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Pharma, Biotech & Medtech 2019 in ReviewAmy Brown, Elizabeth Cairns, Edwin Elmhirst – February 2020
Vantage Pharma, Biotech and Medtech 2019 in review
On almost all measures the pharma and biotech sectors had a very successful 2019.
A fourth-quarter surge on the stock markets meant that many publicly listed companies ended the year on a high
note, as investors flocked to drug developers both big and small. This was in no small part driven by a late flurry of
deal making, capping off a year that was already heading for the record books.
Medtech arguably did even better, justifying its reputation as a safe haven for investors’ cash, particularly judging
by the big-cap groups’ stock performance. Moreover, the rises seen in big- and mid-cap medtechs’ share prices
outpaced anything biopharma could muster.
EvaluatePharma calculates that global drug makers spent $217bn on M&A deals, a touch below 2014’s record-
breaking levels. Medtech business development activity, by contrast, regressed to the mean after a bonanza in 2017
and tumbleweeds last year.
The late market rally also kept the IPO window open at the end of the year, a period that many were expecting to be
marked by investor caution as the US headed into a presidential election year. In the end 2019 was actually a pretty
respectable period for biotech flotations, with 55 new issues arriving on Western exchanges.
Almost the opposite pattern was seen in medtech, market optimism contributing to a very welcoming atmosphere for
fledgling public companies. 2019’s medtech IPOs were larger, on average, than the sums raised by floating biotechs.
That is, until the fourth quarter, when things seemed to go awry, despite the stock markets being in rude health.
The degree to which drug makers and device companies compete for shareholder enthusiasm is debatable, but it
seems likely that at least some investors switched allegiance from medtech to biotech in the dying month of 2019.
In the biopharma IPO and the venture financing worlds, 2019 also saw an increasing concentration of capital into the
hands of fewer developers. The average amounts raised per IPO and per venture round were close to record highs,
as investors sought to fully finance their portfolio companies.
This came alongside a dip in the total venture capital invested in start-ups on 2018; that was a record year for the
sector, however, and a cooling was probably inevitable. A retrenchment was also seen in medtech, with both the
number of deals and the total cash raised dwindling from the prior year.
Elsewhere, the FDA confirmed that it remained one of biopharma’s best friends, approving another bumper crop of
medicines, including several speedy approvals. This is another way in which the fates of biopharma and medtech
seemed to diverge; the US FDA’s rate of approving novel medical devices dropped starkly in the second half.
Report authors | Amy Brown, Elizabeth Cairns, Edwin Elmhirst – February 2020
2 Copyright © 2020 Evaluate Ltd. All rights reserved.Vantage Pharma, Biotech and Medtech 2019 in review
Unless stated, all data are sourced to Evaluate and were accessed in January 2020
Contents
Introduction 2
Pharma and Biotech 2019 in review 4
Late surge sees biopharma end the year on a high note 4
Last-ditch rally saves 2019 float tally 8
Biopharma venture financing retreats, but not by much 10
A big finish confirms 2019 as a takeover year to remember 13
Cash-rich biotechs turn down the licensing deal volume 16
Rare diseases top another strong year for novel drug approvals 19
Vantage MedTech 2019 in review 22
Big cap medtechs see out the decade in style 22
A thoroughly average year for medtech mergers 24
How low can medtech venture investment go? 27
Poor fourth quarter mars strong year for medtech floats 29
A quiet six months for device approvals 31
Outlook for 2020 33
3 Copyright © 2020 Evaluate Ltd. All rights reserved.Vantage Pharma, Biotech and Medtech 2019 in review
4 Copyright © 2020 Evaluate Ltd. All rights reserved.Late surge sees biopharma end the year on a high note
Pharma and Biotech 2019 in review
Late surge sees biopharma end the year on a high note
The biopharma sector managed to largely shake off fears about a tightening of drug pricing
legislation in the US last year, and most big cap stocks celebrated healthy, double-digit share
increases. Perhaps most extraordinary of all was the turnaround effected by Lilly, which at
the end of the third quarter had stood off 3% year to date, but in the following three months
managed to climb sufficiently to finish the year up 14%.
In fact, most US groups enjoyed a fourth-quarter comeback. Thus indices such as the Nasdaq biotech, S&P pharma
and Dow Jones pharma and biotech, which were either flat or up in anaemic single digits at the end of the summer,
roared back to end 2019 with double-digit gains.
Stock index 12-mth % change
Nasdaq Biotechnology (US) 24%
S&P Pharmaceuticals (US) 12%
Dow Jones Pharma and Biotech (US) 14%
S&P 500 (US) 29%
DJIA (US) 22%
Dow Jones Stoxx 600 Healthcare (EU) 29%
Thomson Reuters Europe Healthcare (EU) 26%
Euro Stoxx 50 (EU) 20%
FTSE-100 (UK) 12%
Topix Pharmaceutical Index (Japan) 21%
Indices
Overall, however, the year belonged to a trio of EU-based big cap stocks: Astrazeneca, driven by the oncology
drugs Tagrisso and Lynparza, Roche, propelled by Ocrevus and Hemlibra, and Novartis. The last has remained an
aggressive asset buyer, and in Zolgensma looks to have a marketed product that could, after several false starts,
mark gene therapy’s coming of age.
On the debit side, Pfizer remained big pharma’s worst-performing stock, driven down by concerns over its corporate
strategy. Abbvie, like Lilly, saw a major fourth-quarter recovery, finishing down 4% after standing off 18% at the end of
the third quarter.
5 Copyright © 2020 Evaluate Ltd. All rights reserved.Late surge sees biopharma end the year on a high note
Among large biopharma companies just outside the big cap sphere, those not based in the west continued to
dominate. Jiangsu Hengrui is emerging as one of China’s most popular healthcare picks thanks to its strength in
oncology, while Chugai – majority-owned by Roche – is reaping the rewards of the Swiss group’s Hemlibra success.
At the bottom of the table Regeneron continued to suffer from the imminent erosion of its Eylea franchise, and Gilead
was unable to shake off questions over its lack of business development nous.
Still, the worst performer in this stock category was actually Biogen, a somewhat surprising result given that some
now think that the company’s Alzheimer’s project aducanumab is headed for US approval this year. Before the
biotech’s shock claim that the amyloid-beta MAb actually works the stock had been trading off 30% on the year.
