Full Press Release Details
SAVARA REPORTS FOURTH QUARTER AND FULL YEAR 2017 FINANCIAL RESULTS
AND PROVIDES BUSINESS UPDATE
Anticipating completion of enrollment in Molgradex Phase 3 IMPALA study in Q3 2018
Anticipating completion of enrollment in AeroVanc Phase 3 AVAIL study in Q1 2019
Anticipating completion of enrollment in Molgradex Phase 2a OPTIMA study in Q3 2018
Conference call scheduled for today at 5:30 p.m. E.T.
AUSTIN, TX March 14, 2018 Savara Inc. (NASDAQ: SVRA), an orphan lung disease company, today reported fourth
quarter and full year 2017 financial results and provided a business update.
2017 was transformative for Savara and served as a solid foundation as
we aim to build a preeminent orphan lung disease company, stated Rob Neville, chief executive officer of Savara. Our public listing in the capital markets, two successful public offerings, the progression of our two lead programs into
Phase 3 development in PAP and CF, as well as our expansion into a new and exciting therapeutic area, NTM, exceeded even our most aggressive plans, and was an outstanding achievement for our entire team. With two late-stage clinical studies ongoing,
our focus in 2018 will be on the continued advancement of our core programs, while actively exploring further expansion of our pipeline.
Upcoming Milestones and Recent Developments
Fourth Quarter Financial Results (Unaudited)
Savara s net loss for the fourth quarter of 2017 was $6.5 million, or $(0.23) per share, compared with a net loss
of $4.0 million, or $(1.31) per share, for the fourth quarter of 2016.
Research and development expenses were $6.4 million for
the fourth quarter of 2017, compared with $3.5 million for the fourth quarter of 2016.
General and administrative expenses for the fourth
quarter of 2017 were $2.8 million, compared with $0.9 million for the fourth quarter of 2016.
As of December 31, 2017, we had
cash of $22.1 million and short-term investments of $72.2 million. The Company s operating expenses for the fourth quarter of 2017 were approximately $9.3 million. Savara ended the fourth quarter of 2017 with approximately $14.8
million outstanding in long-term debt on its balance sheet, which we utilized to bolster operations.
Fiscal Year 2017 Financial Results
Savara s net loss for the year ended December 31, 2017 was $29.8 million, or $(1.76) per share, compared with a net loss of
$10.9 million, or $(5.62) per share for the year ended December 31, 2016.
Research and development expenses increased by $10.3 million, or
126%, to $18.5 million for the year ended December 31, 2017 from $8.2 million for the year ended December 31, 2016. The increase was primarily due to $7.8 million in increased development costs associated with the
development of Molgradex, which was not part of the Savara development plan until mid-July 2016, and an increase of $1.5 million in AeroVanc CMC and study costs as we initiated our Phase 3 clinical trial.
Additionally, in April 2017 we began incurring costs for our Aironite program which totaled $1.0 million for the year ended December 31, 2017 versus $0 for the year ended December 31, 2016.
General and administrative expenses increased by $8.3 million, or 292%, to $11.1 million for the year ended December 31, 2017 from
$2.8 million for the year ended December 31, 2016. The increase was due to $2.2 million of expense in connection with the changes in fair value of the contingent consideration associated with the Serendex acquisition and approximately
$2.8 million of expense in connection with the merger with Mast Therapeutics, Inc. and financing activities and related costs including legal and accounting expenditures. Savara personnel costs increased $1.5 million due to increased
administrative personnel costs which includes the addition of several finance and accounting personnel. In 2017, Savara incurred increased costs associated with being a public company. These costs included certain legal, accounting and filing costs,
as well as public company insurance costs, all of which totaled approximately $1.0 million. Additionally, administrative costs of Savara ApS (Denmark) totaled $0.8 million during the year ended December 31, 2017 and such entity was
not part of Savara until July 15, 2016, and had costs of only $0.3 million for the five and a half months under our ownership through December 31, 2016.
