Last close As at 05/08/2026
USD5.00
▲ −1.80 (−26.47%)
Market capitalisation
USD62m
Research: Healthcare
OpGen reported 2020 sales of $4.2m, up 20% compared to the $3.5m in sales in 2019, with growth mainly due to the merger with Curetis. We expect the company to be able to build on this level with the help of the future 510(k) clearance of its Acuitas AMR Gene Panel test in bacterial isolates as well as potential approvals for the Unyvero platform in China and Colombia. To maintain the momentum, OpGen plans to initiate a clinical trial program for complicated urinary tract infections (cUTI) and invasive joint infections (IJI) with the Unyvero platform in H221.
Written by
OpGen |
2020 results |
Financial update |
Pharma & biotech |
6 April 2021 |
Share price performance
Business description
Next events
Analysts
OpGen is a research client of Edison Investment Research Limited |
|||||||||||||||||||||||||||||||||||||||||||||||||
OpGen reported 2020 sales of $4.2m, up 20% compared to the $3.5m in sales in 2019, with growth mainly due to the merger with Curetis. We expect the company to be able to build on this level with the help of the future 510(k) clearance of its Acuitas AMR Gene Panel test in bacterial isolates as well as potential approvals for the Unyvero platform in China and Colombia. To maintain the momentum, OpGen plans to initiate a clinical trial program for complicated urinary tract infections (cUTI) and invasive joint infections (IJI) with the Unyvero platform in H221.
Year end |
Revenue ($m) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/19 |
3.5 |
(11.9) |
(7.38) |
0.0 |
N/A |
N/A |
12/20 |
4.2 |
(25.3) |
(1.57) |
0.0 |
N/A |
N/A |
12/21e |
10.5 |
(25.6) |
(0.65) |
0.0 |
N/A |
N/A |
12/22e |
26.4 |
(16.8) |
(0.42) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortization of acquired intangibles, exceptional items and share-based payments.
Bacterial isolates 510(k) clearance review resumed
The FDA has resumed the review of the 510(k) submission for the Acuitas AMR Gene Panel test in bacterial isolates, which had been put on hold due to COVID-19. OpGen believes it has addressed all the remaining requests of the FDA, though the exact timing of a clearance is unknown as the FDA is still capacity constrained due to the large number of emergency use authorizations related to the pandemic.
Moving closer to a Chinese launch
In March, OpGen announced that the Chinese National Medical Products Administration (NMPA) approved the Unyvero instrument system for use in China. Next up would be an approval for the Unyvero A50 pneumonia cartridge, which is necessary for a product launch. As a reminder, OpGen partner Beijing Clear Biotech has significant minimum purchase requirements over the eight-year deal, totaling €150m in revenue to OpGen over that period.
Approval in Colombia expected in H221
In January, OpGen announced a distribution agreement with Annar Health Technologies for Colombia. Annar is responsible for product registration, which is expected to complete in H221. Annar has agreed to purchase a minimum of 10 Unyvero systems over the three-year term following approval.
Valuation: $103m or $2.68 per share
We have adjusted our valuation to $103m or $2.68 per basic share, from $59m or $2.93 per share, previously. The total valuation increase is due to higher net cash and rolling forward our NPV, while the per share value decreased due to a higher number of shares outstanding. The company had $13.4m in gross cash at the end of 2020 and added an additional $23.4m in net proceeds through a private placement in February and $9.65m in gross proceeds through warrant exercises in March. The company expects to have $40m in gross cash at the end of Q121.
Partnerships are key to success
OpGen has some significant partnerships in place that can significantly affect the adoption of its diagnostic systems. OpGen is partnered in China with Beijing Clear Biotech (BCB), which has agreed to minimum purchase levels of 360 Unyvero A50 systems as well as over 1.5m Unyvero cartridges over the duration of the agreement following regulatory clearance by the NMPA. Based upon previously agreed transfer price levels, this volume equates to €60m in cumulative revenues from China over the first five years for OpGen and then €30m annually over the following three years (note that these are minimum purchase levels and actual revenues could be higher). In March, OpGen announced that the NMPA approved the Unyvero instrument system for use in China. Next up would be an approval for the Unyvero A50 pneumonia cartridge, which is necessary for a product launch. Precise timelines are unknown, but the partners continue to interact closely with the Chinese regulatory agency.
