Corporate Presentation - Delivering on our commitment to patients - Zealand pharma
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
Corporate
Presentation
Delivering on our commitment to patients
April 2021
Contents Introduction: Zealand Today and 2025 Ambition Commercial Programs Clinical Programs Pre-Clinical Pipeline Additional Company Information Corporate Presentation 2
Forward looking statement This presentation contains “forward-looking statements”, as that term is defined in the Private Securities Litigation Reform Act of 1995, as amended, that provide Zealand Pharma’s expectations or forecasts of future events regarding the research, development and commercialization of pharmaceutical products. The reader is cautioned not to rely on these forward-looking statements. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions, which may cause actual results to differ materially from expectations set forth herein and may cause any or all of such forward- looking statements to be incorrect, and which include, but are not limited to, the occurrence of adverse safety events; risks of unexpected costs or delays; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates or expansion of product labeling; failure to obtain regulatory approvals in other jurisdictions; product liability claims; and the direct and indirect impacts of the ongoing COVID-19 pandemic on our business, results of operations and financial condition. If any or all of such forward-looking statements prove to be incorrect, our actual results could differ materially and adversely from those anticipated or implied by such statements. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. All such forward-looking statements speak only as of the date of this presentation and are based on information available to Zealand Pharma as of the date of this release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice. Corporate Presentation 3
Zealand Today and 2025 ambition• Corporate Presentation 4
Zealand Pharma is entering an exciting 2021
Plan for a successful launch of Zegalogue® and optimize
commercialization
Execute on our robust late-stage clinical pipeline
Advance our early-stage programs into the clinic
Maintain a strong financial and
organizational position
Corporate Presentation 5
We are boldly pursuing our ambition as a fully
integrated biotech
Invest in innovative peptide research platform
5x25
and robust pipeline
Have 5 commercialized products by 2025
Optimize commercial operations Maintaining a strong balance sheet1
DKK thousand
Fully operational US 1,500,000
infrastructure
1,000,000
High prescriber coverage
Established relationships 500,000
with KOLs and HCPs
0
2016 2017 2018 2019 2020
Cash & cash equivalents Restricted cash Securities
Corporate Presentation
1 6
Additional DKK 749 million gross proceeds secured through directed issue in January 2021
Significant pipeline evolution and a commitment to
continue to deliver Preclinical Phase 1 Phase 2 Phase 3
Approved/
Cleared
Metabolic
V-Go® Wearable Insulin Delivery Type 2 Diabetes management
ZEGALOGUE® (dasiglucagon) injection Severe hypoglycemia in diabetes
Dasiglucagon S.C. Continuous Infusion Congenital hyperinsulinism
Dasiglucagon Bi-Hormonal Artificial Pancreas Pump Type 1 Diabetes management
Metabolic
Dasiglucagon Adjustable Mini-Dose PBH/ T1D exercise-induced hypo
BI 456906 GLP-1/GLU Dual Agonist1 Obesity/ NASH/ T2D
ZP 8396 Amylin Analog Obesity
ZP 6590 GIP Agonist Obesity
Glepaglutide GLP-2 Analog Short Bowel Syndrome
GI & Inflammatory
Dapiglutide GLP-1/GLP-2 Dual Agonist SBS+
ZP 9830 Kv1.3 Ion Channel Blocker IBD+
ZP 10000 ɑ4β7 Integrin Inhibitor IBD
Complement C3 Inhibitor2 Undisclosed
1 Licensed to Boehringer Ingelheim: EUR 345 million outstanding potential development, regulatory and commercial milestones + high single to low double digit % royalties on global sales
2 Licensed to Alexion: USD 610 million potential development, regulatory and commercial milestones + high single to low double digits % royalties on net sales
Corporate Presentation 7
Commercial programs• Corporate Presentation 8
Commercial Overview
Severe Type 2
hypoglycemia Diabetes
Corporate Presentation 9
Severe
hypoglycemia
“Diabetes affects me all the time,
Severe hypoglycemia is an acute,
life-threatening condition resulting from a and I have to think about
critical drop in blood glucose levels. Among it no matter what I do.”
