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Building Canada’s leading specialty pharmaceutical company
Knight Therapeutics Inc.(TSX: GUD)
May 2019
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, 2018. 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.
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Forward Looking Statements
• Better a GUD Knight than a bad one
• We never rest at Knight
• May you always have a GUD-Knight
• 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
• GUD luck Jonathan
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A Knight is Born
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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
✓ Proven leadership with alignment, expertise and determination to build Paladin 2.0
✓ Proven ability to develop a pipeline of innovative, new products
✓ Proven track record of profitable growth and capital stewardship
Why Invest in Knight?Disciplined capital stewardship and relentless focus on our long-term strategy
Successes at Knight to Date
✓ Raised $685M at increasing valuations
✓ FDA approval for Impavido® in Mar. 2014 and sold PRV for US$125M
✓ In-licensed over 20 innovative pipeline products from 19 companies
✓ Acquired NeurAxon Inc. and the Neuragen® brand
✓ Sold or out-licensed rights to Neuragen, Impavidoand NeurAxon
✓ Lent over $170M to 15 partners and generated double-digit return
✓ Generated $225M of net income, to date
✓ Proven strategy to build a profitable specialty pharmaceutical company
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Knight’s Consistent Investment Attributes
✓ First-in-class corporate governance
✓ Deployed over $350M of capital, to date
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Growth StrategiesFiring on Multiple Cylinders
• In-license or acquire innovative pharmaceuticals in Canada and select “rest of world” markets
• Acquire mature or “under-promoted” products from Big Pharma
• Develop near-term, low risk / low expense products
• Strategic lending and fund investments are tools in support of the core strategy
− Strategic loans to source near and long-term product pipeline − Ceased fund investments beyond committed capital
In-licensing or Acquiring
Product Rights
Rest of World
• Partner of choice for 2nd / 3rd tier markets
• High growth countries with stable legal and regulatory systems, IP protection
• Focus on Big Pharma’s non-core geographies / 2nd tier markets
• Partner with international operators via investment and strategic loans to expand ROW infrastructure
Product Portfolio
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Expanding Pipeline of Innovative Pharmaceuticals
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Product Selection Criteria
• Knight takes on late-stage commercialization risk, not early-stage development risk with lower probability of success
• Focus on later stage products (Phase II, Phase III or approved in foreign markets) with lower clinical / regulatory risk
• Opportunistic approach to earlier stage products via de-risked structures (e.g. equity or loans)
• Structure transaction to meet partner needs while protecting downside risk• Manage return to address associated risks
Taking on Commercialization Risk, NOT Development Risk
Several months 1 – 2 Years 1 – 4 Years
Pre - IND Phase I Phase II Phase IIl NDA / Approval
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Pain Support
Movantik® for the treatment of opioid-induced constipation
• Exclusive license agreement with AstraZeneca for Movantik® in Canada and Israel
• First oral once-daily peripherally acting mu-opioid receptor antagonist (PAMORA) approved in Canada (launched in Canada in October 2015)
• Opioid induced constipation (OIC) affects between 26%-79% of patients taking an oral opioid1,2
• Knight began commercial launch In March 2017 – calling on over 3,000 physicians - 11% of prescribers who represent >50% of Rx
1Canadian Guideline for Safe and Effective Use of Opioids for Chronic Non-cancer Pain2Chronic opioid induced constipation in patients with non-malignant pain
Two innovative products for opioid supportive care
Probuphine™ a novel implant for opioid dependence
• Exclusive in-license agreement with Titan for Canada
• Subdermal implant for opioid addiction; delivers buprenorphine continuously for 6 months
• Addresses issues of patient adherence/compliance and diversion/illicit use
• Received Canadian regulatory approval in April 2018 and launched commercially in Q4 2018
