SIGA Technologies — Second quarter as expected, onward to H223

SIGA Technologies (NASDAQ: SIGA)

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Research: Healthcare

SIGA Technologies — Second quarter as expected, onward to H223

SIGA has reported Q223 results, which came in largely as expected, and management has provided key operational highlights. Activity in the second half of the year has started to firm up with upcoming TPOXX deliveries (for H223) and better-than-expected international orders (offsetting IV orders that will likely be received in FY24). We maintain our FY23 product revenue estimate of $155m and note H223 management sales guidance of $143–158m. We await further clarity on PEP immunogenicity trials, which we believe are the next material catalyst. As we incorporate the reported quarterly results and slight shift in revenue mix for the balance of the year, our valuation adjusts to $1.24bn or $17.46 per share (vs $1.25bn or $17.53 per share previously).

Written by

Arron Aatkar

Associate analyst

Healthcare

SIGA Technologies

Second quarter as expected, onward to H223

H123 results update

Pharma and biotech

10 August 2023

Price

US$5.6

Market cap

US$398m

Net cash (US$m) at 30 June 2023

76.2

Shares in issue

71.1m

Free float

56%

Code

SIGA

Primary exchange

Nasdaq

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

10.2

(5.7)

(76.3)

Rel (local)

8.5

(13.1)

(78.1)

52-week high/low

US$26.2

US$4.8

Business description

SIGA Technologies is a commercial-stage health security company focused on the treatment of smallpox and other orthopoxvirus. It has contracts with both the US and Canadian governments for TPOXX, its treatment for smallpox, and is expanding internationally.

Next events

Q223 results

November 2023

Analysts

Arron Aatkar, PhD

+44 (0)20 3077 5700

Nidhi Singh

+44 (0)20 3077 5700

Jitisha Malhotra

+44 (0)20 3077 5700

SIGA Technologies is a research client of Edison Investment Research Limited

SIGA has reported Q223 results, which came in largely as expected, and management has provided key operational highlights. Activity in the second half of the year has started to firm up with upcoming TPOXX deliveries (for H223) and better-than-expected international orders (offsetting IV orders that will likely be received in FY24). We maintain our FY23 product revenue estimate of $155m and note H223 management sales guidance of $143–158m. We await further clarity on PEP immunogenicity trials, which we believe are the next material catalyst. As we incorporate the reported quarterly results and slight shift in revenue mix for the balance of the year, our valuation adjusts to $1.24bn or $17.46 per share (vs $1.25bn or $17.53 per share previously).

Year end

Revenue
(US$m)

EBITDA*
(US$m)

PBT*
(US$m)

EPS*
(US$)

P/E
(x)

Net cash*
(US$m)

12/21

133.7

89.6

89.1

0.91

6.1

103.1

12/22

110.8

43.2

43.7

0.46

12.2

98.8

12/23e

175.2

100.5

102.4

1.10

5.1

115.3

12/24e

181.0

102.3

104.7

1.17

4.8

171.0

Note: *EBITDA, PBT and EPS (diluted) are normalized, excluding amortization of acquired intangibles, exceptional items and share-based payments.

BARDA deliveries to drive H223

In Q223, SIGA reported $5.9m in revenue (vs $16.7m in Q222), consisting of international orders of $1.3m and R&D-related revenues of $4.6m. We expect FY23 revenue will be largely weighted to H223 (vs $14.2m total in H123). Specifically, H223 sales are expected to be driven by US domestic deliveries of oral TPOXX to the US strategic national stockpile (SNS), IV TPOXX deliveries to the SNS and oral TPOXX to the US Department of Defense (DoD). We also expect $16m from international orders, which has further upside potential that is currently not reflected in our estimates as government orders are often challenging to time.

PEP remains a key growth catalyst

While the expanded safety trial under the PEP label expansion program demonstrated positive results, SIGA is conducting a detailed review of the preliminary data from the immunogenicity trial in combination with the JYNNEOS vaccine. The initial analysis indicated a lower number of patients than expected recording measurable immune response to JYNNEOS vaccine in both placebo and TPOXX treated groups and requires further review. We look forward to incremental details on this front in the second half, as the PEP label expansion presents the most material (potential) upside opportunity, in our opinion.