the most feared complications of diabetes
Anders, living with Type 1 diabetes
treatment, severe hypoglycemia requires
another person for rescue
Read more of Anders’ story at
zealandpharma.com/anders-story
Corporate Presentation 10Severe hypoglycemia remains a
major issue for people on insulin
• Insulin treatment is the main cause of
severe hypoglycemia in people with diabetes1
• 8.4M Adults and Children on Insulin Therapy2
• Approximately 4.0M patients are on Multiple
Daily Injections of Insulin3
• Despite this, there were only approximately 540,000
patients with glucagon therapy in 20204
• Glucagon should be prescribed for all individuals at
increased risk of level 2 or 3 hypoglycemia so that it
is available should it be needed5
1The International Hypoglycemia Study Group. Lancet Diab and Endo 2019; 7,(5): 385-96.; 2 Diabetes Surveillance System,
Centers for Disease Control: gis.cdc.gov/grasp/diabetes/diabetesatlas.html; Accessed March 1, 2021. 3 Brixner et
al. ClinTher. 2019 Feb;41(2):303-313. 4 Symphony Health Trx Quantity; 5 ADA Standards of care. Diabetes Care 2021 Jan; 44
(Supplement 1): S1-S2
Corporate Presentation 11ZEGALOGUE provides an attractive treatment option for
patients and providers alike
Recovery
Consistent 99% of patients in the main adult phase
3 trial recovered within 15 minutes
10
minutes All pivotal phase 3 studies
reported the same median time to recovery
Median time to blood glucose recovery
of 10 minutes in adults and children
Corporate Presentation
12ZEGALOGUE will launch at the right time in a growing
market that is driven by innovation
Launch timed to capture Rescue market growing with Innovation driven market with
‘Back to school’ seasonality new entrants new entrants capturing share
TRx Units Dispensed (M)
1.2
+60% Rx Volume Lift +10%
+6%
Weekly Glucagon Market
0.9 ~300m
USD 63%
TRx Volume
78%
0.6 100%
1.0
0.9
0.9
0.3
37%
22%
Jun Jul Aug Sep Oct
0.0
2018 2019 2020 2018 2019 2020
Source: Symphony Health TRx Quantity
Legacy products New Entrants
Corporate Presentation
13V-Go® for optimized insulin delivery to Type 2 diabetes patients: clinically relevant reductions in A1c with less insulin 1. Cziraky M, et al. JHEOR 2019;6(2):70-83. 2. Grunberger G, et al. Drugs Real World Outcomes, 2019. 3. Lajara R, et al. Diabetes Therapy. 2015;6(4):531-545. 4. Harrison C, et al. Poster presented at AACE 26th Annual Scientific Meeting, May 2017. 5. Sutton D, et al. Advances in Therapy. 35(5), 631-643 2018. 6. Sink J, et al Poster Presented at Diabetes Technology Meeting, Nov. 2014. 7. Wu P, et al. Poster presented at AACE 27th Annual Scientific Meeting, May 2018. 8. Omer A, et al. Poster presented at ADA 73rd Scientific Sessions, June 2013. 9. Hundal R, et al. Poster presented at the Academy of Managed Care Pharmacy, April 2018. 10. Lajara R, et al. Endocr Pract 2016 Jun;22(6):726-35. 11. Mehta S, et al. Abstract published in The Journal of the American Osteopathic Association Nov 2017:117 and poster presented at OMED 12. Rosenfeld CR, et al. Endocr Pract. 2012;18(5):660-667. 14
Zealand is well positioned for delivering success
Experienced Field Force Established Market Access Team
§ 15 years average diabetes experience § 20 years average experience with US payers
§ Long-standing presence with diabetes HCPs § Existing relationships with key national
through V-Go and regional payers and PBMs through V-Go
§ Mix of live and inside sales resources covering § Expanded account management footprint across
>80% of the Glucagon prescribing market commercial, medicaid, and medicare accounts
Scalable Patient Services Footprint COVID Ready Promotional Mix
§ Existing V-Go® Patient Support capabilities & § Live and virtual customer engagement mix
personnel across sales, marketing, market access, patient
§ Optimized patient support capability for support, and medical affairs
ZEGALOGUE to help address patient and HCP § Tested and optimized to succeed in COVID and
needs at launch post-COVID selling environment
Corporate Presentation 15Clinical programs• Corporate Presentation 16
Clinical project overview
Congenital Post bariatric Obesity and
Hyperinsulinism hypoglycemia associated
metabolic
diseases
Type 1 diabetes Short bowel
syndrome
Corporate Presentation 17Congenital
Hyperinsulinism
Congenital hyperinsulinism (CHI) is an
ultra-rare and devastating congenital
disorder in newborns. It is caused by a
defect in pancreatic beta cells, resulting in
insulin overproduction. This leads to
persistently and dangerously low blood
sugar levels (hypoglycemia).
