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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d)

OF THE SECURITIES EXCHANGE ACT OF 1934

 

Date of Report (Date of Earliest Event Reported):  November 12, 2019

 

NABRIVA THERAPEUTICS PLC

(Exact name of registrant as specified in its charter)

 

Ireland

 

001-37558

 

Not Applicable

(State or other jurisdiction of
incorporation)

 

(Commission File Number)

 

(I.R.S. Employer Identification
No.)

 

25-28 North Wall Quay,
IFSC, Dublin 1, Ireland

 

Not Applicable

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (610) 816-6640

 

Not Applicable

(Former name or former address, if changed since last report.)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

o    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading Symbol(s)

 

Name of each exchange on which
registered

Ordinary Shares, nominal value $0.01 per share

 

NBRV

 

The Nasdaq Global Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company x

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. x

 

 

 


 

Item 2.02  Results of Operations and Financial Conditions.

 

On November 12, 2019, Nabriva Therapeutics plc (the “Company”) issued a press release announcing its consolidated financial results for the quarter ended September 30, 2019.  The full text of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein by reference.

 

Item 7.01.  Regulation FD Disclosure.

 

The Company will host a conference call to discuss the financial results and recent corporate highlights on Tuesday, November 12, 2019 at 4:30 PM Eastern Time, and a live webcast of the call will be available through the investor relations section of the Company’s website.

 

The slide presentation to be used by the Company during the conference call is attached hereto as Exhibit 99.2 and incorporated herein by reference. The information in this Current report on Form 8-K, including Exhibit 99.1 and Exhibit 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01  Financial Statements and Exhibits.

 

(d)           Exhibits

 

The following exhibits shall be deemed to be furnished, and not filed:

 

Exhibit No.

 

Description

99.1

 

Press release issued by Nabriva Therapeutics plc dated November 12, 2019

99.2

 

Nabriva Presentation dated November 12, 2019.

 

2


 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

NABRIVA THERAPEUTICS PLC

 

 

Date: November 12, 2019

By:

/s/ Gary Sender

 

 

Gary Sender

 

 

Chief Financial Officer

 

3


Exhibit 99.1

 

 

Nabriva Therapeutics Reports Third Quarter 2019 Financial Results and
Recent Corporate Highlights

 

-More than 200 hospital formulary reviews of XENLETATM scheduled before the end of the year-

 

-Approximately 50% of all covered lives have outpatient formulary access to XENLETA-

 

-Initiating focused community sales efforts for XENLETA-

 

-Conference call today at 4:30 p.m. Eastern Time-

 

Dublin Ireland, November 12, 2019 — Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, today announced its financial results for the three and nine months ended September 30, 2019 and recent corporate highlights.

 

“Gaining U.S. Food and Drug Administration (FDA) approval and launching XENLETA™ (lefamulin) for the treatment of community-acquired bacterial pneumonia (CABP) just three weeks later were transformational events for Nabriva in the third quarter,” said Ted Schroeder, Chief Executive Officer of Nabriva Therapeutics. “XENLETA is a new class of IV and oral antibiotic with a novel mechanism of action that is convenient for patients being treated in the hospital, transitioning treatment out of the hospital or initiating treatment in the community. We made key strategic investments to prepare the market over the past 18 months and remain singularly focused on continuing to build a solid foundation for the successful launch of XENLETA. As a result of these efforts, we have already exceeded our expectations for 2019 with regard to market access, scheduled formulary reviews, and product availability at our distributors. With more than 200 hospital formulary reviews scheduled before the end of the year, we believe we are well on our way to exceeding the hospital penetration of recently launched antibiotics.  Even more exciting, approximately 50% of all covered lives have outpatient formulary access to XENLETA — the vast majority with no prior authorization or step edits required. Coverage includes both key commercial and Medicare formularies. XENLETA tablets are now available for patient discharge at more than 50% of our initial 900 hospital target accounts. We believe that our extensive pre-commercial launch activities coupled with our distribution channel that utilizes specialty pharmacy partners such as Walgreens Community Specialty Pharmacy and Option Care Health will make it easier for patients to obtain XENLETA,” added Mr. Schroeder.

 

RECENT CORPORATE AND DEVELOPMENT HIGHLIGHTS

 

XENLETA

 

·                  In August 2019, received approval from the U.S. FDA for Nabriva’s new drug applications (NDA) for the oral and intravenous formulations of XENLETA for the treatment of community-acquired bacterial pneumonia in adults.

 


 

·                  In August 2019, earned a $5.0 million milestone payment under the licensing agreement with Sinovant Sciences related to the U.S. regulatory approval of XENLETA. Under the license agreement with Sinovant Sciences, Nabriva is eligible for up to approximately $85 million in additional regulatory and commercial milestone payments and low double-digit royalties on sales in Greater China.

 

·                  In September 2019, XENLETA became commercially available in the U.S. through major specialty distributors for both the oral (600 mg every 12 hours) and the IV (150 mg every 12 hours) dosage forms indicated with a short 5-to-7-day course of therapy.

