IPO Report: Nabriva Therapeutics AG (NBRV)

Francis Gaskins  |

Nabriva Therapeutics AG (NBRV) is a clinical stage biopharmaceutical company engaged in the research and development of novel anti-infective agents to treat serious infections, with a focus on the pleuromutilin class of antibiotics. The company is based in Vienna, Austria,

Two other companies are scheduled for the week of Sept. 14. The full IPO calendar is available at IPO Premium.

SEC Documents

Manager, Joint-managers: Leerink Partners, RBC Capital Markets
Co-managers: Needham & Company, Wedbush PacGrow

End of lockup (180 days): Wednesday, March 16, 2016
End of 10-day quiet period: Sept. 28, 2015

Analyst report estimate:  for paid subscribers only

NBRV scheduled a $96 million IPO with a market capitalization of $268 million at a price range midpoint of $16 for Friday, Sept. 18, 2015 on Nasdaq.  Price range reduced to $10.50, shares increase to 9mm.

NBRV IPO Summary

NBRV is a clinical stage biopharmaceutical company engaged in the research and development of novel anti-infective agents to treat serious infections, with a focus on the pleuromutilin class of antibiotics.

NBRV is developing its lead product candidate, lefamulin, to be the first pleuromutilin antibiotic available for systemic administration in humans.

NBRV IPO Valuation


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Nabriva Therapeutics AG (NBRV)







Annualizng June 6 mos


NBRV IPO Conclusion

Neutral slightly plus

Focused on community-acquired bacterial pneumonia treatments

Expects phase 3 clinical trial top line data end of 2017

P/E of -8.7 indicated fairly heavy cash burn rate relative to market cap

Price to book of 2.4

NBRV Business

NBRV is a clinical stage biopharmaceutical company engaged in the research and development of novel anti-infective agents to treat serious infections, with a focus on the pleuromutilin class of antibiotics.

NBRV is developing its lead product candidate, lefamulin, to be the first pleuromutilin antibiotic available for systemic administration in humans.

NBRV is developing both intravenous, or IV, and oral formulations of lefamulin for the treatment of community-acquired bacterial pneumonia, or CABP and intends to develop lefamulin for additional indications other than pneumonia.

Forest Stock Purchase Agreement
In 2012, NBRV entered into a stock purchase agreement with Forest Laboratories Inc., or Forest, pursuant to which Forest agreed to reimburse NBRV for certain external research and development costs and provide NBRV with a $25.0 million loan in exchange for an exclusive right to acquire 100% of  outstanding shares during a one year option period.

NBRV and Forest also agreed on a joint development plan for lefamulin during the option period as part of preparations for the start of Phase 3 clinical trials and established a joint development committee to oversee the activities and approve any amendments to the joint development plan.

Each party had a single vote and decisions had to be made unanimously. Each party was responsible for its own internal costs associated with the joint development plan. As part of this arrangement, Forest reimbursed NBRV for €2.9 million in out-of-pocket third-party research and development costs incurred in connection with the joint development plan in 2013.

In 2013, Forest decided not to exercise its right to acquire us and terminated the stock purchase  agreement. In connection with this termination, NBRV exercised its contractual right to repurchase the $25.0 million loan for €1.00.

NBRV no longer has a commercial relationship with Forest, and no rights or obligations remain outstanding under the stock purchase agreement.

Clinical trials
NBRV has completed a Phase 2 clinical trial of lefamulin for acute bacterial skin and skin structure infections, or ABSSSI.

Based on the clinical results of lefamulin for ABSSSI, as well as its rapid tissue distribution, including substantial penetration into lung tissue and fluids, NBRV is preparing to initiate two pivotal, international Phase 3 clinical trials of lefamulin for the treatment of moderate to severe CABP.

These will be the first clinical trials NBRV has conducted with lefamulin for the treatment of CABP. NBRV plans to initiate the first of these trials in the fall of 2015 and the second trial in the first half of 2016.

Both trials are designed to follow draft guidance published by the FDA for the development of drugs for CABP and guidance from the European Medicines Agency, or EMA, for the development of antibacterial agents.

Based on NBRV’s expectations regarding initiation of these trials and its estimates regarding patient enrollment, NBRV expects to have top-line data available for both trials in late 2017.

If the results of these trials are favorable, including achievement of the primary efficacy endpoints of the trials, NBRV expects to submit applications for marketing approval for lefamulin for the treatment of CABP in both the United States and Europe in 2018.

NBRV believes that lefamulin is well suited for use as a first-line empiric monotherapy for the treatment of CABP because of its novel mechanism of action, spectrum of activity, including against multi-drug resistant pathogens, achievement of substantial drug concentrations in lung tissue and fluids, availability as both an IV and oral formulation and favorable safety and tolerability profile.

Fast track granted
Fast track designation is granted by the FDA to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need.

The U.S. Food and Drug Administration, or FDA, has designated the IV formulation of lefamulin as a qualified infectious disease product, or QIDP, which provides for the extension of statutory exclusivity periods in the United States for an additional five years upon FDA approval of the product for the treatment of CABP, and granted fast track designation to this formulation of lefamulin.

