Antares Pharma Investor Presentation · 7 •Innovative self-delivery of testosterone (T)...

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NASDAQ: ATRS making medicines betterAntares Pharma Investor Presentation August 2020

Transcript of Antares Pharma Investor Presentation · 7 •Innovative self-delivery of testosterone (T)...

Page 1: Antares Pharma Investor Presentation · 7 •Innovative self-delivery of testosterone (T) replacement therapy for at home use •Virtually painless subcutaneous injection •Convenient,

NASDAQ: ATRS

making medicines better™

Antares Pharma Investor PresentationAugust 2020

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NASDAQ: ATRSSafe Harbor Statement

This presentation contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: Teva’s successful commercialization of teriparatide injection in Europe and future revenue from the same; the uncertainty regarding the duration, scope and severity of the COVID-19 pandemic and the mitigation measures and other restrictions implemented in response to the same and the impact on reinstated 2020 full-year revenue guidance, demand for our products, new patients and prescriptions, future revenue, product supply, and our overall business, operating results and financial condition; market acceptance, adequate reimbursement coverage and commercial success of XYOSTED® and future revenue from the same; successful development including the timing and results of the clinical bridging and Phase 3 clinical trial of the drug device combination product for Selatogrel with Idorsia Pharmaceuticals and FDA and global regulatory approvals and future revenue from the same; market acceptance of Teva’s genericepinephrine auto-injector product and future revenue from the same; the ability of Lunatus to obtain regulatory approvals for XYOSTED® in Saudi Arabia and UAE and successfully commercialize the product and future revenue from the same; our expectations regarding whether the FDA will pursue withdrawal of approval for AMAG Pharmaceuticals Inc.’s Makena® subcutaneous auto injector following the recent FDA advisory committee meeting and future prescriptions, market acceptance and revenue from Makena® subcutaneous auto injector; Teva’s ability to successfully commercialize VIBEX® Sumatriptan Injection USP and the amount of revenue from the same; continued growth of prescriptions and sales of OTREXUP®; the timing and results of the Company’s or its partners’ research projects or clinical trials of product candidates in development; actions by the FDA or other regulatory agencies with respect to the Company’s products or product candidates of its partners; continued growth in product, development, licensing and royalty revenue; the Company’s ability to meet loan extension and interest only payment milestones and the ability to repay the debt obligation to Hercules Capital; the Company’s ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as ''may'', ''will'', ''should'', ''would'', ''expect'', ''intend'', ''plan'', ''anticipate'', ''believe'', ''estimate'', ''predict'', ''potential'', ''seem'', ''seek'', ''future'', ''continue'', or ''appear'' or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K, and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this presentation. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this presentation, except as required by law.

©2020 Copyright Antares Pharma, Inc. All Rights Reserved.

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NASDAQ: ATRS

At Antares Pharma, we leverage pharmaceutical and medical device expertise to develop innovative products that address needs in underserved therapeutic areas

Who We Are – A Pharmaceutical Technology Company

• Our novel drug delivery technology can provide multiple product opportunities and life-cycle management solutions

• Revenue streams from our portfolio of proprietary and partnered products provide robust opportunities for continued growth

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NASDAQ: ATRS

• Antares Pharma is an innovative leader in self-administered injection technology

• We are a commercial, revenue-generating Company which develops combination products focused on rescue therapies

• Five products utilizing Antares devices were commercialized in the past six years. The three most recent:

• XYOSTED® (testosterone enanthate)

• Generic EpiPen® (epinephrine)

• Makena® (hydroxyprogesterone)

• Record 2019 revenue of $123.9M (+95% vs. 2018)

• Strong second quarter 2020 revenue of $32.4M and first 6-month 2020 revenue of $65.5M