In January, OpGen announced a distribution agreement with Annar Health Technologies for Colombia. Annar is responsible for product registration, which is expected to complete in H221. Annar has agreed to purchase a minimum of 10 Unyvero systems over the three-year term following approval. The dollar value of these minimum purchases was not disclosed but the company estimated on its 2020 results conference call that typical revenue per instrument system per year can range from ‘high five figures’ to ‘low six figures’. So once the instruments are fully in place and utilized, OpGen could see revenue of approximately $1m per year from the Annar partnership based on these estimates.
The company is also currently negotiating with the New York State Department of Health to extend its participation in the New York State Infectious Disease Digital Health Initiative, which is currently scheduled to end on 31 March 2021 (the current agreement has a one-year term). The company is confident that the agreement will be extended and expanded at attractive commercial terms. So far four testing centers that serve 30 hospitals in New York State are running Acuitas AMR Gene Panel tests and the company has seen a ramp up in test volumes in Q420 and Q121.
OpGen continues to seek additional partnerships, including for its subsidiary Ares Genetics as well as for the next generation Unyvero A30 platform.
Valuation
We have adjusted our valuation to $103m or $2.68 per basic share, from $59m or $2.93 per share. The total valuation increase is due to higher net cash and rolling forward our NPV, while the per share value decreased due to a higher number of shares outstanding from recent financings, as described below.
Exhibit 1: OpGen valuation table
Product |
Main indication |
Status |
Probability of successful commercialization |
Launch year |
Peak sales ($m) |
Patent protection |
Economics |
rNPV |
OpGen/Curetis Diagnostic Platform |
cUTI, lower respiratory |
Market (RUO)/ registration |
40% |
2020 |
183 |
2039 |
100.0% |
82.8 |
Total |
|
|
|
|
|
|
|
82.8 |
Net cash (Q121e) |
19.9 |
|||||||
Total firm value |
102.7 |
|||||||
Total basic shares (m) |
38.3 |
|||||||
Value per basic share ($) |
2.68 |
|||||||
Options (m) |
6.8 |
|||||||
Total number of shares (m) |
45.1 |
|||||||
Diluted value per share ($) |
2.28 |
|||||||
Source: Edison Investment Research
Financials
OpGen reported revenue of $4.2m for 2020, up 20% compared to $3.5m in 2019, mainly due to the inclusion of Curetis products following the business combination with Curetis. Product sales were up 25% to $2.7m while collaboration revenue was mainly unchanged at $1.3m. Laboratory services were $0.2m, up from almost nothing in 2019 due to the inclusion of Ares Genetics’ laboratory services after the Curetis merger. R&D expenses increased from $5.1m in 2019 to $10.0m, while SG&A expenses were up from $8.5m to $12.4m mainly due to the Curetis merger. OpGen’s 2020 net loss was $26.2m compared to $12.4m in 2019. Following these results, we are maintaining our 2021 revenue estimate of $10.5m and slightly reducing our R&D and SG&A estimates by $0.2m and $0.3m respectively. We also are introducing our 2022 estimates, which feature $26.4m in sales.
The company had $13.4m in gross cash (and $20.1m in debt) at the end of 2020 and added an additional $23.4m in net proceeds through a private placement in February to a single US-based healthcare-focused institutional investor (resulting in the issuance of 8.3m shares and 4.167m share purchase warrants exercisable at $3.55 per share) and $9.65m in gross proceeds through warrant exercises (leading to the issuance of 4.84m shares) in March. The company expects to have $40m in gross cash at the end of Q121 and a quarterly cash burn rate of $5m to $6m in 2021. Note that we have eliminated the additional financing need of $36.6m through to profitability (currently expected in 2023) that we had previously estimated prior to the recent financings.