Background• Exclusive in-license agreement with Ardelyx for Canada
• First-in-class, proprietary, minimally absorbed, oral product
• New Drug Application submitted to FDA in September 2018 for IBS-C
• Completed one Phase IIb/III study in hyperphosphatemia
Opportunity• Innovative product for two indications
• Strategic fit with Movantik
• Allows Knight to start building a presence in a new specialty area
• Knight expects to submit Ibsrela for regulatory approval in 2019
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Ibsrela™ (Tenapanor)Unique mechanism of action to treat IBS-C
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
• Approved by Health Canada in November 2018
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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
• New Drug Submission accepted for review by Health Canada in February 2018
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Women’s Health Portfolio Two complementary unique late-stage women’s health products
JoyestaTM (TX-004HR)Estradiol vaginal softgel capsule for treatment of symptoms of vulvar and vaginal atrophy (VVA)
• Approved in the US in May 2018
• Only product in its therapeutic class to offer a 4 mcg (lowest effective dose) and 10 mcg dose
• Data showing onset of action at 2 weeks
• Easy/less messy administration
• Less discomfort
• Will compete in >$60M* market growing at 4 year CAGR of 8%*
BIJUVATM (TX-001HR)Only fixed-dose combination of bio-identical estrogen and progesterone for the treatment of vasomotor symptoms of menopause (VMS)
• Approved in the U.S. in October 2018
• Significant improvements in frequency and severity of hot flashes at weeks 4 and 12
• Fewer side effects associated with bio-identical progesterone than with synthetic progestins
• Combination may increase compliance
• Will compete in >$115M market declining at CAGR of 1.3%*
• Exclusive in-license agreement with TherapeuticsMD for Canada and Israel
• Leverage of Knight’s balance sheet through $20M USD equity investment in TherapeuticsMD
• Knight expects to submit both products for approval in 2019
* Based on 2017 IQVIA Canada
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Nerlynx™Novel treatment for HER2 positive breast cancer
Background• Exclusive in-license agreement with Puma Biotechnology for Canada
• Irreversible pan-HER tyrosine kinase inhibitor
• New Drug Submission accepted for review by Health Canada in July 2018 for extended adjuvant treatment of early stage HER2+ breast cancer
Opportunity• Anticipated to be Knight’s first commercial launch in oncology
• ~24,000 patients diagnosed each year with early stage breast cancer, ~20% of whom are HER2+
• Potential label expansion opportunities in metastatic HER2+ breast cancer and solid tumors with HER2 mutations
Therapeutic Area Product Licensor Indication / Potential Indication Status Transaction Date NCE IP
Pain / Gastrointestinal
Movantik® AstraZeneca Opioid-induced constipationMarketed in CAN & approved in ISR
December 2016 ✓ ✓
Probuphine™ Braeburn Opioid addiction Marketed February 2016 - ✓
Ibsrela™ ArdelyxIrritable bowel syndrome with constipation
Pending submission March 2018 ✓ ✓
Mytesi® Jaguar Symptomatic relief of non-infectious diarrhea in adult patients with HIV or AIDS on antiretroviral therapy
Pending submission September 2018
✓ ✓
Pre-Clinical – Phase II September 2018Other diarrhea disorders
NeurAxon Family N/AAcute migraine, pain and neurological disorders
Pre-Clinical – Phase II January 2015 ✓ ✓
Antibe Family Antibe Chronic pain and inflammation Pre-Clinical – Phase II November 2015 ✓ ✓
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Growing and Diverse Pipeline An impressive portfolio of innovative prescription pharmaceuticals, prioritizing 4 therapeutic areas
Note: NCE – New Chemical Entity; IP – Intellectual Property
(1) Marketed as IMVEXXY in the US
(2) Marketed as BIJUVA in the US
Therapeutic Area Product Licensor Indication / Potential Indication Status Transaction Date NCE IP
Ophthalmic
AzaSite™ Akorn Bacterial conjunctivitis Approved July 2015 - ✓
Iluvien® Alimera Diabetic macular edema Approved July 2015 - ✓
Netildex™ SIFI Ocular inflammation Submitted August 2016 - ✓
Women’s Health
Joyesta™ TherapeuticsMD Moderate-to-severe dyspareunia Pending submission February 2019 - ✓
Bijuva™ TherapeuticsMDModerate-to-severe vasomotor symptoms due to menopause
Pending submission February 2019 - ✓
OncologyNerlynx® Puma HER2-positive breast cancer Submitted January 2019 ✓ ✓
