Immutep has entered into a clinical trial collaboration and supply agreement with Merck/Pfizer to investigate the combination of its APC activator eftilagimod alpha (efti) with avelumab in patients with advanced solid tumors. Avelumab is the big pharma pair’s investigational anti-PD-L1 immune checkpoint inhibitor (ICI). We view the additional validation from big pharma is as a very positive development for Immutep, which could bring the added bonus of early identification of additional target indications. We maintain our valuation at $387m or $12.80/ADR.
Written by
Immutep |
A second big pharma collaboration for efti |
Merck/Pfizer collaboration |
Pharma & biotech |
27 September 2018 |
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Immutep has entered into a clinical trial collaboration and supply agreement with Merck/Pfizer to investigate the combination of its APC activator eftilagimod alpha (efti) with avelumab in patients with advanced solid tumors. Avelumab is the big pharma pair’s investigational anti-PD-L1 immune checkpoint inhibitor (ICI). We view the additional validation from big pharma is as a very positive development for Immutep, which could bring the added bonus of early identification of additional target indications. We maintain our valuation at $387m or $12.80/ADR.
Year end |
Revenue (US$m) |
PTP |
EPADR |
DPADR |
P/E |
Gross yield |
06/17 |
3.1 |
(6.4) |
(0.28) |
0.0 |
N/A |
N/A |
06/18 |
5.2 |
(8.3) |
(0.40) |
0.0 |
N/A |
N/A |
06/19e |
8.3 |
(5.2) |
(0.17) |
0.0 |
N/A |
N/A |
06/20e |
2.1 |
(11.3) |
(0.37) |
0.0 |
N/A |
N/A |
Note: Converted at A$1/US$0.76 for the table above and throughout the note.
Additional validation from big pharma
Immutep already has an ongoing clinical trial collaboration with the US-based Merck and Company (known as MSD outside the US), which is totally separate from Merck KGaA, including the TACTI-mel and TACTI-002 studies. It now has the additional validation of having a second big pharma team review the efti data and conclude that there is a potentially meaningful benefit from efti/ICI combination therapy. The encouraging results from the first three TACTI-mel cohorts included a 33% response rate from the start of efti/Keytruda combination therapy and 61% response rate from the start of the Keytruda monotherapy screening period.
Avelumab combination to be added to INSIGHT trial
The study of avelumab plus subcutaneous (SC) efti in patients with a range of advanced solid tumors will be included as an arm of the INSIGHT study (NCT03252938), which is underway at a single site in Germany. The combination would fit neatly into INSIGHT, which already includes arms investigating intra-tumoral and intraperitoneal administration of efti, as well as a third arm investigating SC efti in combination with chemo in solid tumors. This strategy should allow the efti/avelumab combination study to start before the end of CY18.
Competitive tension a potential added bonus
Having a deep level of engagement with two big pharma companies (or three counting Pfizer) could bring the added bonus of increased competitive tension when the time comes to negotiate a partnership deal for efti.
Valuation: Unchanged at $387m, $12.80 per ADR
Our valuation is unchanged at $387m, $12.80/ADR (undiluted), or $9.08/ADR after diluting for options and convertible notes. Our valuation includes a modest allowance for expansion of efti indications beyond the ongoing studies in breast, head and neck, melanoma and lung cancers. Gross cash at 30 June was $17.8m. We assume Immutep will receive a risk-adjusted $6m IMP731 milestone payment from GSK in FY19, which would extend its cash reach to the end of FY20.
Exhibit 1: Financial summary
|
US$000s |
2016 |
2017 |
2018 |
2019e |
2020e |
|
Year end 30 June |
IFRS |
IFRS |
IFRS |
IFRS |
IFRS |
||
PROFIT & LOSS |
|||||||
Revenue |
|
|
1,481 |
3,129 |
5,209 |
8,283 |
2,111 |
Cost of Sales |
(5,365) |
(5,720) |
(7,592) |
(8,352) |
(7,935) |
||
Gross Profit |
(5,307) |
(3,304) |
(5,504) |
(5,669) |
(5,839) |
||
EBITDA |
|
|
(9,191) |
(5,895) |
(8,691) |
(5,739) |
(11,662) |
Operating Profit (before GW and except.) |
|
(9,329) |
(5,905) |
(8,699) |
(5,741) |
(11,666) |
|
Intangible Amortization |
(1,515) |
(1,283) |
(1,367) |
(1,254) |
