Liquidia Reports Third Quarter 2020 Financial Results and Provides Corporate Update
- Bolstered and Defended LIQ861 Patent Position
- Advanced Efforts in Support of the RareGen, LLC Merger and Integration
- Company to Host Webcast and Conference Call Today at 8:00 a.m. ET
“Despite the ongoing COVID-19 pandemic, we continue to make progress in defending our right to bring LIQ861 forward for patients, while also making significant strides to advance our mission through an improved balance sheet, cash runway, and intellectual property position with respect to dry powder inhaled treprostinil. These are all important achievements as we move closer to the potential approval and long-term commercialization of LIQ861.” said
$75 Millionin Gross Proceeds from Public Offering to Strengthen Balance Sheet
Closed underwritten public offering of 9,375,000 shares of common stock at a public offering price of $8.00 on
July 2, 2020, generating net proceeds of approximately $70.3 million, which further augments the Company’s balance sheet in advance of potential U.S. Food and Drug Administration(FDA) approval of LIQ861.
- Completed Chief Financial Officer Transition and Initiated Optimization of Financial Operations
Completed a transition of Chief Financial Officer responsibilities to Steven Bariahtaris as interim Chief Financial Officer in
August 2020. Following his appointment, Mr. Bariahtarisand the finance team enhanced the Company’s financial planning and budget controls and initiated a process of implementing a more cost-efficient operating plan to further improve the Company’s cashflow into 2022.
- Bolstered LIQ861 Intellectual Property Position
Received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for patent application No. 16/099,135 (’135) in
August 2020related to LIQ861 covering methods of treating pulmonary hypertension (PH) with doses between about 100 micrograms to about 300 micrograms of dry powder treprostinil. The patent will substantially strengthen Liquidia’s intellectual property position with respect to dry powder inhaled treprostinil and represents an important milestone for LIQ861 on its path to potential commercialization. Of note, greater than 70 percent of patients who have been enrolled in the INSPIRE and extension studies titrated to LIQ861 doses of 100 micrograms or more. For context, pharmacokinetic studies demonstrated that the 79.5 mcg dose of LIQ861 correlates with nine breaths of Tyvaso (54 mcg), the maximum recommended label dose of Tyvaso. The patent, which is expected to be issued in the fourth quarter of 2020, should have a term that expires no earlier than 2037.
- Defended Right to Advance LIQ861 as an Innovation for Patients
Continued to vigorously defend patent positions in order to bring the innovation of dry powder treprostinil to patients.
Defended against assertion of infringement. In
Petition for Inter Partes Review. At the end of
- Advanced Efforts in Support of the Proposed RareGen, LLC Merger and Integration
The proposed acquisition of
RareGen, LLC(“RareGen”) reinforces Liquidia’s commitment to the PAH community and Liquidia’s continued pursuit to address the unmet needs of patients and the healthcare professionals who treat them. The potential introduction of LIQ861 as a more convenient inhaled treprostinil over the currently available inhaled option, combined with RareGen’s parenteral treprostinil option, emphasize Liquidia’s commitment to addressing the patient continuum of treatment. In addition, these combined entities further enhance the organization’s knowledge base, customer reach and commercial planning in preparation for the potential launch of LIQ861, if approved. The special meeting of Liquidiastockholders to consider the RareGen merger and related matters is scheduled for November 13, 2020.
Third Quarter 2020 Financial Results
As of September 30, 2020, cash totaled $79.6 million. On July 2, 2020, the Company completed an underwritten public offering of 9.375 million shares at a price of $8.00 per share, resulting in gross proceeds of $75.0 million and net proceeds of approximately
- Research and Development (R&D): R&D expenses were $7.7 million for the third quarter of 2020 compared with $10.9 million for the same period of 2019. The decrease of $3.3 million was primarily driven by a decrease in clinical trial related expenses.
- General and Administrative (G&A): G&A expenses were $7.2 million for the third quarter of 2020, compared with $2.4 million for the same period of 2019. The increase of $4.8 million was primarily due to an increase of
$2.8million expenses related to the RareGen acquisition and other legal expenses, $1.1 millionin compensation and consulting expenses, and $0.9 millionof reclassified spending from R&D to G&A.
- Interest Income: Interest income was
$35,000for the third quarter of 2020, compared with $162,000 for the same period of 2019.
- Interest Expense: Interest expense was
$191,000for the third quarter of 2020, compared with $265,000for the same period of 2019.
- Net Loss: Net loss was $15.0 million for the third quarter of 2020, compared with $13.4 million for the third quarter of 2019. The increase of $1.5 million was primarily due to an increase in G&A expenses, partially offset by a decrease in R&D expenses.