Antares Pharma Overview

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NASDAQ: ATRS

First 6 Months 2020 Revenue = $65.5M

Rapidly Growing and Diversified Revenue Mix

First 6 Months 2018 Revenue = $26.9M

29%

53%

11%

7%

Proprietary Products

Partner Products

Development

Royalty

42%

37%

7%

14%

27%

49%

6%

19%

First 6 Months 2019 Revenue = $51.7M

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NASDAQ: ATRS

making medicines better™

Proprietary Commercial Products

August 2020

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• Innovative self-delivery of testosterone (T) replacement therapy

for at home use

• Virtually painless subcutaneous injection

• Convenient, once-a-week dosing

• Low risk of transfer compared with topical products

• T levels maintained for as long as the patient remains on

therapy*

• ~72% of all commercial lives covered

• ~25,000 patients prescribed since launch

XYOSTED® (testosterone enanthate) for injection

*Studied for 52 weeks when taken every week, as directed. Achieving desired blood levels may require dose adjustments at Week 7 based upon Week 6 blood levels. Some patients fell below minimum level of 300 ng/dL despite dose adjustments.

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NASDAQ: ATRS

Ctrough Stable For 52 Weeks

0

200

400

600

800

1000

1200

0 24 486 12 18 26 38 52Week 1

Pre-Dose

Green lines represent the defined range of 300 – 1100 ng/dL

………….. Baseline

Full Prescribing Information including Boxed Warning and Important Safety Information at www.xyosted.com

XYOSTED® Strong Clinical Data

• 98.5% of patients in a 52-week Phase 3 study achieved testosterone levels in the normal, physiologic range at week 12

• Narrow peak-to-trough ratio of 1.8

• Steady, predictable pharmacokinetics*

• Easy up/down titration scheme

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NASDAQ: ATRSTestosterone Market

652,129

477,548

154,426

0

100,000

200,000

300,000

400,000

500,000

600,000

700,000

Month

Total Market Injectables Topical Solutions Linear (Total Market) Linear (Injectables) Linear (Topical Solutions)

TRT Growth: 7.9%

TRT Topical Growth: -1.7%

2019 TRT TRx: 7.1M

2019 TRT Injectable TRx: 5.2M

2019 TRT Topical TRx: 1.8M

TRT Injectable Growth: 9.9%

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NASDAQ: ATRS

• ~132,000 XYOSTED TRx’s to date written by ~ 6,000 different physicians• 2Q 20 TRx’s increased 11% sequentially versus 1Q 2020• July 2020 TRx’s increased to 13,342 from 12,673 in June 2020

XYOSTED® Quarterly TRx Growth

0.0K

5.0K

10.0K

15.0K

20.0K

25.0K

30.0K

35.0K

40.0KRefills NRx's TRx's

Bloomberg/Symphony Health Solutions

32,821

27,830

19,543

11,315

4,032

36,573

20,915

15,658

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NASDAQ: ATRS

Commercial Experience

Broad XYOSTED® Utilization Across Specialties

1Q 20 IQVIA Data

Other(72)11%

Nurse PractitionersPhysician Assistants

20%

Urology23%

Primary Care20%

Endocrinology26%

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NASDAQ: ATRS

making medicines better™

Partner Products August 2020

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NASDAQ: ATRS

Commercial Experience

Teva’s Generic EpiPen

• FDA-approved as therapeutically equivalent to Mylan’s EpiPen® and fully substitutable at the pharmacy

• Antares receives cost plus margin on all devices sold to Teva plus mid-to-high, single-digit royalties on in-market sales

• EpiPen, Sr. limited commercial launch January-June 2019; Fully available July 2019

• EpiPen, Jr. launched August 2019

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NASDAQ: ATRS

Commercial Experience

Generic EpiPen® Quarterly TRx Prescription Trends

Bloomberg/Symphony Health Solutions

0

100,000

200,000

300,000

400,000

500,000

600,000

700,000

800,000

900,000

1,000,000

Q119 Q219 Q319 Q419 Q120 Q220

236,894 / 27%

125,108 / 22%

28,753 / 6%183,171 / 36% Teva

Total Epi Market

568,381

861,879

483,913

206,134 / 43%

464,151

175,553 / 38%

448,471

506,086

July 2020: 85,144

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NASDAQ: ATRS

making medicines better™

Development PipelineAugust 2020

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NASDAQ: ATRS

• Teva awaits FDA approval for their ANDA for generic Forteo®

• Six-month exclusivity

• Fully substitutable at pharmacy

• Teva launched in 10 European countries and Israel and Canada

• Forteo® generated full year 2019 revenue of $646 million in U.S. and $759million in ROW by Lilly