Share price Market capitalisation ($bn)
Top 3 risers12-mth change 31 December
201912-mth change
($bn)
Astrazeneca 31% 130.82 34.60
Roche 29% 271.67 61.11
Novartis 27% 214.44 18.62
Top 3 worst performers
Pfizer (10%) 216.83 (35.49)
Abbvie (4%) 130.94 (7.74)
Johnson & Johnson 13% 383.91 37.80
Share price Market capitalisation ($bn)
Top 3 risers12-mth change 31 December
201912-mth change
($bn)
Jiangsu Hengrui Medicine 100% 54.5 26.5
Chugai Pharmaceutical 58% 52.2 20.5
CSL 49% 85.1 25.4
Top 3 worst performers
Biogen (1%) 53.5 (7.1)
Regeneron Pharmaceuticals 1% 40.5 0.8
Gilead 4% 82.2 0.3
Big pharma: top risers and fallers in 12 months Source: Evaluate® January 2020
Other big drugmakers ($25bn+): top risers and fallers in 12 months Source: Evaluate® January 2020
A spectacular end to the year for biotech stocks helped generate several clear winners among the world’s small drug
makers across 2019. The broad geographical spread of the best-performing companies really stands out, with most
major regions represented in the top five gainers.
6 Copyright © 2020 Evaluate Ltd. All rights reserved.Late surge sees biopharma end the year on a high note
The same goes for the sector laggards, where failures and disappointments brought down companies from Japan’s
Sumitomo Dainippon, to Nektar in the US and Irlab in Sweden. It is notable however that even the worst performers
among the mid-caps avoided all-out calamity – previous years have seen much more severe declines in this category.
Nektar, which has been hurt by flagging confidence in its lead cytokine asset, stands out as the sole US faller. US
biotechs have benefited the most from the market rally, and companies based in America dominate the list of
small-cap risers.
Share price Market capitalisation ($bn)
Top 5 risers12-mth change 31 December
201912-mth change
($bn)
Galapagos 125% 13.3 8.3
Sino Biopharmaceutical 111% 17.5 9.2
Daiichi Sankyo 106% 47.4 25.3
Seattle Genetics 102% 19.6 10.5
Vifor Pharma Group 65% 11.6 4.6
Top 5 worst performers
Sumitomo Dainippon Pharma (39%) 7.8 (4.5)
Aurobindo Pharma (37%) 3.8 (2.1)
Teva Pharmaceutical Industries (36%) 10.7 (6.1)
Piramal Enterprises (36%) 4.3 (1.7)
Nektar Therapeutics (34%) 3.8 (1.9)
Mid cap ($5-25bn): top risers and fallers in 12 months Source: Evaluate® January 2020
It is among the small caps that the more frothy aspects of the market can really be seen: Kodiak and Arrowhead, for
example, have a long way to go to prove the worth of their respective projects, though the latter has been boosted
by deal making in the RNAi space.
The Medicines Company’s takeout by Novartis is an example here – the deal has not gone through but the stock is
sitting on a 344% gain this year. The target group has been removed from this ranking, as have Arqule and Synthorx,
whose takeouts by Merck & Co and Sanofi represented gains of 621% and 302% on the beginning of 2019.
The fallers are as usual populated by companies blighted by clinical failure; in a sign of the competitive nature of the
Duchenne muscular dystrophy space, both Solid and Wave are in the doldrums after setbacks with their respective
contenders for the muscle wasting condition.
7 Copyright © 2020 Evaluate Ltd. All rights reserved.Late surge sees biopharma end the year on a high note
Share price Market capitalisation ($m)
Top 5 risers12-mth change 31 December
201912-mth change
($m)
Kodiak Sciences 913% 2,666 2,405
Arrowhead Pharmaceuticals 411% 6,064 4,919
Eidos Therapeutics 317% 2,152 1,646
Epizyme 299% 2,240 1,752
Reata Pharmaceuticals 264% 5,063 3,717
Top 5 worst performers
Novavax (89%) 106 (598)
Irlab Therapeutics (88%) 152 (128)
Solid Biosciences (83%) 205 (745)
Wave Life Sciences (81%) 275 (964)
Aptinyx (79%) 115 (439)
Small cap ($250m-$5bn): top risers and fallers in 12 months Source: Evaluate® January 2020
More in-depth analyses of biopharma share price movements over 2019 can be found here:
8 Copyright © 2020 Evaluate Ltd. All rights reserved.Last-ditch rally saves 2019 float tally
Last-ditch rally saves 2019 float tally
Until October it had looked as if the IPO window for young drug makers might be shutting as
western stock markets contracted. Instead 14 listings, including four $100m-plus floats, helped
2019 finish with a flourish as the markets bounced back to health.
As with all the data in the pharma and biotech section of this report, this analysis looks only at drug developers,
excluding sectors like medtech and genomics.
1,500
1,250
750
1,000
500
250
1,750
2,000
3,000
2,250
2,500
2,750
Source: Evaluate® January 2020Biotech initial public o�erings by quarter on Western exchanges
Am
ount
rai
sed
($m
)
IPO
cou
nt
26
24
22
20
18
16
14
12
10
8
6
4
2
0
Amount raised ($m)
IPO count
2015
Q1
802
Q2
1,798
Q3
1,548
Q4
2016
Q1
594
Q2 Q3
54
1
Q4
464
941
2017
Q1 Q2
1,026
677
Q3
995
Q4
1,381
2018
Q1
449
Q2 Q3 Q4
2019
Q1
1,046
Q2
1,952
Q3
599
Q41,2
58
1,234
2,25
0
1,908
0
15
25
16
22
10
17
12
6
8
16
12
14 14
21
20
13 13
21
7
Year
141,841
The strong fourth quarter means that, looking back over the decade, 2019 was far from a disappointing period for
drug maker flotations. The average amount raised, at $88m, was the second highest over the decade; this suggests
that the concentration of capital into the hands of fewer companies is not limited to the venture financing field.