Advaxis Family Advaxis HPV-associated cancers and others Phase I – Phase III August 2015 ✓Biologic ✓
Other
Impavido® N/A Leishmaniasis Marketed February 2014 ✓ ✓
Tenapanor Ardelyx Hyperphosphatemia Phase III March 2018 ✓ ✓
Arakoda™60P
Prevention of malaria Pending submission December 2015 ✓ ✓
60P family Other tropical diseases Phase II December 2015 ✓ -
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Growing and Diverse Pipeline An impressive portfolio of innovative prescription pharmaceuticals, prioritizing 4 therapeutic areas
Rest of World Pharma
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Finding Other Knights
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Rest of World StrategyIdentify markets with attractive growth profiles
ROW (ex-US, Europe, Japan,
China) specialty pharma will
continue to grow
Leveraging [13+] licensed products in select international markets
Partner of choice for 2nd / 3rd tier markets
Deploy financial strength and BD capabilities to accelerate growth in focus markets
Strategic investments to increase capacity to evaluate international opportunities
• High-growth countries with expanding access and funding for medicines
• Stable legal and regulatory systems, including IP protection
• Focus on Big Pharma’s non-core geographies / 2nd tier markets
• LATAM prioritization driven by:− Market size− Underlying growth drivers− Proximity / current presence − Compelling pan-American (ex-USA)
“one-stop shop” commercial solution
• Additional ROW growth levers identified in Middle East, Africa, Eastern Europe
Target Geographies
Diligent and calculated approach to ROW strategy
Strategic LendingAnother Source of Products and Return on Investment
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Strategic Lending OverviewLeveraging the balance sheet to source additional products and an attractive return
Company
Nominal
Loan
Balance(1)
Interest
Rate Maturity
Product
Rights
Synergy US$7.0M 10.5% 2020 ✓
60° Pharma US$6.8M 15% 2020 ✓
Crescita C$3.6M 9% 2022 ✓
Medimetriks US$1.0M 13% 2019
Ember US$0.5M 12.5% n/a ✓
Moksha8 US$10.5M 15% 2024
Triumvira US$5.0M 15% 2020 ✓
Total(2) C$44.8M
• Secured loans with life-sciences companies in exchange for product rights or pipeline assets for Canada and select international markets
• Over C$170M loaned to over a dozen strategic loan partners generating double-digit annual return on invested capital
• Lending has served a valuable role in securing product and pipeline assets− Sourced a number of early-stage
pipeline products and two commercial consumer health assets (Neuragen and Synergy family of products)
Access to in-licensed product or M&A are threshold criteria for future investment
(1) As at Mar. 31, 2019
(2) Total converted to CAD using closing exchange rates on Mar. 31, 2019
• Committed up to US$25M in strategic financing agreement. Loaned US$10M to date at 15% interest rate, maturing early 2024, fully secured
• An additional US$100M loan may be issued to Moksha8 for corporate development or acquisition of product licenses
• Own warrants at a nominal exercise price for 5% of the fully diluted shares of Moksha8
• Allows Knight access to partner in Mexico and Brazil
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Strategic Lending Supports GrowthSecured loans with Moksha8 (US$10M) and Triumvira (US$5M)
• Access to early stage, novel T cell technology with limited capital at risk
• Issued US$5M bridge-loan at 15% interest rate maturing early 2020
• Own warrants representing 3.5% of the fully diluted common shares of Triumvira
• In-licensed commercial rights to Triumvira’s future oncology products in select territories
Securing ROW infrastructure Securing product rights
“The Moksha 8 transaction is consistent with Knight’s expansionstrategy internationally, where it seeks strong partner companieswith regional expertise. The deal also highlights a string of increasedbusiness development activity by Knight recently with eighttransactions by our count in the past 12 months vs. one in the yearprior. We see this activity by Knight as a strong leading indicator forcontinued record revenue and shareholder value creation.”
February 21, 2019
“The [Triumvira] transaction is in keeping with Knight’s targetedlending strategy. That is, on top of a 10-15% interest rate, the dealcomes attached to warrants and product rights. With licensedgeographies including Canada, Israel, Mexico, Brazil and Colombia,this is in line with Knight’s goal of expanding its presence in thelarge and underserved Latin American market.”