The fast track designation for the IV formulation of lefamulin will allow for more frequent interactions with the FDA, the opportunity for a rolling review of any new drug application, or NDA, NBRV submits and eligibility for priority review and a shortening of the FDA’s goal for taking action on a marketing application from ten months to six months.

NBRV believes that pleuromutilin antibiotics can help address the major public health threat posed by bacterial resistance, which the World Health Organization, or WHO, characterized in 2010 as one of the three greatest threats to human health.

Increasing resistance to antibiotics
Increasing resistance to antibiotics used to treat CABP is a growing concern and has become an issue in selecting the appropriate initial antibiotic treatment prior to determining the specific microbiological cause of the infection, referred to as empiric treatment.

For example, the U.S. Centers for Disease Control and Prevention, or CDC, has classified Streptococcus pneumoniae, the most common respiratory pathogen, as a serious threat to human health as a result of increasing resistance to currently available antibiotics.

In addition, the CDC recently reported on the growing evidence of widespread resistance to macrolides, widely used antibiotics that disrupt bacterial protein synthesis, in Mycoplasma pneumoniae, a common cause of CABP that is associated with significant morbidity and mortality.

Furthermore, Staphylococcus aureus, including methicillin-resistant S. aureus, or MRSA, has emerged as a more common cause of CABP in some regions of the world, and a possible pathogen to be covered with empiric therapy.

In recognition of the growing need for the development of new antibiotics, recent regulatory changes, including priority review and regulatory guidance enabling smaller clinical trials, have led to renewed interest from the pharmaceutical industry in anti-infective development.

For example, the Food and Drug Administration Safety and Innovation Act became law in 2012 and included the Generating Antibiotic Incentives Now Act, or the GAIN Act, which provides incentives, including access to expedited FDA review for approval, fast track designation and five years of potential data exclusivity extension for the development of new QIDPs.

Intellectual property

As of August 31, 2015, NBRV owned 20 different families of patents and patent applications, including 19 families directed to the various pleuromutilin derivatives as compositions of matter, processes for their manufacture, and their use in pharmaceutical compositions and methods of treating disease.

The remaining family is directed to ß-lactamase inhibitors. In addition, as of August 31, 2015, NBRV owned one provisional patent application.

NBRV’s patent portfolio includes 19 issued U.S. patents, 17 granted European patents and 14 granted Japanese patents, as well as patents in other jurisdictions.

NBRV also has pending patent applications in the United States, Europe, Japan and other countries and regions, including Asia, Australia, Eastern Europe, and South America, including notably Canada, Brazil, China, Israel, India and Taiwan among others.

All of these patents and patent applications are assigned solely to NBRV and were either originally filed by NBRV or originally filed by Sandoz and subsequently assigned to us.


Many of NBRV’s competitors may have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than NBRV does.

These competitors also compete with NBRV in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, NBRV’s programs. Smaller or early stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies.

NBRV’s commercial opportunity could be reduced or eliminated if its competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than any products that NBRV may develop.

NBRV’s competitors also may obtain marketing approvals for their products more rapidly than NBRV obtains approval for its, which could result in NBRV’s competitors establishing a strong market position before NBRV is able to enter the market.

In addition, NBRV’s ability to compete may be affected because in some cases insurers or other third-party payors seek to encourage the use of generic products. This may have the effect of making branded products less attractive, from a cost perspective, to buyers.

NBRV expects that if lefamulin is approved for CABP, it will be priced at a significant premium over competitive generic products. This may make it difficult for NBRV to replace existing therapies with lefamulin.

The key competitive factors affecting the success of NBRV’s product candidates are likely to be their efficacy, safety, convenience, price and the availability of coverage and reimbursement from government and other third-party payors.

Currently, the treatment of CABP is dominated by generic products.

For hospitalized patients, combination therapy is frequently used. Many currently approved drugs are well established therapies and are widely used by physicians, patients and third-party payors.

NBRV also is aware of various drugs under development for the treatment of CABP, including solithromycin (under Phase 3 clinical development by Cempra Inc.), dalbavancin (under Phase 3 clinical development by Allergan plc), omadacycline (under Phase 3 clinical development by Paratek Pharmaceuticals Inc.) and delafloxacin (under Phase 3 clinical development by Melinta Therapeutics Inc.).

5% shareholders pre-IPO

Chen Yu         17.9%

Chau Khuong    16.2%

Denise Pollard-Knight   14.4% 

HBM Healthcare Investments (Cayman) Ltd. and an affiliated entity          18.0%

Entities affiliated with Vivo Capital         17.9%

OrbiMed Private Investments V, L.P.      16.2%

Phase4 Ventures III L.P.                14.4%

The Wellcome Trust Limited as trustee of the Wellcome Trust      11.0%

Omega Fund IV, L.P.     8.3%

Entities affiliated with Novartis Bioventures Ltd.     5.4%            


No dividends are planned.

Use of proceeds

NBRV expects to receive $83 million from its IPO and use it for the following:

$80.0 million (€71.7 million) to fund the clinical development of lefamulin for CABP;

$3.0 million (€2.7 million) to pursue the clinical development of lefamulin for additional indications and for earlier stage research and development activities;

$4.9 million (€4.4 million) for the scheduled payments of principal and interest under its loan agreement with Kreos through July 2017; and

the remainder for working capital and other general corporate purposes.


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