8-K
0001445499false00014454992022-04-142022-04-14

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): April 14, 2022

 

 

IMPEL NEUROPHARMA, INC

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

001-40353

26-3058238

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

201 ELLIOTT AVE. W, SUITE 260,

 

Seattle, Washington

 

98119

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 206 568-1466

 

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class

 

Trading
Symbol(s)

 


Name of each exchange on which registered

Common Stock, $0.001 Par Value Per Share

 

IMPL

 

The NASDAQ Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 


Item 7.01 Regulation FD Disclosure.

On April 14, 2022, the Company updated its corporate presentation, which it intends to use as part of investor presentations. A copy of the presentation is attached to this Report as Exhibit 99.1 and is incorporated by reference into this Item 7.01.
 

This information contained in this Current Report on Form 8-K, including the attached Exhibit 99.1, shall be deemed “furnished” and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference to such filing.

 

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

 

 

 

 

Number

 

Description

 

 

99.1

 

Presentation of Impel Neuropharma, Inc.

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

 

IMPEL NEUROPHARMA, INC.

 

 

 

 

Date:

April 14, 2022

By:

/s/ John Leaman
 

 

 

 

John Leaman
Chief Financial Officer

 


Slide 1

Impel NeuroPharma, Inc. Corporate Presentation April 2022 Exhibit 99.1


Slide 2

Forward-Looking Statements This presentation and the accompanying oral commentary contains forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. Forward-looking statements include all statements other than statements of historical fact contained in this presentation, including information concerning our future financial performance, business plans and objectives, timing and success of our planned development activities, our ability to obtain regulatory approval, the potential therapeutic benefits and economic value of our product candidates, potential growth opportunities, competitive position, industry environment and potential market opportunities. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. These factors, together with those that may be described in greater detail in our most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q and other reports the company files from time to time with the Securities and Exchange Commission, may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this presentation, and although we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted a thorough inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain and investors are cautioned not to unduly rely upon these statements. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Certain information contained in this presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and the Company’s own internal estimates and research. While the Company believes these third-party sources to be reliable as of the date of this presentation, it has not independently verified, and makes no representation as to the adequacy, fairness, accuracy or completeness of, any information obtained from third-party sources. In addition, all of the market data included in this presentation involves a number of assumptions and limitations, and there can be no guarantee as to the accuracy or reliability of such assumptions. Finally, while we believe our own internal research is reliable, such research has not been verified by any independent source.


Slide 3

The Impel Investment Opportunity POD® Technology: Clinically Validated and Broad Utility Unique approach targeting upper nasal space; broad disease area applicability Trudhesa™ - Significant Commercial Opportunity in Migraine Market Large, growing and dynamic market with significant unmet need Highly Targeted Commercialization Strategy Initial 60-person salesforce; targeting 8K physicians (35% of Market Rxs) Strong early launch performance INP105: Poised to Fill a Major Unmet Need Targeted for acute treatment of agitation and aggression in autism Proven and Experienced Leadership Team


Slide 4

The Trudhesa Clinical Profile


Slide 5

Trudhesa PK Levels – Comparable to IV DHE; Surpassed Migranal AUC in the First Two Hours – Thought to Be Critical to DHE Efficacy and Tolerability Trudhesa Delivers Comparable Blood Levels vs. IV DHE vs. MIGRANAL 4x increase in Cmax 3x increase in AUC Much improved consistency of dosing, similar to IV infusion Similar blood levels (20 mins - 48 hours) without early Cmax spike associated with nausea & vomiting Treatments


Slide 6

Trudhesa – Impressive Efficacy from Phase III Study Migraines Treated 4th 12 weeks 3rd 12 weeks 2nd 12 weeks 1st 12 weeks 2,559 1,736 502 476 38% 35% 38% 34% 38% Percentage of subjects with 2 Hr Pain Freedom First Dose TRUDHESA 52% Percentage of subjects with 2 Hr MBS Freedom Consistent 2 Hr Pain Freedom over 5,273 Migraines Treated 74% of Enrolled Patients Continued Through 24 Weeks and 90% Enrolled Through 52 Week Extension


Slide 7

Trudhesa – Impressive Migraine Relapse-Free Data 86% of patients with migraines achieved pain freedom at 2 hours and are migraine and rescue med free at 48hrs % of TRUDHESA Patients Not Requiring Rescue Med or Recurrence of Migraine at 24 and 48 Hours (Of Those Pain Free at 2 Hours) *by week 21-24.


