-- Company provides update on ZEMDRITM commercialization and launch
--
-- Conference call today at 8:30 a.m. Eastern Time --
SOUTH SAN FRANCISCO, Calif., Nov. 08, 2018 (GLOBE NEWSWIRE) -- Achaogen, Inc. (NASDAQ: AKAO), a biopharmaceutical company
discovering, developing and commercializing innovative antibacterial agents to address multi-drug resistant (MDR) gram-negative
infections, today reported financial results for the third quarter ended September 30, 2018, and provided an update on its
commercial and corporate activities.
“Momentum for ZEMDRI continues to build and we are pleased with the interest we are seeing for the product as a result of
ZEMDRI’s strong clinical data, differentiated profile, and versatility across inpatient and outpatient treatment settings,” said
Blake Wise, Achaogen’s Chief Executive Officer. “We also advanced other important corporate priorities, including the submission of
a Marketing Authorization Application for plazomicin to the European Medicines Agency while streamlining operations and reducing
expenses.”
Recent Highlights and Upcoming Milestones
- ZEMDRI Launch Update: The launch focus continues to be the education of physicians on the clinical profile
of ZEMDRI and building the foundation to support product use across the hospital and outpatient settings. The commercial
organization continues to build momentum on key leading indicators including: formulary review and approval, orders of antibiotic
susceptibility testing materials and customer readiness for therapeutic drug management testing. ZEMDRI revenues for the quarter
represent approximately two months of product sales prior to broad formulary approval or the availability of the NTAP
supplementary reimbursement, which went into effect on October 1st. During the quarter, ZEMDRI achieved net revenues of $291,000
and, to date, 60% of use has been in the outpatient setting.
-
European Marketing Authorization Application (MAA): On October 15, 2018, Achaogen announced the submission of
a Marketing Authorization Application (MAA) to the European Medicines Agency for plazomicin seeking approval for the following
indications:
- Complicated urinary tract infections (cUTI), including pyelonephritis
- Bloodstream infections (BSI) due to certain Enterobacteriaceae and
- Infections due to Enterobacteriaceae in adult patients with limited treatment options
- NTAP Designation: On October 1, 2018, a New Technology Add-on Payment (NTAP) went into effect for
ZEMDRI. The NTAP designation is granted for new technologies that demonstrate substantial clinical improvement over current
treatments and provides hospitals with a payment, in addition to the standard-of-care Diagnostic Related Group (DRG)
reimbursement, of up to 50% of the cost of ZEMDRI when prescribed to Medicare patients in a hospital setting for a period of two
to three years.
Other Corporate Milestones
- Strategic Review and Restructuring: On November 5, 2018, the Company announced a review of strategic
alternatives to maximize shareholder value and a restructuring to preserve cash resources and reduce total expenses.
Third Quarter 2018 Financial Results
Cash Position: At September 30, 2018, Achaogen had $58.2 million in unrestricted cash, cash equivalents and
short-term investments compared to $164.8 million at December 31, 2017.
Revenue: Achaogen reported ZEMDRI net product sales of $0.3 million for the three months ended September 30,
2018. The full commercial launch of ZEMDRI occurred on July 20, 2018 so there were no similar product sales in the same
period in 2017. Contract revenue totaled $1.7 million for the third quarter of 2018 compared to $0.6 million for the same period in
2017. The increase in contract revenue during the third quarter was primarily related to the BARDA C-Scape contract. As of
September 30, 2018, $7.6 million remains under the BARDA C-Scape contract and up to an additional $6.0 million may be available
under BARDA contract options. All Achaogen contract revenue consisted of U.S. government and Gates Foundation funding for the
research and development of product candidates.
Research and Development (R&D): R&D expenses in the third quarter of 2018 were $21.7 million, compared
to $25.3 million reported for the same period in 2017. The decrease in R&D expenses during the quarter was primarily due to a
decrease in personnel and facility related costs.
Selling, General and Administrative (SG&A): SG&A expenses in the third quarter of 2018 were $18.9
million, compared to $11.8 million for the same period in 2017. The increase in SG&A expenses during the quarter was primarily
due to an increase in personnel and facility related costs.
Restructuring Expenses: Restructuring expenses in the third quarter of 2018 were $7.9 million. There were
no restructuring charges for in the same period in 2017. Restructuring charges include severance and payroll related costs,
stock-based compensation costs and net facility exit costs related to our corporate restructuring announced on July 26, 2018.
Warrants and Derivative Liabilities: Change in warrant and derivative liabilities for the third quarter
of 2018 was a $4.9 million gain compared to a $6.8 million gain for the same period in 2017. The decrease was primarily due to the
change in the estimated fair value, which decreased due to the change in our stock price.