Valuation: Adjusts to $17.46 per share

Based on the quarterly results, including updated net cash balance ($76.2m), lower share count (71.1m vs 71.3m previously) and slight mix adjustments, our valuation for SIGA adjusts to $1.24bn or $17.46 per share (vs $1.25bn or $17.53 per share previously).

Financials

SIGA reported Q2 revenues of $5.9m, consisting of $1.3m in product sales and $4.6m in R&D related revenues. Product sales ($1.3m) were related to incremental international orders from a European country and lower than the $8.6m product sales in Q222 (mainly comprised of oral TPOXX delivery to the US DoD of $3.6m and to international entities of $5.0m). As a reminder, the timing of government orders and deliveries often fluctuates and gives rise to variations in comparisons over periods. R&D-related revenue decreased to $4.6m in Q223 (vs $8.1m in Q222) due to the timing of clinical trial activity during the quarter.

Gross profit on product sales for the period stood at $0.3m in Q223 versus $7.7m in Q222, mainly reflecting manufacturing cost related to lower oral TPOXX deliveries during the quarter as compared to higher TPOXX deliveries in Q222. R&D expenses decreased to $5.1m in Q223 from $6.8m (Q222) due to lower vendor-related expenses associated with lesser clinical activities for the PEP label expansion study and BARDA contract, which was partially offset by higher regulatory fees related to the EMA regulatory submissions. SG&A expenses decreased 24.7% y-o-y to $4.4m, primarily due to reduced promotional fees related to lower international sales during the quarter. The company recorded an operating loss of $4.6m (Q223) compared to an operating profit of $3.0m in Q222. Net loss stood at $2.9m in Q223 versus a net profit of $2.0m in Q222.

Management has provided H223 revenue guidance of between $143m and $158m, including $113m from oral stockpile TPOXX deliveries under the BARDA 19C contract and roughly $30–45m through a combination of domestic and international deliveries, including IV TPOXX delivery to the US SNS and oral TPOXX delivery to US DoD.

Based on Q223 performance and increased visibility on upcoming contractual obligations, we have adjusted the mix but our overall FY23 and FY24 revenue forecasts remain unchanged at $175.2m and $181.0m, respectively. We have adjusted the revenue mix slightly to reflect stronger international revenues and slightly later recognition of IV TPOXX revenues. Within our product-related revenue estimate of $154.7m in FY23, we continue to estimate oral TPOXX deliveries of $112.5m for BARDA and $10.7m for the US DoD ($5.6m pending deliveries for H223) in the year. However, we expect FY23 IV TPOXX sales of $16m (vs $26m previously), with the remaining $10m now expected to be delivered in FY24 (of the total $26m in IV sales anticipated in FY23 previously). We expect this to be offset by higher than previously anticipated international oral TPOXX orders of $16m in FY23 ($5m previously). Discussions with international governments are ongoing and we anticipate there could be further upside.

For FY24, our overall product-related revenue estimates remained unchanged at $160.3m. However, the IV TPOXX delivery mix is anticipated to shift and we now expect it to consist of IV TPOXX deliveries of $10m from the August 2022 order (pushed out to FY24 with recognition from FY23) and $16m from the latest July 2023 order. The July 2023 IV TPOXX order was for $25m in totat and we expect the remaining $9m to be delivered in FY25.

We note that IV TPOXX is a lower-margin business with a gross margin of c 35% unlike oral TPOXX with c 85% margin, hence, the increased oral TPOXX order estimates from international markets and later timing of IV TPOXX deliveries to FY24 led to a reduction in our COGS estimates for FY23 ($28.4m vs $34.4m previously). While our R&D estimates remain unchanged for both FY23 and FY24 at $22.8m and $23.0m, respectively, our SG&A estimates in FY23 increase to $24.1m ($21.4m previously) to incorporate additional promotional fees from international sales. FY24 SG&A estimates remain unchanged. Incorporating the above-mentioned changes, our operating profit estimates for FY23 and FY24 now stand at $100.0m ($96.7m previously) and $101.8m (unchanged), respectively. After adjusting our interest rate expectations on net cash, our revised net income estimates are $77.8m and $79.6m, up from previous estimates of $73.5m and $77.4m, respectively.