• ATRS will supply devices at reasonable margin plus receive single digit tomid-teens royalty on Teva end sales of generic Forteo®

Generic Forteo® (teriparatide)

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NASDAQ: ATRSIdorsia Global Development Agreement

• Global development agreement with Idorsia Pharmaceuticals for selatogrel, a New Chemical

Entity, with the QuickShot auto injector

• Selatogrel is a fast acting and highly selective P2Y12 receptor antagonist intended for the

treatment of suspected Acute Myocardial Infarction (AMI)

• Phase 2 data demonstrated that subcutaneous administration of selatogrel resulted in a potent

and rapid platelet inhibition effect

• Idorsia is preparing for a clinical bridging study followed by a global Phase 3 study in 2021

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NASDAQ: ATRS

• ~14 million people with history of Myocardial Infarction (MI)

• ~7.6 million Americans have survived a MI

• ~750,000 occurrences of new or recurrent MI1 annually

• 550,000 have a first MI + 200,000 have a recurrent MI

• Product Justification

• Onset of action of all oral P2Y12 inhibitors may be delayed by >6 hours in the

setting of acute myocardial infarction (AMI)

• Currently, the only non-oral P2Y12 inhibitor available is Cangrelor, which is

administered IV in patients undergoing PCI

• Need for a P2Y12 inhibitor that achieves consistently fast and effective platelet

inhibition in AMI

Myocardial Infarction Market Opportunity

1. Mozaffarian D et al. Circulation 2016

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NASDAQ: ATRSDiversified Combination Products Portfolio

HYDROXYPROGESTERONE

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NASDAQ: ATRS

making medicines better™

Financial ResultsAugust 2020

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NASDAQ: ATRS

$45.7$52.2 $54.5

$63.6

$123.9

Revenue Guidance

$135-155M

2015 2016 2017 2018 2019 2020

+4% vs. 2016 +17% vs. 2019*+17% vs. 2017 +95% vs. 2018

Revenue Growth and 2020 Projections

Projected CAGR of 21%*

* Based on mid-point of 2020 revenue guidance

+72% vs. 2014 +14% vs. 2015

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NASDAQ: ATRSIncome Statement Summary

(in millions, except EPS) 2Q 2020 2Q 2019Increase

(Decrease)6M 2020 6M 2019

Increase(Decrease)

Revenue 32.4 28.4 14% 65.5 51.7 27%

Gross Profit 19.9 16.0 24% 37.9 28.3 34%

Margin 61% 56% 58% 55%

Total Operating Expenses 16.9 17.6 (4)% 36.3 34.9 4%

Net Income/(Loss) $2.2 $(2.2) 200%* $(0.2) $(7.8) 98%*

Earnings Per Share $0.01 $(0.01) $0.00 $(0.05)

* Calculated in absolute terms

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NASDAQ: ATRS

2019 revenue of $123.9 million, a 95% increase over 2018 reported revenue

2Q 2020 revenue of $32.4M, a 14% increase vs. 2Q 2019

XYOSTED® – the fastest Growing Branded Testosterone Product

Entered into a global agreement with IdorsiaPharmaceuticals to develop a selatogrel/QuickShot drug device rescue pen

Signed international distribution agreement with Lunatus for XYOSTED®

Continued XYOSTED® prescription growth

Continued generic EpiPen® and EpiPen® Jr. prescription growth

Potential 2020 FDA approval and global launch of Teva’s generic teriparatide (Forteo®)

Expanding operational capabilities with new office, laboratory, manufacturing and warehouse space

2020 Catalysts

RecentAccomplishments

Foundation

As a Pharmaceutical Technology Company, we identify, develop, and commercialize important rescue and self-injection medicines

Antares Pharma: 2020 Catalysts

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NASDAQ: ATRS

making medicines better™

Thank youQuestions