Net Loss: Achaogen reported a net loss of $41.8 million for the third quarter of 2018, compared to a net loss
of $29.9 million for the same period in 2017. Diluted net loss was $1.02 per share for the third quarter of 2018, compared to
diluted net loss of $0.85 per share for the same period in 2017. As of September 30, 2018, there were approximately 46.0 million
shares of common stock outstanding.
Conference Call
The Company will host a conference call and webcast today at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time. To participate by
telephone, please dial 866-952-8559 (domestic) or 785-424-1745 (international); conference ID: ACHAOGEN. A live and archived audio
webcast can be accessed through the Investors section of the Company's website at www.achaogen.com. The archived audio webcast will remain available on the Company's website for
30 days following the conference call.
About Achaogen
Achaogen is a biopharmaceutical company passionately committed to the discovery, development, and commercialization of innovative
antibacterial treatments for MDR gram-negative infections. Achaogen's first commercial product is ZEMDRI, for the treatment of
adults with complicated urinary tract infections, including pyelonephritis. The Achaogen ZEMDRI program was funded in part with
federal funds from the Biomedical Advanced Research and Development Authority (BARDA). The Company is currently developing C-Scape,
an orally-administered beta-lactam/beta-lactamase inhibitor combination, which is also supported by BARDA. C-Scape is
investigational, has not been determined to be safe or efficacious, and has not been approved for commercialization. For more
information, visit the Achaogen website at www.achaogen.com.
Forward-Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical facts contained herein
are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, the potential uses and
advantages of ZEMDRI (plazomicin), launch metrics for ZEMDRI, the approval of plazomicin by the EMA, the outcome of Achaogen’s
strategic review, Achaogen’s expectations regarding the timing and impact of its restructuring, Achaogen’s strategic and commercial
objectives and the Achaogen pipeline of product candidates. Such forward-looking statements involve known and unknown risks,
uncertainties, and other important factors that may cause Achaogen's actual results, performance, or achievements to be materially
different from any future results, performance, or achievements expressed or implied by the forward-looking statements. Such risks
and uncertainties include, among others, the risks and uncertainties that the strategic review may not be successful, the risks and
uncertainties of commercialization and gaining market acceptance, uncertainties inherent in the development process, the risks and
uncertainties of the regulatory approval process, the risk when bacteria will evolve resistance to ZEMDRI, Achaogen’s reliance on
third-party contract manufacturing organizations to manufacture and supply ZEMDRI, its product candidates and certain raw materials
used in the production thereof and the risk that Achaogen's proprietary rights may be insufficient to protect ZEMDRI, its
technologies and product candidates. For a further description of the risks and uncertainties that could cause actual results to
differ from those expressed in these forward-looking statements, as well as risks relating to the Achaogen business in general, see
Achaogen’s current and future reports filed with the Securities and Exchange Commission, including its Annual Report on Form 10-K
filed on February 27, 2018, and its Quarterly Report on Form 10-Q filed on November 8, 2018. Achaogen does not plan to publicly
update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future
events, changed circumstances, or otherwise.
Investor and Media Contact:
Martin Forrest
mforrest@achaogen.com
650-419-3920
Source: Achaogen, Inc.
© 2018 Achaogen, Inc. All Rights Reserved.
| |
| Achaogen, Inc, |
| Condensed Consolidated Statement of
Operations |
| (in thousands except share and per share data) |
| (unaudited) |
| |
| |
Three Months Ended |
|
Nine Months Ended |
| |
September 30, |
|