“Even though he appears to
be such a normal kid, any
moment his blood sugar can
drop to a really dangerous
level.”
Read more of Crosby’s story at Julie, mom to Crosby who was born with
zealandpharma.com/crosbys-story congenital hyperinsulinism
Corporate Presentation 18Congenital Hyperinsulinism (CHI) is an ultra-rare
but devastating disorder in neonates and children
A disease that affects 1:30,000 - 1:50,000 births
• ~300 newborns are diagnosed every year with genetically
determined CHI in the U.S. and EU1,2
Persistent episodes of hypoglycemia
• Most common cause of serious episodes of hypoglycemia
during childhood, due to inappropriate insulin secretion2,3
Substantial burden of disease
• Insufficient response to existing medical treatment3
• High risk of seizures and permanent brain injury4
• Most severe cases require pancreatic surgery5
• Prolonged hospitalization and intolerable burden to patients,
families, caregivers, and healthcare systems2,6
1 https://www.orpha.net/consor/cgi-bin/ (not including transient cases due to perinatal stress or diabetic mother); 2 Congenital Hyperinsulinism International. Available at: http://congenitalhi.org; 3 De Leon et al. Nat Clin Pract Endocrinol Metab
2007;3:57-68, Lubchenco and Bard. Pediatrics. 1971 May;47(5):831-8, Hussain et al. Diabetes 2005 54:2946–2951; 3 Thornton PS et al., J Pediatr. 2015;167(2):238-45; ); 4 Meissner T et al., Long-term follow-up of 114 patients with
congenital hyperinsulinism. Eur J Endocrinol 2003;149:43-510; 5 Yorifuji et al. Pediatrics International 2014;56:467; 6 Eljamel et al. Orphanet Journal of Rare Diseases 2018;13:123
Corporate Presentation 19Congenital hyperinsulinism
Zealand has a comprehensive Phase 3 program
to address the unmet need in CHI
Trial 17109 – Completed* Trial 17103 - Ongoing Open-label extension study 17106 -
Ongoing
12 patients, age 7 days-12 months. Maximum 44 patients,
32 patients, age 3 months-12 years.
First patients enrolled; phase 3 trial age 1 month onwards
Trial completed
readout expected in 2021
Hypo-prone, maximum therapy, Newly diagnosed, dependent on IV Patients from 17109 and 17103
incl. pancreatic surgery glucose with ongoing positive benefit/risk
8 weeks of treatment 25 days of treatment Allows for long-term data
(4 weeks follow-up) (4 weeks follow-up)
*Dasiglucagon on top of standard of care (SOC) did not significantly reduce the rate of hypoglycemia compared to SOC alone when assessed by intermittent self-measured plasma glucose (primary endpoint). However, hypoglycemia was
reduced by 40–50% when assessed by blinded continuous glucose monitoring (exploratory analysis). Dasiglucagon treatment was assessed to be safe and well tolerated in the study. 31 out of 32 patients have continued into the long-term
extension study
Corporate Presentation 20Dasiglucagon in
Type 1 Diabetes
Management
The Bihormonal Bionic Pancreas
A person with type 1 diabetes depends on
multiple daily insulin injections to maintain
plasma glucose in the normal ranges.