Webcast and Conference Call
The Company will host a webcast and conference call
Liquidia is a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel products using its proprietary PRINT® technology to transform the lives of patients. PRINT is a particle engineering platform that enables precise production of uniform drug particles designed to improve the safety, efficacy and performance of a wide range of therapies. Currently, Liquidia is focused on the development of two product candidates for which it holds worldwide commercial rights: LIQ861 for the treatment of pulmonary arterial hypertension (PAH) and LIQ865 for the treatment of local post-operative pain. Liquidia is headquartered in Research Triangle Park, NC. For more information, please visit www.liquidia.com.
RareGen is a portfolio company of PBM Capital Group, a healthcare investment firm. RareGen provides strategy, investment, and commercialization for rare disease pharmaceutical products. RareGen has a national sales force focused on cardiology and pulmonology specialties.
Important Information About the Transaction and Where to Find It
In connection with the proposed RareGen merger transaction, the Company and
Participants in the Solicitation
The Company, RareGen and certain of their respective directors, executive officers and employees may be deemed to be participants in the solicitation of proxies in respect of the proposed transaction and related matters. Information regarding the Company’s directors and executive officers, including a description of their direct interests, by security holdings or otherwise, is contained in the Company’s Form 10-K for the year ended December 31, 2019 and its proxy statement filed on April 28, 2020, which are filed with the SEC. Additional information is available in the registration statement on Form S-4 and the proxy statement/prospectus.
No Offer or Solicitation
This communication is not intended to and shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote of approval, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
Cautionary Statements Regarding Forward-Looking Statements
This press release may include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical facts, including statements regarding our future results of operations and financial position, our strategic and financial initiatives, our business strategy and plans and our objectives for future operations, are forward-looking statements. Such forward-looking statements, including statements regarding clinical trials, clinical studies and other clinical work (including the funding therefor, anticipated patient enrollment, safety data, study data, trial outcomes, timing or associated costs), regulatory applications and related timelines, including potential FDA approval of the NDA for LIQ861, the timeline or outcome related to our patent litigation pending in the U.S. District Court for the District of Delaware or its inter partes review with the PTAB, the issuance of patents by the USPTO and our ability to execute on our strategic or financial initiatives, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives and financial needs. These forward-looking statements are subject to a number of risks discussed in our and Liquidia Corporation’s filings with the SEC, including the risk that our proposed acquisition of RareGen is not consummated or that the expected benefits and synergies from the proposed acquisition are not realized, the impact of the coronavirus (COVID-19) outbreak on our company and our financial condition and results of operations, as well as a number of uncertainties and assumptions. Moreover, we operate in a very competitive and rapidly changing environment and our industry has inherent risks. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the future events discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Nothing in this press release should be regarded as a representation by any person that these goals will be achieved, and we undertake no duty to update our goals or to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise.
Vice President, Corporate Development and Strategy
-Financial Tables Follow-
|Prepaid expenses and other current assets||1,095,331||590,251|
|Total current assets||80,646,372||56,386,629|
|Property, plant and equipment, net||7,388,376||9,253,965|
|Operating lease right-of-use assets, net||2,698,344||2,823,430|
|Liabilities and stockholders’ equity|
|Accrued stock offering expenses||0||1,289,413|
|Other accrued expenses||1,409,976||1,525,919|
|Current portion of operating lease liabilities||638,862||566,390|
|Current portion of finance lease liabilities||1,113,670||1,244,229|
|Current portion of long-term debt||5,585,636||5,585,637|
|Total current liabilities||14,231,602||16,874,318|
|Long-term operating lease liabilities||5,183,539||5,670,971|
|Long-term finance lease liabilities||310,513||1,056,747|
|Commitments and contingencies|
|Preferred stock — 10,000,000 shares authorized as of
|Common stock —
shares issued and outstanding as of
|Additional paid-in capital||324,159,065||250,158,766|
|Total stockholders’ equity||65,281,107||34,947,547|
|Total liabilities and stockholders’ equity||$||91,111,135||$||68,842,067|
|Three Months Ended||Nine Months Ended|
|Costs and expenses:|
|Cost of revenue||—||—||—||807,192|
|Research and development||7,660,979||10,942,561||26,974,320||32,330,454|
|General and administrative||7,151,788||2,377,687||16,201,249||7,807,920|
|Total costs and expenses||14,812,767||13,320,248||43,175,569||40,945,566|
|Loss from operations||(14,812,767||)||(13,320,248||)||(43,175,569||)||(32,873,446||)|
|Other income (expense):|
|Total other income (expense), net||(155,913||)||(102,811||)||(500,691||)||(217,568||)|
|Net loss and comprehensive loss||$||(14,968,680||)||$||(13,423,059||)||$||(43,676,260||)||$||(33,091,014||)|
|Net loss attributable to common stockholders, basic
|Weighted average common shares outstanding, basic
Source: Liquidia Technologies, Inc.