Date No. of IPOs Amount raised ($bn)
Avg. amount raised ($m)
No. raising >$100m
2019 55 4.9 88 17
2018 68 7.2 106 31
2017 50 3.9 77 15
2016 45 2.3 51 3
A decade of biopharma flotations Source: Evaluate® January 2020
Date No. of IPOs Amount raised ($bn)
Avg. amount raised ($m)
No. raising >$100m
2015 78 5.1 65 17
2014 97 6.5 67 18
2013 54 3.3 60 7
2012 19 1.0 51 2
9 Copyright © 2020 Evaluate Ltd. All rights reserved.Last-ditch rally saves 2019 float tally
A look at trends in investor sentiment shows that the final quarter of the year is traditionally a tough period to float,
and last year was no exception. However, the average discount to initially proposed price ranges was at least less
severe than in the final quarter of 2018.
The second chart below looks at the difference between the average share price achieved while a company was
private – a figure supplied in most US registration documents – and the price at float. Early investors are apparently
not able to achieve the valuation uplifts at IPO they once could.
Source: Evaluate® January 2020Average Nasdaq premium/(discount) to IPO price range
Ave
rage
pre
miu
m/d
isco
unt
5%
0%
-5%
-10%
-15%
-20%
10%
-25%
Year
Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4
2015
Note: NASDAQ IPOs only
2016 2017 2018 2019
Source: Evaluate® January 2020Median increase in pro-IPO average share price to float
Med
ian
incr
ease
140%
160%
80%
100%
120%
60%
40%
20%
180%
0%H1 2015 H2 2015 H1 2016 H2 2016 H1 2017 H2 2017 H1 2018 H2 2018 H1 2019 H2 2019
A more in-depth analysis of the biotech IPO market can be found here:
10 Copyright © 2020 Evaluate Ltd. All rights reserved.Biopharma venture financing retreats, but not by much
Biopharma venture financing retreats, but not by much
The financing climate for young drug makers cooled last year, but cash was far from scarce.
If anything, the major concern heard from private investors is the long-term implications of an
excess of capital.
There were few signs of restraint in 2019, however. The average financing size dipped on 2018’s peak but remained
at record levels; the frequency of mega rounds, those that amassed $100m or more, barely slowed.
Year Total investment ($bn)
Financing count
Avg per financing ($m)
No. of rounds ≥$50m
No. of rounds ≥$100m
2019 13.9 396 36.7 110 32
2018 17.9 467 40.2 130 39
2017 13.2 518 37.8 76 19
2016 10.5 484 23.0 52 15
2015 11.5 533 22.4 59 15
Biopharma and venture capital – a look at the topline numbers Source: Evaluate® January 2020
All of which points to an even more pronounced concentration of capital into the hands of a shrinking number
start-ups – the count of rounds raised fell to below 400 last year for the first time since at least 2010, according to
EvaluatePharma.
2.5
3.5
1.5
6.0
4.5
5.5
2.0
3.0
1.0
0.5
4.0
5.0
Source: Evaluate® January 2020Global quarterly biopharma venture investments
VC
inve
stm
ent (
$bn
)
Inve
stm
ent c
ount
160
150
140
130
120
110
100
80
60
40
20
90
70
50
30
10
0
Other
Investment ≥ $50m
Investment ≥ $100m
Count
2015
Q1
2.71 2.70
3.01 3.042.83
Q2 Q3 Q4
2016
Q1 Q2 Q3 Q4
2017
Q1 Q2 Q3 Q4
2018
Q1 Q2 Q3 Q4
2019
Q1 Q2 Q3 Q4
Year
2.43 2.36
2.84 2.95
4.10
4.724.96
4.19
2.17
3.84
3.10
3.77
3.2296 95
139 137
117
140
134
124
106
120
151
138
105
124
114
131
113109
106
99
0
3.953.99
1 1 Copyright © 2020 Evaluate Ltd. All rights reserved.Biopharma venture financing retreats, but not by much
The focusing of capital reflects a shift in investment strategy that has been widely embraced by these company
builders and which, as they describe it, allows start-ups to be properly funded and given the best chance of success.
There is some evidence that this strategy is working. The median time to exit via M&A, measured from date of
company foundation to buyout, dipped noticeably in 2019, while time to IPO is also historically swift.
Time to IPO is largely a reflection of the relative receptiveness of stock markets, of course. In terms of takeouts, in
the private sphere the M&A wheels are increasingly being greased by deal structures that contain future payments,
contingent on future successes.
The chart below finds that the proportion of private company takeouts that involved some sort of contingent value
jumped to almost 60% in 2019, substantially higher than in the previous two years.
This analysis also shows that the number of private takeouts has declined substantially over the past five years, both
in absolute terms and as a proportion of all deals. True, the venture-backed world is substantially better funded now,
making selling out less of a necessity. But viewed alongside a declining number of venture financings, the drop in
private transactions is a trend to keep an eye on.
Source: Evaluate® January 2020Time to exit (from established) for venture backed companies
Med
ian
time
to e
xit (
year
s)
8
10
12
6
4
2
14
0H1 2015 H2 2015 H1 2016 H2 2016 H1 2017 H2 2017 H1 2018 H2 2018 H1 2019 H2 2019
Median time to IPO
Median time to M&A
12 Copyright © 2020 Evaluate Ltd. All rights reserved.Biopharma venture financing retreats, but not by much
Source: Evaluate® January 2020Private takeout deals
Dea
l cou
nt
% o
f dea
ls w
ith c
ontin
gent
pay
men
ts
20
40
60
80
100
120
30%
40%
50%
20%
10%
60%
0
Number of private takeout deals (with terms disclosed)
% deals with contingent payments
Year2015
100
2016
64
2017
42
2018
42
2019
35
42
56
45
40
57
0
A more in-depth analysis of the venture financing climate for biopharma can be found here:
13 Copyright © 2020 Evaluate Ltd. All rights reserved.A big finish confirms 2019 as a takeover year to remember
A big finish confirms 2019 as a takeover year to remember
A long wished-for pick-up in company takeouts at the end of last year confirmed 2019 as a
bumper period for biopharma deal-making. EvaluatePharma calculates that global drug makers
spent $217.2bn on M&A deals, a touch below 2014’s record-breaking levels.
The table below illustrates just how much firepower was unleashed last year, relative to spending throughout the
decade, though the vast majority of the cash deployed in 2019 went on buying Celgene for $74bn and Allergan
for $63bn.