Slide 8

Trudhesa – Impressive Reduction in Hospital, ER and Urgent Care Visits * EAER is a standardized metric used by payors to judge the effectiveness of a medication in lowering medical costs # Hospitalizations # ER Visits # Urgent Care Visits INCIDENCE (n) Exposure Adjusted Event Rate (EAER)* ~73% Reduction in ER Visits Achieving a 100% Reduction in Hospitalizations / Urgent Care Provides Tangible Economic Value to Payors Baseline TRUDHESA


Slide 9

The Trudhesa Market Opportunity and Commercialization Strategy


Slide 10

Migraine: Strong Market Growth but Ongoing Unmet Need Migraine – Large Growing Market with Significant Unmet Need Despite New Treatment Innovations Nurtec ODT and Ubrelvy Patient Claims Show ~60% Therapy Abandonment 90 Day Post Start Source: Symphony Health Patient Claims (Mar’20 – Dec’21) 57% 66% 27M 24M +13% 30M +11% 88% 12% 81% 19% 75% 25% Source: Symphony Health


Slide 11

Disciplined Go-To-Market Approach Concentrated prescriber base allows for high market coverage at launch Source: Symphony Health Our Focus: Targeting Highest Productive Writers # Reps Mkt Coverage Physicians Targeted Neuro Avg Yearly TRx / HCP PCP Avg Yearly TRx / HCP Wave 1 60 ~35% ~8k (5.6k Neuro + 2.4k PCP) ~90% of Neuro Mkt ~5% of PCP Mkt 1,474 678 Wave 2 +60 ~45% ~16k (6.3k Neuro + 9.7k PCP) ~100% of Neuro Mkt ~25% of PCP Mkt 1,085 489 Wave 2 Increases the Number of Reps to 120 and Expands Coverage to 16k HCPs Covering 45% of Market 60 Reps ~8k High Productive HCP’s ~35% Mkt Coverage 120 Reps ~16k High Productive HCP’s ~45% Mkt Coverage


Slide 12

Case in Point – Ubrelvy and Nurtec ODT Both Showing Highly Concentrated Prescriber Bases in Migraine Source: Symphony Health (Prescriber counts since launch thru Dec’21) 2.4k Writers Generate 50% of TRx (91% Neuros & 93% Impel Targets) 6.5k Writers Generate Next 25% of TRx (45% Neuros & 46% Targets) 57.7k Writers 25% of TRx 1.8k Writers Generate 50% of TRx (92% Neuros & 91% Impel Targets) 4.7k Writers Generate Next 25% of TRx (56% Neuros & 57% Targets) 49.2k Writers 25% of TRx Source: Symphony Health (Prescriber counts since launch thru Dec’21) Ubrelvy: ~8.9k Writers Generate ~75% of TRx Since Launch Nurtec ODT: ~6.5k Writers Generate ~75% of TRx Since Launch


Slide 13

Trudhesa Pricing Reflective of Value and Innovation * WAC Price represents cost for 1 retail prescription package


Slide 14

Percent of Rx Shipments Reimbursed by month vs. Forecast Current Percent of Commercial Lives Contracted Percent of Rx Shipments Reimbursed *Source: Internal Pharmacy Data


Slide 15

Trudhesa nTRx Growth Continued Through Q1’22 Launch Focus: Drive Rapid Adoption of Trudhesa Source: Symphony Health Growth of 3X in Q1 vs Q4


Slide 16

Trudhesa - nTRx Growth Continued Through Q1’22 Launch Focus: Drive Rapid Adoption of Trudhesa +38% +21% +26% Source: Symphony Health


Slide 17

Trudhesa -Expanding Breadth and Depth of Prescribing Launch Focus: Generate Immediate Uptake in Prescribing Launch Focus: Creating Depth & Breadth Current Prescribers Avg 4.3 nTRx’s Avg 5.9 nTRx’s Avg 15.2 nTRx’s 786 63% 16% 22% 786 21% 41% 16% 21% Internal Pharmacy data 1,068 60% 18% 22% 903 24% 44% 15% 17% 903 58% 19% 23% 1,068 19% 41% 16% 24%


Slide 18

Trudhesa nTRx Share of Acute Branded Market Among All Writers Holiday Weeks + Omicron Trudhesa Market Share Increase in utilization among expanding base of prescribers Return to strong share growth among prescribers in February Source: Symphony nTRx data (n=699) thru 2/25 Acute Branded Market = Trudhesa, Nurtec ODT, Ubrelvy Continued Share Penetration Within The Acute Branded Market Among Trudhesa Writers