 

·                  In September 2019, under its agreement with Hercules Capital, Inc., received a term loan advance of $10.0 million following the approval by the FDA of the NDA for XENLETA.

 

·                  In September 2019, announced that the Journal of the American Medical Association (JAMA) published results from the company’s LEAP 2 clinical trial, (available online and published in print on November 5, 2019) “Oral Lefamulin vs Moxifloxacin for Early Clinical Response Among Adults with Community-Acquired Bacterial Pneumonia: The LEAP 2 Randomized Clinical Trial”.

 

·                  In September 2019, presented data at the ASM/ESCMID Conference in Boston, demonstrating the utility of XENLETA for patients with CABP.

 

·                  In October 2019, presented data on the pooled results from the completed Phase 3 clinical trials of XENLETA at the CHEST Annual Meeting 2019 in New Orleans.

 

·                  Presented data from XENLETA (lefamulin) and CONTEPO™ (fosfomycin) clinical development programs at IDWeek 2019, held October 2-9 in Washington, D.C. Nabriva, along with collaborators, presented a total of 14 posters, including 11 for lefamulin and three for fosfomycin.

 

·                  In November 2019, launched a focused commercial effort for XENLETA tablets in the community treatment setting.

 

CONTEPO

 

·                  In August 2019, provided an update following a Type A Meeting with the FDA. Nabriva continues to work with its contract manufacturing partners to address observations made by the FDA in the complete response letter (CRL) to the CONTEPO NDA. Based on the work performed to date, the NDA for CONTEPO is expected to be resubmitted in the fourth quarter of this year.  FDA has classified the resubmission as “Class 2,” establishing a review timeline of up to 6 months from the receipt date. No new clinical or non-clinical data or analyses regarding the safety or efficacy of CONTEPO were requested in the CRL or at the Type A meeting.

 

FINANCIAL RESULTS

 

Three Months Ended September 30, 2019 and 2018

 

·                  For the three months ended September 30, 2019, Nabriva Therapeutics recorded revenues of $6.9 million, a $6.5 million increase versus the three months ended September 30, 2018.  The increase was

 


 

primarily as a result of the aforementioned $5.0 million milestone payment from Sinovant Sciences and $1.4 million in net product sales of XENLETA following its commercial launch in September 2019. The Company reported a net loss of $17.8 million, or $0.24 per share, compared to a net loss of $52.8 million, or $0.90 per share, for the three months ended September 30, 2018.

 

·                  Research and development expenses decreased by $35.2 million from $40.8 million for the three months ended September 30, 2018 to $5.6 million for the three months ended September 30, 2019. The decrease was primarily due to a prior year charge of $31.9 million associated with in-process research and development expenses associated with the acquisition of Zavante assets and lower costs associated with the development of XENLETA in the current year.

 

·                  Selling, general and administrative expense increased by $5.9 million from $12.6 million for the three months ended September 30, 2018 to $18.5 million for the three months ended September 30, 2019. The increase was primarily due to an increase of $3.2 million in advisory and consulting costs associated with pre-commercialization activities, additional personal costs of $1.4 million in connection with the commercial launch of XENLETA and higher stock based compensation costs of $0.7 million.

 

Nine Months Ended September 30, 2019 and 2018

 

·                  For the nine months ended September 30, 2019, Nabriva Therapeutics recorded revenues of $9.1 million, a $0.3 million increase versus the nine months ended September 30, 2018. Nabriva reported a net loss of $59.7 million, or $0.83 per share, compared to a net loss of $84.0 million, or $1.85 per share, for the nine months ended September 30, 2018.

 

·                  Research and development expenses decreased by $39.6 million from $60.8 million for the nine months ended September 30, 2018 to $21.2 million for the nine months ended September 30, 2019. The decrease was primarily due to the previously mentioned charge associated with the Zavante acquisition of $31.9 million as well as declines in costs associated with the development of XENLETA.

 

·                  Selling, general and administrative expense increased by $13.8 million from $31.6 million for the nine months ended September 30, 2018 to $45.3 million for the nine months ended September 30, 2019. The increase was primarily due to staffing and consulting costs associated with the launch of XENLETA and expense associated with stock based compensation.

 

·                  As of September 30, 2019, Nabriva Therapeutics had $78.3 million in cash, cash equivalents and short term investments compared to $102.0 million as of December 31, 2018. Existing cash resources and anticipated revenues are expected to fund operations into the third quarter of 2020.

 

Please refer to our Annual Report on Forms 10-K for the fiscal year ended December 31, 2018 and our Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2019, which are filed with the U.S. Securities and Exchange Commission, for additional information regarding our business and financial results.