Source: Evaluate® January 2020A decade of biopharma M&A
Com
bine
d de
al v
alue
($bn
)
Dea
l cou
nt
20
40
60
80
120
100
140
160
180
200
220
240
260
280
280
300
120
100
140
180
160
200
260
240
220
80
40
60
20
0
Combined deal value ($bn)
Deal count
Year
2011
64.1
2012
48.4
2013
79.4
2014
219.5
2015
188.1
2016
94.3
2017
74.6
2018
147.4
2019
217.2
232224
234 236
299
207 203
179
153
0
An important point here is that this analysis incorporates various types of M&A deal. As well as company takeouts –
which accounted for around half of the transactions last year – minority and majority stake purchases, acquisitions of
business units, reverse mergers and option deals are also counted.
This should be remembered when looking at the total transaction volume, which has been declining since hitting a
peak in 2015, and currently sits at a low for the decade. This has been driven by a slump in these other types of
M&A deals – straight company takeouts have remained largely flat over the past couple of years.
14 Copyright © 2020 Evaluate Ltd. All rights reserved.A big finish confirms 2019 as a takeover year to remember
When looking specifically at straight company takeouts, below, the data reveal a rebound in mid-size deals in 2019,
to the highest level since 2015. Big pharma’s “sweet spot” will fall somewhere into here, although the ideal bolt-on
price will differ between companies.
Source: Evaluate® January 2020Pharma and biotech M&A transactions announced each quarter
Com
bine
d de
al v
alue
($bn
)
Dea
l cou
nt
30
20
10
40
50
60
70
80
90
100
110
70
80
20
10
30
60
50
40
0
Combined deal value ($bn)
Deal count
2016 2017 2018 2019
Q1
44.6
Q2
22.8
Q3
17.4
Q4
9.5
Q1
40.3
Q2
4.3
Q3
20.1
Q4
9.8
Q1
38.4
Q2
90.4
Q3
7.8
Q4
10.8
Q1
92.1
Q2
82.4
Q3
11.2
Q4
31.5
60
47
53
47
74
34
44
51
47
43 4346
43
31
39 40
Shire – Baxalta: $32bn
J&J – Actelion: $30bn
Abbvie –Allergan: $63bn
Takeda – Shire:$64bn
Bristol-Myers Squibb –Celgene: $74bn
0
2015 2016 2017 2018 2019
$0-500m 87 54 45 47 33
$500m-1bn 10 15 9 9 12
$1-15bn 20 14 8 13 17
$15-30bn 2 0 0 0 0
$30bn+ 0 1 1 1 2
All 119 84 63 70 64
Biopharma company takeouts, by size bracket Source: Evaluate® January 2020
Meanwhile, last year premiums climbed to the highest point since at least 2015, with research-stage companies
commanding particularly high prices.
Premiums can be considered as a proxy for the level of competition for assets, and a look at the following analyses
suggests that last year acquirers were fighting over some of these deals. The median takeout premium for a
research-stage drug developer reached 97% in 2019, the highest level for at least five years.
15 Copyright © 2020 Evaluate Ltd. All rights reserved.A big finish confirms 2019 as a takeover year to remember
That 97% median premium was derived from 28 transactions, almost double the number of research-stage buyouts
that happened in 2015.
Source: Evaluate® January 2020Median takeout premiums
Med
ian
take
out p
rem
ium
s
50%
60%
80%
70%
90%
40%
30%
20%
10%
100%
02015 2016 2017 2018 2019
All deals
Research-stage targets
A more detailed analysis of this M&A data can be found here:
16 Copyright © 2020 Evaluate Ltd. All rights reserved.Cash-rich biotechs turn down the licensing deal volume
Cash-rich biotechs turn down the licensing deal volume
Another big area of deal making for biopharma is the licensing deal market and, echoing the
decline being seen in straight company takeouts, activity has been fading over the past couple
of years.
When cash is easy to come by, young drug makers can keep their options open, and this is one likely reason for the
downward trends seen in both M&A and licensing.
The chart above looks at long-term trends in licensing deals between drug makers – it excludes medtech or
diagnostic collaborations – and counts only those transactions with a disclosed up-front fee. This analysis therefore
understates the real volume of licensing deals happening, though it should still reflect overall trends.
Using only deals with up-fronts allows a more rigorous look at trends – the “biobuck” total deal values cited are
rarely useful beyond headline fodder for press releases, and in most cases will go largely unpaid.
Up-front fees represent a real chunk of cash changing hands, and this analysis of EvaluatePharma data show that the
sector paid out $7.4bn in these initial payments over 118 deals last year. Both of these figures are five-year lows.
2.4
2.0
1.2
1.6
0.8
0.4
2.8
3.2
4.8
3.6
4.0
4.4
Source: Evaluate® January 2020Licensing deal up-fronts 2015-19
Com
bine
d up
-fro
nt v
alue
($bn
)
# in
-lice
nsin
g de
als
with
dis
clos
ed v
alue
60
55
50
45
40
35
30
25
20
15
10
5
0
Combined up-front value ($bn)
# in-licensing deals with disclosed value
2015
Q1 Q2 Q3 Q4
2016
Q1 Q2 Q3 Q4
2017
Q1 Q2 Q3 Q4
2018
Q1 Q2 Q3 Q4
2019
Q1 Q2 Q3 Q4
2.22
1.43
2.492.61
1.91
1.25
1.881.64 1.58
2.26
3.31
1.301.12
0
Year
1.090.90
3.18
1.94
58
29
38
48
35
44
3739
33 33
38
55
44
36
33
53
31 3132
24
3.63
3.16 2.99
17 Copyright © 2020 Evaluate Ltd. All rights reserved.Cash-rich biotechs turn down the licensing deal volume
Source: Evaluate® January 2020Mean in-licensing deal up-front
Mea
n up
-fro
nt ($
m)
60
80
120
100
140
40
20
160
02015 2016 2017 2018 2019
Preclinical/research project
Phase I
Phase II
Phase III
Source: Evaluate® January 2020Median in-licensing deal up-front
Med
ian
up-f
ront
($m
)
15
20
35
25
40
30
45
10
5
50
02015 2016 2017 2018 2019
Preclinical/research project
Phase I
Phase II
Phase III
A further analysis of these data shows that asset prices held up last year, however. Most notably, the average up-front
fee paid for a phase II asset surged to almost $140m, a more than five-year high.
Averages can, however, be skewed by outliers, though this jump at phase II can also be seen in the median values.