Read more at
zealandpharma.com
Corporate Presentation 21Glycemic data from phase 2 study supports decision to
move to phase 3 with bihormonal bionic pancreas
Phase 2 home-use clinical trial testing Phase 3 trial initiation expected in H2 2021 based
the iLet® bionic pancreas using Dasiglucagon1 on positive EoP2 meeting with the FDA
Insulin-Only Bihormonal
Mean CGM glucose level 149 mg/dL 139 mg/dL
Time spent in range
71% 79%
(70-180 mg/dL)
Mean CGM glucoseThe Bihormonal Bionic Pancreas Pivotal Trial (BH BPPT)
will serve as the Phase 3 trial for use of Dasiglucagon in the
iLet for adults and children with T1D
Primary endpoint
ADULTS (≥ 18y)
Bihormonal with Dasiglucagon (BHBP) • A1C superiority of BH
n ~ 350
Insulin-Only iLet (IOBP) BHBP iLet versus IO iLet (26w)
Usual Care* Secondary endpoints
• A1C superiority of BH
iLet versus Usual Care
BHBP
• Non-inferiority for time in
hypoglycemia/hypo
PEDS (6–17y)
Usual Care*
events
n ~ 350
Insulin-Only iLet (IOBP) BHBP
• Long-term safety and
Bihormonal with Dasiglucagon (BHBP)
efficacy as measured
over 52 weeks
WEEKS 26 52 65
*Usual care will be the insulin treatment the patient is on when rendomized to the trial including multiple daily injections and any marketed insulin pump
Corporate Presentation 23Type 1 diabetes
Commercial opportunity
Potential glucagon market value of USD 1-3 billion in 2030 depending on bi-hormonal artificial pancreas pump share of the total diabetes pump
market1
Pump adoption expected to Major growth drivers for dual
increase rapidly hormone pumps
Estimated number of pump users, U.S. only2
Fully-automated Bi-Hormonal AP pump Increasing number of insulin-treated Type 1 and 2 Diabetes
Closed loop insulin-only AP pumps >1,000,000 patients3
Other traditional or hybrid insulin pumps
Broader patient segment eligible for pump usage
400,000 Improving technology and pump system integration
2018 2025 2030
1Zealand projections based on glucagon WAC price of USD ~10-15/day. 2 Zealand forecast based on ZS Associates analysis, DataMonitor Diabetes Report 2018, ADA, LSI Report 2018, AACE Report 2014, Meddevicetracker, March
2017. Estimated pump users include T1D and T2D insulin-treated patients. Other traditional pump systems include suspend, predictive suspend, and hybrid closed loop pump systems. 3 JDRF.