February 21, 2019
Strategic Fund Investment
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Long-term Path for Product Rights
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Strategic Fund Investment OverviewAttractive financial return with product access upside optionality
• Fund investments were made to obtain preferential access to innovative products for Canadian market
• Financial returns have been attractive, but fund investments have not been as effective at generating product leads− Sourced Iluvien® and Advaxis portfolio− Core challenges with sourcing product
under fund structure (lack of “new” opportunities, GP fiduciary duties and conflict with LPs)
• No longer investing into funds, beyond already committed capital (3)
Fund Amount Stage Geography
Teralys C$30.0M VCAP Fund of funds Canada
Domain US$25.0M Early stage N.A.
Forbion €19.5M All clinical stages Europe
Sectoral US$13.0M Late stage to small cap Global
Sanderling US$10.0M Early stage N.A.
HarbourVest C$10.0M VCAP Fund of funds Canada
TVM US$1.6M All clinical stages Global
Bloom Burton(1) C$1.5M Commercial stage Canada
Genesys C$1.0M Early Stages N.A.
Total(2) C$126.7M All stages Worldwide
(1) Bloom Burton healthcare lending trusts are managed by Stratigis Capital Advisors
(2) Total converted to CAD at Bank of Canada exchange rates as of the commitment dates; using the Mar. 29, 2019 exchange rates, total fund commitments would be C$138.0M
(3) As at March 31, 2018, C$54.0M commitment was remaining
We’ve ceased allocating capital to funds, beyond already committed capital
Why Knight?
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Partner of Choice for Canada and RoW
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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• 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
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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 and Chief Financial Officer
• Paladin Labs, Chief Financial Officer
Amal Khouri, B.Sc., M.B.A.
VP Business Development
• Novartis, Global Business Development and Licensing
• Paladin Labs, Business Development
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Board of DirectorsKnight has a highly skilled and experienced Board of Directors
Board Member Qualifications
James Gale (Chairman)
• Paladin Labs, Board member from 2008 to 2014• Signet Healthcare Partners, Managing Director
Jonathan Ross Goodman
• Knight Therapeutics, Founder and CEO• Paladin Labs, Co-founder, former President & CEO
Samira Sakhia• Knight Therapeutics, President and CFO• Paladin Labs, CFO from 2001 to 2015
Robert Lande • Paladin Labs, Board member from 1995 to 2014• FXCM Group LLC, President
Sylvie Tendler• Pharmaceutical Market Research Consultant• The Tendler Group Inc., Founder
Nancy Harrison
• Co-founder and former President of MSI Methylation Sciences
• Former Partner and Senior Vice President of Ventures West Management Inc.
Michael Tremblay• Former President of Astellas Canada • Former Chairman of Innovative Medicines Canada
Kevin Cameron• Chief Executive Officer of Ionetix• Co-founder and President of Glass Lewis & Co.
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Financial and Strategic Assets
Asset Description
Cash and marketable securities $748 million1 ($5.24 / share)
Key Marketed Products Movantik®, Impavido®, Probuphine™
Approved Products Iluvien®
Products Pending Approval Netildex™, Nerlynx®
Products Pending Submission Ibsrela®, Mytesi®, JoyestaTM (TX-004HR), BijuvaTM (TX-001HR)
Product Pipeline 20+ products in various stages of development
Strategic Fund Investments $126.7 million2 in total commitments
Strategic Loans $44.8 million3 of loans receivable
Rest of World Pharma Up to $25M strategic loan to Moksha8
1 Cash, cash equivalents and marketable securities as at March 31, 20192 Based on the exchange rates in effect on the dates of the fund commitments. Carrying value as at March 31, 2019 was $102M.3 Nominal loan balance as at March 31, 2019
• Experienced and dynamic management team
• Proven ability to develop a rich pipeline of new
products
• Proven ability to secure mutually beneficial
transactions
• Proven track record of profitable growth
• Financial strength to execute our strategy
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Summary
Building Canada’s leading specialty pharmaceutical company
29May 2019
Knight Therapeutics Inc.(TSX: GUD)
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