 

Company to Host Conference Call

 

Nabriva’s management will host a conference call today at 4:30 p.m. ET to discuss the financial results and recent corporate highlights. The dial-in number for the conference call is (866) 811-8671 for domestic

 


 

participants and (409) 981-0874 for international participants, with Conference ID #5576567. A live webcast of the conference call can be accessed through the “Investors” tab on the Nabriva Therapeutics website at www.nabriva.com.  A replay will be available on this website shortly after conclusion of the event for 90 days.

 

About Nabriva Therapeutics plc

 

Nabriva Therapeutics is a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics received U.S. Food and Drug Administration approval for XENLETA™ (lefamulin injection, lefamulin tablets), the first systemic pleuromutilin antibiotic for community-acquired bacterial pneumonia (CABP). Nabriva Therapeutics is also developing CONTEPO™ (fosfomycin) for injection, a potential first-in-class epoxide antibiotic for complicated urinary tract infections (cUTI), including acute pyelonephritis. For more information, please visit www.nabriva.com.

 

About XENLETA

 

XENLETA (lefamulin) is a first-in-class semi-synthetic pleuromutilin antibiotic for systemic administration in humans discovered and developed by the Nabriva Therapeutics team. It is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow. XENLETA’s binding occurs with high affinity, high specificity and at molecular sites that are different than other antibiotic classes. Efficacy of XENLETA was demonstrated in two multicenter, multinational, double-blind, double-dummy, non-inferiority trials assessing a total of 1,289 patients with CABP.  In these trials, XENLETA was compared with moxifloxacin and in one trial, moxifloxacin with and without linezolid. Patients who received XENLETA had similar rates of efficacy as those taking moxifloxacin alone or moxifloxacin plus linezolid. The most common adverse reactions associated with XENLETA included diarrhea, nausea, reactions at the injection site, elevated liver enzymes, and vomiting.

 

INDICATION AND IMPORTANT SAFETY INFORMATION

 

INDICATION

 

XENLETA is a pleuromutilin antibacterial indicated for the treatment of adults with community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms: Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, and Chlamydophila pneumoniae.

 

USAGE

 

To reduce the development of drug-resistant bacteria and maintain the effectiveness of XENLETA and other antibacterial drugs, XENLETA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

 

IMPORTANT SAFETY INFORMATION

 

CONTRAINDICATIONS

 

XENLETA is contraindicated in patients with known hypersensitivity to XENLETA or pleuromutilins.

 

XENLETA tablets are contraindicated for use with CYP3A4 substrates that prolong the QT interval.

 


 

WARNINGS AND PRECAUTIONS

 

XENLETA has the potential to prolong the QT interval. Avoid XENLETA in patients with known QT prolongation, ventricular arrhythmias, and patients receiving drugs that may prolong the QT interval.

 

Based on animal studies, XENLETA may cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception.

 

Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all systemic antibacterial agents, including XENLETA, with severity ranging from mild diarrhea to fatal colitis. Evaluate if diarrhea occurs.

 

ADVERSE REACTIONS

 

The most common adverse reactions (>2%) for (a) XENLETA Injection are administration site reactions, hepatic enzyme elevation, nausea, hypokalemia, insomnia, and headache and (b) XENLETA Tablets are diarrhea, nausea, vomiting, and hepatic enzyme elevation.

 

USE IN SPECIFIC POPULATIONS

 

In patients with severe hepatic impairment, reduce the dosage of XENLETA Injection to 150 mg infused over 60 minutes every 24 hours. XENLETA Tablets are not recommended in patients with moderate or severe hepatic impairment due to insufficient information to provide dosing recommendations.

 

Avoid XENLETA Injection and Tablets with concomitant strong or moderate CYP3A or P-gp inducers. Monitor for reduced efficacy of XENLETA.

 

Avoid XENLETA Tablets with strong CYP3A or P-gp inhibitors.

 

Monitor for adverse reactions of sensitive CYP3A substrates administered with XENLETA Tablets.

 

XENLETA has not been studied in pregnant women. Verify pregnancy status in females prior to initiating XENLETA and advise females to use contraception during treatment and for 2 days after the final dose. Lactating women should pump and discard milk for the duration of treatment with XENLETA and for 2 days after the final dose.

 

To report SUSPECTED ADVERSE REACTIONS, or administration during pregnancy, contact Nabriva Therapeutics US, Inc. at 1-855-5NABRIVA or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

Please see Full Prescribing Information for XENLETA.