It is also revealing that phase III assets tend to attract lower prices than those at earlier clinical stages – hope
and hype are apparently much more effective tools to drive up price tags than later-stage data, which might
inconveniently reveal the true value of an asset.
18 Copyright © 2020 Evaluate Ltd. All rights reserved.Cash-rich biotechs turn down the licensing deal volume
Product (status on deal) Company Deal partner Up-front fee ($m)
Total deal value ($bn)
Enhertu (phase III) Astrazeneca Daiichi Sankyo 1,350 6.9
SRP-9001 (phase II) Roche Sarepta 750 2.9
Bintrafusp Alfa/M7824 (phase II) Glaxosmithkline Merck KGaA 339 4.2
AKCEA-ANGPTL3-LRx (phase II) Pfizer Akcea 250 1.6
DCR-HBVS (phase I) Roche Dicerna 200 1.7
Biggest research-stage licensing deals of 2019 Source: Evaluate® January 2020
A more in-depth analysis of licensing deal data can be found here:
19 Copyright © 2020 Evaluate Ltd. All rights reserved.Rare diseases top another strong year for novel drug approvals
Rare diseases top another strong year for novel drug approvals
It was not only a takeover spree that put the wind in biopharma’s sails towards the end of last
year – the FDA contributed with several surprisingly speedy approvals.
Average approval times in the breakthrough designation category improved markedly in 2019, to give the regulator
its best score since 2013; the 6.3-month mean is even more remarkable considering that in that year, when BTD
was first introduced, only three projects used this pathway. In 2019 the average was derived from the review of
15 projects.
Source: Evaluate® January 2020CBER+CDER average approval times
Ave
rage
rev
iew
tim
e (m
onth
s)
5
10
15
20
25
0
Standard
Breakthrough therapy
Priority review
Standard decade average
Priority review decade average
PDUFA IV PDUFA VIPDUFA V
2010(n=26)
2011(n=33)
2012(n=42)
2013(n=32)
2014(n=49)
2015(n=56)
2016(n=25)
2017(n=54)
2018(n=61)
2019(n=49)
Two of the class of 2019 – Trikafta and Enhertu – made it into the 10 fastest approval decisions since 2010. Behind
these agents there were plenty of other quick reviews last year, however: almost a quarter of 2019’s submissions
were approved in less than six months.
20 Copyright © 2020 Evaluate Ltd. All rights reserved.Rare diseases top another strong year for novel drug approvals
A look at the picture across the whole of 2019 confirms that the US drugs regulator remains one of the sector’s best
friends. Over the year the agency approved 49 novel medicines with a fifth-year sales potential of $27.1bn, according
to a Vantage analysis of EvaluatePharma data.
Nine drugs predicted to become future blockbusters launched last year, four of which are predicted to be bringing
in more $2bn in the US by 2024. As well as Trikafta, this includes two new arrivals for Abbvie: the psoriasis antibody
Skyrizi and the Jak inhibitor Rinvoq for RA.
Pfizer’s amyloidosis treatment Vyndaqel is also seen as having a hugely successful future, with 2024 sales of $2.5bn
pencilled in. This therapy and Trikafta both treat rare diseases and are prime examples of the sort of products that
biopharma is chasing right now: small, definable patient populations in which big price tags are accepted.
Product Year approved Status Months to approval
Blincyto 2014 Breakthrough therapy 2.5
Iclusig 2012 Priority review 2.6
Jevtana 2010 Priority review 2.6
Spinraza 2016 Priority review 3.0
Alecensa 2015 Priority review 3.1
Trikafta 2019 Breakthrough therapy 3.1
Xtandi 2012 Priority review 3.3
Kalydeco 2012 Priority review 3.5
Zelboraf 2011 Priority review 3.6
Enhertu 2019 Breakthrough therapy 3.7
Green light ahead: the fastest FDA decisions since 2010 Source: Evaluate® January 2020
21 Copyright © 2020 Evaluate Ltd. All rights reserved.Rare diseases top another strong year for novel drug approvals
Source: Evaluate® January 2020FDA approval count vs. 5th year US sales
US
sal
es 5
th y
ear
post
app
rova
l ($
bn)
Tota
l NM
Es +
bio
logi
cals
app
rove
d
5
10
15
20
25
35
30
60
50
40
30
20
10
0
US sales 5th year post approval ($bn)
Total NMEs + biologicals approved
Avg. number of annual approvals. 43
Year
2010 – Prevnar 13 (Pfizer), Victoza (Novo Nordisk), Prolia/Xgeva (Amgen)
2011 – Xarelto (J&J/Bayer), Eylea (Regeneron/Bayer)
2012 – Eliquis (Bristol-Myers Squibb/Pfizer), Stribild (Gilead)
2013 – Sovaldi (Gilead), Tecfidera (Biogen)
2014 – Opdivo (Bristol-Myers Squibb), Harvoni (Gilead)
2015 – Orkambi (Vertex), Ibrance (Pfizer)
2016 – Tecentriq (Roche), Epclusa (Gilead), Venclexta (Abbvie)
2017 – Ocrevus (Roche), Dupixent (Sanofi)
2018 – Biktarvy (Gilead), Epidiolex (GW Pharmaceuticals)
2019 – Vyndaqel (Pfizer), Skyrizi (AbbVie)
2019
27.1
2010
12.7
201 1
11.9
2012
12.9
2013
14.3
2014
25.8
2015
25.1
2016
10.0
2017
26
33
42
32
49
56
2018
27.5
25
54
33.5
61
49
0
A more in-depth analysis of FDA approval data can be found here:
Vantage MedTech 2019 in review
22 Copyright © 2020 Evaluate Ltd. All rights reserved.Big cap medtechs see out the decade in style
Big cap medtechs see out the decade in style
The good times continued to roll for big cap device makers last year. No group in this cohort –
those with a market cap of $10bn or more – endured a share price fall over the year.
These businesses have been aided by the general market atmosphere. The indices covering US-listed medtech
companies are up around 30% and, highly unusually, EU-listed healthcare groups seem to be equalling this performance.
Stock index % change in 2019
Thomson Reuters Europe Healthcare (EU) 26%
Dow Jones U.S. Medical Equipment Index 31%
S&P Composite 1500 HealthCare Equipment & Supplies 27%
Indices
The big-cap medtech cohort includes only companies that obtain more than 40% of their revenues from the sale of
diagnostic or therapeutic medical technology.
