Nanexa: NEX-22, partner projects, and Novo Nordisk evaluation prioritized

Research Update

2024-02-22

09:00

Analyst Q&A

Closed

Fredrik Thor answered 3 questions.

Redeye updates its view of Nanexa following the Q4 report and recent events in the company. The report offered no surprises and we reiterate our stance that 2024 will be an important year for the company, as we hope for a breakthrough related to its partner deals and NEX-22 clinical trial.

FT

Fredrik Thor

Q4 2023 – No surprises

Total revenue amounted to SEK14.96m (8m), including 6.8m in turnover and SEK8m in capitalized development costs. Out of the 6.8m in turnover, SEK1.73m related to revenues from Pharmashell evaluation agreements (including Novo Nordisk) and SEK5m related to accrual of deferred revenues from the USD4m exclusivity agreement with Novo Nordisk. OPEX amounted to SEK-66.3m (-25m). The increase in OPEX mainly relates to depreciation of the book value of capitalized development costs related to NEX-18 and NEX-20 of SEK-45m. Nanexa’s cash position amounted to SEK65m, and the company guides for a cash runway until mid-2025.

 Focused approach

We like the company’s focused approach and believe that it should give the company some time to deliver, hopefully, a “full-scale” deal related to the Novo Nordisk evaluation, its other partner projects or possibly related to NEX-22. In the report, the company mentions that it is currently answering some questions related to the application to start a phase I trial with NEX-22, and that study start potentially could be pushed to Q2. However, data is still expected to be presented in H2 this year.
The company is also prioritizing its partnering projects, both the most public one with Novo Nordisk and others.

Reiterated base case

We did a more thorough review of our valuation in relation to the outcome of Nanexa's rights issue and largely reiterate our valuation, only making some model fine tuning with a net-zero effect. We reiterate our base case of SEK3.3 per share.

Key financials

SEKm2021202220232024e2025e
Revenues18.028.259.571.315.0
Revenue Growth661%56.4%111%19.8%-78.9%
EBIT-36.0-58.0-76.616.0-39.6
Net Income-36.1-58.6-76.516.0-39.6

Q4 2023 review

  • Total revenue amounted to SEK14.96m (8m), including 6.8m in turnover and SEK8m in capitalized development costs. Out of the 6.8m in turnover, SEK1.73m related to revenues from Pharmashell evaluation agreements (including Novo Nordisk) and SEK5m related to accrual of deferred revenues from the USD4m exclusivity agreement with Novo Nordisk, which was adjusted downwards somewhat. Capitalization mainly relates to investments in NEX-22 and some extent, NEX-20 and Pharmashell.
  • OPEX amounted to SEK-66.3m (-25m). The increase in OPEX mainly relates to depreciation of the book value of capitalized development costs related to NEX-18 and NEX-20 of SEK-45m.
  • Cash flow from current activities SEK-7.4m (-26.97m), and net cash flow for the period amounted to SEK-44.6m (-15.5m)
  • Cash position (and short-term investments) at the end of Q4 amounted to SEK65m (81.2m).

Overall, Nanexa’s OPEX (when excluding depreciation) has come down, and it is clear from yesterday’s conference call that cost control remains a priority. This includes (as previously announced) the pausing of NEX-20 and NEX-18, broader savings across the organization (for example, consultants), and also effectivizations related to the use of Nanexa’s production facility: Mr Svanström mentions during the call that GMP status only is needed when the company is producing for clinical studies, and thus that there are savings to be done in between. Overall, the report mentions that the company has a cash runway through H1 2025, which is a relatively long runway compared to other Swedish peers.