 

Forward-Looking Statements

 

Any statements in this press release about future expectations, plans and prospects for Nabriva Therapeutics, including but not limited to statements about its ability to successfully launch and commercialize XENLETA for the treatment of CABP, including the availability of and ease of access to XENLETA through major U.S. specialty distributors, marketing exclusivity and patent protection for XENLETA, the development of CONTEPO for cUTI, the clinical utility of XENLETA for CABP and of CONTEPO for cUTI, plans for and timing of the review of regulatory filings for CONTEPO, efforts to bring CONTEPO to market, the market opportunity for and the potential market acceptance of XENLETA for CABP and CONTEPO for cUTI, the development of XENLETA and CONTEPO for additional indications, the development of additional formulations of XENLETA and CONTEPO, plans to pursue research and development of other product candidates, the sufficiency of Nabriva Therapeutics’ existing cash resources and its expectations regarding how far into the future its existing cash resources will fund its ongoing operations and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,”

 


 

“may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: Nabriva Therapeutics’ ability to successfully implement its commercialization plans for XENLETA and whether market demand for XENLETA is consistent with its expectations, Nabriva Therapeutics’ ability to build and maintain a sales force for XENLETA, the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, whether results of early clinical trials or studies in different disease indications will be indicative of the results of ongoing or future trials, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of CONTEPO for the treatment of cUTI, the ability to retain and hire key personnel, the availability of adequate additional financing on acceptable terms or at all and such other important factors as are set forth in Nabriva Therapeutics’ annual and quarterly reports and other filings on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Nabriva Therapeutics’ views as of the date of this press release. Nabriva Therapeutics anticipates that subsequent events and developments will cause its views to change. However, while Nabriva Therapeutics may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Nabriva Therapeutics’ views as of any date subsequent to the date of this press release.

 

CONTACTS:

 

For Investors

Gary Sender

Nabriva Therapeutics plc

ir@nabriva.com

 

For Media

Mike Beyer

Sam Brown Inc.

mikebeyer@sambrown.com

312-961-2502

 


 

Consolidated Balance Sheets

(unaudited)

 

(in thousands, except share data)

 

As of
December 31, 2018

 

As of
September 30, 2019

 

 

 

 

 

 

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

102,003

 

$

78,101

 

Restricted cash

 

 

228

 

Short-term investments

 

225

 

175

 

Accounts receivable, net and other receivables

 

3,871

 

6,540

 

Contract asset

 

1,500

 

 

Inventory

 

 

162

 

Prepaid expenses

 

1,154

 

1,202

 

Total current assets

 

108,753

 

86,408

 

Property, plant and equipment, net

 

1,139

 

2,655

 

Intangible assets, net

 

98

 

343

 

Long-term receivables

 

428

 

716

 

Total assets

 

$

110,418

 

$

90,122

 

 

 

 

 

 

 

Liabilities and equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

3,304

 

$

3,221

 

Accrued expense and other current liabilities

 

14,502

 

11,663

 

Total current liabilities

 

17,806

 

14,884

 

Non-current liabilities

 

 

 

 

 

Long-term debt

 

23,718

 

34,241

 

Other non-current liabilities

 

264

 

1,782

 

Total non-current liabilities

 

23,982

 

36,023

 

Total liabilities

 

41,788

 

50,907

 

Commitments and contingencies (Note 12)

 

 

 

 

 

Stockholders’ Equity:

 

 

 

 

 

Ordinary shares, nominal value $0.01, 1,000,000,000 ordinary shares authorized at September 30, 2019; 67,019,094 and 77,993,161 issued and outstanding at December 31, 2018 and September 30, 2019, respectively

 

670

 

780

 

Preferred shares, par value $0.01, 100,000,000 shares authorized at September 30, 2019; None issued and outstanding

 

 

 

Additional paid in capital

 

461,911

 

492,105

 

Accumulated other comprehensive income

 

27

 

27

 

Accumulated deficit

 

(393,978

)

(453,697

)

Total stockholders’ equity

 

68,630

 

39,215

 

Total liabilities and stockholders’ equity

 

$

110,418

 

$

90,122

 

 


 

Consolidated Statements of Operations

(unaudited)

 

 

 

Three Months Ended
September 30,

 

Nine Months Ended
September 30,

 

(in thousands, except share and per share data)

 

2018

 

2019

 

2018

 

2019

 

Revenues:

 

 

 

 

 

 

 

 

 

Collaboration revenue

 

$

 

$

5,051

 

$

6,500

 

$

6,051

 

Product revenue, net

 

 

1,445

 

 

1,445

 

Research premium and grant revenue

 

461

 

424

 

2,359

 

1,652

 

Total revenue

 

461

 

6,920

 

8,859

 

9,148

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Cost of product sales

 

 

(15

)

 

(15

)

Research and development expenses

 

(40,804

)

(5,601

)

(60,800

)

(21,213

)

Selling, general and administrative expenses

 

(12,582

)

(18,503

)

(31,555

)

(45,339

)

Total operating expenses (1)

 

(53,386

)

(24,119

)

(92,355

)

(66,567

)

Loss from operations

 

(52,925

)

(17,199

)

(83,496

)

(57,419

)

Other income (expense):

 

 

 

 

 

 

 

 

 

Other income (expense), net

 

(54

)

(10

)

(172

)

116

 

Interest income

 

11

 

94

 

39

 

176

 

Interest expense

 

(8

)

(709

)

(19

)

(2,512

)

Loss before income taxes

 

(52,976

)

(17,824

)

(83,648

)

(59,639

)

Income tax benefit (expense)

 

151

 

29

 

(307

)

(80

)