A sign of just how good 2019 was for the larger-scale device makers is that the worst-performing company still saw
a share price rise of 12%. The last time this analysis showed across-the-board stock rises was two years ago. But the
lowest rise that year was 7%, suggesting that 2019 was better still.
Share price 12-mth change
Market cap at Dec 31 ($bn)
Market cap 12-mth change ($bn)
Top 5 risers
Insulet ($) 116% 10.6 5.9
Olympus (¥)* 100% 21.4 5.9
Dexcom ($) 83% 20.0 9.4
Straumann (SFr) 54% 15.2 5.3
Edwards Lifesciences ($) 52% 48.7 16.6
Top 3 worst performers
Becton Dickinson ($) 12% 73.6 8.6
Varian Medical Systems ($) 15% 12.9 1.7
Siemens Healthineers (€) 17% 42.4 0.5
Large cap ($10bn+) medtech companies: top risers and fallers in 2019 Source: Evaluate® January 2020
* Olympus carried out a 4:1 stock split in April.
23 Copyright © 2020 Evaluate Ltd. All rights reserved.Big cap medtechs see out the decade in style
Lower down the size scale, new products and strategic execution buoyed mid and small-cap medtechs, and no
fewer than five mid-size medtech groups more than doubled in. But the mid-size cohort seems to be doing better
than the smaller groups, perhaps pointing to the inherent volatility at this end of the market.
Share price 12-mth change
Market cap at Dec 31 ($bn)
Market cap 12-mth change ($bn)
Top 5 risers
Novocure ($) 152% 7.8 4.7
Nevro ($) 202% 3.6 2.5
Natera ($) 141% 2.6 1.7
Sectra (SKr) 107% 1.5 0.8
El En (€) 161% 0.7 0.4
Top 5 fallers
Abiomed ($) (48%) 7.7 (6.9)
ICU Medical ($) (19%) 3.9 (0.8)
Merit Medical Systems ($) (44%) 1.7 (1.3)
Inogen ($) (45%) 1.5 (1.2)
Meridian Bioscience ($) (50%) 0.4 (0.4)
Other significant risers and fallers in 2019 (ranked on market cap) Source: Evaluate® January 2020
While the mid-cap device companies tended to sink or swim owing to technological successes or failures, the smaller
groups’ shareholders appear motivated for the most part by financial performance. For those wishing to invest in device
developers the big caps are still the safest bet – but the mid-cap range is where the greatest gains may be seen.
More in-depth analyses of medtech share price movements over 2019 can be found here:
24 Copyright © 2020 Evaluate Ltd. All rights reserved.A thoroughly average year for medtech mergers
A thoroughly average year for medtech mergers
Despite last year seeing the completion of no fewer than 13 transactions worth more than $1bn,
the medtech M&A landscape came nowhere near the heights reached in 2015 and 2017. Still,
at $49.5bn, the total value of all the deals closed at least showed an increase from the previous
year’s low total.
The number of deals also shrunk – to the lowest annual figure for more than a decade. With just 152 mergers and
acquisitions having closed last year the situation might soon become dire for small companies seeking a buyer.
And the M&A climate has clouded over recently, with the FTC forcing Illumina and PacBio to call off their megadeal.
2020 could be quieter still.
Source: Evaluate® January 2020Medtech M&As over the last decade – number and value of deals closed
Tota
l dea
l val
ue ($
bn)
Dea
l cou
nt
20
40
60
80
120
100
140
160
180
200
280
320
120
160
200
240
80
40
0
Total deal value ($bn)
Deal count
Year
2010
25.4
2011
59.6
2012
44.9
2013
23.3
2014
43.6
2015
128.2
2016
49.6
2017
98.6
2019
49.5
2018
29.0
274 278
247239
229
251263
212
152
213
0
The strong stock market performance of medtech players over 2019 will have played its part here. Valuations are
soaring, and many groups will now be prohibitively expensive to potential buyers. The consolidation of years past
will also have had consequences for 2019’s M&A scene. There are fewer exit opportunities simply because there
are fewer companies around to buy.
25 Copyright © 2020 Evaluate Ltd. All rights reserved.A thoroughly average year for medtech mergers
Deal-making activity is white-hot in a few areas, however. Robotic surgery companies are finally gearing up to compete
with Intuitive Surgical, and many larger groups, eager to avoid being left behind, have bought in similar technologies.
Many of the very largest deals were focused on hospital-based technologies, with makers of orthopaedic implants,
sterilisation products and IT systems being taken over. Perhaps the buyers here feel that there are efficiencies to be
had that will allow them to make a success of this low-margin segment.
Source: Evaluate® January 2020Medtech M&As by size – number of deals closed over the last decade
Num
ber
of d
eals
10
20
30
40
50
60
70
80
110
90
100
120
130
140
150
Year
Up to $100m
$100m-$1bn
$1bn plus
2010
5
38
91
2011
11
46
77
2012
6
40
76
2013
4
35
66
2014
8
47
60
2015
18
32
70
2016
12
33
67
2017
19
32
51
2018
8
42
43
2019
13
29
38
0
Note: only includes deals with known value.
26 Copyright © 2020 Evaluate Ltd. All rights reserved.A thoroughly average year for medtech mergers
Completion date
Acquirer Target Value ($bn) M&A focus
Oct 11 3M Acelity 6.7 Wound management
Apr 1 Johnson & Johnson Auris Health 5.8 Endoscopy; general & plastic surgery
Feb 11 Veritas Capital and Elliott Management
Athenahealth 5.7 General hospital & healthcare supply; healthcare IT
Aug 19 Boston Scientific BTG 4.2 Cardiology; general & plastic surgery; neurology; radiology
Feb 22 Colfax DJO Global 3.2 Orthopaedics; physical medicine
Apr 1 Fortive Advanced Sterilization Products business of J&J
2.8 Endoscopy; general hospital & healthcare supply
Nov 8 Exact Sciences Genomic Health 2.8 In vitro diagnostics
Feb 21 Fresenius Medical Care Nxstage Medical 2.0 Blood; nephrology
Aug 26 Agilent Technologies Biotek 1.2 In vitro diagnostics
Mar 31 Montagu Private Equity and Astorg
Nemera 1.2 Drug delivery
Top 10 deals closed in 2019 Source: Evaluate® January 2020
There is an argument to be made that 2020 could see an upswing in M&A. The markets might well be more skittish
in the run-up to the US presidential election, depressing valuations and making acquisitions of listed groups likelier,
though it should be remembered that medtech is generally less prey to wider market volatility than biopharma.
