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SAVARA REPORTS SECOND QUARTER 2019 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE Molgradex aPAP Program: Continue with Regulatory Interactions, Expect FDA Written Responses to Type C Meeting in October Anticipate Filing

Key Takeaway: SAVARA REPORTS SECOND QUARTER 2019 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE Molgradex aPAP Program: AUSTIN, TX August 8, 2019 Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, today reported financial results for the second quarter ending June 30, 2019 and pro

Full Press Release Details

SAVARA REPORTS SECOND QUARTER 2019 FINANCIAL RESULTS
AND PROVIDES BUSINESS UPDATE
Molgradex aPAP Program:
AUSTIN, TX August 8, 2019 Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, today reported financial
results for the second quarter ending June 30, 2019 and provided a business update.
Our highest corporate priority continues to be the
Molgradex aPAP program, said Rob Neville, Chief Executive Officer, Savara. While the IMPALA study did not achieve statistical significance on its pre-specified primary endpoint, the totality of the
efficacy data are encouraging and reinforce the important role of Molgradex to improve oxygenation and reduce surfactant burden in these patients. Additionally, with adverse event frequencies similar to placebo, we believe this drug has a compelling
risk-benefit profile. We are proceeding with regulatory interactions to determine the best path forward, while simultaneously preparing for an additional Phase 3 study should that be required.
Recent Developments and Upcoming Highlights
Molgradex for autoimmune pulmonary alveolar proteinosis (aPAP)
Molgradex for nontuberculous mycobacterial (NTM) lung infection
Exploratory Pipeline
Second Quarter Financial Results (Unaudited)
Savara s net loss attributable to common stockholders for the three months ended June 30, 2019 was $21.9 million, or $(0.57) per
share, compared with a net loss attributable to common stockholders of $11.6 million, or $(0.37) per share, for the three months ended June 30, 2018.
Research and development expenses were $10.5 million for the three months ended June 30, 2019, compared with $9.3 million for the
three months ended June 30, 2018. The increase was primarily due to $2.2 million in increased development costs associated with the development of Molgradex and AeroVanc, which was partially offset by $1.0 million in expense in the
form of common stock issued in connection with an asset purchase in the second quarter of 2018.
General and administrative expenses for the three months
ended June 30, 2019 were $4.2 million, compared with $2.5 million for the three months ended June 30, 2018. The increase was primarily due to increased personnel costs and other legal, accounting, insurance, commercial strategy,
business development, and operating activities.
During the three months ended June 30, 2019, we recognized a $7.4 million non-cash impairment charge to the carrying value of our goodwill following the results of our IMPALA study.
of June 30, 2019, Savara had a carrying value of its debt of approximately $24.8 million and had cash, cash equivalents, and short-term investments of approximately $111.7 million. Under the current operating plan, the
Company believes this is sufficient capital to fund planned operations into 2021.
Conference Call and Webcast
Savara will host a conference call today at 4:30 p.m. Eastern Time (ET)/1:30 p.m. Pacific Time (PT). Shareholders and other interested parties may access the
conference call by dialing (855) 239-3120 from the U.S., (855) 669-9657 from Canada, and (412) 542-4127 from elsewhere
outside the U.S. and request the Savara Inc. call. A live webcast of the conference call will be available online in the Investors section of Savara s website
Approximately one hour after the call, a replay of the webcast will be
available on Savara s website for 30 days, and a telephone replay will be available through August 15, 2019 by dialing (877) 344-7529 from the U.S., (855)
669-9658 from Canada and (412) 317-0088 from elsewhere outside the U.S. and entering the replay access code 10133438.
Savara is an orphan lung disease company.
Savara s pipeline comprises Molgradex, an inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP), in Phase 2a
development for nontuberculous mycobacterial (NTM) lung infection in both non-cystic fibrosis (CF) and CF-affected individuals with chronic NTM lung infection; and
AeroVanc, a Phase 3-stage inhaled vancomycin for treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in CF. Savara s strategy involves expanding its pipeline
of potentially best-in-class products through indication expansion, strategic development partnerships and product acquisitions, with the goal of becoming a leading