Net loss

 

$

(52,825

)

$

(17,795

)

$

(83,955

)

$

(59,719

)

 

 

 

 

 

 

 

 

 

 

Loss per share

 

 

 

 

 

 

 

 

 

Basic and Diluted ($ per share)

 

$

(0.90

)

$

(0.24

)

$

(1.85

)

$

(0.83

)

 

 

 

 

 

 

 

 

 

 

Weighted average number of shares:

 

 

 

 

 

 

 

 

 

Basic and Diluted

 

58,442,987

 

75,161,147

 

45,369,040

 

72,153,390

 

 


(1)                                 Total operating expenses include non-cash stock based compensation expense of $4.1 million and $7.9 million for the three and nine month periods ended September 30, 2019 compared to $1.4 million and $3.4 million for the corresponding periods in the prior year.

 


 

Condensed Consolidated Statements of Cash Flows

(unaudited)

 

 

 

Nine Months Ended
September 30,

 

(in thousands)

 

2018

 

2019

 

Net cash provided by (used in):

 

 

 

 

 

Operating activities

 

$

(50,492

)

$

(56,405

)

Investing activities

 

(4,375

)

131

 

Financing activities

 

68,596

 

32,680

 

Effects of foreign currency translation on cash and cash equivalents

 

(167

)

80

 

Net increase/(decrease) in cash, cash equivalents and restricted cash

 

13,562

 

(23,674

)

Cash, cash equivalents and restricted cash at beginning of period

 

86,769

 

102,003

 

Cash, cash equivalents and restricted cash at end of period

 

100,331

 

78,329

 

 


Exhibit 99.2

Third Quarter 2019 Financial Results & Corporate Update November 12, 2019

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Safe Harbor and Disclaimer This presentation contains forward-looking statements about future expectations, plans and prospects for Nabriva Therapeutics, including but not limited to statements about launch and commercialization of XENLETA for the treatment of CABP, the development of CONTEPO for cUTI, the clinical utility of XENLETA for CABP and of CONTEPO for cUTI, plans for and timing of the review of regulatory filings for CONTEPO, efforts to bring XENLETA and CONTEPO to market, the market opportunity for and the potential market acceptance of XENLETA for CABP and CONTEPO for cUTI, plans for distributing and timing of the availability of XENLETA, the development of XENLETA and CONTEPO for additional indications, the development of additional formulations of XENLETA and CONTEPO, plans to pursue research and development of other product candidates, the sufficiency of Nabriva Therapeutics’ existing cash resources and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: Nabriva Therapeutics’ ability to successfully implement its commercialization plans for XENLETA and whether market demand for XENLETA is consistent with its expectations, Nabriva Therapeutics’ ability to build and maintain a sales force and commercially launch of XENLETA on the timeline expected, or at all, the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, Nabriva Therapeutics’ reliance on third-party manufacturers for the commercial supply of XENLETA and third-party distributors to make XENLETA available to hospitals and the medical community and the ability of such third parties to comply with regulatory requirements, the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, whether results of early clinical trials or studies in different disease indications will be indicative of the results of ongoing or future trials, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of CONTEPO for the treatment of cUTI or of XENLETA for the treatment of CABP, the ability to retain and hire key personnel, the sufficiency of cash resources and need for additional financing and such other important factors as are set forth in Nabriva Therapeutics’ annual and quarterly reports and other filings on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this presentation represent Nabriva Therapeutics’ views as of the date of this presentation. Nabriva Therapeutics anticipates that subsequent events and developments will cause its views to change. However, while Nabriva Therapeutics may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Nabriva Therapeutics’ views as of any date subsequent to the date of this presentation. 2

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3 Nabriva Q3 2019 Earnings Call: Agenda 3rd Quarter Overview & Business Update Ted Schroeder, Chief Executive Officer Commercial Highlights Francesco Maria Lavino, Chief Commercial Officer Financial Review Gary Sender, Chief Financial Officer Closing Remarks and Q&A Ted Schroeder, Chief Executive Officer and Team

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3rd Quarter Business Update Ted Schroeder, Chief Executive Officer

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Nabriva in 2019: A Transformative Year Strengthened balance sheet and extended cash runway into Q3 20 * CONTEPO is an investigational drug candidate and has not received regulatory approval for any indication. Information provided in this slide is based on research and development performed to date. Continued data flow to the scientific community, including LEAP 2 publication in JAMA Executing on the plan to resubmit the CONTEPO* NDA in Q4 19 Xenleta™ (lefamulin) received U.S. FDA approval on August 19th for community acquired bacterial pneumonia (CABP) Launched XENLETA on September 9th as the first novel IV and oral antibiotic class with a new mechanism of action in two decades in the U.S. 5