Conference Call and Webcast
Savara will hold a conference call today beginning at 5:30 p.m. Eastern Time / 4:30 p.m. Central Time to provide an overview and business
update. 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 should request the Savara Inc. call. A live webcast of the conference call will be available online from the Investors section of Savara s website at
http://www.savarapharma.com/investors/events/. Replays of the webcast will be available on Savara s website for 30 days, and a telephone replay will be available through March 21, 2018 by dialing (877)
344-7529 from the U.S., (855) 669-9658 from Canada, and (412) 317-0088 from elsewhere outside the U.S. by entering replay
access code 10117656.
an orphan lung disease company. Savara s pipeline comprises: Molgradex, an inhaled granulocyte-macrophage colony-stimulating factor, or GM-CSF, in Phase 3 development for PAP, and in Phase 2a development
for NTM lung infection; and AeroVanc, a Phase 3 stage inhaled vancomycin for treatment of MRSA infection in cystic fibrosis. 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, in 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)
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 about our aim to build a preeminent orphan lung disease company, our expansion into NTM as a new and
exciting therapeutic area, our focus in 2018 being on the continued advancement of our core programs and actively exploring further expansion of our pipeline, the timing of the completion of enrollment and topline data of our Molgradex Phase 3
IMPALA study, the timing of completion of enrollment and topline data of our AeroVanc Phase 3 AVAL study, the timing of completion of enrollment of our Molgradex Phase 2a OPTIMA study 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. Because such statements are subject to risks and uncertainties, actual results may differ materially from
those expressed or implied by such 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, risks and uncertainties associated with the outcome of our ongoing
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 timing and ability of Savara to raise additional equity capital to fund continued
operations; the ability to successfully develop our product candidates, and 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. 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.
Ioana C. Hone (ir@savarapharma.com)
Kelly Mueller (kmueller@troutgroup.com)
Media: LaVoieHealthScience
Sharon Correia (scorreia@lavoiehealthscience.com)
Savara Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(In thousands, except for share and per share amounts)
| Three months ended December 31, (Unaudited) | Year ended December 31, | |||||||||||||||
| 2017 | 2016 | 2017 | 2016 | |||||||||||||
| Total net revenue | $ | $ | 400 | $ | $ | 400 | ||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 6,434 | 3,488 | 18,512 | 8,182 | ||||||||||||
| General and administration | 2,771 | 866 | 11,081 | 2,820 | ||||||||||||
| Depreciation and amortization | 91 | 90 | 363 | 346 | ||||||||||||
| Total operating expenses | 9,296 | 4,444 | 29,956 | 11,348 | ||||||||||||
| Loss from operations | $ | (9,296 | ) | $ | (4,044 | ) | $ | (29,956 | ) | $ | (10,948 | ) | ||||
| Interest and other (expense)/income, net | (16 | ) | (282 | ) | (3,475 | ) | (332 | ) | ||||||||
| Loss before income taxes | $ | (9,312 | ) | $ | (4,326 | ) | $ | (33,431 | ) | $ | (11,280 | ) | ||||
| Income tax benefit | 2,810 | 357 | 3,634 | 357 | ||||||||||||
| Net loss | $ | (6,502 | ) | $ | (3,969 | ) | $ | (29,797 | ) | $ | (10,923 | ) | ||||
| Other expenses attributable to common shareholders | (24 | ) | (982 | ) | (94 | ) | ||||||||||
| Net loss attributable to common shareholders | $ | (6,502 | ) | $ | (3,993 | ) | $ | (30,779 | ) | $ | (11,017 | ) | ||||
| Net loss per share basic and diluted | $ | (0.23 | ) | $ | (1.31 | ) | $ | (1.76 | ) | $ | (5.62 | ) | ||||
| Weighted average shares basic and diluted | 28,652,104 | 3,045,672 | 17,521,119 | 1,960,490 |
Savara Inc. and Subsidiaries
| December 31, 2017 | December 31, 2016 | |||||||
| Cash, cash equivalents and short-term investments | $ | 94,313 | $ | 13,373 | ||||
| Working capital | 91,849 | 11,158 | ||||||
| Total assets | 159,628 | 28,934 | ||||||
| Total liabilities | 40,319 | 20,948 | ||||||
| Redeemable convertible preferred stock | 43,861 | |||||||
| Stockholders equity (deficit) | 119,309 | (35,875 | ) |