Financing and OPEX (White)

Source: Nanexa (historical); Redeye Research (estimates)

 In other words, we like the company’s focused approach and believe it should give the company some time to deliver, hopefully, a “full-scale” deal related to the Novo Nordisk evaluation, its other partner projects or possibly related to NEX-22. In the report, the company mentions that it is currently answering some questions related to the application to start a phase I trial with NEX-22 and that the study start could potentially be pushed to Q2. However, that data will still be presented in H2 this year. We reiterate our stance that since a release profile of 28 days can be obtained, we judge that Nanexa has the potential to obtain a pharmacokinetic profile that meets the requirements, the TPP, and the therapeutic window in the clinical phase I trial. In other words, we think the trial will generate much useful information.

The company is also prioritizing its partnering projects, both the most public one with Novo Nordisk and others. We hope that Novo Nordisk, by the end of the year, has chosen to exercise its option and, together with Nanexa, enter into a licensing deal.  In November 2023, the company announced that it had entered into an evaluation agreement with a large global pharmaceutical company about a depot formulation of a monoclonal antibody, which we think is an exciting area where Nanexa’s platform demonstrates great flexibility. While timelines are uncertain, we think there is a lot of optionality in the company’s several evaluation agreements, as we expect that one or several will lead to sharp agreements in the end. During yesterday's call, Nanexa also mentioned that it has optimized its processes in recent years to ensure that there are sharp substances that are evaluated and, overall, to ensure that the evaluation process is not too long.

Valuation

We did a more thorough review of our valuation in relation to the outcome of Nanexa's rights issue and largely reiterate our valuation, only making some model fine tuning related to FX and share price assumptions with a net zero effect. We further adjust our OPEX estimates somewhat to align with the company's guidance for cash runway, and expect costs to follow the NEX-22 trial to a higher extent. We note that the company has made some room to deliver, given the cash runway into mid-25, and think that it will be vital for the company to deliver some form of commercial validation during the year. We still include some value related to NEX-20 (and to some extent NEX-18) but have earlier pushed our expectations for the next clinical activities. We may further adjust these parameters during the year. We reiterate our base case of SEK3.3 per share for now.

AssetOriginator DrugLoARoyaltiesPeak sales (USDm)Est. launchDeal size (USDm)rNPV (SEKm)rNPV (Per share)
NEX-18Vidaza7%13%992030120570.3
NEX-20Revlimid24%15%53120291505732.9
NEX-22Victoza11%15%68820291502501.2
Novo DealGLP-1 Class9%5%774-751050.5
Technology value (SEKm)985.04
Net cash* (SEKm)104.60
Shared costs** (SEKm)-428.32
Equity value (SEKm)661.32
Shares outstanding (million)135.70
Diluted shares outstanding (million)199.98
Equity value per share (SEK)3.3

Investment thesis

Case

Drug delivery case with early validation

Last year Novo Nordisk provided significant validation of Nanexa and its PharmaShell drug delivery technology platform. The share rallied some 70%. In our view, Nanexa’s extensive collaboration with Applied Materials Inc. (semiconductor giant and leading manufacturer within Atomic Layer Deposition) has the potential to secure a long-term deal and prompt considerable momentum for the continued commercialisation of Nanexa’s projects and commercial strategy. Having Novo Nordisk as its largest shareholder, we believe the parties might be ready to enter a licensing deal with Novo Nordisk in the next 10–16 months. We see considerable upside to our base case of SEK3.3 per share following the recent capital injection and low expectations baked into the company’s valuation despite solid fundamental progress.

Evidence

PharmaShell in place reduce burden for partners in more than one way

PharmaShell focuses on long-acting injectables to improve upon existing drugs. Not only will this enhance the benefit for patients. It will also allow partners to maximise their product’s value and maintain market share upon patent expiry. It is challenging to value pharmaceutical compounds in terms of technology transfer, e.g., the feasibility of bringing R&D to large-scale and/or commercial manufacturing. Through a transformative collaboration agreement with Applied Materials, the ifs and buts with the drug manufacturing scaling-up of PharmaShell are de-risked. Most of Nanexa’s projects are in the preclinical and early clinical stages, so the evaluation agreement with Novo Nordisk is a considerable achievement. We believe the collaboration with Applied Materials and the valuation and investment agreement with Novo Nordisk imply significant validation of the PharmaShell platform and the company’s commercial strategy.