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XENLETA Launch Highlights Executing on our 90 Day Plan to Build a Solid Foundation for a Successful Launch Significant Interest and Uptake in Hospitals XenletaTM (lefamulin) launched in the US on September 9th, just 3 weeks after approval Nabriva Sales Force has called on all 900 target hospitals* (>2,400 HCPs*) By the end of 2019, we expect >200 hospital accounts to have reviewed XENLETA at their Pharmacy & Therapeutics Committees XENLETA tablets currently available for patient discharge at >50% of our 900 target hospital accounts Key Market Access Milestones To date, ~50% of all covered lives have access to XENLETA Coverage includes key commercial and Medicare formularies, the majority with no prior authorization or step edits required XENLETA has been granted C Code C9054 (Pass Through Status), effective on Jan 1, 2020 Enables outpatient departments to bill Medicare for XENLETA IV at ASP + 6% 6 Net Sales of $1.4MM generated in the first 3 weeks * As of 11/4/19 All internal launch KPIs for 2019 have been met or exceeded

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Nabriva in 2019: A Transformative Year Strengthened balance sheet and extended cash runway into Q3 20 * CONTEPO is an investigational drug candidate and has not received regulatory approval for any indication. Information provided in this slide is based on research and development performed to date. Continued data flow to the scientific community, including LEAP 2 publication in JAMA Executing on the plan to resubmit the CONTEPO* NDA in Q4 19 Xenleta™ (lefamulin) received U.S. FDA approval on August 19th for community acquired bacterial pneumonia (CABP) Launched XENLETA on September 9th as the first novel IV and oral antibiotic class with a new mechanism of action in two decades in the U.S. 7

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Pneumonia A Leading Cause of Morbidity, Mortality, and Healthcare Cost #3 Cause of hospital readmission6 ~5MM Cases Annually in US1 #5 Cause of total hospitalizations7 #1 Cause of infectious death5 Mortality rate ~$17B ~15% in hospital8 ~25 – 30% in ICU9,10 Direct costs of pneumonia11 8 Distribution of S. pneumoniae Resistance to Azithromycin, Ampicillin, and Doxycycline in the US4 The CDC has deemed drug-resistant S. pneumoniae a serious public health threat2,3 References in Appendix

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Commercial Highlights Francesco Maria Lavino, CCO 9

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Outpatients Transition of Care In-Patients Prioritized Accounts Community Hospital Point of Care: Initial Nabriva Focus 1 2 3 A: Healthcare Cost and Utilization Project (HCUP) 2013, Age 18+ (projected to 2029) B: Community Data (CDC 2009-2010), Age 18+ (projected to 2029) C: Company Sponsored Market Research, Medical Marketing Economics, July 2016, (N=122) ED Treatments & Discharge ~ 0.9MM PatientsA,C Hospital Discharge ~ 2.4MM PatientsA,C Hospital In Patient ~ 3.8MM TreatmentsA,C Office Based ~ 2.3MM PatientsB Patients numbers approximately six years after launch & continue to grow until LOE, following the CABP epidemiology growth**~3.0MM Hospital Initiated Outpatients and ~0.9MM of ED Outpatients. XENLETA Commercial Strategy Three Distinct and Significant Opportunities for the Treatment of CABP 10

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Pull Through Supporting a Successful Launch Supporting the Transition of Care Strategy Ensure HUB Service in place to enable effective discharge 1 2 Ensure XENLETA Sales Force connects with prioritized accounts to accelerate Formulary Placement & Transition of Care 3 Ensure XENLETA is scheduled for review at P&T committee 4 Ensure XENLETA is on formulary of key commercial and Medicare plans with no or limited restrictions 11 XENLETA Availability Sales Force Institutional Access Hospital Formulary Access Managed Care Access XENLETA Launch: Priorities for the First 90 Days Preparation Builds a Solid Foundation for a Successful Launch

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September 9th XENLETA launch 3 weeks after approval Specialty distributors have adequate inventory ASD, Cardinal Specialty and McKesson Specialty Walgreens Community Specialty Pharmacy and Option Care Health Initial orders include hospitals & specialty pharmacies >200 orders for XENLETA from Hospitals & Specialty Pharmacies Walgreens and Option Care Health stocking of XENLETA tablets supports the Transition of Care To date, more than 30 Hospitals placed an initial order Majority of orders from strong academic medical centers or Priority 1 accounts Majority of orders for XENLETA tablets in the outpatient pharmacies Transition of care distribution for XENLETA: One key to successful launch Nabriva Rx Connect launched on Sep 19th in collaboration with Rx Crossroads by McKesson to initiate HUB Transition services, co-pay assistance, PAP and bridge dosing 1 12 XENLETA Availability XENLETA Launch: Priorities for the First 90 Days Preparation Builds a Solid Foundation for a Successful Launch

