Altus Pharmaceuticals Inc. (ALTU)

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Altus Pharmaceuticals Reports Second Quarter 2008 Results
Tuesday August 5, 8:00 am ET
- - Company on Track to Report Phase 3 Trizytek Top-line Results in Third Quarter - -


CAMBRIDGE, Mass.--(BUSINESS WIRE)--Altus Pharmaceuticals Inc. (NASDAQ: ALTU - News), a biopharmaceutical company focused on the development and commercialization of oral and injectable protein therapeutics for patients with gastrointestinal and metabolic disorders, today reported financial results for the quarter ended June 30, 2008.

For the second quarter of 2008, the Company reported a net loss attributable to common stockholders of $25.3 million, or $0.82 per share, compared to a net loss attributable to common stockholders of $30.5 million, or $1.06 per share, in the second quarter of 2007. The Company did not recognize any revenue in the second quarter of 2008 and recognized revenues of $1.5 million in the second quarter of 2007.

Research and development expenses totaled $21.0 million in the second quarter of 2008 compared to $17.9 million in the second quarter of 2007. Second quarter 2008 R&D spending reflects increased clinical and manufacturing costs associated with TrizytekTM [porcine-free enzymes] and manufacturing related costs for ALTU-238. General, sales and administrative expenses were $4.7 million in the second quarter of 2008 compared to $4.1 million in the second quarter of 2007. This increase is primarily due to increases in personnel and stock-based compensation expenses. The total expenses for the second quarter were $25.7 million compared to $33.6 million in the second quarter of 2007. Included in the second quarter 2007 total expenses was a charge of $11.5 million associated with the termination of the Dr. Falk Pharma agreement and reacquisition of European marketing rights to Trizytek.

“I am very pleased with the Company’s recent accomplishments, particularly completing the last patient visit in the Trizytek Phase 3 efficacy trial and the signing of a long-term growth hormone supply agreement for our ALTU-238 program,” stated Dr. Georges Gemayel, President and Chief Executive Officer of Altus Pharmaceuticals. “Coming on board in June provided an excellent opportunity for me to learn and to work with the Altus team to build upon the Company’s earlier successes. We are moving in the right direction and remain focused on delivering on our stated goals. The Altus technology platform has generated three programs in clinical development with two additional programs in preclinical development, and I believe its many valuable applications will fuel a bright future for Altus.”

2008 Financial Guidance

Cash, cash equivalents and short-term marketable securities balances at June 30, 2008 totaled $92.8 million. The Company believes its current cash position will fund operations into the first half of 2009.

Recent Altus Accomplishments:


Appointed Dr. Georges Gemayel President and Chief Executive Officer
Announced last patient visit for the Phase 3 Trizytek efficacy trial
Reported Phase 1 safety data for ALTU-237
Secured long-term growth hormone supply for ALTU-238 program
Commenting on the Trizytek efficacy trial, Gemayel stated, “We believe Trizytek will be the first pancreatic enzyme replacement with demonstrated robust safety and efficacy data. Our next stated corporate milestone is reporting top-line Trizytek efficacy data in the third quarter of 2008. In June we announced that 134 patients completed the efficacy trial. Currently, we are in the final stages of data compilation for the trial.”

In the second quarter of 2007, the Company announced the start of its Phase 3 DIGEST trials (Determining the efficacy and safety of an Innovative GastrointESTinal enzyme complex). The DIGEST clinical trials are evaluating the efficacy and safety of Trizytek, an investigational oral enzyme replacement therapy for cystic fibrosis patients with pancreatic insufficiency. Altus’ consistent and pure enzyme combination, Trizytek, is designed to improve fat, protein and carbohydrate absorption in pancreatic insufficient individuals. The DIGEST efficacy trial, which tested a one capsule per meal dosing regimen, was designed to study the fat absorption in cystic fibrosis patients with exocrine pancreatic insufficiency through the measurement of the coefficient of fat absorption (CFA). In parallel, Altus is conducting long-term safety studies that will evaluate Trizytek in cystic fibrosis and chronic pancreatitis patients with pancreatic insufficiency over one year of open-label treatment.

Commenting on the ALTU-237 program, Gemayel stated, “First and foremost, the ALTU-237 Phase 1 results demonstrated a favorable safety profile, which was the primary objective of the study. We believe that ALTU-237 has the potential to address the unmet needs of hyperoxaluria patients. We and our external advisors also agree that the proof of concept for ALTU-237 can only be evaluated in hyperoxaluria patients. We are considering our options for moving ALTU-237 into a proof of concept Phase 2 trial, which would be targeted to start in 2009. Going forward, we will be coordinating our planning for this program with the Company’s strategic planning process, which we expect to communicate later this year.”

Conference Call Access Information

The Company will host a conference call to discuss the second quarter results at 11:00 a.m. ET on August 5. The call may be joined via telephone by dialing [phone] or [phone] (for international participants) at least 5 minutes prior to the start of the call. The conference confirmation code is: 4217438. For 72 hours following the call, an audio replay can be accessed by dialing [phone] or [phone] and using the conference confirmation code 4217438.