Corporate Presentation 24Dasiglucagon adjustable minidose
Zealand is exploring novel treatment opportunities for mini-
doses of dasiglucagon
Mini-doses of dasiglucagon increase blood glucose
levels from hypoglycemia in people with type 1 Exercise-induced hypoglycemia in
diabetes (T1D)1 T1D
• In-clinic trials confirmed potential for
dasiglucagon
• “Free living” Phase 2 study planned for H1
2021
Post-Bariatric hypoglycemia (PBH)
• In-clinic Phase 2 trial confirmed potential for
dasiglucagon in treating PBH
• Phase 2b outpatient study planned for H1
2021
1 Hovelmann et al. Diabetes, Obesity and Metabolism 2019; 21(3): 601-610
Corporate Presentation 25BI 456906, a long-acting GLP-1-Glu dual agonist is in Phase 2
as a potential novel treatment of T2D, obesity and NASH
Boehringer-Ingelheim is
progressing the development of
Zealand’s dual agonist BI 456906*
Phase 1a: SAD trial COMPLETED
Healthy Volunteers
Phase 1b: MAD COMPLETED
Obese/OW; 16 weeks
Phase 1: PK/safety COMPLETED
Japanese HV Expected
completion
Phase 2: T2D
350 subjects; 16 wks; Glycemic control, BW
Q3 2021
Phase 2: Obesity Q3 2022
350 subjects; 46 weeks
Phase 2: NASH Q1 2023
240 subjects; 48 weeks
Sanchez-Garrido MA et al. Diabetologia 2017
* Licensed to Boehringer Ingelheim: EUR 345 million outstanding potential development, regulatory and commercial milestones + high single to low double digit % royalties on global sales 26Short bowel
syndrome
”My worst fear was to become
Patients with SBS have undergone what I am today: a short bowel
massive intestinal surgery resulting in
significantly reduced or complete loss of patient.”
intestinal function
Marianne, living with short bowel syndrome
Read more of Marianne’s story at
zealandpharma.com/marianne-story
Corporate Presentation 27Glepaglutide is our lead candidate for treatment of SBS
Glepaglutide1 – Phase 2 data with increases in intestinal absorption
Long-acting stable GLP-2 analog following 3 weeks treatment
• Forms depot at injection site with Change in wet weight Clear dose-response
effective half-life of ~50 hours absorption (g/day)2 on multiple endpoints2
• Once- or twice-weekly dosing via a
simple autoinjector • Increase in intestinal fluid
and energy absorption
• Reduction in fecal wet
weight output
• Increase in urine production
• Increase in body weight
• Appeared safe and well-
tolerated
Mean Baseline Wet Weight Absorption (g/day)
525 538 288
1 IP protection: Compound patent 2026 + 5 years patent term extension - Dosing regime (pending) 2038 - Clinical formulation (pending) 2039
2 Naimi, R., ASPEN 2018 Nutrition Science and Practice Conference (Abstract number 2829969t).
Corporate Presentation 28Glepaglutide – Pivotal Phase 3 trial progressing
toward results in 2022
Trial design
• Double-blind, placebo
controlled trial in 129 SBS
patients evaluating safety and
efficacy of once and twice
weekly dosing over 24 weeks
Primary and key
secondary endpoints
• Reduction in weekly parenteral
support (PS volume)
• >20% reduction in PS volume
• Reduction in weekly days on PS
Corporate Presentation 29Short bowel syndrome
Commercial opportunity
Opportunity to take majority share of future >USD 1.5 billion market with glepaglutide as potential best-in-class long acting GLP-2 analog
Estimated number of treated SBS Major growth drivers for GLP-treatments
patients and market value potential
across major markets
Increasing awareness of rehabilitation options5
The US 1, 2 EU 1, 3 Japan 4
Patients Value USD Patients Value USD Patients Value USD
Improving GLP-2 treatment options
2020 1,000 ~0.4bn 2020 300 ~0.1bn 2020 0 -
2030 >4,000 >1.0bn 2030 >2,000 >0.4bn 2030 >1,000 TBD
Improving therapy adherence
RoW
Potential to be determined
12020 patient and value estimate based on Takeda Q2 2020 financial report, Truven Redbook, WAC and 20-25% discount. 2 2025 forecast based on Transparency Market Research; Short Bowel Syndrome Market, 2017. Number of
patients estimated by dividing with U.S. average price. 3 2030 forecast based on Zealand feasibility study 2018 and annual expected growth of 5%. Value based on existing GLP-2 WAC price. 4 No GLP-2 treatment currently approved in
Japan. Patient forecast based on MHLW estimate. Price level to be defined by first GLP-2 introduction. 5 SBS prevalence doubled in one decade due to increased awareness and improved care (Brandt, 2016,
Journal of Parenteral and Enteral Nutrition).