Anticipate PEP update in Q323

Under its PEP label expansion program, SIGA has two ongoing clinical trials for oral TPOXX in smallpox treatment. Of the two clinical trials, one is an expanded safety study, with nine clinical sites in the United States. During the quarter, the company received clinical results from the study, which do not indicate any drug-related serious adverse events, hence, it successfully clears this stage. The second study is the TPOXX plus JYNNEOS immunogenicity trial, which is a supplemental study to compare the enrolled patients’ immune response between the two groups: one with JYNNEOS smallpox vaccine and placebo and second with JYNNEOS vaccine while on TPOXX treatment. In the preliminary analysis of the trial data, the company did not observe any meaningful difference in immunogenicity between the two groups, which is in line with management’s expectation. However, the number of responders with measurable immune response to JYNNEOS vaccine in both groups were lower than expected. Therefore, the company is conducting further review of the preliminary data and plans to provide a further update during Q323 results.

We note that PEP label expansion presents an important growth catalyst, with potential for an expansion of the US stockpile expansion opportunity (over the next few years). As a reminder, an infected individual would usually receive a 14-day course of TPOXX treatment, whereas an individual at risk of exposure (but not showing symptoms) would receive a PEP treatment (over 28 days), hence, this might double the order potential from 1.7m to 3.4m doses. We do not anticipate this delay to impact our probability or estimates for the PEP opportunity.

Valuation

We value SIGA on a risk-adjusted NPV basis for its various programs and contracts, forecasting to the end of the patent life in each geography. The aforementioned changes to our estimates, rolling forward our model and incorporating the new net cash figure has resulted in a slightly adjustment to our SIGA valuation to $1.24bn or $17.46 per share from $1.25bn or $17.53 per share previously. With a net cash balance of $76.2m and strong second half pipeline, we believe SIGA is adequately funded to support its clinical and market expansion plans.

We would like to highlight that SIGA has paid a special dividend of $0.45/share in H123 (totalling $32.0m), which translates into a payout ratio of c 42% of our projected FY23 net income of $76.2m. Additionally, SIGA continued share buybacks worth $11.0m in H123, indicating evidence of returning capital to shareholders.

Exhibit 1: SIGA’s valuation

Product/program

Main indication

Status

Probability of Success

Approval/Launch/
First Contract year

Peak sales ($m)

rNPV ($m)

TPOXX (US base - Oral)

Treatment of smallpox

On market

100%

2018

123

363

TPOXX (Canada)

Treatment of smallpox

On market

100%

2020

19

49

TPOXX US IV and pediatric formulations

Treatment of smallpox

IV (NDA approved May 2022), pediatric (being formulated)

60–100%

2022-2025

30

27

TPOXX US PEP

Post-exposure prophylaxis following exposure to smallpox

Development

50%

2025

128

234

TPOXX EU, Japan, Korea, Australia

Treatment of smallpox

EMA approved

55%

2022

346

224

Commercialization of TPOXX, PEP. US, Canada, Europe, Asia

Treatment of monkeypox

2024

173

269

Total

 

 

 

 

 

1,165

Net Cash (Q223) ($m)

76.21

Total firm value ($m)

1,241

Total basic shares (m) outstanding

71.1

Value per basic share ($)

$17.46

Source: Edison Investment Research


Exhibit 2: Financial summary

$000s

2021

2022

2023e

2024e

Year end 31 December

US GAAP

US GAAP

US GAAP

US GAAP

PROFIT & LOSS

 

 

Revenue

 

133,670

110,776

175,159

180,974

Of which Product revenue

126,803

86,662

154,684

160,294

Of which R&D revenue

6,868

24,114

20,476

20,681

Cost of Sales

(16,602)

(10,433)

(28,404)

(33,059)

Gross Profit on product sales

110,201

76,229

126,279

127,234

Research & Development

(9,942)

(22,526)

(22,751)

(22,978)

General & Administrative

(18,034)

(35,117)

(24,066)

(23,123)

EBITDA

 

89,615

43,218

100,463

102,338

Operating Profit (before amort. and excepts.)