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2 13 60 highly experienced, Territory Business Managers (TBMs) launching XENLETA 100% have in depth hospital experience (average of 14.5 years) 75% have ID experience (average of 9.5 years) Hospital experience includes ED, ICU, Cardiac-Cath/Procedure Areas To date, TBMs have connected with all 900 Target Hospital Accounts* TBMs made >2000 Hospital Calls with over 2,400 HCP’s* Access to all Nabriva Priority 1 accounts identified in pre-commercial profiling Initial orders generated in either priority or profiled accounts, demonstrating value of pre-commercial preparation XENLETA Launch: Priorities for the First 90 Days Preparation Builds a Solid Foundation for a Successful Launch * As of 11/4/19 Sales Force Institutional Access

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3 14 >200 hospital accounts plan to review XENLETA by Dec 31st >400 total hospital accounts expected to review XENLETA by end of Q1 20 Majority of hospitals pending review by end of Q1 20 are large systems or Nabriva priority accounts Trend indicates higher hospital access within 6 months, compared to recently launched hospital antibiotics XENLETA Launch: Priorities for the First 90 Days Preparation Builds a Solid Foundation for a Successful Launch Hospital Formulary Access

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4 15 Majority of clinical reviews in first 90 days ~ 150MM (49%) of covered lives have access; majority with no utilization management (PA/ST) ~ 45MM Commercial and Medicare Part D lives under contract, ~90% with no utilization management In process of contracting with all Commercial and Medicare Part D plans for coverage with no Utilization Management (no Prior Authorization or Step Edits) Coverage expected to increase through Q1 20 XENLETA expected to be reviewed by plans accounting for >80% of Total Covered Lives XENLETA Launch: Priorities for the First 90 Days Preparation Builds a Solid Foundation for a Successful Launch Managed Care Access

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XENLETA Opportunity for Increased Reimbursement in the Transition of Care 16 XENLETA IV has been granted a C Code C9054 (Pass Through Status), effective on Jan 1, 2020 Will allow Outpatient departments to bill Medicare at ASP + 6% for XENLETA IV XENLETA’s J Code Application expected to be submitted by Dec 31st Approval expected by Oct 2020, effective Jan 2021 CMS could award new J codes on a quarterly basis that would expedite approval Will allow for Outpatient departments to bill Medicare and Commercial Plans with a permanent code at ASP + 6% for XENLETA IV

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XENLETA Launch Near Term Priority Continue to finalize Medicare and Commercial contracts to further expand XENLETA access Continue to work with Key Hospital Accounts to help secure P&T Review of XENLETA Drive Initial Purchase and Utilization at High Priority Accounts, Prior to Formulary Review Pull Through Appropriate Patients and Expand Utilization Maximize Utilization of XENLETA in Hospitals who have the Focus and Infrastructure Consistent with our “Transition of Care” Strategy Launch of a Focused Community Effort A Strong Foundation Leads to “Pull Through” 17 New and Re-Orders in Hospitals Provide a Substantial Foundation of “Customers” Using XENLETA in the Inpatient and Outpatient Setting

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The Focused Effort in the Community Targeted outreach designed to leverage existing hospital sales force to begin accessing the 2.3MM CABP outpatients A substantial opportunity that differentiates XENLETA from other recent antibiotic launches Targeting visits to over 6,000 community HCPs who are: Within close proximity to our key hospital accounts High prescribers of key oral antibiotics for CABP Nabriva Rx Connect services expanded to remove barriers Includes shipping XENLETA directly to appropriate patients 18 This Photo by Unknown Author is licensed under CC BY-NC-ND

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Financial Review Gary Sender, CFO 19

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Q3 19 – Finance Highlights XenletaTM (lefamulin) launched on September 9th in the US - just 3 weeks after approval Net sales of $1.4MM in the first 3 weeks on the US Market, exceeding 2019 expectations Cash & short term investments = $78.3 MM on September 30th, higher than Q2 19 ending balance Significant cash inflows in Q3 from Sinovant milestone payment, debt draw and ATM activity Cash runway extended by one quarter and expected to fund operations into the Q3 20 20

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Three Months Ended, September 30, Change (in thousands) 2018 2019 3 months Revenues Product revenue, net $ 0 $ 1,445 $ 1,445 Collaboration revenue 0 5,051 5,051 Research premium and grant income 461 424 (37) Operating expenses Cost of revenue – product sales 0 (15) (15) Research and development (40,804) (5,601) 35,203 Selling, general and administrative (12,582) (18,503) (5,921) Total operating expenses (53,386) (24,119) 29,267 Loss from operations (52,925) (17,199) 35,726 Other income (expense) Other income (expense), net (54) (10) 44 Interest income 11 94 83 Interest expense (8) (709) (701) Income (loss) before income taxes (52,976) (17,824) 35,152 Income tax (expense) benefit 151 29 (122) Net income (loss) (52,825) (17,795) 35,030 Other comprehensive income (loss), net of tax 0 0 0 Total comprehensive income (loss) $ (52,825) $ (17,795) $ 35,030 Income Statement – Q3 19 versus Q3 18 Third quarter highlights: XENLETA net sales of $1.4 MM, with GTN under 30% $5MM collaboration revenue from Sinovant milestone payment COGS recorded reflects final preparation of finished product. Most product costs previously expensed 2018 R&D include in process R&D related to the Zavante acquisition; 2019 R&D expenses have decreased SG&A expense higher due to increasing investments in our commercial organization Interest expense from Hercules loan 21