Challenge

Still at an early stage

Nanexa’s assets are still at the early stage, and so risky inflexion points related to clinical development remain. Unlike with a typical biotech company, the clinical and regulatory risks in Nanexa are significantly lower, in our view, since the PharmaShell platform focuses on long-acting injectables to improve already approved and marketed pharmaceuticals. Still, we believe positive proof-of-concept data is crucial and that is likely to take additional time to produce.

Challenge

Additional capital required to advance all projects

With Nanexa’s project prioritization, its cash runway could extend into 2025. However, the company’s current plan is to focus its resources on NEX-22 and its partnering projects and thus not to conduct clinical trials in the near term with NEX-18 and NEX-20. We endorse Nanexa’s focused strategy but conclude that additional capital, either through a deal or rights issue, would be needed to continue development with these drug candidates.

Valuation

SOTP Suggests Upside

Our DCF model indicates a base case of SEK3.3 per share (bull: SEK6 and bear: SEK0.5) using a sum-of-the-parts valuation based on a DCF model with risk adjustment and a 15% WACC. In the coming 12–18 months, we believe catalysts such phase I data with NEX-22 and the potential of entering into a licensing agreement with Novo Nordisk could lift the share considerably from current levels, given the enforced cash position and low expectations baked into today’s share valuation where the enterprise value is close to zero.

Quality Rating

People: 3

Business: 3

Financials: 0

Financials

Income statement
SEKm2021202220232024e2025e
Revenues18.028.259.571.315.0
Cost of Revenue0.000.000.000.000.00
Operating Expenses54.086.2136.155.354.6
EBITDA-36.0-58.0-76.616.0-39.6
Depreciation7.510.559.90.000.00
Amortizations0.000.000.006.08.0
EBIT-36.0-58.0-76.616.0-39.6
Shares in Associates0.000.000.030.030.03
Interest Expenses0.190.670.940.000.00
Net Financial Items-0.19-0.660.120.000.00
EBT-36.2-58.6-76.516.0-39.6
Income Tax Expenses-0.01-0.060.000.000.00
Net Income-36.1-58.6-76.516.0-39.6
Balance sheet
Assets
Non-current assets
SEKm2021202220232024e2025e
Property, Plant and Equipment (Net)9.715.114.215.717.2
Goodwill0.000.000.000.000.00
Intangible Assets45.765.240.548.053.5
Right-of-Use Assets0.080.000.000.000.00
Other Non-Current Assets0.060.100.210.210.21
Total Non-Current Assets55.580.555.064.071.0
Current assets
SEKm2021202220232024e2025e
Inventories0.270.490.001.02.0
Accounts Receivable3.58.11.90.005.0
Other Current Assets0.000.0010.70.003.0
Cash Equivalents105.781.265.267.757.1
Total Current Assets109.589.777.868.767.1
Total Assets165.0170.2132.8132.6138.0
Equity and Liabilities
Equity
SEKm2021202220232024e2025e
Non Controlling Interest0.000.000.000.000.00
Shareholder's Equity151.3109.195.8111.8117.2
Non-current liabilities
SEKm2021202220232024e2025e
Long Term Debt0.000.002.12.12.1
Long Term Lease Liabilities0.000.000.000.000.00
Other Non-Current Lease Liabilities2.622.33.83.83.8
Total Non-Current Liabilities2.622.35.95.95.9
Current liabilities
SEKm2021202220232024e2025e
Short Term Debt1.30.000.000.000.00
Short Term Lease Liabilities0.000.000.000.000.00
Accounts Payable3.74.77.80.005.0
Other Current Liabilities6.134.223.215.010.0
Total Current Liabilities11.138.831.115.015.0
Total Liabilities and Equity165.0170.2132.8132.6138.0

Rating definitions

The team

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