Slide 19

Encouraging Feedback From Trudhesa Patients Leading To High Refill Rates Trudhesa New Patient Refill Rate Patient Survey: Trudhesa Performance Compared to Other Abortives Source: Ipsos Patient Survey (n=200) How does Trudhesa nasal spray compare to other abortive medications you have used previously for your migraines on the following? Source: Internal Pharmacy data


Slide 20

Trudhesa - Use in Broad Pool of Patients Source: Symphony Source of Business data Prescribers Showing Broad Mix of Patient Types When Using Trudhesa ~30-40% of Trudhesa Patients Being Either Switched From or Added to Gepants Source: Symphony Patient Claims Data (data on approx.3,500 patients)


Slide 21

Among Early Prescribers Trudhesa Filling a Need in the Post Triptan Market Source: Symphony NBRx data (n=800) thru 3/25 Acute Branded Market = Trudhesa, Nurtec ODT, Ubrelvy Current 4 Week NBRx Share vs Nurtec and Ubrelvy Among Current Trudhesa Prescribers


Slide 22

Impel Pipeline Growth Opportunities


Slide 23

INP105 – Acute Treatment of Agitation and Aggression in Autism *Nominal times used for mean plot INP105 - SIMILAR PK TO OLANZAPINE INJECTION, BUT FASTER TO PEAK BLOOD LEVELS Rapid Tmax, Cmax and AUC of INP105 matches 5mg olanzapine RAPID ONSET Faster to peak blood level than IM WELL-TOLERATED Minimal syncope POD DELIVERY Non-invasive delivery administered by self or caregiver TARGETS UNMET NEED Currently no approved therapies for acute agitation in autism Target Product Profile Phase IIa Proof of Concept Trial – The CALM 201 Study – Anticipated to be initiated in 1H 2022 Clinical Development to Date – Phase 1B INP105 ACES (agitation scale) change matches IM 5 mg (N=20) 5 mg (N=10) (N=10)


Slide 24

Impel Financials and Summary


Slide 25

Financial Results for Q4 and FY 2021 Product Revenue, Net $0.6M for 4th quarter 2021 and $0.7M for full-year 2021 Initial shipments of TRUDHESA to specialty pharmacies were initiated in late September 2021 ahead of the October commercial launch Research and Development (R&D) expenses $4.5M for 4th quarter 2021 vs. $8.8M for the same period in 2020 $20.6M for the full year 2021 vs. $28.3M for the full year 2020 Decrease primarily due to reduction in TRUDHESA clinical expenses as the Phase 3 study was closed Selling, General and Administrative (SG&A) expenses $19.9M for 4th quarter 2021 vs. $4.8M for the same period in 2020 $50.9M for full year 2021 vs $17.0M for the full year 2020 Increase primarily due to the ramp up in spending to support the commercial and marketing activity to support the Trudhesa launch


Slide 26

Financial Results for Q4 and FY 2021 (cont’d) Net Loss $24.7M for 4th quarter 2021 or ($1.07) per common share vs. $14.2M or ($19.81) per common share for same period in 2020 $76.7M for full year 2021 or ($5.25) per common share vs. $46.3M or ($91.05) per common share in full year 2020 Cash Runway As of December 31st, 2021, the company had cash and cash equivalents of $88.2 million On March 16th, Company signed $100 million Royalty and Debt financing with Oaktree Capital; upon signing, the Company repaid the $32 million Oxford/Silicon Valley debt with prepayment fee Company believes it has sufficient resources to fund the Company into 2024


Slide 27

Impel – Overall Summary and Guidance Continued strong launch momentum with Trudhesa supported by a market access coverage and positive physician and patient feedback Strengthened financial position with projected cash runway into 2024 Planned Initiation of INP105 Phase IIa Proof of Concept Study (CALM 201 Study) in 1H2022 Based on YTD Performance, Company is providing prescription guidance of between 70,000 – 85,000 for Trudhesa for 2022 A Continued Journey of Transformation


Slide 28

Q&A


Slide 29

Experienced Management Team JOHN LEAMAN, MD Chief Financial Officer JOHN HOEKMAN, PhD Chief Technology and Development Officer LYNN GOLD Senior Vice President, Regulatory Affairs JENNIFER BERMAN Vice President, Marketing LEN PAOLILLO Chief Commercial Officer STEPHEN SHREWSBURY, MD Chief Medical Officer SHEENA AURORA, MD VP Medical Affairs, Migraine JERRY PENN Vice President, Market Access & Trade ADRIAN ADAMS Board Chairman & Chief Executive Officer NEUROSCIENCE INSTITUTE HEADACHE CENTER