company in its field. Savara s management team has significant experience in orphan drug development and pulmonary medicine, identifying unmet needs, developing and acquiring new product candidates, and effectively advancing them to approvals
and commercialization. More information can be found at www.savarapharma.com. (Twitter: @SavaraPharma, LinkedIn: www.linkedin.com/company/savara-pharmaceuticals/)
Forward Looking Statements
Savara cautions you that statements in this press release that are not a description of historical fact are forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words referencing future events or circumstances such as expect, intend, plan,
anticipate, believe, and will, among others. Such statements include, but are not limited to, statements regarding our highest corporate priority being the Molgradex aPAP program, that the totality of the IMPALA
efficacy data are encouraging and reinforce the important role of Molgradex to improve oxygenation and reduce surfactant burden in aPAP patients, the belief that Molgradex has a compelling risk-benefit profile, that we are proceeding with regulatory
interactions to determine the best path forward, while simultaneously preparing for an additional Phase 3 study should that be required, that we expect written responses from the FDA in October 2019, that we anticipate filing for Breakthrough
Designation in the U.S., statements regarding the timing of top line results from our OPTIMA and AVAIL studies, statements regarding the enrollment of our AVAIL study, including the timing of completion of enrollment, that future development of the
amikacin/fosfomycin program will be considered at a later time, the belief that Savara has sufficient capital to fund planned operations into 2021 under the current operating plan, and Savara s strategy. Savara may not actually achieve any of
the matters referred to in such forward-looking statements, and you should not place undue reliance on these forward-looking statements. These forward-looking statements are based upon Savara s current expectations and involve assumptions that
may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without
limitation, the outcome of our planned meeting with the FDA to discuss the IMPALA data and path forward, risks and uncertainties associated with the outcome of our ongoing and planned clinical trials for our product candidates, the ability to
project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources for Savara s operations and to conduct or continue planned clinical development programs,
the ability to obtain the necessary patient enrollment for our product candidates in a timely manner, the ability to successfully identify product acquisition candidates, the ability to successfully develop our product candidates, the risks
associated with the process of developing, obtaining regulatory approval for and commercializing drug candidates such as Molgradex and AeroVanc that are safe and effective for use as human therapeutics, and the timing and ability of Savara to raise
additional equity capital as needed to fund continued operations. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. For a detailed description of our risks and uncertainties, you are encouraged
to review our documents filed with the SEC including our recent filings on Form 8-K, Form 10-K and Form 10-Q. You are cautioned
not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Savara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on
which they were made, except as may be required by law.
Financial Information to Follow
Savara Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(in thousands, except for share and per share amounts)
Three months ended Six months ended
June 30, June 30,
(Unaudited) (Unaudited)
2019 2018 2019 2018
Operating expenses:
Research and development $ 10,464 $ 9,268 $ 20,483 $ 17,807
General and administration 4,211 2,486 6,974 4,254
Impairment of acquired IPR&D 21,692
Impairment of goodwill 7,420 7,420
Depreciation and amortization 59 153 197 260
Total operating expenses 22,154 11,907 35,074 44,013
Loss from operations $ (22,154) $ (11,907 ) $ (35,074 ) $ (44,013 )
Other income, net 215 313 1,023 1,016
Loss before income taxes $ (21,939) $ (11,594 ) $ (34,051 ) $ (42,997 )
Income tax benefit 4,555
Net loss $ (21,939) $ (11,594 ) $ (34,051) $ (38,442 )
Net loss per share - basic and diluted $ (0.57) $ (0.37 ) $ (0.91) $ (1.23 )
Weighted average shares - basic and diluted 38,440,647 31,433,494 37,235,209 31,376,425
Other comprehensive income (expense): 211 (819 ) 12 (502 )
Total comprehensive loss $ (21,728) $ (12,413 ) $ (34,039) $ (38,944 )
Savara Inc. and Subsidiaries
Condensed Consolidated Balance Sheet data
June 30, December 31,
2019 2018
Cash, cash equivalents, and short-term investments $ 111,732 $ 110,830
Working capital 105,116 106,090
Total assets 147,330 152,287
Total liabilities 34,531 44,068
Stockholders equity 112,799 108,219
Last updated: Aug 8, 2019