A more in-depth analysis of medtech M&A activity over 2019 can be found here:
27 Copyright © 2020 Evaluate Ltd. All rights reserved.How low can medtech venture investment go?
How low can medtech venture investment go?
Private medical device companies raised a respectable amount of venture cash in 2019 – just
shy of $5bn – but an analysis of trends over the past decade shows a steady decline in the
number of deals done each year.
That said, the top 10 deals of 2019 comprise only 40% of the cash that flowed into the sector; last year’s leaderboard
made up more than half of the total raised. Perhaps the climate for smaller, younger companies seeking growth
capital might be improving, if only slowly.
100
80
Source: Evaluate® January 2020Medtech VC investment, 2014-2019
Inve
stm
ent (
$m
)
Fina
ncin
g co
unt
1,200
800
400
2,400
2,800
2,000
1,600
3,200 140
120
60
40
20
0
Investment ($m)
Financing count
Year
2014
Q1
903
Q2
1,436
Q3 Q4
2015
Q1
1,055
Q2 Q3
1,374
Q4
1,027
2016
Q1
1,432
Q2
983
Q3
993
Q4
2017
Q1
2,87
0
Q2
1,478
Q3 Q4
2018 2019
Q1 Q2 Q3 Q4
1,408
956
1,707
2,07
3
Q1 Q2 Q3 Q4
1,086
81197
8
2,02
5
891
1,581
9621,1
02 1,255
1,517
114
128
112107
116
75
89 90
76
89
80
104
78
67
48
60
71
58
114
56
45
55
5046
0
Excluding Verily’s monster $1bn round, the other $4bn raised in 2019 was doled out to just 195 companies, meaning
that the average size of these rounds, $24.9m, has barely decreased from last year’s bloated figure.
VCs still prefer to minimise their risk, and there are several ways of doing this. One is to build huge syndicates.
Another is to wait until a target company has gained not only approval for its technology but reimbursement too.
28 Copyright © 2020 Evaluate Ltd. All rights reserved.How low can medtech venture investment go?
Date Round Company Investment ($m) Focus
Jan 3 Undisclosed Verily Life Sciences 1,000 Diabetic care; ophthalmics; patient monitoring
Sep 17 Series C CMR Surgical 240 General & plastic surgery
Jul 24 Series B Freenome 160 In vitro diagnostics
May 19 Series A Thrive Earlier Detection 110 In vitro diagnostics
Jun 20 Series D Acutus Medical 100 Cardiology
Dec 3 Series D Impulse Dynamics 80 Cardiology
Feb 11 Series E Nuvaira 79 Anaesthesia & respiratory
Jan 3 Series D Ablative Solutions 77 Cardiology
Jan 4 Undisclosed Sophia Genetics 77 Healthcare IT
Jun 28 Undisclosed Saluda Medical 75 Neurology
Top 10 VC rounds of 2019 Source: Evaluate® January 2020
The top 10 may be sucking up a smaller proportion of the total funding than in years past, but there is no denying the
declining number of deals done each year. A look at this trend over the 2010s shows a peak in 2013, with 489 VC
rounds raised by device makers. This number has shrunk every year since.
If this trend continues at the same rate of decline the situation will become extremely parlous by 2022 or 2023.
A more in-depth analysis of medtech VC activity over 2019 can be found here:
100
200
300
400
500
0
Source: Evaluate® January 2020A decade of decline – annual medtech VC deals
Fina
ncin
g co
unt
600
Year
2010
448
2011
517
2012
422
2013
489
2014
468
2015
387
2016
335
2017
297
2018
244
2019
196
29 Copyright © 2020 Evaluate Ltd. All rights reserved.Poor fourth quarter mars strong year for medtech floats
Poor fourth quarter mars strong year for medtech floats
The device sector enjoyed a mid-year IPO bonanza, and the amount raised by the 15 groups
that went public in 2019 is impressive, at $2.5bn. After floating, however, the class of 2019
had a torrid time. Seven of the 13 listing companies have seen their valuations wither, and the
dental group Smiledirectclub, which conducted 2019’s largest flotation, has been the worst
performer of all.
The middle of 2019 was astonishingly strong when it comes to the sheer amount of money raised on the public
markets by medical device companies. The graph below excludes the multibillion-dollar IPOs of Convatec and
Siemens Healthineers in 2016 and 2018 respectively, as well as Smiledirectclub’s $1.3bn offering in September,
so as to give a fairer picture of underlying trends.
Source: Evaluate® January 2020Medtech IPOs, 2014-2019
Tota
l dea
l val
ue ($
m)
Dea
l cou
nt
600
500
400
300
200
100
900
1,100
1,000
800
700
1,200
Total deal value ($m)
Deal count
Year
2014
Q1
293
Q2
652
Q3 Q4
2015
Q1
208
Q2 Q3
480
Q4
172
2016
Q1
48
Q2
57
Q3
93
Q4
2017
Q1
25
Q2
86
Q3 Q4
2018 2019
Q1 Q2 Q3 Q4
259
695
376
264
Q1 Q2 Q3 Q4
1,076
108
1,183
152
123
7
208
278
384
306
6
5
4
3
2
1
9
11
10
8
7
12
0
12
6
7
5
8
5
3
2
4
2
4
1
5
1
3
6
8
5
8
3
5
10
2
5
0
Broadly those companies that went out on US exchanges did better than those in the rest of the world, and only
three of the 10 US-based offerings lost money.
30 Copyright © 2020 Evaluate Ltd. All rights reserved.Poor fourth quarter mars strong year for medtech floats
Overall, the 2019 data show an obvious, and potentially worrying, pattern. Both the top 10 table and the quarterly
analysis show a definite shrinking of investor appetite going into the third quarter. The fourth quarter’s two offerings
were small – less than $60m – but still had to be priced below their initially proposed ranges to get away, and both fell
again once trading commenced. Almost all the groups that listed in spring and summer were able to charge a premium.
