech (1995) Ltd. in exchange for 10% of Knight1
• Founded in 1996, Medison has grown to sales of approximately $206M in 2016
• Medison represents 20+ European and American pharmaceutical and biotech companies including Amgen®, Biogen® and Ipsen®
• As at March 31, 2017, Knight had received dividends from Medison totalling $6.9M
27
GUD MedisonInvestment in Medison Biotech
1 Medison ownership of Knight is currently below 10% due to dilution
Why Knight?
28
Partner of Choice for Canada and RoW
29
Knight’s Management Experience
Partnering• Built Canadian business through collaborations with over 30 companies• Deals structured to meet partners’ needs
Regulatory• Significant experience in all aspects of the regulatory process• ~30 submissions to Health Canada with a 90% success rate
Pricing and Reimbursement
• Extensive experience and success with PMPRB, provincial formularies and private payors • PMPRB acceptance of all major brands’ launch prices• Track record in obtaining significant price increases in public markets• Successfully negotiated favourable listings
Commercial• Commercialized over 60 products • Grew Canadian revenue to ~$150M and international revenue to ~$120M• Built sales and marketing teams/expertise across multiple therapeutic areas
Building Bench Strength
30
Management Team
Jonathan Ross Goodman B.A., LL.B., M.B.A.
Chief Executive Officer
• Paladin Labs, Co-Founder, President & CEO
• Procter & Gamble, Brand Management
Samira Sakhia, CPA, M.B.A.
President
• Paladin Labs, Chief Financial Officer
Jeffrey Kadanoff, B. Eng., M.B.A.
Chief Financial Officer
• Reitmans, VP Strategic Planning and Development
• Bain & Company, Principal
Amal Khouri, B.Sc., M.B.A.
VP Business Development
• Novartis, Global Business Development and Licensing
• Paladin Labs, Business Development
31
Board of Directors
Board Member Qualifications
James Gale (Chairman)• Paladin Labs, Board member from 2008 to 2014• Signet Healthcare Partners, Managing Director
Dr. Sarit Assouline• Jewish General Hospital, Director of the Chronic
Myelogenous Leukemia Clinic
Jonathan Ross Goodman • Knight Therapeutics, Founder and CEO• Paladin Labs, Co-founder, President & CEO
Meir Jakobsohn • Medison Pharma, Founder and CEO
Robert Lande • Paladin Labs, Board member from 1995 to 2014• Forex Capital Markets, CFO
Samira Sakhia• Knight Therapeutics, President• Paladin Labs, CFO from 2001 to 2015
Sylvie Tendler• Pharmaceutical Market Research Consultant• The Tendler Group Inc., Founder
32
Financial and Strategic Assets
Asset Description
Cash $764 million1 ($5.35 / share)
Marketed ProductsMovantik®, Impavido®, Neuragen®, Flat Tummy Tea™, FOCUSFactor®
Products Pending Approval/Submission Iluvien®, Netildex™, Probuphine™
Product Pipeline 20+ products in various stages of development
Strategic Fund Investments ~$125 million2 in total commitments
Strategic Loans ~$54 million3 of loans receivable
Rest of World Pharma ~$80M equity investment in Medison (28.3%)
1 Cash, cash equivalents and marketable securities as at March 31, 20172 Based on the exchange rates in effect on the dates of the fund commitments3 As at March 31, 2017, based on the exchange rates in effect on that date
• Proven ability to develop a rich pipeline of new
products
• Proven ability to secure profitable licensing and
secured loan agreements
• Proven track record of profitable growth
• Experienced and dynamic management team
• Financial strength to execute our strategy
33
Summary
Building Canada’s leading specialty pharmaceutical company
34June 2017
Knight Therapeutics Inc.(TSX: GUD)