(1,141) |
||
Exceptionals |
(36,076) |
0 |
0 |
0 |
0 |
||
Operating Profit |
(46,920) |
(7,188) |
(10,065) |
(6,995) |
(12,807) |
||
Other |
(1,304) |
(571) |
245 |
0 |
0 |
||
Net Interest |
194 |
79 |
135 |
535 |
379 |
||
Profit Before Tax (norm) |
|
|
(10,439) |
(6,397) |
(8,319) |
(5,206) |
(11,287) |
Profit Before Tax (IFRS) |
|
|
(48,029) |
(7,680) |
(9,686) |
(6,460) |
(12,428) |
Tax |
898 |
560 |
(1) |
0 |
0 |
||
Profit After Tax (norm) |
(9,541) |
(5,837) |
(8,320) |
(5,206) |
(11,287) |
||
Profit After Tax (IFRS) |
(47,132) |
(7,119) |
(9,687) |
(6,460) |
(12,428) |
||
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
|||
Average Number of Shares Outstanding (m) |
2,016.6 |
2,072.5 |
2,079.7 |
3,026.1 |
3,026.1 |
||
Average Number of ADRs Outstanding (m) |
20.2 |
20.7 |
20.8 |
30.3 |
30.3 |
||
EPS - normalized (c) |
|
|
(0.5) |
(0.3) |
(0.4) |
(0.2) |
(0.4) |
EPS - IFRS (c) |
|
|
(2.3) |
(0.3) |
(0.5) |
(0.2) |
(0.4) |
Dividend per share (c) |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
||
Earnings per ADR - normalized ($) |
(47.3) |
(28.2) |
(40.0) |
(17.2) |
(37.3) |
||
Earnings per ADR - IFRS (c) |
(233.7) |
(34.4) |
(46.6) |
(21.3) |
(41.1) |
||
Dividend per ADR (c) |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
||
Gross Margin (%) |
N/A |
N/A |
N/A |
N/A |
N/A |
||
EBITDA Margin (%) |
N/A |
N/A |
N/A |
N/A |
N/A |
||
Operating Margin (before GW and except.) (%) |
N/A |
N/A |
N/A |
N/A |
N/A |
||
BALANCE SHEET |
|||||||
Fixed Assets |
|
|
15,871 |
14,474 |
13,950 |
12,704 |
11,569 |
Intangible Assets |
15,847 |
14,455 |
13,930 |
12,676 |
11,536 |
||
Tangible Assets |
24 |
18 |
20 |
27 |
34 |
||
Other |
0 |
0 |
0 |
0 |
0 |
||
Current Assets |
|
|
16,470 |
12,099 |
21,769 |
16,556 |
5,262 |
Stocks |
0 |
0 |
0 |
0 |
0 |
||
Debtors |
128 |
1,667 |
2,608 |
2,608 |
2,608 |
||
Cash |
15,868 |
9,300 |
17,841 |
12,628 |
1,335 |
||
Other |
473 |
1,131 |
1,319 |
1,319 |
1,319 |
||
Current Liabilities |
|
|
(1,119) |
(2,001) |
(2,929) |
(2,929) |
(2,929) |
Creditors |
(1,098) |
(1,967) |
(2,785) |
(2,785) |
(2,785) |
||
Short term borrowings |
(0) |
(0) |
0 |
0 |
0 |
||
Short term leases |
0 |
0 |
0 |
0 |
0 |
||
Other |
(21) |
(33) |
(144) |
(144) |
(144) |
||
Long Term Liabilities |
|
|
(4,381) |
(4,408) |
(7,314) |
(7,314) |
(7,314) |
Long term borrowings incl. conv. note |
(3,821) |
(4,392) |
(5,051) |
(5,051) |
(5,051) |
||
Long term leases |
0 |
0 |
0 |
0 |
0 |
||
Other long term liabilities |
(560) |
(16) |
(2,263) |
(2,263) |
(2,263) |
||
Net Assets |
|
|
26,841 |
20,164 |
25,477 |
19,017 |
6,589 |
CASH FLOW |
|||||||
Operating Cash Flow |
|
|
(8,811) |
(6,544) |
(6,045) |
(5,739) |
(11,662) |
Net Interest |
216 |
79 |
135 |
535 |
379 |
||
Tax |
0 |
0 |
0 |
0 |
0 |
||
Capex |
(21) |
(5) |
(9) |
(9) |
(10) |
||
Acquisitions/disposals |
99 |
0 |
0 |
0 |
0 |
||
Financing |
20,694 |
(6) |
14,363 |
0 |
0 |
||
Dividends |
0 |
0 |
0 |
0 |
0 |
||
Other |
0 |
0 |
(375) |
0 |
0 |
||
Net Cash Flow |
12,176 |
(6,477) |
8,068 |
(5,213) |
(11,294) |
||
Opening net debt/(cash) |
|
|
(3,991) |
(12,047) |
(4,908) |
(12,791) |
(7,578) |
HP finance leases initiated |
0 |
0 |
0 |
0 |
0 |
||
Other |
(4,120) |
(663) |
(185) |
0 |
0 |
||
Closing net debt/(cash) |
|
|
(12,047) |
(4,908) |
(12,791) |
(7,578) |
3,716 |
Source: Immutep accounts, Edison Investment Research. Note: Solely for the convenience of the reader the financial summary table has been converted to US$ at a rate of US$0.76 to A$1. Immutep reports statutory accounts in Australian dollars. These translations should not be considered representations that any such amounts have been or could be converted into US dollars at the assumed conversion rate.
|
|
Immutep has entered into a clinical trial collaboration and supply agreement with Merck/Pfizer to investigate the combination of its APC activator eftilagimod alpha (efti) with avelumab in patients with advanced solid tumours. Avelumab is the big pharma pair’s investigational anti-PD-L1 immune checkpoint inhibitor (ICI). We view the additional validation from big pharma is as a very positive development for Immutep, which could bring the added bonus of early identification of additional target indications. We maintain our valuation at A$510m or A$0.17/share.