If the window of opportunity is swinging shut, 2020 could be a difficult year for medtechs in search of capital.
Date Company Focus Amount raised ($m)
Discount/ premium Share price change to year end
Sep 12 Smiledirectclub Dental 1,300 12% (62%)
Sep 18 Envista* Dental 589 (2%) 35%
Apr 4 Medacta Group** Neurology; orthopaedics 588 8% (30%)
Jul 26 Livongo Diabetic care; patient monitoring 355 30% (11%)
Jun 27 Adaptive Biotechnologies In vitro diagnostics 345 25% 50%
Apr 4 Silk Road Medical Cardiology; neurology 120 25% 25%
Mar 7 Shockwave Medical Cardiology 111 13% 158%
May 2 Transmedics Surgery 105 0% 19%
Jul 26 Castle Biosciences In vitro diagnostics 74 7% 115%
Sep 20 Exagen In vitro diagnostics 58 (7%) 81%
Top 10 medtech IPOs of 2019 Source: Evaluate® January 2020
* IPO on the NYSE. ** IPO on Six Swiss exchange. All others are Nasdaq.
A more in-depth analysis of medtech IPO activity over 2019 can be found here:
31 Copyright © 2020 Evaluate Ltd. All rights reserved.A quiet six months for device approvals
A quiet six months for device approvals
Increased scrutiny of high risk devices following several well-publicised cases of patient harm
could be one possible reason behind the sharp drop in the rate of FDA approvals of these
types of product in the second half of 2019, as opposed to the first. But this does not explain the
equally precipitous fall in low-risk device clearances, a marked contrast to the figures in 2018.
At the half-year point, 23 innovative high-risk devices had been approved, but the second half of last year saw only
12 premarket approvals and humanitarian device exemptions – the regulatory paths taken by high-risk medical
technologies. At 35, across all of 2019 the total approvals for this class of device was the same as in 2018.
Source: Evaluate® January 2020Medtech approvals over the last decade
Num
ber
of F
DA
app
rova
ls
10
20
30
40
50
60
0
Year
Number of de novos
Number of PMAs/HDEs
2010 2011 2012
3
22
10
44
13
41
2013
18
23
2014
28
33
2015
18
51
2016
26
40
2017
31
50
2018
44
35
2019
22
35
The most obvious factor that might have acted as a brake on the agency’s activity was the furore surrounding
the Implant Files investigation in November 2018. This highlighted several cases of neglectfully designed and
manufactured medical devices, including pacemakers, contraceptive implants and surgical meshes.
This might have prompted the agency to be more circumspect when considering whether to approve high-risk
products or companies more cautious in submitting approval requests.
32 Copyright © 2020 Evaluate Ltd. All rights reserved.A quiet six months for device approvals
The big drop in de novo clearances is harder to explain. Most implanted devices cannot use this pathway so the
Implant Files could only have had a minimal effect.
EvaluateMedTech classification No of PMAs & HDEs Average approval time (mths)
Cardiology 12 13.0
In vitro diagnostics 7 7.2
Orthopaedics 7 18.2
Neurology 3 10.8
Urology 2 8.7
Ear, nose & throat 1 5.9
Obstetrics & gynaecology 1 7.5
Gastroenterology 1 9.2
Anaesthesia & respiratory 1 11.5
Overall 35 12.0
EvaluateMedTech classification Number of de novos Average approval time (mths)
In vitro diagnostics 7 9.8
Neurology 5 10.5
Gastroenterology 2 8.4
Diabetic care 2 4.3
Anaesthesia & Respiratory 1 18.8
Wound Management 1 13.2
Orthopaedics 1 12.5
Endoscopy 1 12.0
Blood 1 11.3
Cardiology 1 10.3
Overall 22 10.2
2019’s PMAs and HDEs by therapy area Source: Evaluate® January 2020
2019’s de novos by therapy area Source: Evaluate® January 2020
A silver lining to this data is that though there are fewer approvals, those that have been granted came through
relatively swiftly. Last year the FDA took an average of 15 months to approve high-risk novel products and 13 months
for low-risk; both of these figures have fallen.
A more in-depth analysis of medtech approval trends over 2019 can be found here:
33 Copyright © 2020 Evaluate Ltd. All rights reserved.Vantage Pharma, Biotech and Medtech 2019 in review
Outlook for 2020
The main driver of caution heading into 2020 was the potential fallout from US presidential election campaigns,
and while the biopharma sector has avoided too much scrutiny so far, this could easily change. The identity of the
final Democratic candidate, and their chance of beating the incumbent, represent important unknowns for drug
developers and their investors.
Outside of this, many of the trends that buoyed pharma and biotech companies in 2019 look set to continue. The
FDA in particular shows no sign of deviating from its lenient ways, and a major test of this stance, the review of
Biogen’s Alzheimer’s disease project aducanumab, is one of the biggest events facing the sector in the coming
months. The outcome of this review will help set sentiment for the remainder of the year.
The drop in device approvals in the second half of 2019 is a worry for that sector. With a rubber-stamp for regulators
increasingly regarded as a validation of a company’s technology, the shortfall could mean fewer VC rounds,
acquisitions and IPOs in the coming year.
Fortunately there is reason to suspect FDA activity might ramp up in 2020. A number of larger medtechs, Medtronic
among them, are aiming to bring a suite of new products to market in 2020, so next year’s device approval figures
could be very different.
For signs of how 2020 might go, investors will also be watching how the M&A markets develop. With several larger
pharma groups under pressure to restock pipelines, there should be no shortage of active deal makers out there.
But the first quarter has been remarkably quiet – perhaps understandable after a busy end to 2019 – and
nervousness will increase should deal-making activity not start to pick up soon. With only one medtech megamerger
yet to close there is no indication that we are heading into bumper year for medtech M&A, either.
These factors could weigh against the medtech VC climate staying strong. That said, there are early signs that then
venture financing landscape in 2020 might ape that of 2019. Certainly the first quarter is off to a strong start, with four
VC rounds topping $80m in the first five weeks of the year. At least one of these might well make the top 10 of 2020;
with luck, there will be smaller sums for start-up companies, too.
An important question for both medtech and biopharma is whether the well-funded smaller ends of these sectors can
be persuaded to sell up at acceptable levels.
Unless stated, all data are sourced to Evaluate and were accessed in January 2020
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