September 30, |
| |
2018 |
|
2017 |
|
2018 |
|
2017 |
| Revenues |
|
|
|
|
|
|
|
| Product revenue, net |
$ |
291 |
|
|
$ |
— |
|
|
$ |
291 |
|
|
$ |
— |
|
| Contract revenue |
|
1,707 |
|
|
|
577 |
|
|
|
6,412 |
|
|
|
9,306 |
|
| Total revenues |
|
1,998 |
|
|
|
577 |
|
|
|
6,703 |
|
|
|
9,306 |
|
| Operating expenses |
|
|
|
|
|
|
|
| Cost of sales |
|
11 |
|
|
|
— |
|
|
|
11 |
|
|
|
— |
|
| Research and development |
|
21,732 |
|
|
|
25,316 |
|
|
|
89,572 |
|
|
|
66,113 |
|
| Selling, general and administrative |
|
18,937 |
|
|
|
11,805 |
|
|
|
54,484 |
|
|
|
27,415 |
|
| Restructuring charges |
|
7,944 |
|
|
|
— |
|
|
|
7,944 |
|
|
|
— |
|
| Total operating expenses |
|
48,624 |
|
|
|
37,121 |
|
|
|
152,011 |
|
|
|
93,528 |
|
| Loss from operations |
|
(46,626 |
) |
|
|
(36,544 |
) |
|
|
(145,308 |
) |
|
|
(84,222 |
) |
| Interest expense |
|
(435 |
) |
|
|
(740 |
) |
|
|
(1,335 |
) |
|
|
(2,170 |
) |
| Change in warrant and derivative liabilities |
|
4,865 |
|
|
|
6,773 |
|
|
|
6,909 |
|
|
|
(3,957 |
) |
| Loss on debt extinguishment |
|
— |
|
|
|
— |
|
|
|
(819 |
) |
|
|
— |
|
| Other income, net |
|
405 |
|
|
|
604 |
|
|
|
1,563 |
|
|
|
1,114 |
|
| Net loss |
$ |
(41,791 |
) |
|
$ |
(29,907 |
) |
|
$ |
(138,990 |
) |
|
$ |
(89,235 |
) |
| Net loss per common share |
|
|
|
|
|
|
|
| Basic |
$ |
(0.92 |
) |
|
$ |
(0.71 |
) |
|
$ |
(3.10 |
) |
|
$ |
(2.31 |
) |
| Diluted |
$ |
(1.02 |
) |
|
$ |
(0.85 |
) |
|
$ |
(3.21 |
) |
|
$ |
(2.31 |
) |
| Weighted-average shares used to calculate net loss per common share |
|
|
|
|
|
|
|
| Basic |
|
45,329,711 |
|
|
|
42,259,001 |
|
|
|
44,854,279 |
|
|
|
38,709,811 |
|
| Diluted |
|
45,794,686 |
|
|
|
43,211,059 |
|
|
|
45,595,838 |
|
|
|
38,709,811 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| |
| Achaogen, Inc, |
| Condensed Consolidated Balance
Sheets |
| (in thousands) |
| |
| |
September 30,
2018 |
|
December 31,
2017 |
| |
(unaudited) |
|
|
| Assets |
|
|
|
| Current assets: |
|
|
|
| Cash and cash equivalents |
$ |
55,635 |
|
|
$ |
145,219 |
|
| Short-term investments |
|
2,589 |
|
|
|
19,572 |
|
| Trade and contract receivables, net |
|
1,981 |
|
|
|
1,357 |
|
| Inventory |
|
637 |
|
|
|
— |
|
| Prepaids and other current assets |
|
6,348 |
|
|
|
6,367 |
|
| Restricted cash |
|
328 |
|
|
|
5,891 |
|
| Total current assets |
|
67,518 |
|
|
|
178,406 |
|
| Property and equipment, net |
|
15,754 |
|
|
|
14,810 |
|
| Restricted cash |
|
6,267 |
|
|
|
3,855 |
|
| Non-current inventory |
|
1,604 |
|
|
|
— |
|
| Other long-term assets |
|
6,158 |
|
|
|
— |
|
| Total assets |
$ |
97,301 |
|
|
$ |
197,071 |
|
| Liabilities, contingently redeemable common stock and stockholders’
equity |
|
|
|
| Current liabilities: |
|
|
|
| Accounts payable |
$ |
10,920 |
|
|
$ |
6,862 |
|
| Accrued liabilities |
|
14,355 |
|
|
|
15,441 |
|
| Loan payable, current portion |
|
— |
|
|
|
12,500 |
|
| Deferred revenue |
|
328 |
|
|
|
2,100 |
|
| Derivative liability |
|
950 |
|
|
|
— |
|
| Total current liabilities |
|
26,553 |
|
|
|
36,903 |
|
| Loan payable, long-term |
|
24,773 |
|
|
|
9,457 |
|
| Warrant liability |
|
2,600 |
|
|
|
9,774 |
|
| Derivative liability, long-term |
|
— |
|
|
|
686 |
|
| Deferred rent |
|
8,588 |
|
|
|
8,289 |
|
| Total liabilities |
|
62,514 |
|
|
|
65,109 |
|
| Commitments and contingencies |
|
|
|
| Contingently redeemable common stock |
|
10,000 |
|
|
|
10,000 |
|
| Stockholders' equity |
|
|
|
| Common stock, $0.001 par value, 290,000,000 shares authorized at
September 30, 2018 and December 31, 2017; 45,967,093 and 42,515,015 shares issued and outstanding at September 30, 2018
and December 31, 2017, respectively |
|
46 |
|
|
|
42 |
|
| Preferred stock, $0.001 par value, 10,000,000 shares authorized and
zero shares issued and outstanding at September 30, 2018 and December 31, 2017 |
|
— |
|
|
|
— |
|
| Additional paid-in-capital |
|
536,569 |
|
|
|
494,758 |
|
| Accumulated deficit |
|
(511,828 |
) |
|
|
(372,838 |
) |
| Accumulated other comprehensive loss |
|
— |
|
|
|
— |
|
| Total stockholders’ equity |
|
24,787 |
|
|
|
121,962 |
|
| Total liabilities, contingently redeemable common stock and
stockholders’ equity |
$ |
97,301 |
|
|
$ |
197,071 |
|