Corporate Presentation 30Dapiglutide has potential to treat SBS as well as a
wider range of gastrointestinal diseases
Dapiglutide1,2 - Long-acting GLP-1/GLP-2
Vehicle Clinical progress
GLP-2 agonist
dual agonist
GLP1/GLP-2 dual agonist Phase 1a (SAD)
Small intestine - Total surface2 area
1000
pPre-clinical pipeline• Corporate Presentation 32
Pre-clinical pipeline in obesity and other metabolic
diseases are designed for dual pharmacology
Zealand Pharma addresses dual Amylin analog and GIP agonist induce more weight loss in combination
pharmacology from several angles with GLP-1 versus GLP-1 alone in preclinical obesity model
Dual agonist (one molecule – two actions) ZP8396, amylin analog alone and in ZP6590, GIP agonist alone and in
• BI456906 – GLP-1/Glucagon receptor-agonist combination with GLP-1 combination with GLP-1
Vehicle
Vehicle
Start of ZP Amylin GLP-1 analogue
analogue treatment ZP Amylin analogue ZP GIP
700 4 GLP-1
GLP-1 analogue + ZP Amylin analogue
2 GLP-1 + ZP GIP
0
650 -2
Body weight (% change from day 0)
-4
***
-6
6%
Body weight (g)
600 -8
-10
Co-formulation or loose combo of mono -12
550
agonists
-14
***
-16 17%
• ZP8396 – Amylin analog 500
-18
-20
• ZP6590 – GIP receptor-agonist Pre-treatment
GLP-1 analogue -22 ***
23%
-24
450 -26
1 4 7 10 13 16 19 22 25 28 31 34 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32
Time (Study days) Study days
• ZP8396 allows for co-formulation with other • ZP6590 allows for co-formulation with other
peptides, including GLP-1 and GIP peptides, including amylin and GLP-1
• Once weekly dosing • Predicted once weekly subcutaneous dosing
• Phase 1 anticipated in 2021 • In IND enabling toxicology studies
Corporate Presentation 33Pre-clinical pipeline for on IBD and other chronic
inflammatory diseases
ZP9830, Kv1.3 blocker for T cell ZP10000, an α4β7 integrin inhibitor Complement C3 peptide inhibitor –
driven chronic inflammatory for oral delivery outlicenced to Alexion
diseases incl. IBD
• Blockage of Kv1.3 ion channels on T effector memory • Binding kinetics on par with antibodies
cells involved in auto-immunity and chronic • Potential for improved tissue penetration
inflammation
• Formulation for oral administration being optimized
• Optimized for selectivity, potency and stability
• In preparation for IND enabling toxicology studies
2000 250 200
• Novel long-acting peptide inhibitor of complement C3
IL-17A [pg/ml]
200
IFN-g [pg/ml]
1500 IL-2 [pg/ml] 150
150 • Attractive target for peptides not addressable by
1000 100 antibodies
100
500 50
50 • Lead molecule half-life extended with improved stability
0 0 0 in formulation and excellent binding properties to C3
-14 -12 -10 -8 -14 -12 -10 -8 -14 -12 -10 -8
Compound conc [log M] Compound conc [log M] Compound conc [log M]
• USD 610 million potential development, regulatory and
commercial milestones + high single to low double
digits % royalties on net sales
• Concentration-dependent inhibition of pro-inflammatory • Oral dosing of ZP10000 reduces colonic lesion &
cytokine release (incl. IFN-g, IL-2 and IL17A) from inflammation in pre-clinical IBD disease model***
stimulated human whole blood*
*Data on file. Concentration-dependent effect on pro-inflammatory cytokine release from Thapsigargin stimulated whole blood.