Exhibit 2: Financial summary
$'000s |
2019 |
2020 |
2021e |
2022e |
||
Year end 31 December |
GAAP |
GAAP |
GAAP |
GAAP |
||
PROFIT & LOSS |
||||||
Revenue |
|
|
3,499 |
4,214 |
10,497 |
26,406 |
Cost of Sales |
(1,632) |
(3,848) |
(5,511) |
(7,922) |
||
Gross Profit |
1,867 |
366 |
4,986 |
18,484 |
||
Sales, General and Administrative Expenses |
(8,496) |
(12,367) |
(13,604) |
(18,794) |
||
Research and Development Expense |
(5,121) |
(9,965) |
(12,157) |
(11,549) |
||
EBITDA |
|
|
(11,741) |
(21,966) |
(20,775) |
(11,859) |
Operating Profit (before amort. and except.) |
|
|
(11,741) |
(21,966) |
(20,775) |
(11,859) |
Intangible Amortisation |
0 |
0 |
0 |
0 |
||
Other |
10 |
0 |
0 |
0 |
||
Exceptionals |
(521) |
(752) |
0 |
0 |
||
Operating Profit |
(12,261) |
(22,718) |
(20,775) |
(11,859) |
||
Net Interest |
(188) |
(3,294) |
(4,782) |
(4,973) |
||
Other |
2 |
(66) |
0 |
0 |
||
Profit Before Tax (norm) |
|
|
(11,928) |
(25,260) |
(25,557) |
(16,832) |
Profit Before Tax (reported) |
|
|
(12,446) |
(26,078) |
(25,557) |
(16,832) |
Tax |
0 |
(132) |
0 |
0 |
||
Deferred tax |
(0) |
(0) |
(0) |
(0) |
||
Profit After Tax (norm) |
(11,928) |
(25,392) |
(25,557) |
(16,832) |
||
Profit After Tax (reported) |
(12,446) |
(26,211) |
(25,557) |
(16,832) |
||
Average Number of Shares Outstanding (m) |
1.6 |
15.8 |
39.4 |
39.8 |
||
EPS - normalised ($) |
|
|
(7.38) |
(1.57) |
(0.65) |
(0.42) |
EPS - Reported ($) |
|
|
(7.70) |
(1.66) |
(0.65) |
(0.42) |
Dividend per share (c) |
0.0 |
0.0 |
0.0 |
0.0 |
||
BALANCE SHEET |
||||||
Fixed Assets |
|
|
3,755 |
32,863 |
34,773 |
36,780 |
Intangible Assets |
1,418 |
24,606 |
26,427 |
28,339 |
||
Tangible Assets |
2,133 |
5,791 |
5,880 |
5,975 |
||
Other |
203 |
2,466 |
2,466 |
2,466 |
||
Current Assets |
|
|
6,667 |
16,888 |
25,205 |
10,671 |
Stocks |
473 |
1,486 |
1,486 |
1,486 |
||
Debtors |
568 |
653 |
686 |
2,641 |
||
Cash |
2,708 |
13,360 |
21,646 |
5,157 |
||
Other |
2,918 |
1,388 |
1,388 |
1,388 |
||
Current Liabilities |
|
|
(4,939) |
(7,372) |
(6,673) |
(6,673) |
Creditors |
(4,565) |
(6,673) |
(6,673) |
(6,673) |
||
Short term borrowings |
(374) |
(699) |
0 |
0 |
||
Long Term Liabilities |
|
|
(1,190) |
(21,188) |
(21,199) |
(21,386) |
Long term borrowings |
(329) |
(19,379) |
(19,221) |
(19,221) |
||
Other long term liabilities |
(860) |
(1,809) |
(1,978) |
(2,165) |
||
Net Assets |
|
|
4,293 |
21,191 |
32,106 |
19,392 |
CASH FLOW |
||||||
Operating Cash Flow |
|
|
(11,505) |
(23,397) |
(22,756) |
(13,968) |
Net Interest |
0 |
0 |
0 |
0 |
||
Tax |
0 |
0 |
0 |
0 |
||
Capex |
(32) |
(130) |
(136) |
(141) |
||
Acquisitions/disposals |
0 |
1,267 |
0 |
0 |
||
Financing |
13,062 |
33,793 |
33,050 |
0 |
||
Dividends |
0 |
0 |
0 |
0 |
||
Other |
(3,836) |
0 |
0 |
0 |
||
Net Cash Flow |
(2,310) |
11,533 |
10,158 |
(14,109) |
||
Opening net debt/(cash) |
|
|
(3,514) |
(2,005) |
6,717 |
(2,424) |
HP finance leases initiated |
0 |
0 |
0 |
0 |
||
Exchange rate movements |
4 |
(1,587) |
0 |
0 |
||
Other |
798 |
(18,669) |
(1,017) |
(2,380) |
||
Closing net debt/(cash) |
|
|
(2,005) |
6,717 |
(2,424) |
14,065 |
Source: company reports, Edison Investment Research
|
|
Research: TMT
Tinexta’s FY20 results were broadly in line with management’s prior guidance and demonstrated margin leverage despite it being a more challenging year due to COVID-19, and a significant improvement in free cash flow generation and net debt. The acquisitions of the Cyber Security businesses have enhanced the group’s growth revenue and EBITDA growth profile, albeit diluting the group’s EBITDA margin. Our DCF-based approach suggests a valuation of €27 per share.