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Q3 19 Balance Sheet (in thousands) As of December 31, 2018 As of September 30, 2019 Current assets Cash and cash equivalents $ 102,003 $ 78,101 Restricted cash 0 228 Short-term investments 225 175 Accounts receivable 3,871 6,540 Contract Asset 1,500 - Inventory - 162 Prepaid expenses 1,154 1,202 108,753 86,408 Non-current assets Property, plant and equip. 1,139 2,655 Intangible assets, net 98 343 Other non-current assets 428 716 1,665 3,714 Total assets $ 110,418 $ 90,122 As of December 31, 2018 As of September 30, 2019 Current liabilities Accounts payable $ 3,304 $ 3,221 Accrued expenses and other cur. liab. 14,502 11,663 Non-current liabilities Borrowings 23,718 34,241 Other non-current liabilities 264 1,782 Total liabilities 41,788 50,907 Stockholders' Equity Common stock 670 780 Additional paid in capital 461,911 492,105 Accumulated other comp, income (loss) 27 27 Accumulated deficit (393,978) (453,697) Total equity 68,630 39,215 Total liabilities and stockholders' equity $ 110,418 $ 90,122 Third Quarter Highlights: Cash and cash equivalents plus short term investments equal $78.3 MM Changes in accounts receivable driven by product sales Increase in borrowings includes additional $10 MM draw from Hercules 22

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Closing Remarks and Q&A Ted Schroeder, CEO 23

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XENLETA: Strongly Positioned for a Successful Launch XENLETA offers a new, differentiated mechanism of action, with a complete spectrum of coverage of main CABP pathogens, including MDR strains, in a well tolerated short course of IV and Oral monotherapy Highly experienced and talented HQ and field teams in Marketing, Market Access and Medical Affairs now supporting 60 Territory Business Managers in the commercial launch of XENLETA The extensive early engagement of the scientific and payor community and the profiling of more than 650 Top Accounts is allowing us to create a solid foundation for a successful launch and a faster uptake, while building for the long term Successful Launch 24

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Q&A 25

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Appendix 26

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References to Slide 8 MIC=minimum inhibitory concentration. *Data presented are from 2010 to September 2019. Dataset provided by JMI Labs and the SENTRY Antimicrobial Surveillance Program. sentry-mvp.jmilabs.com. Accessed October 5, 2019. 1. National Ambulatory Medical Care Survey (NAMCS) and National Hospital Ambulatory Medical Care Survey (NHAMCS) 2009 - 2010. https://www.cdc.gov/nchs/data/ahcd/combined_tables/2009-2010_combined_web_table01.pdf (Last Accessed June 21, 2019). 2. Centers for Disease Control and Prevention. Antibiotic resistance threats in the United States. 2013. www.cdc.gov/drugresistance/pdf/ar-threats-2013-508.pdf. Accessed October 10, 2019. 3. Kim L, et al. Clin Microbiol Rev. 2016;29:525-552. 4. Blondeau JM, et al. J Infect Dis Ther. 2017;5(1). 5: el Bcheraoui C, Mokdad AH, Dwyer-Lindgren L, et al. Trends and Patterns of Differences in Infectious Disease Mortality Among US Counties, 1980-2014. JAMA. 2018;319(12):1248–1260. doi:10.1001/jama.2018.2089 6: Fingar K, Washington R. Trends in hospital readmissions for four high-volume conditions, 2009-2013: Statistical Brief #196. Healthcare Cost and Utilization Project (HCUP) Statistical Briefs. Rockville, MD: Agency for Healthcare Research and Quality; November 2015. http//www.hcup-us.ahrq.gov/reports/statbriefs/sb196-Readmissions-Trends-High-Volume-Conditions.pdf. Accessed February 23, 2016. 7: HCUP Fast Stats - Most Common Diagnoses for Inpatient Stays – 2015 https://www.hcup-us.ahrq.gov/faststats/NationalDiagnosesServlet 8: 2017 CHARTBOOK STATIC ANALYSES - Trends in mortality rates following admission for acute myocardial infarction, chronic obstructive pulmonary disease, heart failure, pneumonia, and acute ischemic stroke. Prepared for CMS by Yale New Haven Health Services Corporation - Center for Outcomes Research and Evaluation (YNHHSC/CORE) September 2017 9: Joya-Montosa Critical Care 2015 19(Suppl 1):P19. 10: AlOtair Journal of Taibah University Medical Sciences Volume 10, Issue 3, Sept. 2015, Pages 293-299. 11: File TM Jr, Marrie TJ. Burden of community-acquired pneumonia in North American adults. Postgrad Med. 2010;122:130–41. 27 Distribution of azithromycin, ampicillin, and doxycycline resistance for S. pneumoniae across the US*4

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