**For lengths, cm; for Myeloperoxidase (MPO), units per gram protein. Inflammation score is a composite of observations and ranges from 0-4. Mean ± SEM
***ZP10000 administered QD at 100 mg/kg in lipid-based vehicle via oral gavage to mice.
Corporate Presentation 34Additional company information Corporate Presentation 35
Our next generation peptide platform builds on solid
know-how and new innovative technologies
Computational chemistry
Library starting points
Next generation
peptide drugs
Rational design Molecular display
Formulation technologies
36Strong balance sheet allows for continued investments
Net Operating Expenses Cash position1
DKK 1,092.1 million / USD 166.9 million DKK 1.28 billion / USD 192.2 million
DKK thousand DKK thousand
1,200,000 1,600,000
1,400,000
1,000,000
1,200,000
800,000
1,000,000
600,000 800,000
600,000
400,000
400,000
200,000
200,000
0 0
2016 2017 2018 2019 2020 2016 2017 2018 2019 2020
R&D expenses G&A expenses Sales & Marketing expenses Cash & cash equivalents Restricted cash Securities
1 Excludes an additional DKK 749 million gross proceeds secured through directed issue
DKK/USD exchange rates used: December 31, 2020 = 6.54 and December 31, 2019 = 6.67
in January 2021
Corporate Presentation 37Strategic Partnerships
Strategic collaboration for GLP-1/glucagon Strategic collaboration for up to four
dual agonist1 complement pathway targets3
• EUR 345 million outstanding potential development, regulatory • Novel long-acting peptide inhibitor of C3 identified
and commercial milestones + high single to low double digit % • USD 610 million potential development, regulatory and
royalties on global sales commercial milestones + high single to low double digits %
• Product candidate for obesity/Type 2 diabetes/non-alcoholic royalties on net sales
steatohepatitis (NASH) • Up to 3 Additional Targets: USD 15 million upfront/target
• Once weekly dosing development/regulatory milestones similar to lead target,
• Phase 2 initiated2 commercial milestones and royalties at slight reduction
• Multiple opportunities for intervention points for novel targeted
therapeutics
1Boehringer Ingelheim holds global development and commercial rights. 2 https://clinicaltrials.gov/ct2/show/NCT04153929. 3 Upfront payment of $25 million for the first target and $15 million equity investment at a subscription price of
$18,68 per share.
Corporate Presentation 38Global organization
Copenhagen, Denmark
Boston, MA
329
Highly skilled employees
and diverse teams1
Marlborough, MA
New York, NY
1 As of December 31, 2020
Corporate Presentation 39Zealand Pharma is facing an exciting 2021
Launch Zegalogue and optimize Advance our early pipeline
commercialization Advance pre-clinical drug candidates towards Phase 1 initiation
Execute launch readiness program for Zegalogue Initiate new pre-clinical projects
Launch Zegalogue in late June 2021 Develop our next generation peptide platform
Deliver on net revenue target for Zegalogue
Deliver on net revenue target for V-GoTM Maintain a strong financial and organizational
position
Execute on clinical pipeline Secured a total of DKK gross 749.0 million through a direct issue and private placement of
new shares –January 2021
Dasiglucagon for dual-hormone artificial pancreas pump: Initiate Phase 3 study
Ensure disciplined financial management and productive investments
Dasiglucagon for congenital hyperinsulinism: Deliver second phase III in 2021 and prepare
NDA/MAA for execution in 2022 –ongoing Focus company on operational performance and organizational health
Glepaglutide for short bowel syndrome: Continue patient enrolment in Phase 3 study –
ongoing
Dapiglutide for short bowel syndrome: Complete MAD Phase 1 program
Corporate Presentation 40Management
Finance & Support
Matt Dallas
Chief Financial Officer
US Business & Operations
Emmanuel Dulac Frank Sanders
Chief Executive Officer
Research & Development
Adam Steensberg
Chief Medical Officer
Technical Development
& Operations
Ivan M. Møller
People & Organization
Christina S. Bredal
Business Development
Marino Garcia
Corporate Presentation 41You can also read