 

89,093

42,700

99,938

101,814

Net Interest

101

1,032

2,470

2,882

Exceptionals

118

401

-

-

Profit Before Tax (norm)

 

89,194

43,732

102,408

104,695

Profit Before Tax (reported)

 

89,312

44,133

102,408

104,695

Tax

(19,861)

(10,228)

(24,578)

(25,127)

Deferred tax

-

-

-

-

Profit After Tax (norm)

69,333

33,504

77,830

79,568

Profit After Tax (reported)

69,451

33,905

77,830

79,568

Average Number of Shares Outstanding (m)

75

73

71

68

EPS - normalized ($), basic

 

0.92

0.46

1.09

1.17

EPS - normalised (c), fully diluted

 

90.75

45.56

110.32

117.80

EPS - reported ($)

 

0.92

0.46

1.09

1.17

 

 

Gross Margin (%)

87

88

82

79

EBITDA Margin (%)

67

39

57

57

Operating Margin (before GW and except.) (%)

67

39

57

56

 

 

BALANCE SHEET

 

 

Fixed Assets

 

5,973

9,250

10,659

10,134

Intangible Assets

898

898

898

898

Tangible Assets

2,366

1,848

1,324

799

Other

2,709

6,503

8,437

8,437

Current Assets

 

208,753

185,786

212,541

275,627

Stocks

19,510

39,273

43,200

45,360

Debtors

83,650

45,407

49,948

54,942

Cash

103,139

98,791

115,260

171,041

Other

2,453

2,316

4,133

4,283

Current Liabilities

 

(30,488)

(21,518)

(20,888)

(20,846)

Creditors

(2,028)

(3,355)

(2,725)

(2,683)

Short term borrowings

-

-

-

-

Other

(28,460)

(18,162)

(18,162)

(18,162)

Long Term Liabilities

 

(9,924)

(3,358)

(3,358)

(3,358)

Long term borrowings

-

-

-

-

Other long term liabilities

(9,924)

(3,358)

(3,358)

(3,358)

Net Assets

 

174,314

170,160

198,954

261,558

Minority Interests

-

-

-

-

Shareholder equity

 

174,314

170,160

198,954

261,558

 

 

CASH FLOW

 

 

Operating Cash Flow

 

11,495

41,611

67,140

74,381

Net Interest

Tax

Capex

(51)

-

-

-

Acquisitions/disposals

-

-

-

-

Financing

-

-

-

-

Dividends

-

(32,940)

(32,071)

-

Other (including share buybacks)

(26,195)

(13,019)

(18,600)

(18,600)

Net Cash Flow

(14,751)

(4,348)

16,469

55,781

Opening net debt/(cash)

 

(117,890)

(103,139)

(98,791)

(115,260)

HP finance leases initiated

Exchange rate movements

-

-

-

-

Other

-

-

-

-

Closing net debt/(cash)

 

(103,139)

(98,791)

(115,260)

(171,041)

Source: Company reports, Edison Investment Research


General disclaimer and copyright

This report has been commissioned by SIGA Technologies and prepared and issued by Edison, in consideration of a fee payable by SIGA Technologies. Edison Investment Research standard fees are £60,000 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

No personalised advice: The information that we provide should not be construed in any manner whatsoever as, personalised advice. Also, the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The securities described in the report may not be eligible for sale in all jurisdictions or to certain categories of investors.

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Copyright: Copyright 2023 Edison Investment Research Limited (Edison).

Australia

Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Crown Wealth Group Pty Ltd who holds an Australian Financial Services Licence (Number: 494274). This research is issued in Australia by Edison AU and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

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United Kingdom

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This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

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United States

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London │ New York │ Frankfurt

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London, WC1R 4PS

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General disclaimer and copyright

This report has been commissioned by SIGA Technologies and prepared and issued by Edison, in consideration of a fee payable by SIGA Technologies. Edison Investment Research standard fees are £60,000 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

No personalised advice: The information that we provide should not be construed in any manner whatsoever as, personalised advice. Also, the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The securities described in the report may not be eligible for sale in all jurisdictions or to certain categories of investors.

Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report, subject to Edison's policies on personal dealing and conflicts of interest.

Copyright: Copyright 2023 Edison Investment Research Limited (Edison).

Australia

Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Crown Wealth Group Pty Ltd who holds an Australian Financial Services Licence (Number: 494274). This research is issued in Australia by Edison AU and any access to it, is intended only for "wholesale clients" within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are “wholesale clients” for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a “personalised service” and, to the extent that it contains any financial advice, is intended only as a “class service” provided by Edison within the meaning of the FAA (i.e. without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision.

United Kingdom

This document is prepared and provided by Edison for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "FPO") (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

United States

Edison relies upon the "publishers' exclusion" from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

London │ New York │ Frankfurt

20 Red Lion Street

London, WC1R 4PS

United Kingdom

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